Pharmaceutical Industry In India: Lack Of Legal Regulation

Posted on March 20, 2012 in Health & Life

By Vrinda Ravi Kumar:

The emergence of the black market and illegal sale of certain commodities has always been in response to certain economic policies laid down by the government, whether it is a ban, privatization or restricted sales policies. The emergence of the drug industry in this side market then, is no surprise, particularly when it comes to prescription drugs and stimulants.

Indian pharmaceutical industry is third largest in volume and 1/14 in terms of capital. The government began to encourage the preceding growth of drug manufacturing by Indian companies in the early 1960s. The Patent Act came out in the 1970s that removed composition patents from food and drugs and kept process patents. This lack of patent protection discouraged multinational corporations, who then decreased their dominance on the pharmaceutical industry from 70% in 1970 to about 35% today. This brought the control of the drug industry under the local people and the government, though much of the pharmaceutical companies are in alliance with foreign laboratories and pharmaceutical companies, making them a mix of public and private enterprise. Indians were hired almost exclusively from low level manual labor to high level management. India gained a global foothold with engineered generic drugs and active pharmaceutical ingredients (API).

However, on January 1, 2005, the enactment of India’s patent law reinstated product patents (for the 1st time since 1972) and mandated patent production on both products and processes for a period of 20 years. This move shifted more capital to individual profit and decreased the amount of money in the government pool for research and further drug development.

Recently, the government has put in a lot of money towards R&D for these pharmaceutical companies and hopefully the department of drug development will rise in the Indian scene, making it a profitable venture, not only due to cheap labor, but for patent claims and better drug design as well.

Following de-licensing claims of the pharmaceutical industry, industrial licensing for most of the drugs and pharmacy products has been done away with. Manufacturers are now free to produce any drug duly approved by the Drug Control Board, and this has allowed a large number of units to independently manufacture legal drugs.

While there may or may not be a problem at the level of manufacture, there comes an even larger branching at the level of distribution, and distribution may not always be done ethically. When the question of stimulant drugs or other high-inducing drugs comes into play, distributors have more places to bargain, especially when these drugs are not sold over the counter or the buyer is underage.

The issue raised here is one of purely an ethical nature. Amphetamines are psycho stimulant drugs that produce increased wakefulness and focus along with decreased fatigue and appetite. Ephedrine is an amphetamine like compound which is widely used as an energy booster, for weight loss and to enhance athletic performances. The FDA has received more than 800 reports of adverse effects related to use of ephedrine alkaloids since 1994. These serious adverse effects include hypertension, palpitations, neuropathy, myopathy, psychosis, stroke, memory loss, heart rate irregularities, insomnia, nervousness, tremors, seizures, heart attacks, and death. The agency has proposed to prohibit the marketing of dietary supplements containing 8 milligrams or more of ephedrine alkaloids per serving.

Furthermore, many of these drugs are labeled as ‘bath salts’ or ‘plant food’, where the manufacture agencies attempt to circumvent regulation by suggesting on the label that the drug is not ‘meant’ for human consumption.

The Mexican drug mafia’s (who control a large majority of worldwide cocaine trade) interest in the made-in-India synthetic drugs marked a change in outlook about the drug market here. “In the past, India was just an opium-growing country, which could also process it to heroin. Now, India is known for its synthetic drugs manufacturing scene. It is relatively easy to clandestinely manufacture synthetic party drugs here, and ship them out to the rest of the world through South Africa, using the well established networks of the international drug cartels,” said an NCB sleuth from Mumbai. What is even worse is that shipping and distribution need not be limited to drug mafia, since small local groups can establish a source of supplies easily. For other drugs, like Ketamine Hydrochloride, it is even easier to procure, considering its legal status.

The question that comes in here is that while it might not be possible to completely check the illegal manufacture of such drugs, does legalizing their manufacture increase the likelihood of unethical distribution? Does checking the production of these drugs one level before distribution decrease the chances of illegal sale? Since the manufacture of these drugs can be done from scratch, being completely synthetic and using legal raw materials, can their hypothetically illegal manufacture and distribution ever be stopped?

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