Drug inspectors hard-pressed to scrutinise factories

Apr 08 2014, 13:27 IST
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SummaryA drugs regulator is among the first to ad mit that oversight of India’s huge pharmaceutical industry can be patchy.

countries seek cheaper drugs. Many manufacturers have failed to pay sufficient attention to quality control, and regulators lack the resources to keep up, some industry officials said.

‘‘Money became the most important thing, not the quality of the product or patients' lives. Corners were cut in ways they wouldn't have been if you had a strong regulator,’’ said former Ranbaxy executive Dinesh Thakur, who blew the whistle on production quality issues at the company in 2005. Ranbaxy paid a record US fine of $500 million in 2013.

Two former senior drug inspection officials, who spoke on condition of anonymity citing a fear of harassment, said a lack of resources, incentives and support from the government resulted in little action against sloppy practices. ‘‘I took salaries for 30 years without doing anything,’’ said one, who worked with CDSCO. ‘‘I visited some of the plants ... not with the intention of taking any action, but just out of curiosity.’’

Asked about these comments, Singh, the drug controller general, said: ‘‘You bring the corrupt people to my notice and I will take action. We have very honest people working for us. India is an honest country.’’

Unlike the FDA, Indian regulators are not required to disclose inspection observations - a system that many blame for lack of transparency and little action against violators.

A committee of lawmakers said in a report in 2012 that the drug regulatory system suffered from "several deficiencies and shortcomings, some systemic and several man-made".

To bolster its capability, India plans to raise the number of inspectors to 5,000 in three to five years from about 1,500 now, according to Singh, the drug controller general of India.

Thakur, the whistleblower who is now the executive chairman of a US-based pharmaceutical consulting company, said bolstering regulatory oversight of the Indian pharmaceutical industry would be a lengthy process.

"That has been going on for 30 years so you're not going to be able to change it overnight. It is cultural, and like all things cultural it will take some time to unwind itself," he said.

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