Regulators step up scrutiny of drug makers

In the aftermath of the Welspun controversy, Business Standard gets deeper into the issue of global scrutiny, in a three-part series

Britain’s drug regulator last month revoked its good manufacturing practice certificate for Pfizer's Chennai plant and put out an alert on products made there. This points to continued quality lapses by pharmaceutical units in the country despite an industry-wide effort to clean up the rot.

Between 2011 and 2016, 27 drug manufacturing plants in India received warning letters from the US Food and Drug Administration (FDA) for data integrity violations and 15 of them had import alerts issued against them, according to a Nomura Research report. None of the alerts has been withdrawn, resulting in delayed product approvals or restrictions in export to the world’s largest pharmaceuticals market.

About a third of all generic drugs consumed in the US are made in India, invoking greater scrutiny of plants in the country. Over the last few years, foreign drug regulators have also stepped up their vigilance as drug companies have not been transparent in their documentation, especially about occasional abnormalities in production.

“The regulators are not so much interested in knowing how we manufacture drugs but want to know how we handle abnormal situations like a machine breakdown or a product failure,” says an industry executive.

Former Ranbaxy executive and activist Dinesh Thakur says the fact that a large number of manufacturing sites in India are cited for breach of data integrity indicates it is a pervasive problem.

Thakur, who unsuccessfully moved the Supreme Court earlier this year for stricter standards for the Indian pharmaceuticals industry, had blown the whistle on malpractices in Ranbaxy. Plant inspections revealed the company had incomplete testing records and an inadequate programme to assess drug quality. In 2013, Ranbaxy had to pay $500 million in fines to the US government after admitting to data falsification and poor manufacturing practices.

Four of Ranbaxy's plants in India--now owned by Sun Pharmaceutical Industries--still have alerts issued against them. Sun Pharmaceutical's Managing Director Dilip Shanghvi had earlier said the company planned to resolve compliance issues one plant at a time and expected one of them to undergo an FDA inspection in 2016-17.

“There is no Chinese wall between facilities that manufacture for domestic consumption and those that make products for export,” Thakur says. “Bad behaviour encouraged by lax regulatory standards locally eventually makes its way into products for export. Foreign regulators do not tolerate behaviour that put their patients at risk,” he adds.

For most foreign drug regulators, data integrity at Indian plants has been a concern. They accord high importance to data generated during research and manufacture to establish whether processes are well managed and if the finished product is safe.

Plant sanitation is another area of slippage. Unimark Remedies' plant in Gujarat received a warning last month after an inspection revealed the manufacturing area had open holes. “During inspection, the investigator observed dirt and birds in the manufacturing area as well as a lizard in the controlled processing area,” the FDA wrote in its warning letter. The company had received a warning last September as well.

DG Shah, secretary general of the Indian Pharmaceutical Alliance (IPA), concurs that violations of the kind detected at the Unimark Remedies plant are unacceptable. “We are working with the FDA to address these issues and reduce instances of warning letters. Quality excellence is the new frontier for the Indian pharmaceutical industry,” he adds.

The IPA in February brought together the heads of pharmaceutical companies and regulators from India and abroad to discuss quality. Companies are now making efforts like automated manufacturing, building a talent pool, and setting up quality cells in plants. Companies that are already on a watch list are training staff and fixing internal systems to restore trust.

“Patient safety is of utmost importance and we are committed to ensuring the quality of our medicines,” a Pfizer spokesperson says.

Indian companies are not alone, the FDA has also warned companies in China and the US for failing to meet quality standards.

“There may be some rotten apples, but all the top pharmaceutical companies in India are committed to addressing quality concerns raised by the FDA,’’ says Sujay Shetty, partner at PwC. “Companies are investing in automation, but it will be equally important for them to focus on the work culture,’’ he adds.