The Government has ordered the Drug Controller General of India (DCGI) to test the quality of drugs produced by Ranbaxy Laboratories Ltd 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 fertilizers Srikant Kumar Jena said in a written reply in Rajya Sabha.
To a query whether the company is selling “some of the medicines” in the country for which it was penalized 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 $500 million. The generic drugs at issue were manufactured at Ranbaxy’s facilities in Paonta Sahib and Dewas in India.