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Indian drug regulator 'colluded with pharma companies'

Cipla, Sun Pharma, Novartis and Bayer all implicated following Ministry of Health report into regulatory standards

The agency responsible for regulating the pharmaceutical sector in India has been criticised in a new report which claims there has been widespread collusion with pharma firms to speed medicines to market.

The Central Drugs Standard Control Organization (CDSCO) looks set to undergo a major revamp in the wake of the report by a committee convened by India's Ministry of Health, which claims that some pharma companies have not met legislative requirements to carry out late-stage trials of their drugs within India.

Both domestic drugmakers such as Cipla and Sun Pharma, as well as multinational corporations including Novartis and Bayer, have been dragged into the debate about regulatory standards.

The committee examined the regulatory approvals process for 42 randomly-chosen medicines and found that documentation for three was missing, while in another 11 cases clinical trials required under Indian law were not carried out.

Among those deemed to have not met the clinical trial requirements were Novartis' cancer drug everolimus, Bayer's anticoagulant rivaroxaban and Cipla's colistimethate antibiotic.

India generally requires that phase III trials are carried out on medicines to determine whether "there are any ethnic differences that can alter the metabolism, efficacy and safety of the drug when administered to patients of different ethnicities living in India", according to the report.

Meanwhile, the panel has also concluded that the CDSCO is understaffed and lacks the resources to carry out its duties effectively.

Bayer, Cipla and Sun Pharma have all insisted they complied with the requirements laid out in the law.

Meanwhile, Novartis said in a statement that it would mount its own investigation into the allegations presented in the Indian government's report, while asserting that it maintains the same high standard for conducting clinical trials around the world for its products.

Another parliamentary panel has now been set up to examine the allegations further, and is due to deliver a report in the next two months.

21st May 2012

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