Clinical errors

Clinical trials need better regulation

The pharmaceutical sector has been hit by one crisis after another. The latest is the Supreme Court directive to the Union health ministry to review 157 clinical trials approved by the Central Drugs Standard Control Organisation. On January 3, after allegations of irregularity in the approval process came up, the Supreme Court had banned clinical trials for all new chemical entities unless they were personally vetted and cleared by the health secretary. The recent directive comes after the government admitted that only five of the 162 approvals granted since then had been vetted by the health secretary. The Supreme Court has asked the ministry to re-examine the other 157 approvals by December 16.

Frost & Sullivan has estimated that in 2010-11 the Indian clinical trial industry was worth $450 million (about Rs 2,800 crore at the current exchange rate). It is growing at 12 per cent annually and will cross the Rs 6,000-crore mark in 2016. However, there are certainly regulatory lacunae. Activists argue that compensation paid for deaths during clinical trials is grossly inadequate. In March this year, Health and Family Welfare Minister Ghulam Nabi Azad informed Parliament that though there were as many as 2,868 deaths during clinical trials from 2005 to 2012, only 89 have been attributed directly to such trials and compensation has been paid only in 45 cases so far. Last year, 436 people died during clinical trials, but only 16 of these deaths have been attributed directly to the trials. Compensation has been paid in only two of these 16 cases: while Novartis gave Rs 2.5 lakh in one case, Sun Pharma made an interim payment of Rs 50,000 in the other case. There are other things wrong as well. Some time ago, a report of the parliamentary committee on health and family welfare suggested that expert opinions necessary for drug approvals were ghost-written by the companies that had sought the approvals. Reports sent in by different experts on the same drug were found to be exact copies of each other, with the same errors!

The mess in clinical trials, in fact, shows how the entire pharmaceutical chain in the country is in dire need of a clean-up. The last few months have brought to light several lapses in the manufacturing operations of top Indian companies. Medicines supplied by Indian companies in the United States were found to have glass and other foreign particles. Ranbaxy in May admitted that it had falsified data while seeking approval to launch its drugs in the US and paid a penalty of $500 million to close the case. In prescription too, all kinds of malpractices have crept in. Doctors prescribe medicine indiscriminately because of the inducements thrown at them by drug companies. Cough syrup, for instance, is freely prescribed in the country, though the rest of the world stopped it many years ago. So, it is not just drug development that needs to be regulated; the downstream activities too call for better monitoring.