The proposal for setting up a National Centre for Research and Development in bulk drugs at NIPER, Hyderabad, pending for nearly three years now, has got the in-principle approval from the Planning Commission, but is still stuck for the clearance from the Standing Finance Committee (SFC).

Sources said the SFC took up the proposal recently after it was accorded in-principle approval by the Planning Commission subject to certain conditions. But the SFC meeting decided to seek more clarifications on the project.

The SFC wanted to know the synergy between the NIPER and proposed Centre, revenue generation projects, recurring expenditure and the phasing of construction. The next meeting of the SFC is likely to clear the project as the Department of Pharmaceuticals (DoP) is gathering the required inputs for the consideration of the committee, sources said.

The centre, proposed at a cost of Rs. 56 crore as per the current estimates, would aim at development of technologies and process for cost competitiveness, environmental impact management, risk management and development of safety in manufacturing operations, knowledge transfer platform between industry and academia.

The research avenues for bulk drugs would be drugs process innovation, drug discovery and development, analytical chemistry, process engineering, cleaner technology, polymorphism, nanotechnology etc., according to the project report.

Another hurdle on the way for setting up the centre is the allotment of land for NIPER, Hyderabad by the State Government which has agreed to spare 50 acres of land. However, it is still being finalized. Hence the construction of the bulk drug centre, which can be completed within 30 months, will start only after the NIPER gets the required land.

The DoP proposed the centre three years ago in view of the rising  competition to the Indian bulk drug industry especially from China affecting the viability of several small units. Andhra Pradhesh, which accounted for 30 per cent of the bulk drug industry, was chosen for the project.

“Indian bulk drug industry is facing problems of innovation and capacity building in an increasingly competitive environment specially from countries like China, Israel, Brazil, etc. The sector largely has SMEs but they are highly fragmented. Hence the industry lacks in its ability to invest in R&D, make processes more cost effective and scale up operations. Therefore a need has been felt to focus on R&D in bulk drugs sector. It is accordingly proposed to establish an R&D centres for bulk drugs,” said the proposal by the DoP.