India’s health ministry has claimed that ‘systemic improvements’ in the country’s drug approval procedures are needed, following a report on alleged corruption.
The parliamentary report alleges irregularities in the approval of drugs from major pharmaceutical companies, including major gaps in clinical evidence.
Companies including Eli Lilly and Bayer have challenged the accuracy of the report, which focuses chiefly on the failings of India’s drug regulator.
The Central Drugs Standard Control Organization (CDSCO) lacked adequate staffing or resources, the report found, and there was evidence of a “collusive nexus” between its officials, drug companies and medical experts.
An example cited was CDSCO’s acceptance of three expert opinions on Bayer’s anti-thrombosis drug rivaroxaban that were identical copies. Bayer responded that it had not played “any role in selecting these experts or evaluating their opinions”.
The report also claimed that CDSCO routinely approved drugs that were not approved in the EU or the US due to lack of clinical evidence.
Critically, it said that of 39 CDSCO-approved drugs it surveyed, 11 had not been tested on patients in different ethnic groups – a key requirement of approval in India.
An example was Lilly’s lung cancer drug pemetrexed – but the company insisted the drug had been tested on a large multi-ethnic patient base.
Irregularities claimed in the approval of drugs from Lundbeck, GSK and Novartis were similarly denied by the companies concerned.
The controversy reflects the growing importance of India and other ‘emerging markets’ for the global pharma industry.
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