P A FrancisWednesday, August 9, 2017, 08:00 Hrs  [IST]

The Union health ministry is reported to be considering to do away with the mandatory three phase clinical trials before launching new drugs if they have proved their safety and efficacy in developed countries. For this exemption, these new drugs should have been approved and marketed for at least two years in the markets of European Union, UK, US, Australia, Canada and Japan. The health ministry already sent the draft proposal in this regard to the ministry of law and justice for clearance. Permission to market new drugs are usually granted by the regulatory authorities in any country including in India only after carefully assessing the adverse drug reactions during the clinical trials. The health ministry thinks that the decision can avoid unnecessary repetition of trials and speed up the introduction of new drugs in the country. The health ministry thinks that change in trial rules should make it easier for the pharmaceutical companies to introduce drugs in India which are already in use in regulated markets. Currently, apart from top MNCs like Pfizer, GSK, Novartis and Novo Nordisk, a large number of contract research organizations and Indian companies are doing clinical trials in India for more than 20 years.

The health ministry is probably right in holding the view that introduction of new drugs get delayed to the extend of five to six years in India after they are launched in the developed markets just because of the stipulation of fresh clinical trials in India too for marketing approval. Such a decision of the health ministry now will be of great advantage to multinational companies as they do not have to conduct highly expensive clinical trials, recruit subjects at high costs and wait for the approval of the regulatory authorities. And whatever new drugs are coming out are from the research labs of MNCs in the developed countries. Granting marketing permission to new drugs without clinical trials in India only on the ground that they are in the markets of developed countries for two years is may not be a perfect move. It is no secret that these developed countries had withdrawn some of the high profile drugs like rimonabant, rosiglitazone, nimesulide, cisapride and phenylpropanolamine from the market some years of their launches on account of serious side effects. And Indian drug regulator followed it up by recalling from Indian market also. All these drugs were introduced in various markets after three phase trials. No chemical drug is totally safe and a marketing permission is given after weighing the extent of benefit over its adverse reactions. Safety is more important than efficacy of a new drug so as to avoid serious injuries to patients. Therefore, a stricter evaluation of safety and efficacy of any new drug should be upon the regulators of individual countries.