Pharma major Dr Reddy's Laboratories Ltd has been charged by the Director of Factories, Andhra Pradesh with being responsible for the loss of two lives in an accident that occurred in one of its manufacturing units here in December 2010.

“We filed charges in a magistrate court in Medak charging Dr Reddy's Laboratories with negligence, issues in standards of equipment, among others, leading to death of two employees,'' Mr G. Bala Kishore, Director of Factories, told Business Line here on Saturday.

The investigation team of Department of Factories had “completed” the investigation into the mishap and had all evidence “ready” to prove its charges.

A chemist and a contract worker died in a “possible leak of poisonous gas” at the Active Pharmaceutical Ingredients (APIs) plant of the company at Bollaram. The victims were handling one of the chemical process in the making of Omeprazole powder.

The plant has approval from the US Food and Drug Administration (USFDA).

SECOND MISHAP

The investigation into the second accident on March 17 at another USFDA-approved unit in which two contract workers were charred to death, is under progress.

“Our investigation is on. We have just served a notice to the company. Three months time has to be given to them,'' the official said.

DENT ON IMAGE

The Hyderabad-based company is likely to face some adverse impact from the USFDA side as two accidents, in a span of about three months, had claimed four lives given the recent tough stand on regulatory aspects by the agency, said industry sources.

“These type of accidents are generally noted by the USFDA to be specifically looked into during subsequent audits for facility approval,'' said a Mumbai-based consultant for regulatory issues abroad.

When contacted Dr Reddy's spokesperson said: “The USFDA comes into picture on matters concerning Good Manufacturing Practises (GMP) issues. However, we will bring to their notice safety related incidents in the following audit, whenever it takes place.''

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