If a proposal of the Department of Pharmaceuticals (DoP) gets through, as many as 250 select small and medium scale pharma companies will get special assistance to develop international competitiveness by upgrading to the standards of highly regulated markets.
The scheme which aims to specially equip the companies to adopt international standards higher than WHO-GMP envisages Rs.2 crore each to 250 select units and the total cost would come around Rs.500 crore. The DoP has already submitted the proposal to the Planning Commission for approval, sources said.
The aim of the scheme is to extend special assistance to build competitiveness of very high standards and 'second line of internationally capable industry for high value pharma products for strong regulated but high value markets.'
It will help them upgrade the manufacturing facilities of pharma units including in the biopharma sector to US Food and Drug Administration (US FDA), European Directorate for the Quality of Medicines (EDQM), Therapeutic Goods Administration (TGA) of Australia and other international standards to enable global generic and biosimilar capabilities, according to the proposal.
“The export of pharmaceutical products constitutes nearly 45 per cent of total turnover of Indian pharma industry. In view of the growing importance of generic medicines and the advent of bio-similars in high regulated world market Indian pharma manufacturers need to build capacity for compliance to the stringent standards of high regulated yet high value market countries – US, West EU, Australia and South Africa. Therefore, it is proposed that 250 select units be provided assistance by 2017 to upgrade their facilities as per the requirement of these countries and other international standards,” according to the proposal.
“This will be done at the rate of 50 units per year at the cost of Rs.2 crore per unit and a total cost of Rs.500 crore. The assistance proposed to be given would be one-time capital assistance to enable quick time bound implementation given the urgency of capacity building in light of the steep patent cliff of small and large molecules valued at US$ 300 billion by 2015,” it said.