With the clinical trial sector coming under the scanner of judiciary, the regulatory authorities have intensified the monitoring of the clinical trials in the recent past and notices were issued in 235 cases.
The regulatory authorities have so far inspected 577 clinical trial sites in the last few years and notices were issued to the investigators/sponsors/ethics committees seeking clarifications in 235 cases, according to the figures compiled by the Health Ministry.
Increased scrutiny of the applications, new guidelines, and stringent measures by the government have on the other hand resulted in a sharp decline in the number of clinical trial approvals also. Till the end of August this year, the Drug Controller General of India (DCGI) has given permission to only 162 clinical trial applications.
Already there was a declining trend in the approvals. In 2010, the CDSCO received a total of 546 applications for conducting clinical trials in the country, of which 529 were given permission. In 2011, the number of applications went down to 346 and the approvals were given to283 trials. The total number of approvals has gone down further to 253 and the number of applications was 480 during 2012, according to the figures.
After the clinical trials came under the scanner of the Supreme Court and following an order on January 3, 2013, the Government had set up Apex Committee and Technical Committee to supervise the clinical trials. The Government had also constituted 12 New Drugs Advisory Committees (NDACs).
The NDACs met 78 times and a total of 1122 applications for approval of clinical trials, new drugs and fixed dose combinations were evaluated. Out of these 1122 applications, 331 were related to approval of Global Clinical Trial (GCT) including clinical trials of new chemical entities.
Of these 331 GCT applications, NDACs after deliberations have recommended for approval of 285 applications. For 46 applications, no recommendation has been made. Out of above 285 applications so far, DCG (I) has given approval to conduct clinical trials in 162 cases.
Interestingly, the Supreme Court through an order on September 30 this year, has put a stay on these approvals given in 162 cases, following a petition by the health activist group -- Swasthya Adhikar Manch which alleged large number of irregularities.