As pharma majors await final word from the Supreme Court over clinical trials in India,the fate of 162 government-approved global clinical trials is set to hang in the balance further with the latest disclosure that 157 of them were cleared before the new regulatory regime.
In a revelation that may jeopardise the prospect of a judicial nod for the clinical trials in the country,the Ministry of Health is going to inform the court that out of 162 approvals granted by the Drug Controller General of India (DCGI) till August 31 this year,157 approvals were given in 2012. Only five approvals were given between January 1 and August 31,which involved scrutiny of cases by the Technical and the Apex Committee.
A Bench led by Justice R M Lodha had on the last date asked the government to adduce all details regarding the regulatory and safety regime for conducting clinical trials in India. It had said the clearances given in 162 cases shall be considered only after the authorities satisfy the court on the mechanism adopted to approve the trials,most of which involve new chemical entities (NCEs).
The latest affidavit by the government however makes it clear that except in five cases,all approvals were given before a more stringent three-tier clearance system was put in place by the authorities,following a nudge by the court.
The Technical Committee and the Apex Committee had come into being only after the SC in its order of January 3 issued directives to the government for strict compliance with the Drugs and Cosmetics Act to ensure supervision and monitoring of trials of NCEs.
Before this order,there were only 12 New Drug Advisory Committees that recommended the trials and DCGI subsequently approved them. However,in the new regime,the Technical and Apex Committees,which have top bureaucrats like the Health Secretary,DGHS and DG (ICMR) as members,examine the recommendations of the Advisory Committees before forwarding them to DGHI.
Hence,the governments affidavit admits that most of the trials approved escaped the rigorous scrutiny for want of the new regulatory system.
The ministrys affidavit,which also details various rules and regulations under the Drugs and Cosmetics Act,will face the test in the court on Monday when the Bench examines its response.
In March,the Centre informed the court that at least 80 people died due to illegal clinical trials in the last seven years. The ministry said there were 2,644 serious adverse events of deaths during clinical trials during 2005-2012. Of these,80 have been attributed to clinical trials,while the other deaths could be due to terminal illnesses or other life-threatening diseases. Compensation was paid to families of 44 victims till 2011.
According to the ministry,there were around 12,000 incidents of other adverse effects in this period,of which 506 directly pertained to clinical trials.