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Aims At Providing A Longer Term Stable Policy Environment

Bio Spectrum

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October 2017

To overcome the challenges like Declining CAGR; Non-adherence to quality standards and norms; Growing competition from other countries; Dependence on imports for the key starting materials as also of the APIs; Lack of R&D and discovery of new molecules, and to improve the situation of the pharma industry, India has come up with draft pharma policy 2017.

- Narayan Kulkarni

Aims At Providing A Longer Term Stable Policy Environment

With the aim to boost domestic manufacturing of drugs, levy cap on trade margins, crackdown on unfair marketing practices and limit 'loan licensing' by pharma companies, the Department of Pharmaceuticals (DoP), Ministry of Chemicals and Fertilizers, government of India has come up with a 18 page Draft Pharmaceutical Policy, 2017 on August 17.

The new Draft Pharmaceutical Policy, 2017 addresses a range of issues including indigenous production of active pharmaceutical ingredient (API), quality control and regulatory approval, manufacturing arrangements, foreign direct investment, innovation and R&D and intellectual property. A major portion of the draft is devoted to pricing and makes various recommendations for the re-structuring of the National Pharmaceuticals Pricing Authority (NPPA) and changes to the Drug Price Control Orders (DPCO) says All India Drug Action Network (AIDAN), an independent network of several non-government organizations working to increase access and improve the rational use of essential medicines.

Welcoming the efforts of Department of Pharmaceuticals, Indian Pharmaceutical Alliance (IPA) compliments secretary, DoP for initiating work on a comprehensive Pharmaceutical Policy. Reacting to the draft policy DG Shah, Secretary General, IPA said “We welcome the efforts of DoP to incorporate in one document various elements from the 1978 Policy as modified in 1986 and 1994 and focus on some new issues.”

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