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Corporate Aug 23, 2013

Govt asks DCGI to check quality of drugs sold by Ranbaxy

New Delhi: The government today said it has ordered the Drug Controller General of India (DCGI) to check the quality of drugs produced by Ranbaxy Laboratories and to check if the firm is following standard manufacturing norms at its various manufacturing plants.

"The DCGI has already been ordered to review the good manufacturing practices compliance of the manufacturing facilities of Ranbaxy in India as well as to ascertain the quality, safety and efficacy of drugs manufactured for the domestic market at these facilities," Minister of State of Chemicals and Fertilisers Srikant Kumar Jena said in a written reply in Rajya Sabha.

Reuters

Reuters

To a query whether the company is selling "some of the medicines" in the country for which it was penalised in the US, Jena said as per the US law, any drug is considered adulterated if it is not manufactured, processed, packed in conformity with the current good manufacturing practice (GMP)
regulations of the US Food and Drug Administration (USFDA).

"However, as per Drugs and Cosmetic Act and Rules, in India, manufacturing of drugs not in conformity of with GMP is viewed non compliance to GMP," Jena said.

In May this year, Ranbaxy had pleaded guilty to "felony charges" in the US Court of Maryland for manufacture and distribution of certain drugs not in conformity with the GMP regulation, which are considered as adulterated drugs as per the US law, and as a result agreed to pay a fine of USD 500
million.

The generic drugs at issue were manufactured at Ranbaxy's facilities in Paonta Sahib and Dewas in India.

PTI

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