Indian regulator wants to expand its ranks

The outcry over lax regulations of clinical trials and drug approvals has not been lost on India's government, and the Central Drugs Standard Control Organization is looking to expand its ranks of experts.

The CDSCO currently has 12 committees that review trials, drugs and devices in the country, Pharmalot reports, and the agency is looking to "bring more transparency, consistency and accountability in the approval process and to have wider representation of experts of various disciplines from across the country," according to a written notice.

Critics have accused the Indian regulator of being too chummy with the drugmakers it polices, and, taking that to heart, the CDSCO appears to be trying to avoid conflicts of interest, asking applicants to disclose any and all contract work they've done over the past two years.

The news follows the agency's proposal to strengthen India's clinical trial regulations, looking to institute unannounced inspections of trial facilities and stricter guidelines for the ethics committees that approve studies. Furthermore, the CDSCO has a draft guidance that would standardize the amount of money paid out to patients or their families if they are injured or killed during a trial.

Watchdog groups have said the proposed changes don't go far enough, but some researchers say just the opposite: Cracking down on CROs and drugmakers will only imperil one of India's fastest-growing industries, they argue.

- here's Pharmalot's report
- check out the CDSCO's notice (PDF)

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