FDA Warns India's Emcure Pharma for Repeatedly Fudging Data at Plant

FDA Warns India's Emcure Pharma for Repeatedly Fudging Data at Plant
March 17, 2016
By Mark Terry, BioSpace.com Breaking News Staff

The U.S. Food and Drug Administration (FDA) sent a warning letter to India-based Emcure Pharmaceuticals, citing “significant violations” of standard manufacturing practices found during a site inspection between Jan. 27 and Feb. 4.

“We observed multiple examples of incomplete, inaccurate, or falsified laboratory records,” the letter, dated March 3, stated. It was addressed to Satish Mehta, Emcure’s chief executive officer, and was posted on the FDA website on March 15.

The falsified records were related to appropriate environmental controls testing, which are performed to ensure drugs aren’t contaminated. An employee at the facility told FDA inspectors that faking records was “routine and due to work pressure.”

Emcure has 15 days to respond to the letter with corrective actions.

In addition to the records issue, the FDA criticized the facility’s design, laboratory setup and testing procedures.

“Your firm failed to establish laboratory controls that include scientifically sound and appropriate specifications, standards, sampling plans, and test procedures,” the letter stated, “designed to assure that drug products conform to appropriate standards of identity, strength, quality and purity.”

Emcure operates eight plants in India. The drugs it manufactures are marketed in the U.S., Europe, Brazil and Japan. It is a private company, although U.S.-based private equity firm Bain Capital owns a stake in the company.

This warning is just one of 42 drug manufacturing facilities in India that the U.S. FDA has banned in recent years as the result of increasing inspections of foreign drug suppliers. Indian companies supply almost 40 percent of the drugs sold in the U.S.

In January 2016, the FDA sent a report to Mumbai, India-based Wockhardt, indicating the company intentionally hid and deleted data regarding failed tests at its Shendra facility.

In July 2015, the World Health Organization (WHO) issued a “notice of concern” (NoC) to India-based contract research organization (CRO) Quest Life Sciences Pvt Ltd over critical lapses from clinical trial standards. A WHO Prequalification Team (PQT) inspected the company’s facility in Chennai, India in late 2014, focusing on Study No. LAZ/032/13, for HA619 Lamivudine, Zidovudine and Nevirapine tablets from Micro Labs Ltd. The three drugs are used to treat HIV.

In 2014, an FDA investigation found quality issues on drugs shipped to the U.S., including falsified records, related to India-based Sun Pharmaceutical Industries Ltd.

And in December 2014, BioSpace reported that the Maharashtra Food and Drug Administration (FDA) in Mumbai, India, has launched hundreds of surprise inspections of WHO certified pharmaceutical units. Those units received WHO certification after joint inspections performed by the Central Drugs Standard Control Organization (CDSCO) and state FDA. Of the 450 or more WHO certified pharmaceutical units, more than 50 had already been inspected.

Although the U.S. FDA has given Emcure 15 days to respond, there is no clear indication what the consequences will be if the company does not meet the deadline.

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