New bulk drug export norms to comply with EU standards

Updated - December 04, 2021 11:19 pm IST

Published - May 23, 2013 11:21 pm IST - NEW DELHI:

The Commerce and Industry Ministry, on Thursday, issued new guidelines for pharmaceutical makers to comply with the European Union (EU) Good Manufacturing Practice (GMP) standards.

In a statement issued here, the Ministry says such a move will give a boost to pharma exports from India. “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 statement adds.

Active Pharmaceutical Ingredients, commonly referred to as bulk drugs in the industry, are used in making medicines. The new legislation, which will come into force from July 2, requires a written confirmation by a competent authority nominated by the government that the API has been manufactured in accordance with the EU GMP standards, the Ministry says in the statement.

The authority will also give a written confirmation that the manufacturing facility, where the API is produced, is subject to control and enforcement of GMP standards and is equivalent to those in the EU countries.

EU directive

The EU had issued a new directive on June 8, 2011, to lay down a community code relating to medicinal products for human use and to ensure that the defective products do not reach consumers. The directive lays down a system of control over the entire supply chain for pharmaceuticals. “Various EU industry members have been expressing their concern over the ability of India to comply with the new procedure by the July 2 deadline. However, India is optimistic that its pharma industry will be able to meet regulatory requirements within the given timeframe.

“This landmark achievement underlines the seriousness of India towards pharma exports. Compliance by pharma industry with the EU directive is expected to have a positive impact on the companies as many of them are aspiring to export to developed countries,” the statement adds.

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