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India to expand expert base for drug reviews

India’s drug regulator is seeking to expand its pool of expert advisers, as the country continues to shake up its medical-science systems.

The Central Drugs Standard Control Organisation (CDSCO) is looking for experts in multiple areas, including cancer, immunology, pharmacology and vaccines, to help “bring more transparency, consistency and accountability” to drugs approvals in India, according to a letter posted on its website yesterday.

As well as providing advice on potential new drugs and devices, these experts may be asked to draw up guidelines for industry and create a ‘roadmap’ for the development of drugs relevant to the Indian population.

The CDSCO’s seeking of more expert advice comes as reforms of multiple aspects of clinical trials move forward in the country. These include overhauling ethics committees — often seen as merely rubber-stamping trials — and providing adequate compensation for injuries sustained in clinical trials (see ‘India shakes up rules on clinical trials‘).

There have been many concerns in recent years over the rapid growth of clinical trials in India — many conducted for or on behalf of major companies in developed nations looking for cheaper research than is available at home. Another announcement yesterday from the CDSCO highlights this. The organization says that it will be clamping down on manufacturers who do not submit the required ‘periodic safety updates’ on recently approved medicines. Some companies have not been following the rules, says the CDSCO, and any that do not get up to date within three weeks may find their drug approvals suspended.


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