With more checks in place, comprehensive guidelines issued and increased number of inspections mounted, the clinical trial sector in the country is getting streamlined better, according to the available indications.
Compared to five cases of irregularities during the year of 2011, only one case of alleged irregularity came to the fore during the current year so far, while the authorities held as many as 14 inspections apart from the routine checks.
In view of the reports of alleged irregularities in clinical trials conducted by Dr Hemant Jain on 1883 children at Chacha Nehru Hospital in Indore, Madhya Pradesh from 2006 to 2010, a team was constituted to carry out detailed inspection of clinical trials conducted by Dr Hemant Jain at the site to verify the compliance to Drugs and Cosmetic Rules (D&C) and other applicable guidelines. The team carried out inspection from 15.04.2012 to 20.04.2012, sources said.
As per the inspection report, out of 26 clinical trials, there were some irregularities in 23 trials. In remaining three clinical trials, there were no irregularities. The main findings in all the 23 trials were that the quorum of the Ethics Committee of MGM Medical College & M Y Hospital that reviewed and accorded approvals of the trial protocols was not as per the requirement of Schedule Y to D&C Rules as no lay person/legal expert was present in the meetings of the Ethics Committee.
Based on findings of the inspection, the concerned sponsor/companies and Dr Hemant Jain (Investigator), have been issued show cause notice on 07-08-2012. Further, the Chairman of the Ethics Committee of the MGM Medical College and MY Hospital, Indore has also been asked on 07-08-2012 to explain the position on the observations made by the inspection team, sources said.
With the authorities tightening the scrutiny of applications in the recent past, the number of approvals also came down this year. Out of the total 390 applications received, the CDSCO granted permission only in 244 cases till October this year. During the last year, the CDSCO had cleared 283 applications out of the total requests of 306 while in 2010, the authorities approved 529 applications against the total number of 546.
“The scrutiny of applications has been made tight now. 12 New Drug Advisory Committees (NDAC) consisting of leading experts from the government medical colleges, institutes from all over the country have been constituted to advise CDSCO in matters related to approval of clinical trials and new drugs. Applications of Investigational New Drugs (IND) ; i.e, New Drug Substances which have never earlier been used in human beings, are evaluated by the IND committee, chaired by the Director General, Indian Council of Medical Research (ICMR),” sources said.
“Every approval/permission for conducting clinical trials now includes a condition that in case of study related injury or death, applicant will provide complete medical care as well as compensation for the injury or death and statement to this effect would be incorporated in the informed consent form,” it was disclosed.