Indian drug companies to follow EU standards

The guidelines are expected to improve the overall quality of Indian products.


New Delhi, May 24, 2013: The government has issued new guidelines which require Indian companies to comply with the Good Manufacturing Practice (GMP) standards of the European Union. The directive came in existence to ensure that the pharma exports to the 27-country region should continue unrestricted. The directive will become effective on July 2, 2013 and prescribes standards for the entire supply chain i.e. from manufacturing to entire supply chain.


It may be noted here that EU had issued a directive in June 2011, laying down rules to ensure medicinal products sold in the region meet stringent quality norms.


"India has demonstrated its keenness to meet international requirements for exports of pharmaceutical products yet again by taking timely action for complying with the new procedural requirements of the EU for import of Active Pharmaceutical Ingredients (API) into the EU," the Ministry of Commerce and Industry said in a statement.


The Central Drugs Standard Control Organisation (CDSO) has already issued detailed guidelines. Now, a competent authority nominated by the government will certify that the API has been manufactured in accordance with the EU code and the facility where the API is manufactured is subject to the GMP standards equivalent to those in the EU countries, the statement said.


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