While the debate over the safety and efficacy of clinical trials in the country continues, another controversy has surfaced. The Indian edition of the Monthly Index of Medical Specialities (MIMS) has accused the Drugs Controller General of India (DCGI) of allowing the marketing of an oncology drug for treating infertility among women. MIMS argues that while marketing older drugs for new cures is a well-accepted practice, the drug has to undergo a fresh set of trials.
This, MIMS says, did not happen — there were no Phase I and II trials and, as for the Phase III trials, they were conducted in private clinics instead of in large hospitals, once again bringing to the fore the whole debate over whether clinical trials were being carried out in the correct manner.
A quite separate but related issue that comes up is in respect of the safety of the drugs being sold across the country, especially since most industry experts will tell you that between 25 per cent and 40 per cent of the drugs sold in the country are believed to be spurious.
This takes place for several reasons. For one, various drug controllers across the country simply do not have enough inspectors to check the thousands of drug producers and the lakhs of chemist shops. So, banned drugs are routinely available at most chemists; in the past, there have been cases where, after the courts have ordered that certain drugs be recalled and re-issued with appropriate warnings, the drugs have been found in the market.
An associated problem is that there are no stringent punishments for firms/chemists caught making/selling spurious drugs. Indeed, most offences in this sphere are routinely bailable. While Sushma Swaraj had proposed a Bill with stringent punishment when she was minister in the NDA government, nothing came of the move. It is, of course, owing to this poor ability to police and prevent counterfeiting that ensures India remains on the US list of countries with poor protection of intellectual property.
Meanwhile, it is still not clear as to who should be in charge of the drugs regulatory authority. Today, the chemicals ministry is the administrative ministry for the industry (administering such issues as price control), whereas it is the health ministry that gives marketing approvals and regulates quality.
A group of ministers has been set up to resolve the issue. While the chemicals ministry is in favour of one integrated authority under its wing to look after all aspects, the health ministry says the quality of medicines is monitored the world over by health departments.