The government plans to roll out the Rs 10,000-crore Biopharma Shakti scheme – announced in the Union Budget – within the next three months after securing Cabinet approvals. The scheme focuses on speeding up regulatory approvals in addition to supporting start-ups and contract manufacturers. In an interview with FE’s Manu Kaushik, Department of Pharmaceuticals (DoP) Secretary Manoj Joshi said the government is open to considering price hike requests from drugmakers if the companies can demonstrate genuine cost escalation affecting supplies. Edited excerpts:
FE: The government has been working on the Biopharma Shakti scheme for some time. Where does it stand now, and what can the industry expect regarding policy guidelines?
Manoj Joshi: The proposal is ready and is being taken for approval. Subject to approvals, we expect the policy guidelines to be ready in around three months.
The scheme is not just about funding. We are trying to build an entire innovation ecosystem for biological drug discovery. It will cover faster regulatory approvals, funding support for start-ups and large industry, contract research and development organisations (CRDMOs), small-scale GMP manufacturing facilities for clinical trials, and measures to strengthen the biologics ecosystem. Our objective is to reduce both the cost and time required to develop new drugs in India.
FE: What are the biggest gaps that the policy seeks to address?
Joshi: Biological drug discovery requires much more than capital. Start-ups need specialised scientific support, testing facilities, manufacturing infrastructure for clinical trial material and investors who understand biotechnology. Today, several of these capabilities are limited in India. The policy aims to fill these gaps by creating an ecosystem where innovators can discover new molecules using AI, test them, manufacture them for clinical trials and raise funding within India instead of depending on overseas facilities.
FE: The government recently allowed price relaxations for a few medicines by invoking Paragraph 19 of the Drug Prices Control Order. Will more applications be considered?
Joshi: We remain open to considering requests where companies provide detailed evidence of significant rise in production costs that could affect drug availability. We have moved away from cost-plus pricing and do not intend to return to it. But where there is a genuine risk to availability because of cost escalations, which is supported by credible data, we are ready to examine such cases.
FE: The government is also reviewing the Global Tender Enquiry (GTE) exemption list for medical devices. What is the thinking behind this exercise?
Joshi: The objective is to maintain the right balance between encouraging domestic manufacturing and ensuring hospitals continue to have access to advanced technologies that are not yet produced in India.
Manufacturing of sophisticated imaging equipment and robotic devices has increased after the PLI scheme, and domestic value addition is gradually improving. At the same time, technology keeps evolving globally. Wherever India is manufacturing competitively, those products should progressively move out of the exemption list, while products that are not made domestically should remain accessible through imports.
FE: What is your assessment of the implementation of the revised Schedule M manufacturing standards?
Joshi: Compliance is improving gradually. The decision taken by the government to not extend the implementation deadline beyond December 2025 was intended to encourage companies to upgrade their facilities. Companies that fail to comply will not be able to participate in government procurement. While some firms may struggle to meet the higher standards, the industry ultimately has to move towards better manufacturing standards. Government is committed to supporting the industry with skill upgradation and financial support.
FE: A recent NITI Aayog report highlighted India’s dependence on imported APIs, especially from China. How is the government addressing that challenge?
Joshi: Strengthening domestic API manufacturing remains a priority. The PLI scheme has made a beginning, but much more needs to be done. We need Research & Development for better production technologies with improved yields and lower costs, lower environmental impact and better infrastructure support. Whether assistance is provided through PLI or another mechanism, government support will continue because this is a priority area for us.
FE: How does the government plan to strengthen the National Institutes of Pharmaceutical Education and Research (NIPERs) to support India’s biopharma ambitions?
Joshi: The immediate focus is to align NIPERs with the country’s transition towards biologics. Historically, NIPERs have been oriented towards chemistry-based education, but we now need to build capabilities in biological sciences. Under the proposed Biopharma Policy, we intend to strengthen their capacity in biologics, and the three new NIPERs will have a stronger focus on this area.
FE: Can India realistically emerge as a global hub for outsourced drug discovery and early-stage innovation?
Joshi: We already have some capabilities, but they need to be strengthened. CRDMOs are a critical part of the biopharma ecosystem because they support both Indian and multinational companies. We intend to support this industry through faster regulatory approvals as well as financial assistance so that it can expand rapidly.
FE: You have often spoken about India’s need to move beyond generics. Is biologics now the government’s biggest priority?
Joshi: India developed considerable strength in chemistry-based pharma. Globally, innovation is increasingly shifting towards biologics and advanced therapies. India also has to move in that direction. Both the government and industry are gradually shifting their focus from traditional chemistry to biological innovation, especially in cancer and immune therapies.
FE: Artificial intelligence (AI) is becoming an important tool in drug discovery. How does the government plan to encourage its adoption?
Joshi: Indian companies have already begun using AI to shortlist molecules and accelerate drug discovery. We intend to support these efforts financially. AI can substantially reduce development timelines and costs. AI is also used to support clinical trials by reducing the number of patients, thereby reducing cost and time. Regulators must also build the capability to assess AI-assisted research and clinical development.
FE: Some companies argue that India’s “weak” patent and regulatory exclusivity framework discourages innovation. Do you agree?
Joshi: The issue has to be viewed in the context of the market a company is targeting. If a company is developing products primarily for the Indian market, domestic exclusivity provisions become important. But if the product is aimed at global markets, the regulatory and intellectual property framework in those markets matters much more. For drug discovery in India faster regulatory approvals are very important.