India issues new norms for API exports to Europe

The new law requires a written official confirmation that the API has been made as per EU Good Manufacturing Practices

With an aim to boost pharmaceutical exports to the European Union, the government today said it has issued new guidelines to comply with the EU Good Manufacturing Practice (GMP) standards.

"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," Ministry of Commerce and Industry said in a statement.

APIs are commonly referred to as bulk drugs in the pharmaceutical industry and are used in the making of 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 EU Good Manufacturing Practice (GMP) standards.

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

"To comply with the above requirements, the Department of Health & Family Welfare officially declared the Central Drugs Standard Control Organisation (CDSCO) on November 12, 2012. It was also decided that a protocol for the procedure to be complied by the India API Exporters would be laid down by CDSCO, which has been done," it said.

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. It controls manufacture and import for marketing, wholesale and retail distribution. The said directive will be operational from July 2, 2013.     
"Various EU industry members have been expressing their concern about the ability of India to comply with the new procedure by the deadline of July 2. However, India is optimistic that its pharma industry would be able to meet regulatory requirements within the given time frame," it said.

It said in due course of time, online application filing and tracking system would be evolved to bring in sufficient expediency and transparency in the system.

"This landmark achievement underlines the seriousness of India towards pharma exports," it said, adding, compliance by pharma industry with the EU directive is expected to have a "very positive impact" on the companies as many of them are aspiring to export to developed countries.