clinical trial rules

Here is news to say that India’s drug regulator i.e CDSCO has plans to finalize new rules for clinical trials in the coming months that would shorten the review time, as CDSCO is the national regulatory body for Indian medical devices and pharmaceuticals. It’s a licensing authority.


clinical trial rules

The new guidelines released by India’s drug regulator i.e CDSCO (Central Drug Standard Control Organisation) aims to change by reducing the approval time for the reviewing of applications between 30 and 60 days, In the pharmaceutical conference in Mumbai, the deputy drugs controller of the CDSCO Ranga Chandrashekhar said.

The country’s 1.2 billion people and the large burden of diseases make for an attractive patient pool for global pharmaceutical companies looking to test new drugs, but stringent rules in the last few years have caused some companies to move their research work to other countries.

“We have already received comment from stakeholders on our draft, and it should be finalised in about two months,” Mr. Ranga Chandrashekhar said.

The draft was uploaded on the agency’s website in February. If finalised, it would go to the country’s health ministry for approval before being published, he added.

The agency made the rules mandatory for clinical research a few years ago after cases emerged of some patients being enrolled in trials without informed consent, and not being adequately compensated.

The new rules would let the groups of medical experts, that oversee clinical trials decide on the level of compensation for patients who suffer adverse events, Chandrashekhar said.

Tougher compensation rules could turn the industry away from conducting trials at a time when companies have been gradually looking back to India for clinical work, warned D.G. Shah, secretary general of the Indian Pharmaceutical Alliance, which represents large Indian drugmakers.

“There has been some revival (of clinical research) based on some assurances given by the government and simplifications (of rules),” Shah said. But if compensation rules are adopted as mentioned in the draft released by the CDSCO, companies “will run away from here,” he said.

“This is not conducive to doing innovation and research in India,” Shah said.

As part of overhauling drug regulations in the country, the CDSCO is also planning to bring in new rules for the sale of over-the-counter drugs, and e-pharmacies in the coming months, Chandrashekhar said.