India orders probe into main drug regulator
Source: Agencies |
May 12, 2012, Saturday
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Print Edition
Print Edition
THE Indian government announced an inquiry yesterday into the country's main drug regulator, three days after a parliamentary report exposed dysfunction within the agency and alleged serious irregularities in how drugs are approved.
The parliamentary report alleged collusion between officials of the Central Drugs Standard Control Organization, which oversees the licensing, marketing and trials of new drugs in India, and pharmaceutical firms. It also said the agency was chronically understaffed and lacked both expertise and high-tech laboratories to fulfill its growing responsibilities.
The government said in a statement it 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.
The parliamentary report has added fuel to concerns over lax supervision of the global pharmaceutical industry in emerging markets, where Western drug manufacturers are increasingly focusing their sales effort.
The government statement made no mention of any effort to ensure that all drugs now on sale had been properly tested, one of the major concerns of the parliamentary committee, which spent 18 months investigating the CDSCO.
In a single 10-year period, between 2001 and 2010, the CDSCO approved 2,167 drugs, the parliamentary committee was told. Foreign and Indian companies named in the 78-page parliamentary report denied any wrongdoing, saying they had fully complied with Indian laws.
The parliamentary report alleged collusion between officials of the Central Drugs Standard Control Organization, which oversees the licensing, marketing and trials of new drugs in India, and pharmaceutical firms. It also said the agency was chronically understaffed and lacked both expertise and high-tech laboratories to fulfill its growing responsibilities.
The government said in a statement it 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.
The parliamentary report has added fuel to concerns over lax supervision of the global pharmaceutical industry in emerging markets, where Western drug manufacturers are increasingly focusing their sales effort.
The government statement made no mention of any effort to ensure that all drugs now on sale had been properly tested, one of the major concerns of the parliamentary committee, which spent 18 months investigating the CDSCO.
In a single 10-year period, between 2001 and 2010, the CDSCO approved 2,167 drugs, the parliamentary committee was told. Foreign and Indian companies named in the 78-page parliamentary report denied any wrongdoing, saying they had fully complied with Indian laws.
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