The Good Mood Diet
Research shows certain snacks make potent antidepressants, if you eat them right
My grandfather was a wonderful man who loved cookies. When I visited his lovely, old house surrounded by trees, flowers, vegetable gardens, and lawns, we shared all sorts of cookies, always paired with a large glass of cold milk. Over the years, they became so closely associated with visiting Granddad that now, whenever I have one, I feel buoyed by a swell of happy memories.
As it turns out, scientists have a solid explanation for that burst of good cheer. Studies by Richard Wurtman, MD, and Judith Wurtman, PhD, at MIT have shown that snacking on readily digested carbohydrates, such as those in a cookie or bagel, can raise the brain's level of the chemical serotonin, the very same target of modern antidepressant medication.
Of course, other foods are reputed mood boosters, too--though their reputations may not always be deserved. Before I give you a specific plan that will help you benefit from the MIT findings, let's look at a few. Tea is known as "the cup that cheers," and the caffeine in it can certainly improve energy. But that's a physiological response; no studies have confirmed a direct effect on your spirits. Mood booster? The jury's out. (The same is true of coffee.)
Alcohol is commonly thought of as a good-times libation, but it has a dark side. Although a recent study found that moderate drinkers (two drinks a day for men, one for women) had fewer depressive symptoms than nondrinkers, scores of other studies have established that alcohol in large quantities can be a devastating depressant. Mood booster? Perhaps, but only in small amounts.
As for chocolate, which many of us reach for as a pick-me-up: Australian scientists concluded recently that eating the sweet to lift your spirits "is more likely to prolong than abort the dysphoric [depressed] mood. It is not, as some would claim, an antidepressant." Mood booster? Apparently not. (Stick to a 1-ounce serving if you want to benefit from chocolate's disease-fighting antioxidants.)
That brings us to Granddad's cookies, which can brighten your spirits when eaten judiciously. (Incidentally, carb snacking may be more effective for women because they produce substantially less serotonin than men do.) Now, you won't want to try this regimen if you have diabetes or are prediabetic. But if you qualify, try raising your mood-lifting serotonin levels a couple of times a day by doing the following:
Include protein in each of your three meals. This will raise blood levels of tryptophan, a chemical that eventually turns into serotonin. The best sources of tryptophan are poultry, seafood, and lean meat.
Have a small carbohydrate snack about 3 or 4 hours after each meal and about 1 hour before your next one. Make sure that your stomach is empty and that you eat no protein between meals. The carbohydrates should be easily digestible--such as one or two oatmeal cookies, a third of a bagel, a slice of whole wheat bread. This will cause tryptophan in your blood to enter the brain, where it is metabolized into serotonin. Elevated serotonin will improve your mood within 20 to 30 minutes.
If you follow the rules, you'll also fall asleep more quickly at night, because at the end of the day, your brain metabolizes serotonin into the natural sleep aid melatonin. From happy to sleepy, all by way of a cookie. It doesn't get much cheerier than that!
"Indulging in carbs may boost mood-enhancing brain chemicals more effectively in women than in men"
Thomas Crook, PhD, a clinical psychologist, has conducted extensive research to improve our understanding of how the brain works. He is a former research program director at the National Institute of Mental Health and is CEO of Cognitive Research Corp. in St. Petersburg, FL.
Tuesday, October 21, 2008
Friday, October 10, 2008
The Oath
The Oath
By Hippocrates
Written 400 B.C.E
Translated by Francis Adams
I SWEAR by Apollo the physician, and Aesculapius, and Health, and All-heal, and all the gods and goddesses, that, according to my ability and judgment, I will keep this Oath and this stipulation- to reckon him who taught me this Art equally dear to me as my parents, to share my substance with him, and relieve his necessities if required; to look upon his offspring in the same footing as my own brothers, and to teach them this art, if they shall wish to learn it, without fee or stipulation; and that by precept, lecture, and every other mode of instruction, I will impart a knowledge of the Art to my own sons, and those of my teachers, and to disciples bound by a stipulation and oath according to the law of medicine, but to none others. I will follow that system of regimen which, according to my ability and judgment, I consider for the benefit of my patients, and abstain from whatever is deleterious and mischievous. I will give no deadly medicine to any one if asked, nor suggest any such counsel; and in like manner I will not give to a woman a pessary to produce abortion. With purity and with holiness I will pass my life and practice my Art. I will not cut persons laboring under the stone, but will leave this to be done by men who are practitioners of this work. Into whatever houses I enter, I will go into them for the benefit of the sick, and will abstain from every voluntary act of mischief and corruption; and, further from the seduction of females or males, of freemen and slaves. Whatever, in connection with my professional practice or not, in connection with it, I see or hear, in the life of men, which ought not to be spoken of abroad, I will not divulge, as reckoning that all such should be kept secret. While I continue to keep this Oath unviolated, may it be granted to me to enjoy life and the practice of the art, respected by all men, in all times! But should I trespass and violate this Oath, may the reverse be my lot!
THE END
problem vs problem drug
The problem
THE moment we think of mind altering substances (MAS), alcohol and tobacco come to mind because these are widely advertised, glamorised, and governments make huge amounts of money from taxes on them. In the financial year 2000, the Government of Maharashtra reportedly collected Rs 1900 crore from alcohol taxes alone. But historically, governments have attempted to impose prohibition restriction of both manufacture and sale; this gave rise to the Mafia in the US and several organized criminal syndicates in Mumbai and Gujarat.
Excluding alcohol and tobacco, there are numerous MAS. We can group them under three categories.
* Natural products (cannabis products – ganja, charas, bhang; opium poppy, coca leaf, some varieties of mushrooms and opium. In India our concern is restricted to cannabis and poppy).
* Derivative products (heroin from opium; crack and cocaine from coca. In India, heroin is considered a major problem).
* Pharmaceutical drugs, some of which are highly addictive.
Of the various MAS, the manufacture and consumption of alcohol/tobacco would be approximately 100 times more than all the other drugs put together. In Mumbai in 1997, there were about 46000 cannabis + opium + heroin users; there were 3.6 lac tobacco users and 3.4 alcohol users. Nationally, the number of consumers of alcohol or other drugs can only be guessed since no valid national study is available. Alcohol users would probably be over 100 million; cannabis users may be 10 million, opium users may be around 3 million; and heroin users may be around 0.5 million. It must be remembered that just as there are occasional, binge, regular and chronic drinkers, there are various shades of users of cannabis and opium. Though most heroin users tend to become chronic users, recreational use of heroin is not unknown.
Governments have established Food and Drugs Administration departments to approve and to provide guidelines for the production and distribution of pharmaceutical drugs. Medicines with mind altering properties are placed under a category which can be dispensed only under medical prescription. The WHO has established an expert committee to review medicines across the world. It is of interest to note that heroin and cocaine were initially welcomed as ‘wonder drugs’ and were banned only subsequently. In India, Mandrax was banned only in the late 1970s. It was popular with psychiatrists. Coca Cola contained coca extracts in the initial years (1886-1906). Heroin was marketed as a medicine by Bayer (Germany) from 1898 and it was only in 1924 that it was banned.
Globalization and liberalization of the Indian economy began in the mid 1980s. But worldwide homogenization of laws to curb the use of opium and cannabis began as early as in 1912 through various protocols. The following were the stages of control over these substances and their derivatives:
* Religious leaders and reformers in many cultures have been against the use of MAS laying down ethical/moral foundations discouraging their use. However, in India, the use of cannabis and opium has enjoyed religious, social, cultural, recreational and medicinal sanction.
* Monopolizing profit: The British created mechanisms for controlling production, processing, vending and exporting opium and made huge profits. They began with the ‘Patna opium’ (in Bihar and United Provinces); extended their control over ‘Telengana opium’ in the Princely state of the Nizam. But it was much later that they managed to control the ‘Malwa opium’ produced in the current day M.P. and Rajasthan. Capital formation in western India was directly linked to the smuggling of opium to China against the edicts of the British by Parsee, Marwari and Gujarat entrepreneurs. The British also made large profits through taxes on local consumption because they were the monopoly suppliers.1 While for the British, the Dutch and other colonial powers opium was a major article of trade, the US did not get involved in the opium trade. But in the post colonial period, particularly during the Cold War, there was proliferation of cocaine from Latin American countries into the US, and from Afghanistan to many countries.
* Medical reasons: Opium and heroin are physically addictive; i.e. if one were to stop taking opium/heroin, s/he will suffer from lacrimation, stomach cramps, loose motion, shivering and sweating alternatively – all of which stop within seconds of taking another dose. Both drugs also generate tolerance: the body needs a bigger dosage over a period of time to give the same effect.
However, opium has numerous medicinal properties and hundreds of formulations are made from opium extracts in allopathic medicine. India continues to be one of the major legal suppliers to pharmaceutical companies in India and abroad (the US buys 80% of its requirements from India). But worldwide, the cultivation of opium has been put under strict control; registers have be maintained and sent to the International Narcotics Control Board every three months by producer countries.
Cannabis too has medicinal properties though its medical use in allopathy has only recently been admitted and permitted in some parts of the world (including a few states in the US).
The UN banned the non-medical/scientific research use of cannabis and opium in 1961, though no scientific evidence was advanced for the ban on cannabis. The function of the WHO in the UN system is to advise member states on issues that may pertain to public health with scientific data. A perusal of all the discussions leading to the adoption of the Single Convention shows that the WHO was represented in the meetings but did not furnish any data to indicate health hazards of cannabis. It was simply included at the bidding of the USA. In our communications with the WHO, after much prevarication, officials admitted, ‘Some substances have been put under the list for banning not necessarily for the harm they may cause in some cultures but on international solidarity considerations’ (personal communication).
It was only in the late 1980s that scientists injected large doses of tetrahydrochloride (THC – the active principle in cannabis) in the brain of rats and evolved indicators of what high doses of THC can do to the human brain and body. But this in a sense is intellectual fraud. Ganja or charas in its natural form has thousands of compounds and THC is just one of them. THC research findings are not synonymous with cannabis research. Nature is symbiotic. It is like touting the findings on the impact of heroin as the findings of opium.
There are many myths around cannabis. Zimmer and Morgan,2 whose work provides a comprehensive review of all major research and reviews on the subject till 1996, list a few myths:
* Marijuana’s (ganja’s) harm has been scientifically proved; Ganja has no medicinal value; Ganja is highly addictive (unlike opium/heroin, ganja is not physically addictive); Ganja is a gateway drug – those who start with it invariably graduate. While those on hard drugs today may or may not have begun first with ganja, the vice versa is not true. There is a high level of brand loyalty among drug users; only scarcity may push the user to change his/her drug of choice; Ganja kills the brain cells; Ganja causes amotivational syndrome; Ganja impairs memory and cognition; Ganja causes psychological impairment; Ganja use causes crime; Ganja is more damaging to the lungs than tobacco; and Ganja impairs the immune system.
The dynamics of drug control dramatically changed after they were made illegal and their use criminalized. That takes us to the next set of measures.
Law making and the ruling classes: As a former Director General of Police pointed out, ‘A crime free society is an impossible dream. There has always been crime, there will always be crime. Crime can be induced unwittingly by social change, it can be increased by legal change; crime is one price for freedom and at times the means of securing progress. Society accepts that some crime is inevitable and ineradicable; therefore the aim must be to contain it within tolerable bounds... The principle is that the price of wholly eradicating crime is too high to pay... as it would require punishment which a civilized society cannot accept without losing the reputation of being civilized. It is too high a price to pay in resource terms, since the enforcers would outnumber the rest of society and they would need their own police and so on ad infinitum. The administration of the criminal justice system required would be so large as to consume too high a share of available resources. Society therefore has to compromise with crime. Thus, if large gaps in the scale of wealth and social privileges are not narrowed down from time to time, crime will flourish alongside prosperity.’3
Society classifies crimes and indicates the punishment accordingly. Opium consumption was made an offence in the 1930s itself. However, it was not considered a serious crime; the punishment was three months imprisonment or Rs 10000 fine or both. At that time and till the mid-1950s, the law had a benign attitude toward opium addicts. The government created a master list of habituated persons, registered them and made provisions for regular supply of pure opium through government depots at controlled costs. Thus the addicts did not have to commit crimes to raise the money to feed their habit. Cannabis was openly sold through licensed shops; it grew wild and no one bothered about it all except the Gandhians and other social reformers.
That was the Indian definition of crime relating to drugs. But the Americans and their allies in the UN system made another definition in 1961. The Cold War dynamics in Pakistan and Afghanistan contributed to the proliferation of heroin in the region and Indian cities saw the emergence of brown sugar (crude heroin) since the early 1980s. Though this caused alarm, the modalities of handling the problem were never discussed in any forum.
The Government of India accepted the new definition of drug related crime and made drug use a ‘heinous crime’ with a punishment of non-commutable ten years rigorous imprisonment for opium use and five years for cannabis use by the Narcotic Drugs and Psychotropic Substances Act, 1985. Overnight, millions of cannabis and opium users theoretically became people committing an offence worse than murder by consuming these and other drugs. What enjoyed social respect by custom and tradition and was treated by law as a ‘no grave case’ metamorphosed into a horrendous crime.
