Indian firms urge DCGI to ease API imports to EU

Indian drugmakers are urging the Drugs Controller General of India (DCGI) to push for cuts to red tape in the European falsified medicines directive (FMD).

From July imports of active pharmaceutical ingredients (APIs) into the EU will need written confirmation of good manufacturing practice (GMP) compliance from the "competent national regulatory authority", which in India is the DCGI.

Bulk drug firms want the DCGI to apply for an exemption to this requirement on the grounds that the GMP standards they employ are comparable to Europe.

Switzerland has already secured an exemption on this basis, after the European the Commission examined the regulatory framework applicable to active substances exported to the EU from Switzerland - controls and enforcement activities - and concluded that they are equivalent to those of the EU.

This effectively means that Switzerland will not have to issue written confirmation for each consignment of API imported into the EU, which under the FMD will be required as of July 2, 2013.

Brazil, Israel, Australia and Singapore have meanwhile also applied for the exemption, while Canada and Taiwan have so far agreed to issue the compliance declarations, according to comments made at a meeting held towards the end of last year by the UK's Medicines and Healthcare products Regulatory Agency (MHRA).

India however is reportedly yet to make a formal application, something local trade group Pharmexcil wants to change, saysa Pharmabiz report.

Indian bulk drug firms argue that local regulations with which they must comply are in fact equivalent to European GMP standards. However, it is unclear if European authorities would grant India such an exemption.

Concerns about the quality of APIs imported from India and China were widely discussed during the drafting of the falsified medicines bill and it is questionable whether fears have now subsided.

The European Fine Chemicals Group - which represents EU manufacturers of APIs and other fine chemicals, has called for even more stringent controls on imported ingredients including mandatory inspections of all facilities supplying the EU market with the regulatory capacity to carry these out alleviated by mutual recognition of the inspections of other competent authorities.

In the absence of an exemption, it has been suggested that batch certification would be carried out by the DCGI in collaboration with regional offices of India's Central Drugs Standard Control Organisation (CDSCO).