Pharmaceutical majors such as Cipla, Eli Lilly, Novartis and GlaxoSmithKline may now breathe easy. Some of their products, whose approval processes were recently questioned by a Parliamentary standing committee, would continue to be available in the market. This is despite the fact that these drugs were never tested on Indian patients.
The Drugs Controller General of India (DCGI), which approves medicines for sale in the country, has ruled out a review or recall of the 33 medicines approved in India between January 2008 and October 2010 without any human trials.
These drugs include Cubicin, an anti-infective sold by Novartis; Eli Lilly’s cancer drug Alimta and Merck’s Isentress, used in the treatment of HIV. The standing committee had also pulled up Cipla’s antibiotic drug Colistimethate and pulmonary fibrosis drug Pirfenidone, UCB’s Buclizine, used in the prevention and treatment of nausea, vomiting, and dizziness, and GSK’s Ambrisentan. The panel had said these drugs had skipped mandatory phase-III clinical studies.
While the committee raised concern over the irregular approval process followed for these drugs, the DCGI claims all rules and regulations were followed while approving licences for these. “All those drugs were approved according to the rules, regulations and requirements at that time. There were no arbitrations,” DCGI G N Singh told Business Standard. “Withdrawing or recalling those drugs is not a solution. There is a need to ensure safety of drugs, and this is being looked into by an expert committee…not merely for these 33 drugs, but for all drugs to be launched in the future,” he said. He, however, added the regulator was not considering revoking any of these licences, unless the expert panel recommended this.
The report tabled by the Parliamentary committee in May had stated, “There is no scientific evidence to show these 33 drugs are really effective and safe for Indian patients”. Following the committee’s report, the ministry had formed an expert panel to examine the validity of the “scientific and statutory” basis adopted for approving new drugs without clinical trials and suggest steps to bring about systemic improvement in the processing and grant of such approvals and improve the functioning of the drug controller’s office.
Industry experts say the panel does not have the mandate to look into the 33 cases in which licences were issued against existing laws. “The expert committee has been formed by the ministry to only look into deficiencies pointed out by the Parliamentary committee and suggest measures for improvement. It does not have any mandate to look into these 33 drugs,” says C M Gulati, a health expert and editor of Monthly Index of Medical Specialties. He adds there is a need for immediate administrative action against those that violated laws and approved the drugs without trials. The government must also order clinical trials to check the safety and efficacy, he says.