Maintenance of Law and Order: Once the law is made to criminalize drug use, then the administrative mechanism for enforcing the law must be put in place. We have a law that sentences ganja users to a minimum term of five years and users of other drugs to ten years. We have numerous agencies empowered to search, seize and arrest person/properties. Veen has presented the paradigm of ‘Drug Complex’ (analogous to the military industrial complex) which explains the proliferation, expansion and perpetuation of both the drug problem and the repressive machinery.4
Because of repression, the petty peddlers of drugs of yore and their progeny (in India opium production and sale has often been hereditary) have either had to tie up horizontally with other petty traders or with large organized crime syndicates to continue, expand and diversify their merchandise. Since criminalization of drug use and repression induced scarcity increases the price of the merchandise, more people are attracted to enter the business. When governments enhance their efforts to repress the drug industry, the remaining drug entrepreneurs re-organize their activities so as to reduce the risk of detection and prosecution. In the case of India, there were already numerous large organized criminal syndicates involved in smuggling gold, electronic goods, diamonds and so on.5 Drugs and guns are their recent additions.
The government also introduced preventive detention of persons suspected to be involved in drug related offences (PIT NDPS Act). The government had to scrap another law (Terrorist and Disruptive Activities – Prevention – Act or TADA) since it was patently misused against the minorities and select states (Kashmir had the maximum arrests under this act) which empowered the state to incarcerate the accused for six months without giving a chargesheet. However, in the case of narcotics, the general public has been lulled into thinking that these are dangerous people and must be dealt with severely.
Once the government connected organized crime to drugs, it had to develop a law according to the UN mandate to bring in a money laundering bill to control the conversion of ill-gotten money to regular economic purposes. This bill has identical provisions with the one on narcotic drugs. But while no one objected to passing the latter, the money laundering bill has been stalled and returned for review thrice.
The Government of India had to justify the changed definition of the drug problem. Enforcement experts coined the word ‘narco-terrorism’. Indeed, in some countries it may be the case in the context of macro social processes affecting different parts of the world. Our limited research indicates that we (India) may have blindly borrowed the phrase to justify our repressive measures. The home ministry has often alleged that militant groups in Kashmir, Punjab and the North East are trafficking drugs and the profits are sustaining their movement (purchase of guns etc.).
Even though we have no data for Punjab or J&K, we can categorically state that either the enforcement machinery does not work in the North East (the Narcotics Control Bureau has a zonal office there) or else it is the one profiting from drug trade (the Border Security Force in this region is often called Border Smuggling Force!).
It is insufficiently realised that militants do not need drug money for the simple reason that most locals do not accept the legitimacy of the Indian government and so spontaneously support the militants. Almost all government employees pay a regular ‘tax’ to the militants.
The drug most seized in Assam, Manipur, Nagaland, Meghalaya and Mizoram is ganja. If militants are indeed indulging in drug trade for raising funds, they should be dealing in high-value drugs such as cocaine, heroine and not ganja which grows all over Kashmir and the North East in the wild. Though countrywide seizure of cocaine is itself small, not a single ounce has ever been caught in the North East or Kashmir. Heroin seizures too are small in these parts, though our officials often claim otherwise because of the region’s proximity to Myanmar (one of the golden triangle countries).
The second prong for legitimizing this draconian law is linking it to organized criminal groups, automatically evoking images of violent murders, extortion, and so on. In India, organized crime groups have a long history: gold trade and the film industry. Drugs and arms became part of their repertoire only in the late ’80s. A third plank is to show that drugs make users into criminals. While in some countries heroin and crack users do commit crime to support their habit, this has not been the case so far in Mumbai (not even 8% of addicts had committed any crime in our sample of 3000 patients at NARC). A fourth plank is to stigmatize and marginalize the addicts through the media. Repeated portrayals of the worst-case addicts in the media create an image that is hardly typical of drug users in India.
A fifth plank is to create a health scare by the use of slogans such as ‘drugs kill’. This despite any number of old people who have used opium and ganja all their lives, married, worked, had children and settled them while using these drugs.
Governments everywhere are inclined to assume ever greater powers over their citizens. Once the Government of India linked drugs and organized crime, it felt justified in arresting and incarcerating thousands of addicts and petty peddlers in jail, leading people to perceive law enforcement itself as a threat to liberal society. Out of the roughly 1.3 million people serving jail terms in the United States Federal Prisons, about 59.9% are casual and non-violent drug offenders. In the United States 565 out of every 100.000 inhabitants are in jail; in the Netherlands it is ‘only’ 66 (Veen, Drug Complex, 2000). The worst implication for democracy is the inclusion of drug related offences, including consumption, in the list of felonies. Felons lose their voting rights in the US. In some states as many as 30% of African-American males have been disenfranchised.
In Mumbai, police officers have been arrested for planting drugs on innocent people and extorting money for not filing a case. In a major scandal, a large quantity of seized heroin kept in the strong room of the police was substituted with talcum powder. Several top officers of the narcotics cell were summarily relieved from service for their alleged nexus with drug traffickers. The Dutch parliamentary commission that investigated these methods in 1996 found, for example, that 285 tons of drugs had been imported by the Dutch police, of which 100 tons had disappeared on the market (Veen, 2000).
Drug enforcement practices and the drug industry become part of more general efforts in the national and international domain to redistribute power, wealth and security. Though this can be clearly seen in some countries like Colombia, Morocco and Mauritius, unfortunately we do not have sufficient research studies in the drug field, though some documentation is available on organized crime groups.
Just as war is the continuation of politics by other means, so has the ‘war on drugs’ become an extension of foreign policy by other means. International drug policies therefore almost inescapably become enmeshed with geo-political and economic considerations. In the recent history of both industrialized (France, United States, Italy) and developing countries (Turkey, South Africa, Colombia, Mexico) many examples can be cited of cooperation between the secret services, political parties and other elite power groups with-drug trafficking-criminal groups in the repression of domestic opposition, the destabilization of foreign governments, and the support against geo-political foes. Equally, many opposition groups have discovered the importance of drug income to withstand (foreign) control over their territories (e.g., PKK in Turkey, Shining Path in Peru, and the Afghan mujahiddin).
From the very beginning the United States took the lead in building a prohibition regime. Especially since the 1980s, unilateral, bilateral and multilateral forms of pressure, intervention and collaboration were used to force governments to comply with prohibition and stifle the growth of the drug economy. Conditional development aid, extradition treaties (so called International Mutual Legal Assistance Treaties), new types of financial policing to ‘chase the money’ around the international banking system, financing and advising foreign military and police, political pressure and even outright military intervention are among the plethora of instruments applied in the relations between states in this war on drugs.
In many countries the military has been given the lead role in drug repression. In India too, the Border Security Force and military units posted in Kashmir and the North East have been mandated to control drug traffic. In the 1980s, the United States amended the Posse Comitatus Act that since 1878 had prevented military involvement in civil law enforcement to engage in drug law enforcement abroad. Equally, the Dutch navy is patrolling the Caribbean to interdict drug shipments.
Alongside accepting an alien definition of the drug problem, our officials have also put in place a repressive machinery. This has brought in organized crime syndicates into the drug problem. The high profits attract a large number of people criminalizing a segment of professionals such as lawyers, chartered accountants, pilots, chemists, bankers and transport operators. It has also contributed to corrupting our customs, police, judges and so on, thus undermining institutions of governance. Because governments have used drugs as an instrument of diplomacy, the diplomatic community and organized crime syndicates have been brought together in joint ventures in selective places. And as the problem is getting militarized the foundations of democracy are being eroded. The situation and its symbolic presentation enables governments to enact draconian laws against their own citizens. Is this what we want? It is time we ourselves define our own problem in the context of all the social processes that operate in our culture and country.
Footnotes:
* The papers in this symposium were first presented at a UNESCO Seminar organised in collaboration with ICSSR, JNU and NARC. The research was supported under the UNESCO-MOST programme, The help of Sudha Raghavendran and Nishantini J. in editing and reducing the papers is gratefully acknowledged.
1. Amar Farooqui, Smuggling as Subversion – Colonialism: Indian Merchants and the Politics of Opium. New Age Publishers, Delhi, 1998.
2. Lynn Zimmer and John P. Morgan, Marijuana Myths Marijuana Facts. The Lindesmith Center, New York, 1997.
3. V. Vaikunth, ‘Crusade Against Crime: a multi-pronged approach’, The Hindu, 30 January 2001.
4. Hans T. van der Veen, The International Drug Complex: when the visible hand of crime fractures the strong arm of the law – understanding the intertwined dynamics of international crime, law enforcement and the flourishing drug economy. Center for Drug Research, Amsterdam, 2000. The authors gratefully acknowledge CEDRO’s website: cedro-uva.org/lib/veen.complex.html
5. See Charles et al. Organized Crime in Bombay: a descriptive account. UNESCO, Paris, 2001.
THE moment we think of mind altering substances (MAS), alcohol and tobacco come to mind because these are widely advertised, glamorised, and governments make huge amounts of money from taxes on them. In the financial year 2000, the Government of Maharashtra reportedly collected Rs 1900 crore from alcohol taxes alone. But historically, governments have attempted to impose prohibition restriction of both manufacture and sale; this gave rise to the Mafia in the US and several organized criminal syndicates in Mumbai and Gujarat.
Excluding alcohol and tobacco, there are numerous MAS. We can group them under three categories.
* Natural products (cannabis products – ganja, charas, bhang; opium poppy, coca leaf, some varieties of mushrooms and opium. In India our concern is restricted to cannabis and poppy).
* Derivative products (heroin from opium; crack and cocaine from coca. In India, heroin is considered a major problem).
* Pharmaceutical drugs, some of which are highly addictive.
Of the various MAS, the manufacture and consumption of alcohol/tobacco would be approximately 100 times more than all the other drugs put together. In Mumbai in 1997, there were about 46000 cannabis + opium + heroin users; there were 3.6 lac tobacco users and 3.4 alcohol users. Nationally, the number of consumers of alcohol or other drugs can only be guessed since no valid national study is available. Alcohol users would probably be over 100 million; cannabis users may be 10 million, opium users may be around 3 million; and heroin users may be around 0.5 million. It must be remembered that just as there are occasional, binge, regular and chronic drinkers, there are various shades of users of cannabis and opium. Though most heroin users tend to become chronic users, recreational use of heroin is not unknown.
Governments have established Food and Drugs Administration departments to approve and to provide guidelines for the production and distribution of pharmaceutical drugs. Medicines with mind altering properties are placed under a category which can be dispensed only under medical prescription. The WHO has established an expert committee to review medicines across the world. It is of interest to note that heroin and cocaine were initially welcomed as ‘wonder drugs’ and were banned only subsequently. In India, Mandrax was banned only in the late 1970s. It was popular with psychiatrists. Coca Cola contained coca extracts in the initial years (1886-1906). Heroin was marketed as a medicine by Bayer (Germany) from 1898 and it was only in 1924 that it was banned.
Globalization and liberalization of the Indian economy began in the mid 1980s. But worldwide homogenization of laws to curb the use of opium and cannabis began as early as in 1912 through various protocols. The following were the stages of control over these substances and their derivatives:
* Religious leaders and reformers in many cultures have been against the use of MAS laying down ethical/moral foundations discouraging their use. However, in India, the use of cannabis and opium has enjoyed religious, social, cultural, recreational and medicinal sanction.
* Monopolizing profit: The British created mechanisms for controlling production, processing, vending and exporting opium and made huge profits. They began with the ‘Patna opium’ (in Bihar and United Provinces); extended their control over ‘Telengana opium’ in the Princely state of the Nizam. But it was much later that they managed to control the ‘Malwa opium’ produced in the current day M.P. and Rajasthan. Capital formation in western India was directly linked to the smuggling of opium to China against the edicts of the British by Parsee, Marwari and Gujarat entrepreneurs. The British also made large profits through taxes on local consumption because they were the monopoly suppliers.1 While for the British, the Dutch and other colonial powers opium was a major article of trade, the US did not get involved in the opium trade. But in the post colonial period, particularly during the Cold War, there was proliferation of cocaine from Latin American countries into the US, and from Afghanistan to many countries.
* Medical reasons: Opium and heroin are physically addictive; i.e. if one were to stop taking opium/heroin, s/he will suffer from lacrimation, stomach cramps, loose motion, shivering and sweating alternatively – all of which stop within seconds of taking another dose. Both drugs also generate tolerance: the body needs a bigger dosage over a period of time to give the same effect.
However, opium has numerous medicinal properties and hundreds of formulations are made from opium extracts in allopathic medicine. India continues to be one of the major legal suppliers to pharmaceutical companies in India and abroad (the US buys 80% of its requirements from India). But worldwide, the cultivation of opium has been put under strict control; registers have be maintained and sent to the International Narcotics Control Board every three months by producer countries.
Cannabis too has medicinal properties though its medical use in allopathy has only recently been admitted and permitted in some parts of the world (including a few states in the US).
The UN banned the non-medical/scientific research use of cannabis and opium in 1961, though no scientific evidence was advanced for the ban on cannabis. The function of the WHO in the UN system is to advise member states on issues that may pertain to public health with scientific data. A perusal of all the discussions leading to the adoption of the Single Convention shows that the WHO was represented in the meetings but did not furnish any data to indicate health hazards of cannabis. It was simply included at the bidding of the USA. In our communications with the WHO, after much prevarication, officials admitted, ‘Some substances have been put under the list for banning not necessarily for the harm they may cause in some cultures but on international solidarity considerations’ (personal communication).
