The Centre has in principle agreed to set up a model regulatory compliant formulation unit in the National Institute of Pharmaceutical Education and Research (NIPER), Mohali as a demonstration facility for the small and medium scale pharmaceutical units.
The Centre has agreed to allot Rs 80 lakh to set up this demonstration unit which would be used for guidance and short term trials for the SME sector, development of software and helping the regulatory authorities, it is learnt.
The facility may also be thrown open for the SME players on a lease for short durations to conduct experiments on scaling up the technology and output.
The initiative was taken by the authorities after the SME Pharma Industries Confederation (SPIC) moved the high-level NIPER-committee specially floated to look into the status of small and medium sector. A meeting of the committee, recently held under the chairmanship of Department of Science and Technology secretary T Ramasami, favoured the idea of a demonstration unit.
The committee also assured the SPIC delegation about considering their other suggestions including setting up of a similar API unit at the NIPER and slashing charges on small companies in all NIPER activities. SPIC had demanded for 75 per cent rebate in fees, but the government may reduce charges upto 50 per cent for small players.
SPIC also called for regular seminars and interactive sessions between the SME pharma units and the government departments and experts of NIPER with a focus on problems and assistance required. It asked the committee to consider sending faculty and students to SME units for compulsory internship to get updated on the industry on a practical level.
``NIPER should provide spot guidance in regulatory, analytical, research and development assistance to the sector and should help them in filing of DMF for different countries. A model specimen of the same could be kept for reference at the institute,'' the memorandum of the SPIC said.
In collaboration with Ministry of Health/DST, the NIPER should identify new impurities and develop impurity reference standards/ analytical techniques to make Indian pharma industry technically superior and have a edge in the global market, the association urged.
They pointed out that the SME sector, with less resources and guidance at their disposal, has been looking constantly upto NIPER for ways to cut costs and develop innovative products.