Even though one month has passed since the Parliamentary Standing Committee on Health's startling revelations that the Drug Controller General of India (DCGI) has approved as much as 33 drugs without clinical trial on Indian patients during the period of January 2008 to October 2010, all the controversial drugs are still in the market with the Indian regulator contemplating no action on the issue in the immediate future.
Though he vowed that “I will not leave any stones unreturned to ensure the safety of the Indian public as that is our mission”, DCGI Dr GN Singh did not say anything specifically about the action being contemplated by his office against the drugs which have been given approval for marketing by his predecessor without any clinical trial on Indian patients. “I will take action as per the Drugs and Cosmetics Act,” he repeatedly said.
Earlier in May this year, the Parliamentary Standing Committee on Health, headed by Rajya Sabha MP Brajesh Pathak, has found that at least 33 drugs were approved without clinical trial on Indian patients by DCGI, during the period of January 2008 to October 2010.
While experts and public at large are sceptical about the continuance of these drugs in the market due to safety concerns as these drugs were approved without clinical trials on Indian population, the union health ministry as a ritual constituted a committee of experts to look into the procedure of drug approvals. But, there was no word from the ministry about any action against the controversial drugs. Experts feel that these drugs should have been withdrawn from the market till the expert committee putting its seal of safety on these drug.
The expert committee, comprising Dr V M Katoch, secretary and DG, ICMR, Dr P N Tandon, president, National Brain Research Centre, Department of Biotechnology, Manesar and Dr S S Aggarwal, former director, Sanjay Gandhi Postgraduate Institute of Medical Sciences, Lucknow, has been asked to examine the validity of the scientific and statutory basis adopted for approval of new drugs without clinical trials, outline appropriate measures to bring about systemic improvements in the processing and grant of statutory approvals and suggest steps to institutionalise improvements in other procedural aspects of functioning of the CDSCO. The Committee has been asked to submit its report within a period of two months.
The controversial drugs which came in for criticism by the Parliamentary Committee included Everolimus by Novartis, Colistimethate by Cipla, Exemestane by Pharmacia, Buclizine by UCB, Pemetrexid by Eli Lilly, Aliskiren by Novartis, Pentosan by West Coast, Ambrisentan by GlaxoSmithKline, Ademetionine by Akums, Pirfenidone by Cipla, and FDC of Pregabalin, ethylcobolamine, Alpha Lipoic Acid, Pyridoxine and Folic Acid by Theon.
Other drugs in this category included Dronedarone of Sanofi, Aliskiran of Novartis, Irsogladine of Macleods, Everolimus of Novartis, Pemetexid of Eli Lilly and FDC of Pregabalin with other agents.
The list does not conclude here. It also include nimesulide injection by Panacea, doxofylline by Mars, FDC of nimesulide with levocetirizine by Panacea, FDC of pregabalin with other agents by Theon, FDC of tolperisone with paracetamol by Themis, FDC of aceclofenac with thiocolchicoside by Ravenbhel, FDC of ofloxacin with ornidazole by Venus, FDC of aceclofenac with drotaverine by Themis, FDC of glucosamine with ibuprofen by Centaur, FDC of diclofenac with serratiopeptidase by Emcure and FDC of gemifloxacin with ambroxol by Hetero.