It was only in the late 1980s that scientists injected large doses of tetrahydrochloride (THC – the active principle in cannabis) in the brain of rats and evolved indicators of what high doses of THC can do to the human brain and body. But this in a sense is intellectual fraud. Ganja or charas in its natural form has thousands of compounds and THC is just one of them. THC research findings are not synonymous with cannabis research. Nature is symbiotic. It is like touting the findings on the impact of heroin as the findings of opium.
There are many myths around cannabis. Zimmer and Morgan,2 whose work provides a comprehensive review of all major research and reviews on the subject till 1996, list a few myths:
* Marijuana’s (ganja’s) harm has been scientifically proved; Ganja has no medicinal value; Ganja is highly addictive (unlike opium/heroin, ganja is not physically addictive); Ganja is a gateway drug – those who start with it invariably graduate. While those on hard drugs today may or may not have begun first with ganja, the vice versa is not true. There is a high level of brand loyalty among drug users; only scarcity may push the user to change his/her drug of choice; Ganja kills the brain cells; Ganja causes amotivational syndrome; Ganja impairs memory and cognition; Ganja causes psychological impairment; Ganja use causes crime; Ganja is more damaging to the lungs than tobacco; and Ganja impairs the immune system.
The dynamics of drug control dramatically changed after they were made illegal and their use criminalized. That takes us to the next set of measures.
Law making and the ruling classes: As a former Director General of Police pointed out, ‘A crime free society is an impossible dream. There has always been crime, there will always be crime. Crime can be induced unwittingly by social change, it can be increased by legal change; crime is one price for freedom and at times the means of securing progress. Society accepts that some crime is inevitable and ineradicable; therefore the aim must be to contain it within tolerable bounds... The principle is that the price of wholly eradicating crime is too high to pay... as it would require punishment which a civilized society cannot accept without losing the reputation of being civilized. It is too high a price to pay in resource terms, since the enforcers would outnumber the rest of society and they would need their own police and so on ad infinitum. The administration of the criminal justice system required would be so large as to consume too high a share of available resources. Society therefore has to compromise with crime. Thus, if large gaps in the scale of wealth and social privileges are not narrowed down from time to time, crime will flourish alongside prosperity.’3
Society classifies crimes and indicates the punishment accordingly. Opium consumption was made an offence in the 1930s itself. However, it was not considered a serious crime; the punishment was three months imprisonment or Rs 10000 fine or both. At that time and till the mid-1950s, the law had a benign attitude toward opium addicts. The government created a master list of habituated persons, registered them and made provisions for regular supply of pure opium through government depots at controlled costs. Thus the addicts did not have to commit crimes to raise the money to feed their habit. Cannabis was openly sold through licensed shops; it grew wild and no one bothered about it all except the Gandhians and other social reformers.
That was the Indian definition of crime relating to drugs. But the Americans and their allies in the UN system made another definition in 1961. The Cold War dynamics in Pakistan and Afghanistan contributed to the proliferation of heroin in the region and Indian cities saw the emergence of brown sugar (crude heroin) since the early 1980s. Though this caused alarm, the modalities of handling the problem were never discussed in any forum.
The Government of India accepted the new definition of drug related crime and made drug use a ‘heinous crime’ with a punishment of non-commutable ten years rigorous imprisonment for opium use and five years for cannabis use by the Narcotic Drugs and Psychotropic Substances Act, 1985. Overnight, millions of cannabis and opium users theoretically became people committing an offence worse than murder by consuming these and other drugs. What enjoyed social respect by custom and tradition and was treated by law as a ‘no grave case’ metamorphosed into a horrendous crime.
Maintenance of Law and Order: Once the law is made to criminalize drug use, then the administrative mechanism for enforcing the law must be put in place. We have a law that sentences ganja users to a minimum term of five years and users of other drugs to ten years. We have numerous agencies empowered to search, seize and arrest person/properties. Veen has presented the paradigm of ‘Drug Complex’ (analogous to the military industrial complex) which explains the proliferation, expansion and perpetuation of both the drug problem and the repressive machinery.4
Because of repression, the petty peddlers of drugs of yore and their progeny (in India opium production and sale has often been hereditary) have either had to tie up horizontally with other petty traders or with large organized crime syndicates to continue, expand and diversify their merchandise. Since criminalization of drug use and repression induced scarcity increases the price of the merchandise, more people are attracted to enter the business. When governments enhance their efforts to repress the drug industry, the remaining drug entrepreneurs re-organize their activities so as to reduce the risk of detection and prosecution. In the case of India, there were already numerous large organized criminal syndicates involved in smuggling gold, electronic goods, diamonds and so on.5 Drugs and guns are their recent additions.
The government also introduced preventive detention of persons suspected to be involved in drug related offences (PIT NDPS Act). The government had to scrap another law (Terrorist and Disruptive Activities – Prevention – Act or TADA) since it was patently misused against the minorities and select states (Kashmir had the maximum arrests under this act) which empowered the state to incarcerate the accused for six months without giving a chargesheet. However, in the case of narcotics, the general public has been lulled into thinking that these are dangerous people and must be dealt with severely.
Once the government connected organized crime to drugs, it had to develop a law according to the UN mandate to bring in a money laundering bill to control the conversion of ill-gotten money to regular economic purposes. This bill has identical provisions with the one on narcotic drugs. But while no one objected to passing the latter, the money laundering bill has been stalled and returned for review thrice.
The Government of India had to justify the changed definition of the drug problem. Enforcement experts coined the word ‘narco-terrorism’. Indeed, in some countries it may be the case in the context of macro social processes affecting different parts of the world. Our limited research indicates that we (India) may have blindly borrowed the phrase to justify our repressive measures. The home ministry has often alleged that militant groups in Kashmir, Punjab and the North East are trafficking drugs and the profits are sustaining their movement (purchase of guns etc.).
Even though we have no data for Punjab or J&K, we can categorically state that either the enforcement machinery does not work in the North East (the Narcotics Control Bureau has a zonal office there) or else it is the one profiting from drug trade (the Border Security Force in this region is often called Border Smuggling Force!).
It is insufficiently realised that militants do not need drug money for the simple reason that most locals do not accept the legitimacy of the Indian government and so spontaneously support the militants. Almost all government employees pay a regular ‘tax’ to the militants.
The drug most seized in Assam, Manipur, Nagaland, Meghalaya and Mizoram is ganja. If militants are indeed indulging in drug trade for raising funds, they should be dealing in high-value drugs such as cocaine, heroine and not ganja which grows all over Kashmir and the North East in the wild. Though countrywide seizure of cocaine is itself small, not a single ounce has ever been caught in the North East or Kashmir. Heroin seizures too are small in these parts, though our officials often claim otherwise because of the region’s proximity to Myanmar (one of the golden triangle countries).
The second prong for legitimizing this draconian law is linking it to organized criminal groups, automatically evoking images of violent murders, extortion, and so on. In India, organized crime groups have a long history: gold trade and the film industry. Drugs and arms became part of their repertoire only in the late ’80s. A third plank is to show that drugs make users into criminals. While in some countries heroin and crack users do commit crime to support their habit, this has not been the case so far in Mumbai (not even 8% of addicts had committed any crime in our sample of 3000 patients at NARC). A fourth plank is to stigmatize and marginalize the addicts through the media. Repeated portrayals of the worst-case addicts in the media create an image that is hardly typical of drug users in India.
A fifth plank is to create a health scare by the use of slogans such as ‘drugs kill’. This despite any number of old people who have used opium and ganja all their lives, married, worked, had children and settled them while using these drugs.
Governments everywhere are inclined to assume ever greater powers over their citizens. Once the Government of India linked drugs and organized crime, it felt justified in arresting and incarcerating thousands of addicts and petty peddlers in jail, leading people to perceive law enforcement itself as a threat to liberal society. Out of the roughly 1.3 million people serving jail terms in the United States Federal Prisons, about 59.9% are casual and non-violent drug offenders. In the United States 565 out of every 100.000 inhabitants are in jail; in the Netherlands it is ‘only’ 66 (Veen, Drug Complex, 2000). The worst implication for democracy is the inclusion of drug related offences, including consumption, in the list of felonies. Felons lose their voting rights in the US. In some states as many as 30% of African-American males have been disenfranchised.
In Mumbai, police officers have been arrested for planting drugs on innocent people and extorting money for not filing a case. In a major scandal, a large quantity of seized heroin kept in the strong room of the police was substituted with talcum powder. Several top officers of the narcotics cell were summarily relieved from service for their alleged nexus with drug traffickers. The Dutch parliamentary commission that investigated these methods in 1996 found, for example, that 285 tons of drugs had been imported by the Dutch police, of which 100 tons had disappeared on the market (Veen, 2000).
Drug enforcement practices and the drug industry become part of more general efforts in the national and international domain to redistribute power, wealth and security. Though this can be clearly seen in some countries like Colombia, Morocco and Mauritius, unfortunately we do not have sufficient research studies in the drug field, though some documentation is available on organized crime groups.
Just as war is the continuation of politics by other means, so has the ‘war on drugs’ become an extension of foreign policy by other means. International drug policies therefore almost inescapably become enmeshed with geo-political and economic considerations. In the recent history of both industrialized (France, United States, Italy) and developing countries (Turkey, South Africa, Colombia, Mexico) many examples can be cited of cooperation between the secret services, political parties and other elite power groups with-drug trafficking-criminal groups in the repression of domestic opposition, the destabilization of foreign governments, and the support against geo-political foes. Equally, many opposition groups have discovered the importance of drug income to withstand (foreign) control over their territories (e.g., PKK in Turkey, Shining Path in Peru, and the Afghan mujahiddin).
From the very beginning the United States took the lead in building a prohibition regime. Especially since the 1980s, unilateral, bilateral and multilateral forms of pressure, intervention and collaboration were used to force governments to comply with prohibition and stifle the growth of the drug economy. Conditional development aid, extradition treaties (so called International Mutual Legal Assistance Treaties), new types of financial policing to ‘chase the money’ around the international banking system, financing and advising foreign military and police, political pressure and even outright military intervention are among the plethora of instruments applied in the relations between states in this war on drugs.
In many countries the military has been given the lead role in drug repression. In India too, the Border Security Force and military units posted in Kashmir and the North East have been mandated to control drug traffic. In the 1980s, the United States amended the Posse Comitatus Act that since 1878 had prevented military involvement in civil law enforcement to engage in drug law enforcement abroad. Equally, the Dutch navy is patrolling the Caribbean to interdict drug shipments.
Alongside accepting an alien definition of the drug problem, our officials have also put in place a repressive machinery. This has brought in organized crime syndicates into the drug problem. The high profits attract a large number of people criminalizing a segment of professionals such as lawyers, chartered accountants, pilots, chemists, bankers and transport operators. It has also contributed to corrupting our customs, police, judges and so on, thus undermining institutions of governance. Because governments have used drugs as an instrument of diplomacy, the diplomatic community and organized crime syndicates have been brought together in joint ventures in selective places. And as the problem is getting militarized the foundations of democracy are being eroded. The situation and its symbolic presentation enables governments to enact draconian laws against their own citizens. Is this what we want? It is time we ourselves define our own problem in the context of all the social processes that operate in our culture and country.
Footnotes:
* The papers in this symposium were first presented at a UNESCO Seminar organised in collaboration with ICSSR, JNU and NARC. The research was supported under the UNESCO-MOST programme, The help of Sudha Raghavendran and Nishantini J. in editing and reducing the papers is gratefully acknowledged.
1. Amar Farooqui, Smuggling as Subversion – Colonialism: Indian Merchants and the Politics of Opium. New Age Publishers, Delhi, 1998.
2. Lynn Zimmer and John P. Morgan, Marijuana Myths Marijuana Facts. The Lindesmith Center, New York, 1997.
3. V. Vaikunth, ‘Crusade Against Crime: a multi-pronged approach’, The Hindu, 30 January 2001.
4. Hans T. van der Veen, The International Drug Complex: when the visible hand of crime fractures the strong arm of the law – understanding the intertwined dynamics of international crime, law enforcement and the flourishing drug economy. Center for Drug Research, Amsterdam, 2000. The authors gratefully acknowledge CEDRO’s website: cedro-uva.org/lib/veen.complex.html
5. See Charles et al. Organized Crime in Bombay: a descriptive account. UNESCO, Paris, 2001.
india vs drug
The drug scene in India
TRADITIONALLY, Indian cultural diversity successfully handled the varied associations with mind-altering substances among its people without excessive use becoming a cause of major concern. With the entry of tourists from western countries in the 1960s, the association with cannabis became glamorous and the demand from wealthy tourists increased the profit margins of petty peddlers. In the eighties, derivative drugs began to replace natural drugs in the cities. During this period, a set of new legislative measures against drugs, based on the Single Convention of 1961 came to be enforced.
Human behaviour cannot be isolated from the social, cultural and environmental reality surrounding it. While objective reality is related to the processes of production, subjectivity is the experience of individuals that shapes their worldview and lifestyle. Both these realities form the basis for social action.
Earlier, society was self-regulating and did not need precise rules for effective drug control. Drug consumption was carried out openly, legitimised by cultural norms and restricted by traditional demand. It was also free of underground dealings. With the intervention of the U.S., however, indigenous controls have been displaced by a single model, developed for the West. In the Indian context, instead of reducing drug supply, the imposition of this model has resulted in the replacement of culturally sanctioned use by secular use and of traditional suppliers by criminal networks.
