National Pharmaceutical Policy to be finalised shortly

New Delhi, July 28 (UNI) The Government today informed the Rajya Sabha that the National Pharmaceutical Policy (NPA) 2006 is expected to be finalised shortly and the Draft Policy inter-alia aims at checking the prices of essential medicines included in the National List of Essential Medicines, 2003 and formulations based on 74 bulk drugs under the DPCO 1995.

Minister of State for Chemicals and Fertilizers B K Handique said the new proposed elements in the Policy include bulk drug pricing to be based on the rates intimated by bulk drug manufacturing companies, give thrust to R&D in drug industry by allowing 50 per cent additional Maximum Allowable Post Expenses (MAPE) for R&D intensive companies which fulfill the laid down gold standards.

Under the new policy, formulations based on existing 74 bulk drugs under price control of DPCO 1995, MAPE would continue to remain at 100 per cent for one year and their prices would also be frozen for a period of one year.

Replying to a question, Mr Handique said the new NPA has not yet been announced. However, a Draft Cabinet Note on NPA 2006 has been circulated to various Departments/ Ministries for seeking their comments and the replies were awaited.

Some of the salient features of the proposed policy include Strengthening of Drug Regulatory System (by Health Department), Stregthening of patent office infrastructure (by Department of Industrial Policy and Promotion), Focus on Research and Development -- Process Development, Drug Discovery, Drug Development and Clinical Trials, Human Resource Development in Pharmaceutical Sciences through more institutes like National Institute of Pharmaceutical Education and Research (NIPER), Rationalisation of Excise Duty on pharmaceuticals, Streamlining System for Bulk Procurement of Drugs by Government, Promotion of Generic Drugs, Schems for providing accessibility of drugs to the poor especially BPL families, Schemes of interest subsidy for implementation of Schedule M (of Drugs and Cosmetics Rules, 1945) for Good Manufacturing Practices, Restructuring of National Pharmaceutical Pricing Authority (NPPA).

After receipt of comments of various departments, the Draft Policy would be placed before the Cabinet for approval.

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