The Commerce Ministry has put forward a number of measures including special financial package for pharma sector, soft-funding to bio-equivalence centres, and liaison offices in Asian countries to boost the exports of pharma products from India.

In a note sent to the other Ministries concerned, the Commerce Ministry said the need for special financial assistance for the pharma sector had been raised in different meetings of the stakeholders. Besides R&D expenditure, regulatory requirements require large funds. Establishing large number of Bioequivalence centres through soft-funding would lower the costs of bioequivalence tests.

“To maintain the leadership of Indian pharma, research in frontier areas would have to be taken up through a government supported R&D programme to boost innovation and enterprise especially in the MSME sector. To attract more contract manufacturing business, the way forward is to develop capability in existing clusters and providing concessional finance for large scale advanced testing centre, stability testing centres, effluent treatment infrastructure, bioequivalence centres, etc. to enable the individual entrepreneurs build relevant manufacturing capacities and successes in CRAMS space,” the note said.

In Latin American Countries (LAC) such as Mexico, local bioequivalence and separate data requirements are major barriers. India should therefore fund acquisition of a local bioequivalence centre in Mexico (as also in countries where local BE requirements are mandated such as Japan, etc.). A Consortium may be funded by EXIM bank to buy local company/Bioequivalence centre to launch products in those countries, the ministry said.

It also suggested opening of liaison offices in all key Asian countries to provide local agency support for drug registration with local FDAs for both APIs and formulations. These local offices can further provide market information, samples and regulatory and distributor information. Such agency support for multiple companies is permitted universally. Local liaison offices should be opened in 20-25 countries such as Australia, New Zealand, Canada, USA, Mexico, Brazil, Argentina, Peru, South Africa, Vietnam, Ghana, etc.