Self-regulatory body for pharma industry on cards: Mansukh Mandaviya

Mandaviya says joint squads of state and Centre formed for risk-based assessment of plants

Amid rising global scrutiny of India-made medicines, Union Health Minister Mansukh Mandaviya on Friday said there were plans to have a self-regulatory body for the pharmaceutical industry.

Stressing that India has a zero-tolerance policy for any sort of quality compromise, Mandaviya said a joint squad of regulators from both the state and Centre had been formed for inspections of plants.

The minister, however, did not divulge further details on the nature and composition of the self-regulatory body. He said the government was industry-friendly, but it did not want to leave any opportunity for anyone to point out flaws in the quality.

Speaking at the eighth Quality Forum organised by the Indian Pharmaceutical Alliance, Mandaviya said 150 plants had already been inspected, of which over 70 had been issued show-cause notices and 18 issued closure notices. The regulatory authorities have started risk-based audits of plants.

“If any company’s products have a history of failure, then we are auditing these sites. If someone needs handholding, the industry at the regional level should help to improve quality. However, if anyone is callous about quality, they have no right to operate,” Mandaviya said.

Speaking to reporters on the sidelines of the event, the minister highlighted that upon receiving complaints from certain regulatory authorities, India had tested samples of alleged contaminated cough-syrups. “We tried to do a root-cause analysis, and found that one child had diarrhea. Also, not all the samples of the 23 tested were found to be contaminated. This is strange, as if there is a batch failure, all samples from that batch should fail the test,” he said, alluding to the Gambia incident where more than 40 children died after allegedly consuming India-manufactured syrups.

After the Covid-19 pandemic, there is a palpable shift in the way every country or continent is trying to secure its supplies of medicines, Mandaviya said.

“We have supplied pharmaceutical products to 150 countries during the pandemic, and vaccines to around 100 countries. Not a single country has complained of substandard quality,” he said, adding that now countries were looking for Indian pharma companies who can set up manufacturing capacities in their area.

“Indian companies should not miss this opportunity. While we may focus on exports, others may, in the meanwhile, set up local manufacturing plants,” he said, adding that several international organisations were now allocating funds for such proliferation of manufacturing footprint.

To boost local manufacturing, the minister said it was now time to think of innovative models of partnership between the industry and government. “The Centre can pick up stake in a special purpose vehicle for a pharma park where the industry as well as the state government also have stakes. Let’s say the government brings in Rs 1,000 crore for building this plug-and-play infrastructure. Once the park is ready, in about four to five years, the government can sell its equity and exit, and re-invest that amount in another project,” Mandaviya said.