Govt set to notify rules for clinical trials

January 04, 2013 07:07 pm | Updated June 12, 2016 10:11 pm IST - New Delhi

After over 2,242 deaths during clinical drug trials in last five years, the government plans to regulate the $500 million sector by bringing changes in drug laws, to make lapses by pharma MNCs a punishable offence and enhance compensation among other steps.

A day after the Supreme Court rapped the Health Ministry for allowing Indians to be used as “guinea pigs” in the conduct of drug trials, top sources told PTI that the rules meant to monitor clinical trials under the Drugs and Cosmetics Act would be notified within this month.

After notifying these rules, which will lay down guidelines for pharma companies engaging in drug trials in India, the government will further amend the Drugs and Cosmetics Act to make lapses by pharma MNCs a punishable offence under law, they said.

Waking up to regulate the clinical trial sector, the Ministry under the new rules will, for the first time, put specific responsibility on investigators and sponsors of drug trials — making it mandatory for them to address issue of medical management of subjects involved in trials in case of serious adverse events such as death.

The new rules will also prescribe a formula providing for higher compensation in case of serious adverse event like death during the trials and fix a minimum compensation amount.

So far, drug companies have been getting away with arbitrary payments, sometimes as less as Rs. 50,000, in case of death during a trial.

Health Ministry officials finalised the draft rules following a series of meetings on Thursday after the apex court came down heavily on the Ministry for sending a junior officer to file an affidavit in such a serious health matter.

Asking for the personal presence of Health Secretary in the matter, the Supreme Court gave the Ministry four weeks to respond to a PIL in the matter.

The government further aims to set up independent ethics committees under medical institutes to monitor ongoing drug trials in India, the sources said.

Such committees have to be registered with the Drug Controller General of India prior to conduct of clinical drug trials. At present, the pharma company hosting the trial sets up its own committee and has its own investigators for inquiring into serious adverse events (SAEs).

The rules have been finalised after taking into account 300 comments received from the public on the draft circulated earlier by the Health Ministry. Two rounds of discussion with civil society members were held and draft rules prepared amidst stiff opposition from drug companies.

Incidentally, there were no rules governing or regulating the clinical drug trials sector in the country so far.

The Supreme Court had on Thursday said such uncontrolled clinical trial of drugs on humans by MNCs was creating “havoc” in the country and slammed the Centre for failing to stop the “racket” which has taken so many lives.

It said the government has slipped into “deep slumber” in addressing this “menace” and ordered that all drug trials will be done under the supervision of the Union Health Secretary.

As many as 211 deaths in clinical trials have been reported during 2012 (till June) and 438 in 2011. But compensation was paid to only 16 of them who died during drug trials in 2011. In 2010, 668 deaths were reported during drug trials but compensation was paid only in 22 cases. Over the past four years, 10 persons have died every week in such trials.

As per data provided by the Health Ministry, there have been 737 deaths in 2009 and 288 during 2008 during clinical trials in the country.

Pharma companies conducting these trials have been getting away by granting meagre compensations — sometimes as low as Rs. 50,000 — to the legal heirs of the victims.

A total of Rs. 35.21 lakh was paid in 16 cases of drug trial deaths in 2011, by pharma firms like ICON, VEEDA, Pfizer, Sanofi, Fresenius and Sun Pharma.

Compensation was awarded in 22 cases of deaths in 2010 by firms, mostly foreign, like Merck, Quintiles, Lilly, Bayer, Amgen, Bristol Myers, Sanofi, Pfizer and Wyeth. Together, these companies paid Rs. 70.33 lakh in all these cases.

The value of life is only Rs. 2.2 lakh in India if the average compensation paid for deaths during clinical trials of drugs is any yardstick.

And the value is only getting cheaper going by the compensation amount paid in 2011 as against average compensation of Rs. 3.2 lakh for clinical trial-related deaths paid in 2010, according to an analysis of data provided by the Health Ministry.

The alarmingly low-level of compensation for lives lost during clinical trials in India can be credited to the fact that government is yet to frame rules for compensation in such cases under the existing drug regulation laws in the country.

Currently pegged at $500 million, India’s clinical research market is projected to more than double and cross $1 billion mark by 2016 driven by a large and easy-to-access population with much lower cost than in the developed world.

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