How to Apply for the PLI Scheme for Manufacturing Bulk Drugs in India?

The Government of India has implemented the Production Linked Incentive (PLI) scheme for bulk drugs with the objective of enhancing domestic manufacturing capacities in the pharmaceutical industry. This initiative aims to strengthen the manufacturing ecosystem within the country. The scheme focuses on promoting the manufacturing of key starting materials (KSMs), drug intermediates (DIs), and active pharmaceutical ingredients (APIs), which are critical components in the pharmaceutical supply chain.

The scheme aims to reduce dependence on imports and promote self-sufficiency by providing financial incentives to eligible manufacturers of identified bulk drug products. Manufacturers are incentivized to make investments in cutting-edge infrastructure, embrace advanced technologies, and strive for increased value addition in their production processes. By meeting specific eligibility criteria and complying with quality standards, recipients of the PLI scheme can benefit from financial incentives that support their growth and competitiveness in the industry. It is crucial to understand the various aspects of the PLI scheme, including eligibility criteria, incentives, challenges, and the potential impact on the pharmaceutical landscape in India.

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Why apply for the PLI scheme?

Apart from providing significant financial incentives to eligible manufacturers, to help offset the costs of infrastructure development, technology adoption, and production enhancements; recipients of the Production Linked Incentive (PLI) scheme for bulk drugs in India can benefit from a range of other advantages and opportunities.

• Recipients can improve their competitiveness in the domestic and global markets. The scheme encourages recipients to invest in advanced manufacturing technologies, achieve higher value addition, and meet quality standards. This enhances their ability to produce high-quality bulk drugs at competitive prices, making them more attractive to customers and stakeholders.
• The PLI scheme promotes collaboration between industry players, research institutions, and academia. Recipients can benefit from partnerships and knowledge-sharing, leading to synergistic outcomes, improved capabilities, and accelerated innovation.
• The PLI scheme aims to reduce dependence on imports and enhance domestic manufacturing capabilities. By participating in the scheme, recipients can increase their market share by capturing a larger portion of the domestic demand for bulk drugs. This can lead to business growth, expansion, and the establishment of a stronger market presence.
• By manufacturing critical bulk drug products domestically, recipients of the PLI scheme contribute to reducing dependence on imports. This enhances self-reliance, strengthens the pharmaceutical supply chain, and improves the country's resilience in times of disruptions or global market uncertainties.
• The PLI scheme incentivizes recipients to invest in research and development activities, fostering innovation and technological advancements. By allocating resources to R&D, recipients can develop new and improved products, enhance manufacturing processes, and stay at the forefront of industry developments. This can lead to long-term sustainability and competitive advantage.

What are some Key Obligations as a Recipient?

Under the PLI Scheme, the manufacturers are expected to fulfil certain obligations in order to remain eligible for complete benefits of the scheme and avoid penalties which may also impact the company’s reputation.

• It is necessary to ensure that the company meets all the eligibility criteria specified under the PLI scheme, such as minimum investment requirements, production targets, and technical specifications. Failure to comply with these criteria may result in disqualification or withdrawal of incentives.
• Fulfil the production targets specified under the PLI scheme. This may involve manufacturing a certain volume of bulk drugs or achieving specific value additions within the defined timeframes.
• Ensure that the bulk drugs manufactured meet the required quality standards, including compliance with Good Manufacturing Practices (GMP) and relevant regulatory guidelines. Maintain appropriate quality control measures and undergo periodic inspections or audits as required.
• Maintain accurate records and submit periodic reports to the designated authorities as per the PLI scheme's guidelines. This may include production details, investment details, employment generation, and other relevant information.
• Adhere to all applicable environmental and safety regulations while setting up and operating the manufacturing facilities. Implement appropriate waste management practices, pollution control measures, and occupational health and safety standards.
• Utilise the incentives received under the PLI scheme in accordance with the guidelines and objectives of the scheme. Ensure transparent utilisation of funds and provide necessary documentation or reports as requested by the authorities.

How to Pitch for the Scheme?

A manufacturer may need to provide a convincing pitch to the authorities in order to enjoy the benefits of the PLI scheme for the Bulk Drugs Industry in India. Here are some essential steps to pitch for the PLI scheme:

• Research the PLI scheme for Bulk Drugs Industry: Before you pitch for the PLI scheme, make sure to understand the objectives, requirements and eligibility of the scheme.
• Highlight your company's capabilities: It is important to highlight your company's experience, expertise, and capabilities in the field of Bulk Drugs. It is important to share the company's track record, production capacity, and quality standards to demonstrate your ability to meet the production targets under the PLI scheme
• Present your investment and production plans: The PLI scheme for the Bulk Drugs Industry is designed to encourage investments in its manufacturing in India. Therefore, clearly presenting investment plans, including the amount of investment, the sources of funding, and the timeline for investment is necessary. Also, a clear outline of the production plans and plan to achieve the targets can be beneficial.
• Emphasise the benefits of the PLI scheme: Highlighting the benefits of the PLI scheme for the Bulk Drugs Industry and how it will help you scale up your manufacturing operations is important.

Process of Application and Disbursement of Incentives:

The Production-Linked Incentive (PLI) scheme for  is an initiative by the Indian government to promote its manufacturing in India. To apply for the PLI scheme for the Bulk Drugs Industry, an eligible manufacturer may follow the following steps-

• Register on the PLI portal: You can visit the PLI portal (https://pli-eda.gov.in) and create an account by providing your basic details.
• Fill in the application form: The application form may require you to provide details such as your company name, address, production targets, investment plans, etc.
• Upload the required documents: You may also need to upload certain documents such as company registration certificate, PAN card, GST registration, etc.
• Submit the application: After filling in the application form and uploading the required documents, you can submit your application for the PLI scheme for bulk drugs.
• Wait for approval: Once you have submitted your application, it will be reviewed by the PMA. If your application is approved, the incentives shall disburse after completion of all pre-disbursal formalities.

The PLI scheme for bulk drugs is a government initiative to promote domestic manufacturing of bulk drugs and APIs. As a recipient, you must comply with eligibility criteria, establish manufacturing facilities on time, meet production targets, and ensure quality through adherence to regulatory guidelines. This comprehensive overview will provide insights into the significance of the PLI scheme and its role in driving the growth and competitiveness of the bulk drugs sector in India.