The natural psycho-active plants commonly found in India include cannabis, poppy, khat and datura. Cannabis and opium are part of the cultural and religious elements in India, used and kept under control for thousands of years. The international community, however, views these two drugs as particularly troublesome. Cannabis is processed into three main products before it is consumed: bhang, ganja (marijuana) and charas (Chopra, 1990). Opium use flourished despite invasions from Alexander to the Mughals; it was finally monopolised by the British. It takes many forms from being blown through a hubble bubble pipe (hukka) as madak to being brewed with tea as bonda chai.
Drugs in India have medicinal, social, functional and regional uses. These are embedded within its complex cultural fabric. Despite several races, religions and sub-sects, 18 languages and 1,652 mother tongues, Indian culture has formed an identity over the years, which remains dynamic, symbolising cultural continuity and a unified principle of consciousness. This inner structure of tradition contributed towards the growth of a unified worldview, projecting an image of unity in value structures, ritual styles and systems of beliefs.
The early stage of influence of the cultural structure was characterised by Sanskritisation of the little traditions, creating a cultural renaissance of the great tradition. The period under the British brought in legislation and systemic change, but only at a superficial level.
The present phase of modernisation is the most challenging period for Indian tradition, with multiple structural inconsistencies such as democratisation without spread of civic culture (education), bureaucratisation without commitment to universal norms, rise in media participation (communication) and rising expectations without a proportionate increase in resources and distributive justice, verbalisation of welfare ideology without its diffusion in the social structure and its implementation as social policy, over-urbanisation without industrialisation, and finally, modernisation without meaningful changes in the stratification system of castes. It is within this context of emerging changes and tensions that drug abuse and trafficking must be considered.
British policy with regard to poppy cultivation in India was linked to its trade relations with China, whose staple export commodity was tea. Since the British had developed a taste for tea, by 1785 the East India Company was buying and selling 15 million pounds of China tea per year. The problem in trade arose because Britain had no commodity to sell in return to China. This situation led to aggressive sales of opium to China.
The new business strategy changed the earlier association with poppy and cannabis. Unlike poppy, cannabis can be grown anywhere in India; in some regions it grows wild, which has made it difficult to effectively control cultivation. The British went about opium trading, systematically controlling cultivation, consumption, production and sale within the country and its export. Production, however, did not exceed demand, ensuring that profit margins were kept high.
When the locals saw the huge revenue generated by the British from poppy cultivation, their perception changed. A profitable cash crop now, opium became a viable commodity for sale. This facilitated illicit cultivation as well as smuggling of opium across native states and from provinces to the native states.
A widely felt change since Independence has been secular drug use (devoid of cultural or religious significance). Traditional forms of control have dwindled. The reasons can be traced to the onslaught of western tourists in the 1960s and ’70s, the implementation of new drug laws in the 1980s, and liberalisation in the 1990s – structural adjustment – which has led to the marginalisation of large sectors of the population and pushed some of them to adopt drug use and sale as a coping mechanism.
Meanwhile, the new legislation criminalised drug use, pushing users and suppliers underground. The simultaneous influence of secular drug use and commercial drug suppliers in a context of widespread poverty and desperation, and in some areas of political conflict, has paved the way for the spread of heroin, mostly in cities.
The case of alcohol after Independence provides an interesting illustration of the links between changes in the drug scene and legislation. While cannabis and opium products were made illegal throughout India, alcohol has remained legal in many states. Further, the government has taken measures to make it more easily available and to promote its sale, though under the influence of Gandhian philosophy, some states outlawed alcohol.
In a new move towards drug control, the Government of India shut down outlets supplying opium for oral consumption in 1959. At the same time, with the ever-increasing need for revenue, state governments promoted the sale of alcohol to raise tax revenue. In 1979, in order to increase the demand for alcohol, the Government of Maharashtra (GoM) took measures to make alcohol more easily accessible. A large number of licences, allowing tea stalls and eating-houses to sell liquor from 6 pm to 11 pm, were issued. Since the ’80s, industrial night shift workers and college students became the new target group and several bars remain open till 4 am. In the year 2000, the GoM raked in Rs 1900 crore as taxes from alcohol.
Western tourists tipped up the scales for cannabis. Their demand modified the traditional association with drugs that existed in India, roping in several Indian youngsters. It became a sought after substance in certain strata of society. With higher profit margins, and the demand coming from comparatively richer consumers, cannabis laid the dragnet for many traders.
The present drug control strategy of India can be traced back to the Single Convention on Narcotics Drugs of 1961. This was enforced in December 1964 and amended in 1972. The developing countries became puppets in the hands of U.S., via the UN. Increasingly we witnessed the incursion of international drug legislation into the national scene as aid became conditional on countries accepting the U.S. inspired drug laws. This threat was posed (among others) to Nepal when it refused to implement national drug laws modelled on international requirements.
Finally, in 1981, the member states formulated the International Drug Control Strategy that was supposed to cover all aspects of the drug issue: abuse, trafficking, treatment, rehabilitation and crop substitution. In 1984, though the member states pledged to include economic, social and culturally relevant alternative programmes, they had no strategy on how to deal with problems arising from the criminalisation of centuries-old cultural habits in India.
Nevertheless, the Indian government enacted the Narcotic Drugs and Psychotropic Substances Act, (NDPS Act), which did not take into account the Indian situation and its plural cultures. The NDPS Act was designed to conform to the Single Convention of 1961, which the Indian government had signed in 1964. India subscribed to the international goal of eradicating all cultural uses of cannabis within a 25-year period. Since the decision was taken without any planning, little or no attention was given to the methods used to achieve the stated goals and implications. There was no real public debate on the new legislation, and it was adopted without much research.
The government’s mismanagement has led to the leakage of opium produced from licit to illicit channels. After the enactment of the NDPS Act in 1985, there has been an attempt to reduce the area of cultivation. However, high yielding varieties of poppy had been introduced, producing over 42 kg of opium per hectare, whereas the official computation of productivity remained for long at 28 kg per hectare. Further, there was a decrease in the floor purchase price of opium from Rs 280 to Rs 270 per kilo, inducing the farmers to divert sales to drug traffickers instead. Finally, the commission payable to the lambardars (agents who buy opium from the farmers and sell to the government) was reduced from 3.5% to 0.75%. This also gave the agents an incentive to sell opium to the traffickers.
Fresh legislation changed the face of drug trade. With criminalisation, the sale of cannabis/opium became as risky as that of modern drugs such as heroin, if not more. While some traders left for safer pastures, others took to selling hard drugs. A few traders continued to sell cannabis and opium on a small scale and refused to deal with heroin.
However, with an increase in profit margins, new traders appeared among the marginalised sections of society who started dealing in brown sugar heroin (a crude form of the opiate). Addiction to brown sugar set off a chain reaction and helped increase its price. Marketing strategies were established to popularise the drug. This paved the way for a shift from traditional drugs to heroin and other non-traditional substances such as pharmaceutical opiates.
In no country can the modern drug scene be studied in isolation from national developmental dynamics. Drug production, trafficking and use are often linked to the process of marginalisation. Prior to the ’80s, India’s economy was highly regulated. After the initial phase of liberalisation in the ’80s, the country recorded a GNP growth of over 5% a year. However, while the economy was growing, the government gave low priority to improving income distribution.
Out of the present labour force, only 8.5% belong to the organised sector, which means that they have job security and are protected by unions. By and large, unorganised sector workers are self-employed or work as casual labourers in agriculture, construction work and other industrial occupations.
The New Economic Policy (1991), made the labour force and the poorer sections of society even more vulnerable. It weakened the bargaining power of labour and expanded the unorganised sector, thus creating a buyer’s labour market. The spill over from the organised to the unorganised sector has increased in all industries including primary manufacturing, construction, trade and commerce, transport, storage and communication. Job cuts are characteristic of this move. The voluntary retirement scheme (VRS) is another farce. The large number of workers retrenched through VRS have little to look forward to for their chances of finding a new job are negligible.
The introduction of structural adjustment in India as per the dictates of the World Bank and International Monetary Fund has led to many poor urban dwellers becoming marginalised, resorting to drug abuse and petty crime, and to alternative lifestyles as a coping mechanism. In addition, some unemployed youth have joined the ranks of organised crime as enforcers, debt collectors and hired killers. The press has published accounts of hired killers in Mumbai, below the age of 24, with no prior record of criminal activity.
Another consequence of the liberalisation of trade was to push the networks that specialised in smuggling legal goods subjected to stiff import restrictions into switching to new products, mainly drugs and arms. These generate high profit margins because of their illegal status for those who trade in them. The switch allowed organised crime to both maintain its revenue base and to adapt to the new economic environment.
Internal strife within a country is often linked to the spread of drug use. India is no exception. India’s geographical location between the two leading producers of illegal opiates in the world, the Golden Crescent (especially Afghanistan) to the West and the Golden Triangle (especially Burma) to the East, both of which have been entangled in armed conflicts for years, has also facilitated the emergence of drug trafficking.
In 1979, India came into the newly-drawn heroin map as a consequence of the Islamic revolution, the outbreak of war in Afghanistan and the restoration of military rule in Pakistan that disturbed and diverted heroin smuggling networks. Another change in the geopolitical situation was the turmoil in Sri Lanka and the involvement of several militant groups with drug trafficking in India.
Political unrest within India, around the northeastern states and the Jammu-Kashmir border, also account for drug problems. The national policy of repression using the army and other enforcement agencies in these areas for nearly four decades has contributed to both transforming the nature of conflict and the proliferation of small arms in the region. Incidentally, Jammu and Kashmir, Uttar Pradesh, Arunachal Pradesh, Mizoram and Manipur are the main states notified for illicit cultivation.
In 1999, when Indian authorities constructed an electrified fence along the India-Pakistan border in Punjab and parts of Rajasthan, traffickers in heroin, hashish and acetic anhydride turned to unprotected Jammu and Kashmir. Now, with a view to preventing arms-cum-drugs trafficking, the Indian government is building another fence along the Jammu and Kashmir border. Little do we realise that as long as the conflicts persist, this area will continue to be affected by drug trafficking.
Political disturbances do not occur in a vacuum. When a region craves for independence, vested interests or negligence from the centre sometimes leads to deprivation. This was clearly the case in the North East – a region whose underdevelopment is exacerbated by violent conflict, closing down of educational institutions and so on. In this situation of heightened insecurity, even school children have turned to drugs. The rate of Human Immunodeficiency Virus (HIV) infection has only added to the problems since, like other facilities, health care is insufficient to meet the needs of the people.
One can only hypothesise that drug trafficking is linked to sub-nationalist movements in India (cf. publications of the Institute for Defence Studies and Analysis, New Delhi). It may also be applicable to some of the mass movements from the second half of the 1980s. It is conceded that in order to finance their political movement against the state, insurgent groups need a commodity that can be bartered, and drugs are especially suited to that purpose.
All in all, these conflicts have facilitated the smuggling of heroin from multiple sources, thereby multi-plying potential sources of supply within India. Although a hard-to-quantify proportion of the heroin smuggled into India is re-exported abroad, it seems reasonable to assume that some of it becomes available for Indian consumers. As more heroin becomes available, more incentives are generated to become involved in selling it in the domestic consumer market. Therefore, a ‘pressure of supply’ is generated on the domestic consumer market, first in the areas of conflict and then in the country at large. The pressure of supply is coupled with a strong pressure of demand resulting from the poor and stressful living conditions of the population of the areas of conflict, especially the young.
A peculiar system of supply and demand that characterises the Indian drug market is that the users and traders are often the same. To fund their drug consumption many users commit petty crimes, such as theft. Many have resorted to selling drugs in order to bankroll their own habit. The outcome is to multiply sources of supply at the retail level, thereby increasing the chances that more people will become addicted, and resort to crime and peddling to fund their habit.
The drug scene in Mumbai provides a good illustration of the situation prevailing in most Indian cities. In the late sixties, heroin use in Mumbai was restricted to the circles of the rich since it was expensive to buy. However, around 1979, No 3 heroin (brown sugar) began to be marketed. The shift to the sale of brown sugar was mainly because of the criminalisation of cannabis and opium. Selling brown sugar is less risky than selling opium or cannabis since it is less bulky and easier to hide, and the profit margins accruing from its trade are much higher than for traditional drugs.
Marginalised users are the main victims of drug use. When their daily heroin intake becomes impossible to afford, users get involved in rag picking, begging or manual labour. Another widespread means of earning a living is by stealing. Petty drug peddling has become an all-important source of income for some users. Some become regular assistants to peddlers, often receiving drugs, food and a place to sleep in return. They may eventually discontinue the habit as a result of friction between the police and the petty peddlers under whom they work.
It is the purchaser or the intermediary who arranges for the sale of stolen goods. They can make better deals since they are aware of the desperate need of users for the drug. One user explained that it was difficult for them to pretend to be ordinary vendors because they sell their goods only when they are in urgent need of money for drugs, and seldom wait for a good bargain. Besides, they are afraid of being noticed by the police as they carry telltale signs of their habit: black marks on their fingers (resulting from burns from the match sticks used to heat up the heroin).
The sale of stolen goods, though on a small scale, is on a continuous basis, and can be a financially viable proposition for the buyer. While poor users do face problems when they become marginalised, the process of marginalisation can be extremely painful to persons from the richer strata of society, who find it extremely difficult to adjust to the realities of street life in India.
