BACKGROUND: Drugs play a major role in healthcare delivery in the country. Continuous supply of drugs is necessary to ensure delivery of affordable healthcare to the citizens. Any disruption in supply of drugs can have significant adverse impact on drug security of the country.
The scheme is launched with a view to attain self-reliance and reduce import dependence in critical APIs.
Objective: The scheme intends to boost domestic manufacturing of identified KSMs, Drug Intermediates and APIs by attracting large investments in the sector and thereby reduce India’s import dependence in critical APIs.
SALIENT FEATURES:
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- It is a Central Sector Scheme.
- Scope: Under the Scheme, financial incentives are given based on sales made by selected manufacturers for 41 products (which cover all the identified 53 APIs).
- Quantum of Incentive: Financial incentive under the scheme shall be provided on sales of 41 identified products for six years at the rates given below:
- For fermentation based products, incentive for FY 2023-24 to FY 2026-27 would be 20%, incentive for 2027-28 would be 15% and incentive for 2028-29 would be 5%.
- For chemical synthesis based products, incentive for FY 2022-23 to FY 2027-28 would be 10%.
- Applicability: The scheme is applicable only for Greenfield projects.
- Eligibility: Support under the scheme shall be provided only to manufacturers of critical KSMs/Dis and APIs registered in India.
- Tenure of the Scheme: The tenure of the scheme is from FY 2020-21 to FY 2029-30.
- Implementation: The Scheme shall be implemented through a Nodal Agency. Such Nodal Agency shall act as a Project Management Agency (PMA) and be responsible for providing secretarial, managerial and implementation support. Industrial Finance Corporation of India (IFCI) Ltd. Will act as PMA.
- Review: Periodic review will be undertaken by the Empowered Committee (EC) with respect to the progress and performance of the scheme.
- Empowered Committee:
- CEO, NITI Aayog (Chairman)
- Secretary, Department of Pharmaceuticals
- Secretary, Department of Chemicals and Petrochemicals
- Secretary, Department for Promotion of Industry & Internal Trade
- Secretary, Department of Commerce
- Secretary, Ministry of Environment, Forest and Climate Change
- Secretary, Department of Health & Family Welfare
- Experts may be invited as special invitees, as may be felt necessary, from time to time
POINTS TO KNOW |
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| Key Starting Material (KSM): |
Drug intermediates: |
Active pharmaceutical ingredients (APIs): |
| A raw material, intermediate or an API that is used in the production of an API and that is incorporated as a significant structural fragment into the structure of the API. |
These are the drugs used as raw materials for the production of bulk drugs, or they can refer to a material produced during synthesis of an API that must undergo further molecular change or processing before it becomes an API. |
These are the active components in a pharmaceutical drug that produce the required effect on the body to treat a condition. APIs are produced by processing chemical compounds. APIs are broadly categorized into two types – synthetic and natural. Synthetic APIs are further classified into innovative and generic synthetic APIs, based on the type of synthesis used. |
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