The Department of Pharmaceuticals (DoP) has sought Rs.160 crore from the Planning Commission to set up one national and five regional formulation development centres (FDCs), apart from manufacturing training centres to help the small and medium enterprises to help develop new generic formulations.
“Development of generic formulations from patent products for small and big molecules (biosimilars) is a challenge for the SMEs. For this, it is accordingly, proposed to set up Formulation Development Centres which would assist the SME pharma for development of new formulations with a view to taping the vast opportunity opening up due to off patenting of a number of molecules valued at about US$ 300 billion (traditional generics and biosimilars) in the next five to seven years,” said the proposal, now under the consideration of the Planning Commission.
“It is proposed to set up of at least one Regional Formulation Development Centre (RFDC) in each of the identified cluster growth areas of the pharma sector in the country. This may cost Rs.100 crore. Consequent to the need of capacity building of the manufacturing personnel required for manufacturing standards upgradation, it is proposed to set up of one National and five Regional manufacturing standards training centres at the total cost of Rs.60 crore,” the proposal said.
Unlike the large-scale players who are better placed to cash on the boom, the SME sector is placed behind in the competition due to the huge overhead expenses needed additionally to manufacture the formulations which are source of increasing production in the domestic and export market, according to the Department.
A common facility in the form of NFDC will help them in developing new formulations instead of extending separate financial assistance to the units, the Department said, while proposing the idea. “It is important in the context of the fact that drugs worth US$ 300 billion are going to lose their patent in the next five to seven years. As a result, they would come under the generic domain and would be available for manufacturing by any unit,” Department said.