The Commerce Ministry will consider the proposal by the pharma industry to chalk out ways to reimburse the expenses on bio-equivalence studies, ANDA and DMF filing, and stability studies under the Market Access Initiative (MAI) scheme to promote pharmaceutical exports from the country.

This was indicated by Commerce Minister Anand Sharma to a high-level delegation of the Pharmaceutical Export Promotion Council (Pharmexcil) recently. The delegation comprising K D Vora, Nipun Jain, Bhavin Mehta and Ashutosh Gupta appraised the issues faced by the industry and pointed out that the BE and stability studies, apart from the ANDA and DMF filing added huge expenses to the exporters, especially the small and medium scale players.

Due to tariff and non-tariff barriers, the pharma exports from the country were suffering badly and this could be reversed and the export turnovers can be doubled 'if a little more focus is paid to solve such problems', the delegation pointed out.

The Minister also backed the suggestion by the industry leaders that the Indian Pharmacopoeia (IP) should be promoted well in the international markets and steps be taken to ensure its acceptability along with British and US pharmacopoeias. The Minister assured that both the issues – IP and MAI scheme—would be pushed through the Commerce Ministry.

The delegation also expressed concern on the increasing dependence on China for API's (raw materials) and the ingredients. It was pointed out that the public sector undertakings in the pharma sector were capable of producing these raw materials and ingredients.

Today, 60 per cent of the Indian companies depend on China for raw materials, the delegation said, calling for a pilot project for anti-biotics in the first phase by PSUs as 50 per cent of Indian market accounted for antibiotics.

“The Minister was very receptive of all the issues and has assured of his immediate attention towards the issues we have raised. The Minister said the proposal for launching a pilot project for antibiotics will be taken up at appropriate levels,” said Ashutosh Gupta.

“We have discussed the point of view of SME's and we are quite hopeful that the Commerce Ministry will come up with some positive measures to tackle the issues,” said Nipun Jain, the SME Panel chairman of Pharmexcil, who took up the different issues concerning the SME sector with the Minister in detail at the meeting.

Commenting on the meeting, Bhavin Mehta said the meeting was 'highly satisfactory.' “This is part of our efforts to win a comprehensive package for the pharma industry which badly needs a push to regain its momentum. We were assured that the issues would be taken care,” he said.