Ranbaxy laboratory has not been fined USD 500 Million by the United States Food and Drug Administration (USFDA). However, Ranbaxy USA, Inc. pleaded guilty in the US District Court of Maryland for manufacture and distribution of certain drugs not in conformity with the good manufacturing practices (GMP) regulation which is considered as adulterated drugs as per the US law and agreed to pay a fine of USD500 million.
The Hon™ble Supreme Court of India has not admitted the PIL.
As per the US Law, any drug is considered adulterated, if it is not manufactured, processed, packed, etc. in conformity with the Current Good Manufacturing Practice (CGMP) regulations of the USFDA. However, as per Drugs & Cosmetic Act & Rules, in India, manufacturing of drugs not in conformity with Good Manufacturing Practice (GMP) is viewed as non-compliance to GMP under the said Act & Rules.
The Drugs Controller General of India DCG (I) has already been ordered to review the GMP 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.
This information was given by the Minister for Health & Family Welfare Shri Ghulam Nabi Azad in written reply to a question in the Rajya Sabha today.
