NEW DELHI, (Reuters) – 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 Organisation (CDSCO), 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.
In a sign that the panel may have been hastily set up, one of the three experts, Dr P.N. Tandon, president of the National Brain Research Centre, first learned about his appointment when Reuters contacted him for comment. “What committee are you talking about? I have no idea. Could you possibly brief me about it?” he asked.