Drug users make up a substantial proportion of the petty thieves ‘working’ in the city, but they are seldom arrested nowadays. As a result of past ‘bad experiences’ in the lockup with users undergoing withdrawal symptoms (some users broke light bulbs and swallowed the pieces, others ate lizards etc.) the police tend to avoid arresting them for fear of having to rush them to hospital.
In addition, some users have died in custody. Others have developed a strategy to avoid arrest altogether: they slash themselves with a razor blade, usually on the chest or hands. They use a new blade each time for this purpose since they say ‘it is safer’. Police officers are put off by such seemingly ‘crazy’ behaviour and would rather avoid having to deal with it. Another strategy that users have developed in order to avoid the police is to apply human excreta or filth from the gutters onto their bodies.
While many policy-makers advocate tougher law enforcement, few have bothered to understand the extent to which lives are wrecked through the criminalisation of drug use. Previously, the users avoided creating trouble to society. When new legal sanctions came up, antisocial activities became rampant, depending on the extent of their craving. The move towards a drug free existence is a long term process depending upon the user and cannot be attained merely through enforcement.
By criminalising culturally sanctioned drug use and supply, the new legislation has left users free to establish their own individual norms regarding use, and paved the way for an exclusively for-profit motive on the part of the suppliers. Under a prohibition regime, profits become substantial because drug delivery happens despite the law. The special abilities required to do this on a continuous basis usually belong to organised crime.
Organised crime in India was not born out of the drug trade but out of the national tariff barriers, foreign exchange and import restrictions that existed before the introduction of the new economic policies of liberalisation. Thus, Indian import policy left loopholes for illegal trade. In the case of gold, India did not have commercial links with its largest supplier – South Africa. It was then channelled through third countries on its way here. Illegal channels got strengthened with the Gold Control Act. This created its own infrastructure and related services, such as transporters, landing specialists, couriers and money holders, which in turn facilitated the development of other forms of smuggling. With the demand for other foreign consumer goods, with the ‘imported quality’ prestige that the Indian middle class attached to Taiwan, Japan and Singapore-made, the underworld geared itself to cater to these needs.
But with liberalisation of trade and the lowering of barriers previous profit margins plummeted and the players disappeared, but the infrastructure remained intact. So when brown sugar emerged in a early eighties, the freeway was already available.
For nearly five decades centralised planning following the model of the USSR was the rule in India, allowing strong bonding between business, bureaucratic and political interests. Initially, politicians accused the bureaucracy of corruption; then it was the other way round. Now it is commonly accepted that there is collusion and a shared interest between the two parties. However, all agree that government control of the issuing of licences and permits for entrepreneurial activity bred corruption and eroded numerous institutions of governance.
Though there are no records to prove this, there is a widespread feeling that criminals have entered the electoral fray. Some well known organised crime figures have sought status and respectability by getting involved in politics, and in some cases have won elections. The net result has been the entrenchment, within the bureaucracy and the political system, of a set of interests linked to organised crime, and therefore, probably, to the drug trade.
The current drug scene is characterised by the continuing presence of traditional substances which can be used for either cultural or secular purposes, and the spread of new products, all of which are used in a secular way. The use of opiates is evident in parts of the country such as the cities, tourists spots, some border areas and areas located near poppy crops or manufactures of opiates. In India, the commonly used derivatives of opium for non-medical purposes are morphine, brown sugar, pure heroin and codeine.
In three states of North East India, No 4 heroin, smuggled from Burma where it is manufactured on a large scale, is taken through intravenous injection. This region of India has the highest incidence of HIV infection among drug users, mostly youngsters. Their life reels under strict military control, imposition of a curfew after 6 pm. The situation is so bad that some start using heroin at age nine.
Brown sugar had not appeared till 1978; earlier studies do not even include brown sugar in the interview schedule. In the early eighties brown sugar emerged in Kashmir, Bhubaneshwar, Madras, Coimbatore, Pune, Hyderabad, Goa and Bombay. By 1990, it was available in all state capitals. From a phenomenon that began in the metropolitan cities and tourist spots, the use of crude heroin soon spread to newly industrialised district capitals and towns along major train/bus routes. Border villages lying on trafficking routes were also affected. For instance, there are patients coming to Chennai for treatment from the fishing communities of coastal Tamilnadu located on major international heroin trafficking routes.
Besides heroin, abuse of pharmaceutical drugs has become common in certain parts of the country. The lack of proper procedures in the treatment of drug abuse has created a situation where addicts buy prescription drugs over the counter for self-medication and self-detoxification without proper guidance. This leads to a different kind of addiction. The abuse of pharmaceutical drugs among women is more common than the use of substances such as heroin and cannabis products chiefly because pharmaceutical drugs are purchased from legitimate sources and can be consumed under the guise of treatment for an illness. Pharmaceutical companies can market a product for a short span of time (two to three years), and subsequently withdraw it when the adverse effects generate criticism. However, in the process they retain the ability to market a ‘drug’ and yet be clean in the eye of the law.
At present in the rural parts of India, cultural norms are still the order of the day; the question is how long this constructive form can last out against the attack of commercial trafficking networks. It is feared that the criminalisation in the cities and the North East will be replicated in these parts. And with many users vulnerable to HIV, the chances are that this reality will remain hidden.
TRADITIONALLY, Indian cultural diversity successfully handled the varied associations with mind-altering substances among its people without excessive use becoming a cause of major concern. With the entry of tourists from western countries in the 1960s, the association with cannabis became glamorous and the demand from wealthy tourists increased the profit margins of petty peddlers. In the eighties, derivative drugs began to replace natural drugs in the cities. During this period, a set of new legislative measures against drugs, based on the Single Convention of 1961 came to be enforced.
Human behaviour cannot be isolated from the social, cultural and environmental reality surrounding it. While objective reality is related to the processes of production, subjectivity is the experience of individuals that shapes their worldview and lifestyle. Both these realities form the basis for social action.
Earlier, society was self-regulating and did not need precise rules for effective drug control. Drug consumption was carried out openly, legitimised by cultural norms and restricted by traditional demand. It was also free of underground dealings. With the intervention of the U.S., however, indigenous controls have been displaced by a single model, developed for the West. In the Indian context, instead of reducing drug supply, the imposition of this model has resulted in the replacement of culturally sanctioned use by secular use and of traditional suppliers by criminal networks.
The natural psycho-active plants commonly found in India include cannabis, poppy, khat and datura. Cannabis and opium are part of the cultural and religious elements in India, used and kept under control for thousands of years. The international community, however, views these two drugs as particularly troublesome. Cannabis is processed into three main products before it is consumed: bhang, ganja (marijuana) and charas (Chopra, 1990). Opium use flourished despite invasions from Alexander to the Mughals; it was finally monopolised by the British. It takes many forms from being blown through a hubble bubble pipe (hukka) as madak to being brewed with tea as bonda chai.
Drugs in India have medicinal, social, functional and regional uses. These are embedded within its complex cultural fabric. Despite several races, religions and sub-sects, 18 languages and 1,652 mother tongues, Indian culture has formed an identity over the years, which remains dynamic, symbolising cultural continuity and a unified principle of consciousness. This inner structure of tradition contributed towards the growth of a unified worldview, projecting an image of unity in value structures, ritual styles and systems of beliefs.
The early stage of influence of the cultural structure was characterised by Sanskritisation of the little traditions, creating a cultural renaissance of the great tradition. The period under the British brought in legislation and systemic change, but only at a superficial level.
The present phase of modernisation is the most challenging period for Indian tradition, with multiple structural inconsistencies such as democratisation without spread of civic culture (education), bureaucratisation without commitment to universal norms, rise in media participation (communication) and rising expectations without a proportionate increase in resources and distributive justice, verbalisation of welfare ideology without its diffusion in the social structure and its implementation as social policy, over-urbanisation without industrialisation, and finally, modernisation without meaningful changes in the stratification system of castes. It is within this context of emerging changes and tensions that drug abuse and trafficking must be considered.
British policy with regard to poppy cultivation in India was linked to its trade relations with China, whose staple export commodity was tea. Since the British had developed a taste for tea, by 1785 the East India Company was buying and selling 15 million pounds of China tea per year. The problem in trade arose because Britain had no commodity to sell in return to China. This situation led to aggressive sales of opium to China.
The new business strategy changed the earlier association with poppy and cannabis. Unlike poppy, cannabis can be grown anywhere in India; in some regions it grows wild, which has made it difficult to effectively control cultivation. The British went about opium trading, systematically controlling cultivation, consumption, production and sale within the country and its export. Production, however, did not exceed demand, ensuring that profit margins were kept high.
When the locals saw the huge revenue generated by the British from poppy cultivation, their perception changed. A profitable cash crop now, opium became a viable commodity for sale. This facilitated illicit cultivation as well as smuggling of opium across native states and from provinces to the native states.
A widely felt change since Independence has been secular drug use (devoid of cultural or religious significance). Traditional forms of control have dwindled. The reasons can be traced to the onslaught of western tourists in the 1960s and ’70s, the implementation of new drug laws in the 1980s, and liberalisation in the 1990s – structural adjustment – which has led to the marginalisation of large sectors of the population and pushed some of them to adopt drug use and sale as a coping mechanism.
Meanwhile, the new legislation criminalised drug use, pushing users and suppliers underground. The simultaneous influence of secular drug use and commercial drug suppliers in a context of widespread poverty and desperation, and in some areas of political conflict, has paved the way for the spread of heroin, mostly in cities.
The case of alcohol after Independence provides an interesting illustration of the links between changes in the drug scene and legislation. While cannabis and opium products were made illegal throughout India, alcohol has remained legal in many states. Further, the government has taken measures to make it more easily available and to promote its sale, though under the influence of Gandhian philosophy, some states outlawed alcohol.
In a new move towards drug control, the Government of India shut down outlets supplying opium for oral consumption in 1959. At the same time, with the ever-increasing need for revenue, state governments promoted the sale of alcohol to raise tax revenue. In 1979, in order to increase the demand for alcohol, the Government of Maharashtra (GoM) took measures to make alcohol more easily accessible. A large number of licences, allowing tea stalls and eating-houses to sell liquor from 6 pm to 11 pm, were issued. Since the ’80s, industrial night shift workers and college students became the new target group and several bars remain open till 4 am. In the year 2000, the GoM raked in Rs 1900 crore as taxes from alcohol.
Western tourists tipped up the scales for cannabis. Their demand modified the traditional association with drugs that existed in India, roping in several Indian youngsters. It became a sought after substance in certain strata of society. With higher profit margins, and the demand coming from comparatively richer consumers, cannabis laid the dragnet for many traders.
The present drug control strategy of India can be traced back to the Single Convention on Narcotics Drugs of 1961. This was enforced in December 1964 and amended in 1972. The developing countries became puppets in the hands of U.S., via the UN. Increasingly we witnessed the incursion of international drug legislation into the national scene as aid became conditional on countries accepting the U.S. inspired drug laws. This threat was posed (among others) to Nepal when it refused to implement national drug laws modelled on international requirements.
Finally, in 1981, the member states formulated the International Drug Control Strategy that was supposed to cover all aspects of the drug issue: abuse, trafficking, treatment, rehabilitation and crop substitution. In 1984, though the member states pledged to include economic, social and culturally relevant alternative programmes, they had no strategy on how to deal with problems arising from the criminalisation of centuries-old cultural habits in India.
Nevertheless, the Indian government enacted the Narcotic Drugs and Psychotropic Substances Act, (NDPS Act), which did not take into account the Indian situation and its plural cultures. The NDPS Act was designed to conform to the Single Convention of 1961, which the Indian government had signed in 1964. India subscribed to the international goal of eradicating all cultural uses of cannabis within a 25-year period. Since the decision was taken without any planning, little or no attention was given to the methods used to achieve the stated goals and implications. There was no real public debate on the new legislation, and it was adopted without much research.
The government’s mismanagement has led to the leakage of opium produced from licit to illicit channels. After the enactment of the NDPS Act in 1985, there has been an attempt to reduce the area of cultivation. However, high yielding varieties of poppy had been introduced, producing over 42 kg of opium per hectare, whereas the official computation of productivity remained for long at 28 kg per hectare. Further, there was a decrease in the floor purchase price of opium from Rs 280 to Rs 270 per kilo, inducing the farmers to divert sales to drug traffickers instead. Finally, the commission payable to the lambardars (agents who buy opium from the farmers and sell to the government) was reduced from 3.5% to 0.75%. This also gave the agents an incentive to sell opium to the traffickers.
Fresh legislation changed the face of drug trade. With criminalisation, the sale of cannabis/opium became as risky as that of modern drugs such as heroin, if not more. While some traders left for safer pastures, others took to selling hard drugs. A few traders continued to sell cannabis and opium on a small scale and refused to deal with heroin.
However, with an increase in profit margins, new traders appeared among the marginalised sections of society who started dealing in brown sugar heroin (a crude form of the opiate). Addiction to brown sugar set off a chain reaction and helped increase its price. Marketing strategies were established to popularise the drug. This paved the way for a shift from traditional drugs to heroin and other non-traditional substances such as pharmaceutical opiates.
In no country can the modern drug scene be studied in isolation from national developmental dynamics. Drug production, trafficking and use are often linked to the process of marginalisation. Prior to the ’80s, India’s economy was highly regulated. After the initial phase of liberalisation in the ’80s, the country recorded a GNP growth of over 5% a year. However, while the economy was growing, the government gave low priority to improving income distribution.
