Recent reports that the Drug Controller General of India (DGCI) has cleared several drugs for medicinal usage without ensuring the mandatory checks that are required to ensure their efficacy and safety, under the provisions of the Drugs and Cosmetics (2nd Amendment) Rules of 2005, is a blatant violation of the law even by India?s lax standards. Prompt measures must be taken to remedy this major lapse in procedures. What is surprising is that the procedural lapse occurred in spite of clear guidelines which state that even if a drug is already approved or marketed in other countries, it should undergo phase-3 trials in India. In fact, Schedule Y of the Good Clinical Practices for Clinical Research in India, in its amended version of 2005, even lays out that clinical data should be obtained from at least 100 patients spread across several centres. The main objective of phase-3 trials is to verify if the claims made in the product monograph on the basis of foreign studies are equally applicable to Indian patients. The importance attached to this procedure is clear from the specification that even the selection of clinicians for such monitoring and supply of drugs to them needs the prior approval of the licensing authority.
The only concession granted to foreign approved/marketed drugs is that they are exempt from phase-1 and phase-2 trials, the purpose of which is to test maximum approved doses, adverse reactions, therapeutic uses and effective dosage ranges. In addition to all this, companies marketing foreign products are also required to state the restrictions, if any, on the use of the drug in other countries, like dosage limits or exclusion of certain genetic groups, in the interests of better knowledge in the public domain. The guidelines are even more stringent in the case of new drugs invented in other countries, and the data of phase-1trials made abroad has to be submitted with the application. The only exception is for phase-1 trials in the case of drugs which were of special relevance to peculiar health problems in India. The drugs in question approved by the DCGI do not belong to any such category (one of them was a morning after anti-pregnancy pill), and hence this is an issue that should not be taken lightly, especially since some of the formulations have been under some dispute.
