Indian plans for EU API import compliance still being discussed

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Indian plans for EU API import compliance still being discussed
Indian Plans to hand quality oversight of APIs shipped to Europe to ‘competent authority’ are still being discussed according to Pharmexcil.

In September, an article in The Hindu Business Line article entitled “Govt to appoint new authority for certifying quality of API​s” (since taken off line) suggested the Indian Government was about to set up a unit to help manufacturers comply with EU rules on APIs shipped to Europe.

It quoted Pharmexcil chief DG PV Appaji chief as saying that: “The Government is expected to have a ‘competent authority’ in place within two weeks to certify the quality of Active Pharmaceutical Ingredients (APIs) for exports to Europe, as per the new import norms of the European Union​.”

This report now seems to have been premature.

In a clarification statement the Pharmaceuticals Export Promotion Council of India (Pharmexcil) said it “has taken up the above issue with Department of Commerce, Government of India and all aspects of the matter are under active consideration of the related Government agencies.​ 

It was also informed that the issue relating to notification of competent authority, if considered necessary, is also under active consideration.​ 

Related topics: Regulatory & Safety

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