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9 Sep 2013

India to Join PIC/S to Safeguard Drug Exports

India is considering joining the Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme to safeguard its drug exports.

Singapore: India is mulling over joining a global forum that currently has 43 drug importing countries to ensure safety of drug exports. The forum, officially titled ‘Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme' (PIC/S) has the US and the European Union among its key members.

As per the agreement of this forum, drug regulators of member countries ensure compliance with standards rather than individual manufacturers. The looming fear of India's drug exports suffering in the medium to long term is the reason the country is considering this. "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," said Mr PV Appaji, director general, Pharmaceuticals Export Promotion Council (Pharmaexcil), India.

Further, the country's Commerce Ministry recently initiated a discussion with officials of the Drugs Controller General of India (DCGI) and the health ministry to examine the likely impact of joining the forum.

"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," Mr Sudhanshu Pandey, joint secretary, ministry of commerce, opined.

India currently has the highest number of US FDA-approved manufacturing facilities in the world, apart from the US. This is the main reason the country's pharma industry fears losing drug exports to other emerging generic producing nations. India's pharma industry exports grew to $14.5 billion during 2012–2013, up from $13.2 billion the previous year.

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