India further amends clinical trial regulations, looks to reduce timelines
One of the few direct details shows that the country is still grappling with how to speed its timeline for approving trials. CDSCO said it will “fix a timeline of six months for disposal of applications for approval of clinical trials and new drugs. In case of delay beyond six months, the Licensing Authority will record the reason for such delay. Efforts would be made to bring down the timelines ultimately to one month.”
The Department also recognizes that the “current Pharmacovigilance programme needs expansion and strengthening to cover the whole country.” It would be reviewed and reorganized to detect unsafe drugs at the earliest. In addition, a participative system would be put in place involving the medical community, pharmacists, industry and patients. The strengthening of the Pharmacovigilance programme of India is also under consideration in 12th Five Year Plan.
The members for their meetings will be drawn randomly from a large pool of experts. Applications of clinical trials and new drugs will initially be evaluated by the Subject Expert Committees and their recommendations will be reviewed by the Technical Review Committee (TRC).
“The recommendations are actually very reasonable for the most part but there is really no clear path for how or when they might be implemented,” John Lewis, spokesman for ACRO (Association of Clinical Research Organizations) told Outsourcing-pharma.com.
“In the meantime, research in India is pretty much at a standstill. ACRO and others are working through multiple channels to resolve this but we are not optimistic about change until after the 2014 Indian elections.”
Compensation need not be paid for injury or death due to totally proven unrelated causes. However, certain conditions considered as clinical trial related injury or death are under consideration for further amendment.
From a total sanctioned strength of 111 posts in 2008 with 32 Drugs Inspectors, CDSCO says it has increased its sanctioned strength to 475 posts with 279 Drug Inspectors in 2013. It is proposed to increase the strength of the organisation substantially to 1102 posts at different levels during the Twelfth Five Year Plan.
The number of clinical trials an investigator can undertake should be commensurate with the nature of the trial, facility available with the investigator. However, under no circumstances the number of trials should be more than three at a time. In all cases, the details of payment to the Investigator by the sponsor for conducting the study would be made available to the DCGI.
If two or more countries remove a drug from their market on grounds of efficacy and safety, then the continued marketing of the drug in the country will be considered for examination and appropriate action.
Since ethics committees oversee the conduct of clinical trials, provision of examinations of deaths by an Independent Expert Committee to determine the cause of death is more appropriate. Ethics committees would give their opinion on the SAE to the Independent Expert Committee. This procedure has already been incorporated in the D&C Rules, which will continue.
Similarly Phase IV trials are also required to be conducted in India to assess the safety of such drug in post market scenario. Phase I is conducted to estimate the safety and tolerability of an investigational new drug. Phase II, which is a therapeutic exploratory trial, is conducted to evaluate the efficacy of the drug and the common short-term side effects and risks associated with the drug. An important goal for the Phase II trials is to determine the dose and regimen for the Phase III trials.