Out of the present labour force, only 8.5% belong to the organised sector, which means that they have job security and are protected by unions. By and large, unorganised sector workers are self-employed or work as casual labourers in agriculture, construction work and other industrial occupations.
The New Economic Policy (1991), made the labour force and the poorer sections of society even more vulnerable. It weakened the bargaining power of labour and expanded the unorganised sector, thus creating a buyer’s labour market. The spill over from the organised to the unorganised sector has increased in all industries including primary manufacturing, construction, trade and commerce, transport, storage and communication. Job cuts are characteristic of this move. The voluntary retirement scheme (VRS) is another farce. The large number of workers retrenched through VRS have little to look forward to for their chances of finding a new job are negligible.
The introduction of structural adjustment in India as per the dictates of the World Bank and International Monetary Fund has led to many poor urban dwellers becoming marginalised, resorting to drug abuse and petty crime, and to alternative lifestyles as a coping mechanism. In addition, some unemployed youth have joined the ranks of organised crime as enforcers, debt collectors and hired killers. The press has published accounts of hired killers in Mumbai, below the age of 24, with no prior record of criminal activity.
Another consequence of the liberalisation of trade was to push the networks that specialised in smuggling legal goods subjected to stiff import restrictions into switching to new products, mainly drugs and arms. These generate high profit margins because of their illegal status for those who trade in them. The switch allowed organised crime to both maintain its revenue base and to adapt to the new economic environment.
Internal strife within a country is often linked to the spread of drug use. India is no exception. India’s geographical location between the two leading producers of illegal opiates in the world, the Golden Crescent (especially Afghanistan) to the West and the Golden Triangle (especially Burma) to the East, both of which have been entangled in armed conflicts for years, has also facilitated the emergence of drug trafficking.
In 1979, India came into the newly-drawn heroin map as a consequence of the Islamic revolution, the outbreak of war in Afghanistan and the restoration of military rule in Pakistan that disturbed and diverted heroin smuggling networks. Another change in the geopolitical situation was the turmoil in Sri Lanka and the involvement of several militant groups with drug trafficking in India.
Political unrest within India, around the northeastern states and the Jammu-Kashmir border, also account for drug problems. The national policy of repression using the army and other enforcement agencies in these areas for nearly four decades has contributed to both transforming the nature of conflict and the proliferation of small arms in the region. Incidentally, Jammu and Kashmir, Uttar Pradesh, Arunachal Pradesh, Mizoram and Manipur are the main states notified for illicit cultivation.
In 1999, when Indian authorities constructed an electrified fence along the India-Pakistan border in Punjab and parts of Rajasthan, traffickers in heroin, hashish and acetic anhydride turned to unprotected Jammu and Kashmir. Now, with a view to preventing arms-cum-drugs trafficking, the Indian government is building another fence along the Jammu and Kashmir border. Little do we realise that as long as the conflicts persist, this area will continue to be affected by drug trafficking.
Political disturbances do not occur in a vacuum. When a region craves for independence, vested interests or negligence from the centre sometimes leads to deprivation. This was clearly the case in the North East – a region whose underdevelopment is exacerbated by violent conflict, closing down of educational institutions and so on. In this situation of heightened insecurity, even school children have turned to drugs. The rate of Human Immunodeficiency Virus (HIV) infection has only added to the problems since, like other facilities, health care is insufficient to meet the needs of the people.
One can only hypothesise that drug trafficking is linked to sub-nationalist movements in India (cf. publications of the Institute for Defence Studies and Analysis, New Delhi). It may also be applicable to some of the mass movements from the second half of the 1980s. It is conceded that in order to finance their political movement against the state, insurgent groups need a commodity that can be bartered, and drugs are especially suited to that purpose.
All in all, these conflicts have facilitated the smuggling of heroin from multiple sources, thereby multi-plying potential sources of supply within India. Although a hard-to-quantify proportion of the heroin smuggled into India is re-exported abroad, it seems reasonable to assume that some of it becomes available for Indian consumers. As more heroin becomes available, more incentives are generated to become involved in selling it in the domestic consumer market. Therefore, a ‘pressure of supply’ is generated on the domestic consumer market, first in the areas of conflict and then in the country at large. The pressure of supply is coupled with a strong pressure of demand resulting from the poor and stressful living conditions of the population of the areas of conflict, especially the young.
A peculiar system of supply and demand that characterises the Indian drug market is that the users and traders are often the same. To fund their drug consumption many users commit petty crimes, such as theft. Many have resorted to selling drugs in order to bankroll their own habit. The outcome is to multiply sources of supply at the retail level, thereby increasing the chances that more people will become addicted, and resort to crime and peddling to fund their habit.
The drug scene in Mumbai provides a good illustration of the situation prevailing in most Indian cities. In the late sixties, heroin use in Mumbai was restricted to the circles of the rich since it was expensive to buy. However, around 1979, No 3 heroin (brown sugar) began to be marketed. The shift to the sale of brown sugar was mainly because of the criminalisation of cannabis and opium. Selling brown sugar is less risky than selling opium or cannabis since it is less bulky and easier to hide, and the profit margins accruing from its trade are much higher than for traditional drugs.
Marginalised users are the main victims of drug use. When their daily heroin intake becomes impossible to afford, users get involved in rag picking, begging or manual labour. Another widespread means of earning a living is by stealing. Petty drug peddling has become an all-important source of income for some users. Some become regular assistants to peddlers, often receiving drugs, food and a place to sleep in return. They may eventually discontinue the habit as a result of friction between the police and the petty peddlers under whom they work.
It is the purchaser or the intermediary who arranges for the sale of stolen goods. They can make better deals since they are aware of the desperate need of users for the drug. One user explained that it was difficult for them to pretend to be ordinary vendors because they sell their goods only when they are in urgent need of money for drugs, and seldom wait for a good bargain. Besides, they are afraid of being noticed by the police as they carry telltale signs of their habit: black marks on their fingers (resulting from burns from the match sticks used to heat up the heroin).
The sale of stolen goods, though on a small scale, is on a continuous basis, and can be a financially viable proposition for the buyer. While poor users do face problems when they become marginalised, the process of marginalisation can be extremely painful to persons from the richer strata of society, who find it extremely difficult to adjust to the realities of street life in India.
Drug users make up a substantial proportion of the petty thieves ‘working’ in the city, but they are seldom arrested nowadays. As a result of past ‘bad experiences’ in the lockup with users undergoing withdrawal symptoms (some users broke light bulbs and swallowed the pieces, others ate lizards etc.) the police tend to avoid arresting them for fear of having to rush them to hospital.
In addition, some users have died in custody. Others have developed a strategy to avoid arrest altogether: they slash themselves with a razor blade, usually on the chest or hands. They use a new blade each time for this purpose since they say ‘it is safer’. Police officers are put off by such seemingly ‘crazy’ behaviour and would rather avoid having to deal with it. Another strategy that users have developed in order to avoid the police is to apply human excreta or filth from the gutters onto their bodies.
While many policy-makers advocate tougher law enforcement, few have bothered to understand the extent to which lives are wrecked through the criminalisation of drug use. Previously, the users avoided creating trouble to society. When new legal sanctions came up, antisocial activities became rampant, depending on the extent of their craving. The move towards a drug free existence is a long term process depending upon the user and cannot be attained merely through enforcement.
By criminalising culturally sanctioned drug use and supply, the new legislation has left users free to establish their own individual norms regarding use, and paved the way for an exclusively for-profit motive on the part of the suppliers. Under a prohibition regime, profits become substantial because drug delivery happens despite the law. The special abilities required to do this on a continuous basis usually belong to organised crime.
Organised crime in India was not born out of the drug trade but out of the national tariff barriers, foreign exchange and import restrictions that existed before the introduction of the new economic policies of liberalisation. Thus, Indian import policy left loopholes for illegal trade. In the case of gold, India did not have commercial links with its largest supplier – South Africa. It was then channelled through third countries on its way here. Illegal channels got strengthened with the Gold Control Act. This created its own infrastructure and related services, such as transporters, landing specialists, couriers and money holders, which in turn facilitated the development of other forms of smuggling. With the demand for other foreign consumer goods, with the ‘imported quality’ prestige that the Indian middle class attached to Taiwan, Japan and Singapore-made, the underworld geared itself to cater to these needs.
But with liberalisation of trade and the lowering of barriers previous profit margins plummeted and the players disappeared, but the infrastructure remained intact. So when brown sugar emerged in a early eighties, the freeway was already available.
For nearly five decades centralised planning following the model of the USSR was the rule in India, allowing strong bonding between business, bureaucratic and political interests. Initially, politicians accused the bureaucracy of corruption; then it was the other way round. Now it is commonly accepted that there is collusion and a shared interest between the two parties. However, all agree that government control of the issuing of licences and permits for entrepreneurial activity bred corruption and eroded numerous institutions of governance.
Though there are no records to prove this, there is a widespread feeling that criminals have entered the electoral fray. Some well known organised crime figures have sought status and respectability by getting involved in politics, and in some cases have won elections. The net result has been the entrenchment, within the bureaucracy and the political system, of a set of interests linked to organised crime, and therefore, probably, to the drug trade.
The current drug scene is characterised by the continuing presence of traditional substances which can be used for either cultural or secular purposes, and the spread of new products, all of which are used in a secular way. The use of opiates is evident in parts of the country such as the cities, tourists spots, some border areas and areas located near poppy crops or manufactures of opiates. In India, the commonly used derivatives of opium for non-medical purposes are morphine, brown sugar, pure heroin and codeine.
In three states of North East India, No 4 heroin, smuggled from Burma where it is manufactured on a large scale, is taken through intravenous injection. This region of India has the highest incidence of HIV infection among drug users, mostly youngsters. Their life reels under strict military control, imposition of a curfew after 6 pm. The situation is so bad that some start using heroin at age nine.
Brown sugar had not appeared till 1978; earlier studies do not even include brown sugar in the interview schedule. In the early eighties brown sugar emerged in Kashmir, Bhubaneshwar, Madras, Coimbatore, Pune, Hyderabad, Goa and Bombay. By 1990, it was available in all state capitals. From a phenomenon that began in the metropolitan cities and tourist spots, the use of crude heroin soon spread to newly industrialised district capitals and towns along major train/bus routes. Border villages lying on trafficking routes were also affected. For instance, there are patients coming to Chennai for treatment from the fishing communities of coastal Tamilnadu located on major international heroin trafficking routes.
Besides heroin, abuse of pharmaceutical drugs has become common in certain parts of the country. The lack of proper procedures in the treatment of drug abuse has created a situation where addicts buy prescription drugs over the counter for self-medication and self-detoxification without proper guidance. This leads to a different kind of addiction. The abuse of pharmaceutical drugs among women is more common than the use of substances such as heroin and cannabis products chiefly because pharmaceutical drugs are purchased from legitimate sources and can be consumed under the guise of treatment for an illness. Pharmaceutical companies can market a product for a short span of time (two to three years), and subsequently withdraw it when the adverse effects generate criticism. However, in the process they retain the ability to market a ‘drug’ and yet be clean in the eye of the law.
At present in the rural parts of India, cultural norms are still the order of the day; the question is how long this constructive form can last out against the attack of commercial trafficking networks. It is feared that the criminalisation in the cities and the North East will be replicated in these parts. And with many users vulnerable to HIV, the chances are that this reality will remain hidden.
Tuesday, October 7, 2008
Salmonella vs Frozen Stuffed Chicken
Salmonella From Frozen Stuffed Chicken
Do you have frozen, uncooked stuffed chicken entrees such as chicken cordon bleu or chicken Kiev in your freezer? Make sure you follow the cooking directions on the product's label so you don't get sick.
That advice comes from a public health alert issued by the U.S. Department of Agriculture (USDA) after 32 people in 12 states got food poisoning after eating breaded and prebrowned, stuffed chicken entrees that were sold raw and frozen and weren't properly cooked at home.
Those people got sick from salmonella, which are bacteria that can cause diarrhea (often bloody), abdominal cramps, and fever. Most people recover from salmonella infection without treatment, but life-threatening complications can occur; infants, elders, and people with weak immune systems are especially vulnerable.The USDA's public health alert applies to all raw, frozen, breaded and prebrowned, stuffed chicken entrees. But no such products are being recalled; the USDA's message is a reminder to follow the products' cooking directions and to remember that those products are sold raw even though the breading and prebrowning may make them look cooked.
"Although many of these stuffed chicken entrees were labeled with instructions identifying the product was uncooked and did not include microwave instruction for preparation, individuals who became ill did not follow the cooking instructions and reportedly used a microwave to prepare the product," the USDA says in a news release.
Saturday, October 4, 2008
Are Phase I Clinical Trials of Foreign Drugs Permitted in India?
The Indian Clinical Research Outsourcing (CRO) industry is growing rapidly and brings with it attendant regulatory concerns. Of special concern is the matter of Phase- I trials which, in general terms, are first-time trials in the country on human subjects of new drugs especially of investigational new drugs. Since this involves testing on humans of new drugs that is to say drugs generally inadequately tested before on humans, and in the context of investigational new drugs, not tested at all on humans before, the subject is understandably sensitive in the public domain as well. The initial testing on humans of drugs recently invented or discovered in the laboratory and having been tested, if at all, only on animal subjects, is a subject potentially capable of abuse in the absence of proper legal regulation, as featured indeed in a number of books and films. It remains a matter of concern for all jurisdictions and particularly of weak, less developed and more vulnerable ones, that the subject remains in the realm of science fiction. How adequately does Indian law deal with the growing challenge?
