Ranbaxy's drugs to undergo quality test by regulator

Chemicals and fertilizers ministry has asked Drug Controller General of India (DCGI) to check the quality of drugs produced by Ranbaxy Laboratories and whether 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," mentioned the minister of state of chemicals and fertilisers, Srikant Kumar Jena in parliament on August 23, 2013.

Jena while replying to a quesyion that whether the company is selling some drugs in India, for which it was penalised in the US, 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," minister added further.

Earlier in May, 2013, Ranbaxy had pleaded guilty in the US Court of Maryland for manufacture and distribution of certain drugs not in conformity with the GMP regulation and agreed to pay a fine of USD 500 millionFollowing this, a petition was moved in the Supreme Court asking for a direction to the centre to cancel the manufacturing licenses of Ranbaxy and its group companies for allegedly marketing sub-standard medicines.

However, the health ministry had backed Ranbaxy, saying that there was nothing wrong with the quality of its drugs. Infact a team of experts after inspections had ruled out any issue concerning the quality of drugs sold by the company in India.

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