NEW DELHI: The government issued new guidelines on Thursday that require India's drugs companies to comply with the Good Manufacturing Practice (GMP) standards of the European Union to ensure pharmaceuticals exports to the 27-country region continue unrestricted. The directive, which will become effective from July 2, prescribes standards for the entire supply chain, from manufacture to final retail sale. The 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 commerce ministry said in a statement. APIs, which are also referred to as bulk drugs, are used in the making of medicines.
The Central Drugs Standard Control Organisation has issued detailed guidelines. Now, a competent authority nominated by the government will have to 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.