Government is examining the recommendations of an inter-ministerial committee report submitted recently to boost manufacturing active pharmaceutical ingredients (APIs) by setting up of pharma clusters in the country. The Centre is also planning to come out with incentives to boost bulk drug industry, considering the fact that 60 per cent of drug import costing Rs. 12,000 crore is from China.
The plan to set up pharma clusters entails operationalising the existing ones and setting up new ones. An official explained that in order to arrive at competitiveness and quality of APIs, it has been recommended to utilise over 40,000 hectares of land under the Special Ecomonic Zones (SEZ) where companies can get access to common facility and hence generate quality products for both domestic and regulated markets. Telanaga government has also offered 30,000 acres of land for bulk drug manufacturing.
"This is also required as these specific manufacturing units would not only provide competitiveness globally but would be subject to inspections by the foreign regulatory agencies for quality and compliance," he emphasized.
Subsequent to Union ministry of chemicals and fertilisers announcement of setting up of 10 pharma clusters in the country to provide common facilities to the pharmaceutical industry, the Central government would also come out with the much awaited technology upgradation scheme to boost small and medium enterprises (SMEs).
"The Government has taken various measures to promote 'Make in India' initiative in pharmaceutical sector," and had constituted a Committee under the chairmanship of Secretary, department of health research in this direction.
A task force has also been set up to look into the issues of private companies and the SMEs in the pharma sector for their upgradation. An official from the Union chemicals and fertilisers ministry said, "There is also a need to launch schemes for pharma technology upgradation as we are dependent on only China for import of bulk drugs”.
Industry experts voiced out the concern that there is an urgent need to propel SME sector by helping with soft finance for technological upgradation, compliance with GMP standards and setting up of the common or individual effluent treatment plants. The proposal for GMP upgradation is pending for a long time. Around 1000 SMEs will be benefited if the scheme is announced. Upgradation of SMEs to WHO-GMP standards would enable them to export their products and thereby increase their credibility.
Union chemicals and fertilizers minister Ananth Kumar recently announced that pharma clusters will provide common facilities to the pharmaceutical industry, and help them hive off up to 25 per cent of the cost, making them globally competitive. A strategy to develop the clusters has also been framed for its early implementation.
A unified policy, regulation and administration mechanism is required for the pharmaceutical industry. It has therefore been recommended to the Prime Minister to set up a separate department for the same. According to the Minister, Katoch Committee Report on the issue of bulk drugs production in the country has been received in the Ministry, and an action plan is being prepared for its implementation. Once its recommendations are put in place, it will make Indian industry viable and competitive.
The government has finalised a report with certain recommendations grouped into 11 broad groups. These groups include the following like single window clearance mechanism, inducing manufacturing clusters, unified policy mechanism, capacity building across functions, developing a national innovation strategy, creating innovation fund targeted towards specific therapy areas, streamlining IP operations, evidence-based price controls, greater industry academia collaboration, streamlining clinical trials and ensuring quality compliance.