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Regulators Tighten Surveillance on Drug Makers

Sep 19, 2016

Regulators are increasing scrutiny of drug makers in India, Business Standard reports. Last month, regulators in Britain revoked its good manufacturing practice certificate for Pfizer's Chennai plant. The regulators also put out an alert on products made at the facility. The U.S. Food and Drug Administration (FDA) submitted warning letters to 27 drug manufacturing plants in India between 2011 and 2016.

The FDA letters cited data integrity violations; 15 had important alerts issued against them. According to Business Standard, none of the alerts has been withdrawn. This has led to delays in product approvals or restricted exports.

India manufactures approximately one-third of all generic drugs in the United States. As such the FDA has increased its scrutiny over drugs made in the country. "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," an industry executive said.

Dinesh Thakur, an activist and former Ranbaxy executive, notes the fact that many manufacturing sites in India are cited for breach of data integrity, indicating a widespread problem. Ranbaxy paid $500 million in fines to the US government in 2013 after admitting that it falsified data and failed to conduct good manufacturing practices.

"There is no Chinese wall between facilities that manufacture for domestic consumption and those that make products for export," Thakur said, according to Business Standard. "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".

The integrity of data is vital for drug regulators in the US, UK and elsewhere. This data ensures that good manufacturing practices are being conducted and that products are safe. Sanitation has been another issue that brings further scrutiny. An FDA warning was issued to Unimark Remedies' plant in Gujarat. "During inspection, the investigator observed dirt and birds in the manufacturing area as well as a lizard in the controlled processing area," the FDA said.

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