PXL/HO/Cir-028/2020-21 Date: 06.06.2020
Hyderabad
Dear Sir/Madam,
Subject: Notifications by the Department of Pharmaceuticals
1) No.31026/16/2020-Scheme for Promotion of Bulk Drug Parks
2) No.31026/16/2020-Policy on Production Linked Incentive (PLI) Scheme for promotion of domestic manufacturing of KSMs, Drug Intermediates and API
Members are kindly aware that the Pharmexcil had made various recommendations to the Department of Commerce and Department of Pharmaceuticals to scale up the manufacturing of APIs and to ensure uninterrupted supply of quality of APIs for the Nation. Pharmexcil with the support of Ministry of Commerce & Industry has conducted a study on “Strategies to Reduce Import Dependence of APIs, KSMs, and Intermediates” and reports were submitted to all the Ministries.
We are pleased to inform that with the aim to attain self-reliance and Drug security, Govt. of India has agreed to provide incentives to boost manufacture of KSMs/DIs/APIs in the country.
Department of Pharmaceuticals has issued Notifications in this context on Scheme for Promotion of Bulk Drugs and Policy of Production Linked Incentive (PLI) Scheme for promotion of domestic manufacturing of KSMs, Drug Intermediates and Active Pharmaceutical Ingredients. The excerpts from the notifications are as follows:
1) No.31026/16/2020 dt:2nd June.2020-Scheme for Promotion of Bulk Drug Parks:
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Financial Assistance: The Scheme proposes to provide grants-in aid to three (3) Bulk Drugs parks with maximum limit of Rs.1000 crore per Bulk Drug Park or 70% of the project cost of Common Infrastructure Facilities and 90% in case of hilly states and North East Region, whichever is less.
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Scope of Coverage: Admissible for creation of Common Infrastructure Facilities by the State Governments in Bulk Drug Parks. Information on Indicated Common infrastructure facilities and assistance, please refer the Notification.
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Tenure of the Scheme: 2020-2021 to 2024-2025
2) No.31026/16/2020-Policy on Production Linked Incentive (PLI) Scheme for promotion of domestic manufacturing of KSMs, Drug Intermediates and API
A Drug Security Committee constituted by the Department of Pharmaceuticals collated the details of KSMs/APIs for which country is heavily dependent on imports. DoP further constituted a Technical Committee and the Committee has made various recommendations and identified 53 KSMs/APIs based on the therapeutic criticality, essentiality, technology involved and feasibility to manufacture indigenously. Please refer the attachment for List of 53 products (Annexure A).
Quantum of Incentive: Support for Six years for fermentation-based products (first four years @ 20%, fifth year at 15% and sixth year at 5%) and five years for chemically synthesized products (at 10 %) on incremental sales of KSMs/Drug Intermediates/APIs.
Target Segments: As listed in Annexure B.
Eligibility & Tenure of the Scheme: Support under the Scheme shall be provided only to the manufacturers of critical KSMs/Drug Intermediates and APIs in India. The tenure of the scheme will be for a period of eight years from 2020-21 to 2027-28 subsequent to the base year.
A total outlay of Rs. 6940 crores will be provided as an incentive during the tenure of the Scheme.
Members are requested to kindly view the Notifications of the Department of Pharmaceuticals for more information. Copies of the Notifications are enclosed for your ready reference and information.
With regards,
Uday Bhaskar
Director General
Encl: Attach_1
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