BY INVITATION. A law that needs much more than a cosmetic change?

In a welcome move, a June 6 letter from the office of the Directorate-General of Health Services invited suggestions for a “revisit” of the Drugs and Cosmetics Act, 1940 and Rules, 1945 “to match up with the current regulatory requirements relating to safety, efficacy and quality of drugs, medical devices and cosmetics.” The only thing wrong with the move is that it has not been well-publicised among various stakeholders and suggestions for changes are expected within 15 days.

Most of the changes said to be under consideration are welcome: better regulation of clinical trials, stem cell research, bariatric surgery and cosmetic surgery, as also closer watch on efficacy and quality of drugs.

With a few exceptions, stem cell “research” by private parties seems to be an excuse for charging patients the moon and promising them the sky for treating diseases with actually no cure on the horizon. Many vulnerable patients and their families are taken for a ride.

This certainly needs regulation. The jury is out on which of these experiments are motivated by the urge to heal and which by greed. Indeed, the reality of the daily exploitation of the patient, poor or rich, must motivate these attempts at better regulation.

Remedies with tall claims and high prices are not confined to modern medicine practitioners; it is prevalent in the pharma industry, too. The pharma market is rife with irrational, unscientific and/or hazardous medicines in the form of Fixed Dose Combinations (FDCs), accounting for at least 40 per cent of the ₹1-lakh crore domestic market. The Government’s ban on 344 of these FDCs in March evoked loud protests from pharma companies, which then got a stay order from the Delhi High Court. In question is the efficacy and safety of these irrational FDCs. It is a moot point how a decision of a medical expert body recommending the ban of these FDCs can become an issue for courts to deliberate and arbitrate on, even if the process of issuing the ban order was within the legitimate confines of the Drugs and Cosmetics Act

The battle for efficacy and safety of what are unsafe and unwarranted medicines as per standard pharmacology promises to be a long one as the matter is sure to to the Supreme Court.

One of the arguments put forth by pharma industry lobbies, both Indian and MNC, and others like the US India Business Council (USIBC), is that the Government’s move to ban these FDCs and make it safe for Indian patients, will send wrong signals to foreign investors. The same specious argument is trotted out when the Government tries to clean up the irresponsible conduct of clinical trials on the people (which have resulted inter alia in at least 89 deaths since 2005, according to the government figures, and much more according to us), or when punishments for violation of the Drugs and Cosmetics Act, are actually carried out.

Surely, the “revisit” of the Drugs and Cosmetics Act and Rules entails negotiating these minefields, and disinformation, in the political economy of the pharmaceutical industry. One hopes efficacy, safety and public health are given primacy rather than “ease of business”, important as that may be for the economy.

(The author is with LOCOST, Vadodara, and All India Drug Action Network. The views are personal.)

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