Clinical Trial is now, since January 20, 2005, defined in Rule 122 DAA of Drugs and Cosmetics Rules, 1945 is as follows:
Clinical trial means a systematic study of new drug(s) in human subject(s) to generate data for discovering and / or verifying the clinical, pharmacological (including pharmacodynamic and pharmacokinetic) and /or adverse effects with the objective of determining safety and / or efficacy of the new drug."
The Rules themselves are framed under the Drugs and Cosmetics Act, 1940, the principal statute in the field. This is a law enacted by Parliament and applies, alongwith the Rules, in all the states in the country. Drugs themselves to which the statute applies are defined in Section 3 (b) of the Act.
To take drug development to the market, clinical research is necessary at different stages to different ends. These are broadly categorized in phases, Phase I being the earliest and Phase IV being the last.
Rule 122 DA of Drugs and Cosmetics Rules, 1945 requires an application to be made to the statutory Licensing Authority for permission to conduct clinical trials for New Drug/Investigational New Drug and for prior permission to be granted before conducting the clinical trial. This Rule is extracted hereunder in relevant part for a Phase-I trial.
122DA. Application for permission to conduct clinical trials for New Drug/Investigational New Drug
(1) No clinical trial for a new drug, whether for clinical investigation or any clinical experiment by any Institution, shall be conducted except under, and in accordance with, the permission in writing of the Licensing Authority defined in clause (b) of rule 21.
(2) An application for grant of permission to conduct:-
(a) human clinical trials (Phase-I) on a new drug shall be made to the Licensing Authority in Form 44 accompanied by a fee of fifty thousand rupees and such information and data as required under Schedule Y... ..."
.
Provided that the Licensing Authority shall, where the data provided on the clinical trials is inadequate, intimate the applicant in writing…intimating the conditions which shall be satisfied before permission could be considered.
Under Schedule Y, Paragraph 2 (6), Phase- I trials are described. As per this-
The objective of studies in Phase I is the estimation of safety and tolerability with the initial administration of an investigational new drug into human(s). Studies in this Phase of development usually have non-therapeutic objectives and may be conducted in healthy volunteers subjects or certain types of patients. Drugs with significant potential toxicity e.g. cytotoxic drugs are usually studied in patients.... Studies conducted in Phase I, usually intended to evaluate maximum tolerated dose, pharmacokinetics, pharmacodynamics and early measurement of drug activity.
It is only after completion of Phase I trial, the subsequent phases of trial can take place.
A conjoint reading of Rule 122DA (2) (a) and Schedule Y, paragraph 2 (6) indicates that an application and grant of permission is envisaged and is necessary for conducting Phase-I trials in India, which by definition are trials of ‘investigational new drugs’, that is to say new drugs not having previously been tested on humans anywhere. The statutory definition of ‘Investigational New Drug’ is "...means a new chemical entity or product having therapeutic indication but which have never been tested on human being." The Rule by itself without reference to the Schedule seems to cover Phase I trials of ‘New Drug’ more generally defined in Section 122E of The Drug and Cosmetics Act as "a drug" which has not been used in the country to any significant extent under the conditions prescribed, recommended or suggested in the labeling thereof .. even if it is not an ‘Investigational New Drug.’ A reading of the Rule by itself leaves it open to the interpretation that for Phase-I trials, Schedule Y is relevant only for indicating the ‘information and data’ required to support the application. But the scope of the Rule gets restricted to only ‘Investigational New Drugs’ in light of the description of Phase-I in the Schedule as being limited to ‘Investigational New Drugs.’ The reference in the Rule to the Schedule is mandated by the express stipulation in this regard in the language of Clause 2 (a) of the Rule itself. It becomes clear from this that Phase-I trials concerns testing of drugs on human subjects in India of drugs that have never been tested before on human subjects and that applications are maintainable to carry out such tests and permissions will be granted in suitable cases by the Indian Licensing Authority. It is also notable that the statutory provisions cited above do not distinguish between indigenous and foreign ‘investigational new drugs.’ That is to say, that in considering applications for for Phase-I trial in India permissions, the provisions noticed above do not disqualify drugs discovered or developed outside India but instead specifically envisaged as a category in which applications will be entertained and considered for grant of the necessary permission.
What cases of Phase-I trials of foreign drugs will be considered suitable by the Licensing Authority for grant for permission, is governed statutorily yet appears to leave some scope for non-statutory discretion to be exercised ad hoc or in terms of a policy decision. To understand the scope of this discretion, one needs to appreciate the legal position prevailing until 20th January of 2005 when the law was amended, as well as the change in the law.
Earlier, an ‘investigational new drug’ was not a statutory expression. Previously Rule 122-A governed licenses to import new drugs including for the purposes of trials which were required to comply with the guidelines for the same as set out in Schedule Y (unamended). The earlier Rule did not deal specifically with ‘investigational new drugs’ nor specifically with any particular Phase of trial such as Phase-I. Earlier the description of Phase-I trials in Schedule Y did not specifically make it applicable to ‘investigational new drugs,’ in the sense of the expression as only now defined. And the earlier Schedule Y expressly made a distinction between foreign drugs and indigenously discovered or developed drugs. In relevant part, the earlier Schedule Y read as under-
1. Clinical Trials.
1.1 Nature of trials.- The clinical trials required to be carried out in the country before a new drug is approved for marketing depend on the status of the drug in other countries....If the drug is not approved/marketed trials are generally allowed to be initiated at one phase earlier to the phase of trials in other countries.
For new drug substances discovered in other countries phase I trials are not usually allowed to be initiated in India unless phase I data as required under Item 5 of the said Appendix from other countries are available. However, such trials may be permitted even in the absence of phase I data from other countries if the drug is of special relevance to the health problem of India
For new drug substances discovered in India, clinical trials are required to be carried out in India from Phase I as required under through Phase III,...permission to carry out these trials are generally given in stages, considering the data emerging from earlier phase.:
The earlier position was thus clearly that Phase-I trial of an ‘investigational new drug’, as now defined, was not permitted in the usual course if the concerned drug was discovered outside India subject only to the exception that the drug was of special relevance to the health problem of India.
This position changed significantly with the coming into force of the amendment in January of 2005.
The amended Schedule Y now provides-
1. Application for permission.
(1) Application for permission to import or manufacture new drugs for sale or to undertake clinical trials shall be made in Form 44 accompanied with following data in accordance with the appendices, namely:-
(iv) "Human Clinical Pharmacology Data as prescribed in items 5, 6 and 7 of Appendix I are as stated below:-
(a) for new drug substances discovered in India, clinical trials are required to be carried out in India right from Phase I and data should be submitted as required under items 1, 2, 3, 4, 5 (data, if any, from other countries) , and 9 of Appendix I;
(b) for new drug substances discovered in countries other than India, Phase I data as required under items 1, 2, 3, 4, 5 (data from other countries) and 9 of Appendix I should be submitted along with the application. After submission of Phase I data generated outside India to the Licensing Authority, permission may be granted to repeat Phase I trials and/or to conduct Phase II trials and subsequently Phase III trials concurrently with other global trials for that drug. Phase III trials are required to be conducted in India before permission to market the drug in India is granted..."
Post amendment, therefore, the position that emerges from the above reproduced portion of Schedule Y is that in India, Phase- I trials of foreign drugs is possible but only as a ‘repeat’ of an earlier Phase-I trial already conducted outside India and the application for this requires submission of the earlier Phase-I data generated outside India. But if the concerned foreign drug has already been tested on humans outside India in Phase-I trials already held outside India, it will no longer fall within the definition of an ‘investigational new drug’ and therefore not within the description of a ‘Phase-I trial.’ This is anomalous as ‘repeat’ Phase-I trials would have to be envisaged as Phase-I trials to be covered under the scheme of Rule 122DA. Still, the harmonious interpretation of the conflicting statutory provisions would be that Phase-I trials in India of foreign drugs are possible and properly the subject of applications and grant of necessary permissions, only if there is some pre-existing Phase-I data from outside India. The interpretation that the earlier ban on Phase-I trials of foreign drugs has not been abolished by the amendment would be extreme in rendering altogether otiose certain portions of the amended Schedule Y. The key issue, though, remains as to how much such initial foreign Phase-I data would be adequate before permission to ‘repeat’ the Phase-I trial in India can or should be granted.
The second Proviso to Rule 122DA, noticed earlier, enables the Licensing Authority to go into the matter of adequacy/inadequacy of the data provided on a drug in support of the application for grant of the necessary permission. Beyond that it is in the discretion of the Licensing Authority to accord appropriate weight and worth to whatever data is submitted and on the basis thereof, on impose such pre-conditions as considered exigent before considering the application further for grant of permission. Evidently, if the Licensing Authority expects or requires data from a full fledged foreign Phase-I trial, there will be few if any applications for a ‘repeat’ Phase-I trial in India as that would be unnecessary and a waste of time, expense and effort. Evidently also, if the data is so token or nominal that the ‘repeat’ Phase-I trial would actually amount to almost a first-time Phase-I trial, and especially if the drug is potentially particularly novel and hazardous , then the Licensing Authority would be expected to treat it as inadequate.
Clinical Trial is now, since January 20, 2005, defined in Rule 122 DAA of Drugs and Cosmetics Rules, 1945 is as follows:
Clinical trial means a systematic study of new drug(s) in human subject(s) to generate data for discovering and / or verifying the clinical, pharmacological (including pharmacodynamic and pharmacokinetic) and /or adverse effects with the objective of determining safety and / or efficacy of the new drug."
The Rules themselves are framed under the Drugs and Cosmetics Act, 1940, the principal statute in the field. This is a law enacted by Parliament and applies, alongwith the Rules, in all the states in the country. Drugs themselves to which the statute applies are defined in Section 3 (b) of the Act.
To take drug development to the market, clinical research is necessary at different stages to different ends. These are broadly categorized in phases, Phase I being the earliest and Phase IV being the last.
Rule 122 DA of Drugs and Cosmetics Rules, 1945 requires an application to be made to the statutory Licensing Authority for permission to conduct clinical trials for New Drug/Investigational New Drug and for prior permission to be granted before conducting the clinical trial. This Rule is extracted hereunder in relevant part for a Phase-I trial.
122DA. Application for permission to conduct clinical trials for New Drug/Investigational New Drug
(1) No clinical trial for a new drug, whether for clinical investigation or any clinical experiment by any Institution, shall be conducted except under, and in accordance with, the permission in writing of the Licensing Authority defined in clause (b) of rule 21.
(2) An application for grant of permission to conduct:-
(a) human clinical trials (Phase-I) on a new drug shall be made to the Licensing Authority in Form 44 accompanied by a fee of fifty thousand rupees and such information and data as required under Schedule Y... ..."
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Provided that the Licensing Authority shall, where the data provided on the clinical trials is inadequate, intimate the applicant in writing…intimating the conditions which shall be satisfied before permission could be considered.
Under Schedule Y, Paragraph 2 (6), Phase- I trials are described. As per this-
The objective of studies in Phase I is the estimation of safety and tolerability with the initial administration of an investigational new drug into human(s). Studies in this Phase of development usually have non-therapeutic objectives and may be conducted in healthy volunteers subjects or certain types of patients. Drugs with significant potential toxicity e.g. cytotoxic drugs are usually studied in patients.... Studies conducted in Phase I, usually intended to evaluate maximum tolerated dose, pharmacokinetics, pharmacodynamics and early measurement of drug activity.
It is only after completion of Phase I trial, the subsequent phases of trial can take place.
A conjoint reading of Rule 122DA (2) (a) and Schedule Y, paragraph 2 (6) indicates that an application and grant of permission is envisaged and is necessary for conducting Phase-I trials in India, which by definition are trials of ‘investigational new drugs’, that is to say new drugs not having previously been tested on humans anywhere. The statutory definition of ‘Investigational New Drug’ is "...means a new chemical entity or product having therapeutic indication but which have never been tested on human being." The Rule by itself without reference to the Schedule seems to cover Phase I trials of ‘New Drug’ more generally defined in Section 122E of The Drug and Cosmetics Act as "a drug" which has not been used in the country to any significant extent under the conditions prescribed, recommended or suggested in the labeling thereof .. even if it is not an ‘Investigational New Drug.’ A reading of the Rule by itself leaves it open to the interpretation that for Phase-I trials, Schedule Y is relevant only for indicating the ‘information and data’ required to support the application. But the scope of the Rule gets restricted to only ‘Investigational New Drugs’ in light of the description of Phase-I in the Schedule as being limited to ‘Investigational New Drugs.’ The reference in the Rule to the Schedule is mandated by the express stipulation in this regard in the language of Clause 2 (a) of the Rule itself. It becomes clear from this that Phase-I trials concerns testing of drugs on human subjects in India of drugs that have never been tested before on human subjects and that applications are maintainable to carry out such tests and permissions will be granted in suitable cases by the Indian Licensing Authority. It is also notable that the statutory provisions cited above do not distinguish between indigenous and foreign ‘investigational new drugs.’ That is to say, that in considering applications for for Phase-I trial in India permissions, the provisions noticed above do not disqualify drugs discovered or developed outside India but instead specifically envisaged as a category in which applications will be entertained and considered for grant of the necessary permission.
