Most API manufacturers in India prefer to enter the European market for the first reason that it is easier to get a marketing approval from the European Directorate for the Quality of Medicines (EDQM) unlike from US FDA. Secondly, the manufacturing facilities in India are rarely inspected by European inspectors, whereas that is not the case with the US. Moreover, on a whole the regulatory process of EDQM is much more lenient compared to the US FDA.

EDQM was formed last year primarily as an autonomous authority to approve & certify the import of APIs coming to Europe.

"Although you have to file a DMF for exporting an API to Europe, it is easier to get an export approval from the EDQM authorities compared to US FDA. So far, there has been no incidence of inspection from any European inspector on an Indian API facility," said J C Saigal, executive director, International, Nicholas Piramal India Ltd.

"The rush towards Europe could be more on account of less strictness in the regulatory affairs of EDQM compared to US FDA," said Dr. CB Rao, deputy-managing director, Orchid Pharmaceuticals & Chemicals Pvt Ltd.

Essentially, most of the medium size Indian companies have now focussed towards increasing their API export thrust to Europe. Divis Labs, Alembic, FDC, MJ Biopharma, Intas and Orchid are examples of companies who export more to Europe compared to US.

However, experts agree that the ultimate destination of every exporter is the US, which is the biggest market in terms of value and volume. So the European experience is used by the API exporter as a stepping-stone, which will enhance his image as a quality exporter and improves his chances of getting a quicker US FDA approval.

"While expanding his base in Europe, Indian exporter gradually gets ready to meet the US regulatory requirement. The fact that an Indian company is exporting APIs to regulated Europe itself acts as a certificate for a speedy approval from the US FDA for the same product," said Dr. PG Shrotriya, director, technical, MJ Biopharm Pvt Ltd. Europe is very much a preferred destination for products like injectibles, said Dr. Shrotriya.

The US API market is estimated to be about $ 5 billion as the European (regulated) API market is about $ 3 billion.