The Indian government has launched the “Scheme for Promotion of Bulk Drug Parks” to reduce the manufacturing cost of bulk drugs, encourage self-reliance, and enhance the competitiveness of the domestic pharmaceutical industry. By establishing world-class shared infrastructure facilities, the scheme aims to support bulk drug units and streamline the pharmaceutical supply chain. This article offers an overview of the scheme’s objectives, key provisions, and focus areas.
Objective: Enhancing Competitiveness and Self-Reliance
The primary objectives of the Scheme are:
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To lower the manufacturing cost of bulk drugs.
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To enhance India’s self-reliance in bulk drug production by making the domestic industry more competitive.
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To enhance the environmental compliance of the pharmaceutical industry with new and innovative waste management systems.
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To facilitate economies of scale by optimizing resource utilization.
Key Components: Shared Infrastructure and Strategic Support
The scheme focuses on establishing three bulk drug parks across the country. These parks would have shared infrastructure, such as:
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Central Effluent Treatment Plants
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Solvent Recovery and Distillation Plants.
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Steam Generation and Distribution Systems.
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Common Logistics Facilities
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Advanced Testing Centers
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Other essential infrastructure.
Funding and Duration: A Significant Government Investment
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The scheme has a total financial outlay of Rs. 3,000 crore.
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The financial assistance provided under the scheme will cover 70% of the project cost for establishing shared infrastructure, or 90% for North Eastern and Hilly States/UTs (Himachal Pradesh, Uttarakhand, Jammu and Kashmir, and Ladakh). The maximum assistance per bulk drug park is limited to Rs. 1000 crore.
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The scheme’s duration is from Financial Year 2020-21 to 2024-25.
Implementation: A Multi-Layered Approach
The scheme involves several key players:
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State Implementing Agencies (SIAs): Responsible for implementing the approved project of each selected bulk drug park at state level.
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Scheme Steering Committee (SSC): Headed by the Secretary of Department of Pharmaceuticals (DoP), the SSC approves project proposals and monitors progress. The SSC consists of members from Ministry of Environment, Forest and Climate Change, Ministry of Commerce, Ministry of Chemicals and Fertilizers and various other officials.
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Project Management Agency (PMA): A Nodal Agency acts as the PMA and is responsible for the secretarial, managerial, and implementation support.
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State Level Technical Management Committee (SLTMC): This committee reviews project proposals to avoid duplication, and is chaired by State Principal Secretary of the related department.
Selection and Approval: Ensuring Eligibility and Feasibility
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Applications are invited from manufacturers registered in India.
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The initial screening process involves technical feasibility and compliance with guidelines.
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A detailed evaluation of each project is carried out by the PMA, after which proposals are submitted to the SSC.
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The approval process involves a multi-level assessment by various bodies.
Incentives and Support: Facilitating Growth
The scheme aims to provide incentives to help lower the manufacturing cost of bulk drugs and thereby increasing competitiveness of domestic drug manufacturers. The government supports this goal by establishing shared facilities that have high capital costs for companies.
Expected Outcomes: Enhancing Competitiveness and Self-Reliance
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Reduced manufacturing costs for bulk drugs in India.
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Increased competitiveness of the domestic bulk drug industry.
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Improved access to quality testing and infrastructure.
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Environmentally sound waste management practices.
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Reduced dependence on imports, enhancing self-reliance.
Conclusion
The “Scheme for Promotion of Bulk Drug Parks” is a significant stride towards strengthening India’s pharmaceutical capabilities. By promoting state-of-the-art infrastructure and reducing production costs, the scheme strives to make India a self-reliant hub for bulk drug manufacturing and improve the accessibility of affordable and essential medicines.