India seeks IMS Health guidance on PIC/S membership costs

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India has taken another step toward possible membership in the drug manufacturing convention the Pharmaceuticals Inspection Cooperation Scheme (PIC/S) after hiring IMS Health for an assessment of the requirements.

Known as PIC/S, the body promotes good manufacturing practices and includes members from Latin America to Australia and Europe, In Asia, countries include Taiwan, Japan and Malaysia.

India has remained outside the convention--but a sustained crackdown on the quality of exported generic drugs over the past several years by European and U.S. regulators has highlighted the need for uniform standards.

The government wants IMS Health (soon to be merged with U.S. CRO Quintiles) to detail issues such as costs of compliance and what that could mean for exports, Press Trust of India said, citing a junior minister in the government.

"As many countries are requiring the standard of PIC/S it was decided by government to conduct a study to understand the requirements of PICs and the likely implications to the Indian pharma industry," Minister of State for Chemicals and Fertilisers Hansraj Gangaram Ahir was quoted as saying in the lower house of parliament.

India has been cautious on joining the convention with industry reluctantly supporting an initial suggestion for an observer status.

- here's the PTI story carried in the Economic Times

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