New Delhi: The government on Friday said that it has not taken any decision to join the Pharmaceuticals Inspection Cooperation Scheme (PICS), an international instrument between countries and authorities for cooperation in Good Manufacturing Practice (GMP).
"The Department of Commerce has conducted a study on Pharmaceuticals Inspection Cooperation Scheme (PICS). However, no decision has been taken by the Government to join PICS," Health Minister J P Nadda said in a written reply in Lok Sabha.
He said that "isolated" reports of export of sub-standard quality of drugs by some Indian pharmaceutical companies have appeared in the media and on the websites of the regulatory authorities of foreign countries from time to time.
He said that as per recent media reports, major regulatory actions taken against Indian pharmaceutical companies are Aarti Drugs, Palghar, Tarapur, Maharashtra by United States Food and Drugs Administration (USFDA), IPCA Laboratories plants situated at Pithampur, Indore by USFDA, Suchem Laboratories, Ahmedabad by USFDA and Emcure Pharmaceutical, Hinjawadi by USFDA.
The Pharmaceutical Inspection Convention and Pharmaceutical Inspection Cooperation Scheme (jointly referred to as PIC/S) are two international instruments between countries and pharmaceutical inspection authorities, which provide together an active and constructive co-operation in the field of GMP.
PIC/S' mission is "to lead the international development, implementation and maintenance of harmonised Good Manufacturing Practice (GMP) standards and quality systems of inspectorates in the field of medicinal products."
Nadda also said that the Centre's attention has been drawn to a working paper series entitled "Poor Quality Drugs and Global Trade A Pilot Study" by Roger Bate and others of the National Bureau of Economic Research, published in September, 2014.
It reported that India is supplying substandard medicines for markets with non-existent, under-developed or emerging regulatory oversight, notably Africa. "The study is misleading," Nadda said.
