Concerned about the hardships, especially the non-tariff trade barriers that Indian active pharma ingredients (API) industry is facing, the Department of Pharmaceuticals (DoP) is planning to initiate a comprehensive study that will help tackle the issues faced by the exporters especially in the European countries.

The study, to be funded by the DoP and undertaken with the help of some industry organization, will cover all issues related to IPR, regulatory and other issues acting as barriers to API industry in the country.

The department, through the study, is also planning to get the feedbacks of the industry on the possible measures it can initiate to address the problems. This comes, especially in the backdrop of allegations that there is a trust deficit between the industry and the government in the context of government signing Free Trade Agreement(s) with various countries wherein facility of zero duty is being extended.

“There is a need to study the details of APIs production especially in Spain, Italy, Portugal and Eastern Europe and prepare a report on export of Indian APIs/formulation drugs to EU and details of APIs being manufactured in these countries. There is a need to tackle these issues in organized manner wherein representatives of the industry need to be co-opted in the efforts. The Department is also planning a special cell to deal with these aspects,’’ sources said.

The exporting units in the bulk drugs industry have been facing different types of trade barriers, especially from the Europe. There is a requirement to ensure compliance to EDQM standards which is available for only 3 years at a time with such high costs as Euro 15,000 per drug per time.

Then in addition to EDQM, there is further need to obtain certification from each importing country. Further in the case of bulk drugs, a third additional requirement is of a third party audit. This audit compels companies to divulge their intellectual property infringing on their right to protect data guaranteed.

Additional barriers are also being raised in emerging markets like Argentina wherein there is a discrimination in import regulations between bulk drugs (which are allowed) against formulations which are banned.

The bulk drugs component of the domestic industry is around Rs.42,000 crore giving it a share of around 50 per cent of the total domestic market. This gives the Indian bulk drug industry a share of about 9 per cent of the global bulk drugs market of about US$ 102 billion, as per the official data available. The bulk drugs produced in Indian market fall under 21 major therapeutic classes with antibiotics constituting more than 50 per cent of the total production.