NEW DELHI (Reuters) - The government announced an inquiry on Friday into India’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.
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 chairman of the parliamentary committee, Brajesh Pathak, stood by the findings of their investigation. “We went through 12,000 documents to figure out which were the drugs for which proper licensing procedures were not followed,” he told Reuters at his parliamentary office. “There are numerous entries made in the register of the drugs controller that suggest that things were unusual.”
The Indian investigation could prompt separate inquiries into multi-national drug firms by the U.S. Justice Department and the Securities and Exchange Commission, lawyers familiar with such investigations told Reuters on Thursday.
A lobby group for foreign drug companies in India, the Organisation of Pharmaceutical Producers of India (OPPI), said it hoped the government inquiry would result in “effective remedial measures ... to stop (the) recurrence of such serious allegations.”
The parliamentary committee reviewed 39 randomly selected drugs approved by the CDSCO and found that in many cases drugs had not been tested properly and were often approved by unqualified CDSCO officials without expert medical opinion first being sought.
The report also alleged collusion between pharmaceutical companies and medical experts in drafting some of the letters recommending approval of the drugs. The letters were identically worded, to the point of containing the same spelling errors.
It said in the case of 11 of the drugs it reviewed, mandatory Phase III trials - the final stage of testing before a drug is approved - had not been conducted in India as required.
These trials were necessary because there was evidence that some ethnic groups reacted differently to certain drugs, the panel said.
Health Ministry officials told the committee that the requirement for local testing could be waived in cases where the drugs had already undergone multi-national clinical trials involving different ethnic and racial groups.
The committee dismissed this assertion, saying “such irregular approvals spare drug producers the cost and efforts but put patients at risk”.
Editing by John Chalmers and Ian Geoghegan