DoP sets up inter-ministerial coordination committee to promote private pharma sector

The industry has been demanding coordination between various ministries

The Department of Pharmaceuticals (DoP) has set up an inter-ministerial coordination committee to  periodically review the constraints and issues being faced by the pharma industry and will coordinate and facilitate resolution of these, a government notification said Wednesday.

This is one among the various recommendations of the "Task Force on enabling private sector to lead the growth of Pharmceutical Industry", including setting up of funding support.

The committee will be chaired by the DoP Secretary, with other members including the representatives of Chairman of National Pharmaceutical Pricing Authority; Secretary, Department of Health and Family Welfare; Secretary, Ministry of Environment, Forests and Climate Change; Secretary, Department of Industrial Policy and Promotion; and Secretary, Department of Commerce, among others.

The chairman may also decide to invite other government agencies and officials or representatives of industry or their associations to the meeting in the interest of more effective resolution of the pending issues, added the government notification.

The pharma industry has long been demanding coordination between various ministries involved in the sector. "This is a welcome move and the government should also give importance to properly implement the committee to bring the benefits to the industry," Indian Drug Manufacturers Association (IDMA) said in a statement. 

"This is a welcome sign. At present we have to go through approval process with three or more Ministries and this consumes a lot of time. If the Committee can effectively function to reduce this issue, it would benefit the whole industry," said S V Veerramani, president of IDMA.

According to industry sources, pharma firms currently have to approach DoP for licensing approvals. For other regulatory matters, the authority is with the Ministry of Health and Family Welfare, while pricing is overseen by the NPPA. Setting up manufacturing capacity and expansion of facilities requires clearances from Pollution Control Board, among other authorities.

"Many a time, the pollution control board treats the pharma industry as similar to cement or any other chemical industry, without considering the fact that in pharma, the quantity is less while in the others the quantity is mentioned in tonnes. Setting up the Committee may help us to communicate better with the regulators," said an industry expert.

He added that it currently takes up to two years to get a pollution clearance; if a company is looking at capacity addition to address a new, growing market, the approval might come too late by which time the market will not be the same.

The Task Force was set up by the department to promote pharmaceutical manufacturing in India by identifying and addressing the issues faced by the industry.

For strengthening the Indian pharmaceutical sector, the Task Force recommended better industry-government linkages with respect to coordination and consultation. This, it said, would enable the private sector to grow the sector. The recommendations submitted include setting up a High Level Coordination Committee, constitution of a promotional corporate body/registered society to act as a facilitating and promotional body for the Indian Pharmaceutical industry and create a Regulatory Cell in NIPERs and other Institutes to support the Indian pharma sector understand the global regulatory landscape.