Ranbaxy facilities in India are being reviewed after its US arm admitted to manufacturing certain drugs not in conformity with good manufacturing practices and which are considered “adulterated” under US law, Health Minister, Gulam Nabi Azad said today.
However, in India manufacturing of drugs not in conformity with GMP is viewed as non-compliance to GMP under the said Act & Rules, he said.
The Minister was replying to a query in Rajya Sabha on steps taken by the government to ensure that “adulterated” drugs are not sold in India after Ranbaxy USA Inc admitted in the US District Court of Maryland to manufacturing and distribution of certain drugs not in conformity with GMP.
The Drugs Controller General of India has been ordered to review facilities of Ranbaxy in the country to ascertain the quality of drugs manufactured for domestic market, he said.
The Indian drug maker agreed to pay the fine of $500 million after its US arm pleaded guilty, he said.
Azad, in a written reply in Rajya Sabha, said, “The Drugs Controller General of India 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.”
The Minister said the Supreme Court of India has not admitted the PIL against the company here.
“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,” he said.