What cases of Phase-I trials of foreign drugs will be considered suitable by the Licensing Authority for grant for permission, is governed statutorily yet appears to leave some scope for non-statutory discretion to be exercised ad hoc or in terms of a policy decision. To understand the scope of this discretion, one needs to appreciate the legal position prevailing until 20th January of 2005 when the law was amended, as well as the change in the law.
Earlier, an ‘investigational new drug’ was not a statutory expression. Previously Rule 122-A governed licenses to import new drugs including for the purposes of trials which were required to comply with the guidelines for the same as set out in Schedule Y (unamended). The earlier Rule did not deal specifically with ‘investigational new drugs’ nor specifically with any particular Phase of trial such as Phase-I. Earlier the description of Phase-I trials in Schedule Y did not specifically make it applicable to ‘investigational new drugs,’ in the sense of the expression as only now defined. And the earlier Schedule Y expressly made a distinction between foreign drugs and indigenously discovered or developed drugs. In relevant part, the earlier Schedule Y read as under-
1. Clinical Trials.
1.1 Nature of trials.- The clinical trials required to be carried out in the country before a new drug is approved for marketing depend on the status of the drug in other countries....If the drug is not approved/marketed trials are generally allowed to be initiated at one phase earlier to the phase of trials in other countries.
For new drug substances discovered in other countries phase I trials are not usually allowed to be initiated in India unless phase I data as required under Item 5 of the said Appendix from other countries are available. However, such trials may be permitted even in the absence of phase I data from other countries if the drug is of special relevance to the health problem of India
For new drug substances discovered in India, clinical trials are required to be carried out in India from Phase I as required under through Phase III,...permission to carry out these trials are generally given in stages, considering the data emerging from earlier phase.:
The earlier position was thus clearly that Phase-I trial of an ‘investigational new drug’, as now defined, was not permitted in the usual course if the concerned drug was discovered outside India subject only to the exception that the drug was of special relevance to the health problem of India.
This position changed significantly with the coming into force of the amendment in January of 2005.
The amended Schedule Y now provides-
1. Application for permission.
(1) Application for permission to import or manufacture new drugs for sale or to undertake clinical trials shall be made in Form 44 accompanied with following data in accordance with the appendices, namely:-
(iv) "Human Clinical Pharmacology Data as prescribed in items 5, 6 and 7 of Appendix I are as stated below:-
(a) for new drug substances discovered in India, clinical trials are required to be carried out in India right from Phase I and data should be submitted as required under items 1, 2, 3, 4, 5 (data, if any, from other countries) , and 9 of Appendix I;
(b) for new drug substances discovered in countries other than India, Phase I data as required under items 1, 2, 3, 4, 5 (data from other countries) and 9 of Appendix I should be submitted along with the application. After submission of Phase I data generated outside India to the Licensing Authority, permission may be granted to repeat Phase I trials and/or to conduct Phase II trials and subsequently Phase III trials concurrently with other global trials for that drug. Phase III trials are required to be conducted in India before permission to market the drug in India is granted..."
Post amendment, therefore, the position that emerges from the above reproduced portion of Schedule Y is that in India, Phase- I trials of foreign drugs is possible but only as a ‘repeat’ of an earlier Phase-I trial already conducted outside India and the application for this requires submission of the earlier Phase-I data generated outside India. But if the concerned foreign drug has already been tested on humans outside India in Phase-I trials already held outside India, it will no longer fall within the definition of an ‘investigational new drug’ and therefore not within the description of a ‘Phase-I trial.’ This is anomalous as ‘repeat’ Phase-I trials would have to be envisaged as Phase-I trials to be covered under the scheme of Rule 122DA. Still, the harmonious interpretation of the conflicting statutory provisions would be that Phase-I trials in India of foreign drugs are possible and properly the subject of applications and grant of necessary permissions, only if there is some pre-existing Phase-I data from outside India. The interpretation that the earlier ban on Phase-I trials of foreign drugs has not been abolished by the amendment would be extreme in rendering altogether otiose certain portions of the amended Schedule Y. The key issue, though, remains as to how much such initial foreign Phase-I data would be adequate before permission to ‘repeat’ the Phase-I trial in India can or should be granted.
The second Proviso to Rule 122DA, noticed earlier, enables the Licensing Authority to go into the matter of adequacy/inadequacy of the data provided on a drug in support of the application for grant of the necessary permission. Beyond that it is in the discretion of the Licensing Authority to accord appropriate weight and worth to whatever data is submitted and on the basis thereof, on impose such pre-conditions as considered exigent before considering the application further for grant of permission. Evidently, if the Licensing Authority expects or requires data from a full fledged foreign Phase-I trial, there will be few if any applications for a ‘repeat’ Phase-I trial in India as that would be unnecessary and a waste of time, expense and effort. Evidently also, if the data is so token or nominal that the ‘repeat’ Phase-I trial would actually amount to almost a first-time Phase-I trial, and especially if the drug is potentially particularly novel and hazardous , then the Licensing Authority would be expected to treat it as inadequate.
Schedule Y and CROs
Schedule Y and CROs
Schedule Y deals with regulations relating to clinical trial requirements for import, manufacture and obtaining marketing approval for a new drug in India. The procedure for applying for marketing approval depends on the status of the new drug, which can be broadly classified into three categories viz. new drug substances discovered which are already approved/ marketed in other countries, new drug substances discovered which are not approved/ marketed in other countries and new drug substances discovered in India.
In case of the new drug substances discovered which are already approved/ marketed in other countries, it is sufficient if confirmatory trials (phase III) are conducted to obtain sufficient data about the efficacy and safety of the drug in a larger number of patients (minimum 100 in 3-4 centres) generally in comparison with a standard drug or a placebo to confirm efficacy and safety claims made in the product monograph.
For new drug substances discovered which are not approved/ marketed in other countries, permission for clinical trials are given with a phase lag in case new drug substances are not approved/ marketed in other countries.
For eg: phase I of a new drug substance is allowed only if the drug has completed phase I and moved to phase II in other countries; similarly phase II is allowed in India only after completion of phase II in other countries and phase III has commenced.
It is very clear that phase I trials cannot be initiated in India for new drug substances discovered in other countries unless phase I data from other countries is available.
In case of new drug substances discovered in India, clinical trials have to be carried out as human / clinical pharmacology trials (phase I). The phase I trials are carried out on healthy human volunteers (minimum 2 at each dose level) to determine maximum tolerated dose in humans, pharmacodynamic effects, adverse reactions, pharmacokinetic behaviours etc.
Under the exploratory trials or phase II trials are carried out on limited number of patients (normally 10 -12 at each dose level) to determine therapeutic uses, effective dose range and further evaluation of safety and pharmacokinetics.
Confirmatory trials or phase III trials are conducted to obtain sufficient data about the efficacy and safety of the drug in a larger number of patients (minimum 100 in 3-4 centres) generally in comparison with a standard drug or a placebo to confirm efficacy and safety claims made in the product monograph. If the new drug substance is not marketed in any other country Phase III trials should be conducted on a minimum of 500 patients spread across 10 - 15 centres.
It is to be noted that permission for the next phase will be given only after satisfactory completion of the previous phase. For e.g. permission for phase II trials will be given only after phase I trial is completed satisfactorily and data is submitted and reviewed by the regulatory authorities.
Implications of the revised Schedule Y
From a plain reading of the revised Schedule Y of the Drugs and Cosmetics Rules, it is clear that in cases of new drug substances discovered which are already approved and marketed in other countries where confirmatory trials are required and new drug substances discovered in India where all the stages of clinical trials are to be conducted, the regulations look clear and unambiguous.
However, in case of new drug substances discovered which are not approved or marketed in other countries where new drug substances are not approved or marketed in other countries, it puts back India by a step as compared to other countries due to Phase lag that need to be adhered to.
It is heartening to note that the revised Schedule Y will address the issue of phase lag in case of phase II and concurrent trials will be allowed. This is a welcome move since it is a well established fact that patient enrollment rates are high in India as compared to countries like USA and EU which will reduce the time to market. Acceptance of data from phase II trials conducted in India by other countries will pave way for all the drug companies to look at India for all their phase II requirements.
From a broader perspective, drugs will be available for patients in India earlier than what it is today. clinical research organizations (CROs) will be in a position to increase its offerings which is now confined to phase III trials and bioequivalence/ bioavailability studies. Phase II trials will be a great value addition and a major boost to the future of CROs. Needless to say that it will create more jobs, more foreign exchange and increased health for the society in general.
Status quo in case of phase I trials should be viewed from the regulators point. The clinical trial segment is yet to mature to desired levels and abundant caution needs to be exercised on the implications of allowing first in man studies. On the other hand it may still offer indirect advantages like multinational pharmaceutical companies trying to set up R & D units in India or looking at tie-ups for various new drugs being developed by Indian companies.
The relaxation on restrictions to export biological samples and revisiting regulatory procedures are steps in the right direction. This will boost confidence of overseas companies and more investments will follow. India will be the destination for pharmaceutical R & D with its huge knowledge base, alignment of regulatory provisions to global standards etc.
- (The author is MD, Lotus Labs Pvt. Ltd.)
Schedule Y deals with regulations relating to clinical trial requirements for import, manufacture and obtaining marketing approval for a new drug in India. The procedure for applying for marketing approval depends on the status of the new drug, which can be broadly classified into three categories viz. new drug substances discovered which are already approved/ marketed in other countries, new drug substances discovered which are not approved/ marketed in other countries and new drug substances discovered in India.
In case of the new drug substances discovered which are already approved/ marketed in other countries, it is sufficient if confirmatory trials (phase III) are conducted to obtain sufficient data about the efficacy and safety of the drug in a larger number of patients (minimum 100 in 3-4 centres) generally in comparison with a standard drug or a placebo to confirm efficacy and safety claims made in the product monograph.
For new drug substances discovered which are not approved/ marketed in other countries, permission for clinical trials are given with a phase lag in case new drug substances are not approved/ marketed in other countries.
For eg: phase I of a new drug substance is allowed only if the drug has completed phase I and moved to phase II in other countries; similarly phase II is allowed in India only after completion of phase II in other countries and phase III has commenced.
It is very clear that phase I trials cannot be initiated in India for new drug substances discovered in other countries unless phase I data from other countries is available.
In case of new drug substances discovered in India, clinical trials have to be carried out as human / clinical pharmacology trials (phase I). The phase I trials are carried out on healthy human volunteers (minimum 2 at each dose level) to determine maximum tolerated dose in humans, pharmacodynamic effects, adverse reactions, pharmacokinetic behaviours etc.
Under the exploratory trials or phase II trials are carried out on limited number of patients (normally 10 -12 at each dose level) to determine therapeutic uses, effective dose range and further evaluation of safety and pharmacokinetics.
Confirmatory trials or phase III trials are conducted to obtain sufficient data about the efficacy and safety of the drug in a larger number of patients (minimum 100 in 3-4 centres) generally in comparison with a standard drug or a placebo to confirm efficacy and safety claims made in the product monograph. If the new drug substance is not marketed in any other country Phase III trials should be conducted on a minimum of 500 patients spread across 10 - 15 centres.
It is to be noted that permission for the next phase will be given only after satisfactory completion of the previous phase. For e.g. permission for phase II trials will be given only after phase I trial is completed satisfactorily and data is submitted and reviewed by the regulatory authorities.
Implications of the revised Schedule Y
From a plain reading of the revised Schedule Y of the Drugs and Cosmetics Rules, it is clear that in cases of new drug substances discovered which are already approved and marketed in other countries where confirmatory trials are required and new drug substances discovered in India where all the stages of clinical trials are to be conducted, the regulations look clear and unambiguous.
However, in case of new drug substances discovered which are not approved or marketed in other countries where new drug substances are not approved or marketed in other countries, it puts back India by a step as compared to other countries due to Phase lag that need to be adhered to.
It is heartening to note that the revised Schedule Y will address the issue of phase lag in case of phase II and concurrent trials will be allowed. This is a welcome move since it is a well established fact that patient enrollment rates are high in India as compared to countries like USA and EU which will reduce the time to market. Acceptance of data from phase II trials conducted in India by other countries will pave way for all the drug companies to look at India for all their phase II requirements.
From a broader perspective, drugs will be available for patients in India earlier than what it is today. clinical research organizations (CROs) will be in a position to increase its offerings which is now confined to phase III trials and bioequivalence/ bioavailability studies. Phase II trials will be a great value addition and a major boost to the future of CROs. Needless to say that it will create more jobs, more foreign exchange and increased health for the society in general.
Status quo in case of phase I trials should be viewed from the regulators point. The clinical trial segment is yet to mature to desired levels and abundant caution needs to be exercised on the implications of allowing first in man studies. On the other hand it may still offer indirect advantages like multinational pharmaceutical companies trying to set up R & D units in India or looking at tie-ups for various new drugs being developed by Indian companies.
The relaxation on restrictions to export biological samples and revisiting regulatory procedures are steps in the right direction. This will boost confidence of overseas companies and more investments will follow. India will be the destination for pharmaceutical R & D with its huge knowledge base, alignment of regulatory provisions to global standards etc.
- (The author is MD, Lotus Labs Pvt. Ltd.)
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