India to probe alleged irregularities at drug regulator

NEW DELHI Fri May 11, 2012 4:50am EDT

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NEW DELHI (Reuters) - The Indian government announced an inquiry on Friday into the operations of the country's main drug regulator, just days after a parliamentary report exposed dysfunction within the agency and alleged serious irregularities in the drug approval process.

The parliamentary report, based on an 18-month investigation, said the Central Drugs Standard Control Organisation (CDSCO,) was chronically understaffed and ill-equipped to fulfill its responsibilities. It also alleged collusion between some officials and pharmaceutical firms to speed up the process of approving some medicines.

The government said in a statement that it had appointed three experts to look at the scientific basis for approving new drugs without clinical trials and to recommend ways of overhauling the approval procedures. The experts have been given two months to report back to the government with their findings.

Foreign and Indian companies named in the report have since denied any wrongdoing, saying they have fully complied with Indian laws.

The report, however, fuelled concerns over lax supervision of the global industry in emerging markets, where Western drug manufacturers are increasingly focusing their sales effort.

The parliamentary committee reviewed 39 randomly selected drugs approved by the CDSCO and found that in the case of 11, mandatory Phase III trials - the final stage of testing before a drug is approved - had not been conducted in India as required.

Health officials told the committee that this requirement could be waived in cases where the drugs had been thoroughly tested abroad.

(Reporting By Ross Colvin; Editing by John Chalmers)

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