India is considering joining a global forum that prescribes standards for medicine manufacturing to safeguard its drug exports to the member countries. Called the Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme (PIC/S), it currently comprises 43 drug importing countries.
The move assumes significance in the backdrop of Indian drugmaker Ranbaxy being recently penalised $500 million (aboutRs3,350 crore) by the US government for shoddy manufacturing practices. The United States and the European Union are among the key members.
Under an agreement, drug regulators of member countries ensure compliance with standards rather than individual manufacturers. PV Appaji, director general of India's Pharmaceuticals Export Promotion Council (Pharmaexcil), said the country's drug exports could suffer in the medium to long term if India does not join the league. "It is going to impact our export growth as more and more countries are now looking for PIC/S compliance. India should join the league at the earliest."
Sudhanshu Pandey, joint secretary at the commerce ministry, said while joining the forum will help exports grow, there were broader issues. "As there is the requirement that the whole pharma industry, including non-exporters, be compliant with the standards, the issue needs to studied more carefully." He said the commerce ministry held talks with officials of Drug Controller General of India (DGCI) and the health ministry is examining the likely impact of joining the forum.
The Indian pharma industry, which currently has the largest number of US Food and Drug Administration-approved manufacturing facilities outside the United States, does not want to risk losing out on drug exports and prefers the country join the forum quickly. The industry saw its exports growing to $14.5 billion (Rs79,500 crore) during 2012-13, up from $13.2 billion (Rs 63,500 crore) a year ago. "With the US and the EU already a part of this (forum), other countries are joining too," said a spokesperson of drugmaker Dr Reddy's Laboratories.
It could, howeer, hurt companies that are today just about meeting the minimum required standards, the spokesperson said. "Membership would probably become important in the coming years if not so immediately," said Arun Sawhney, chief executive and managing director of Ranbaxy Laboratories. "The Indian regulator should work towards making India a member of PIC/S within the agreed timeframe."
Joining the forum will also help the Indian pharma industry improve quality standards, said Ganadhish Kamat, Lupin's executive vice president-quality assurance. It will "help boost exports and strengthen India's credentials as amongst the best quality manufacturers of pharmaceuticals globally."