India Launches Rs. 10,000 Crore Biopharma Shakti Initiative and Exempts 17 Cancer Drugs from Import Duties
核心洞察
India's Union Budget 2026-27 introduces Biopharma Shakti, a Rs. 10,000 crore initiative over five years aimed at establishing India as a global biopharmaceutical manufacturing hub.
The budget exempts 17 critical cancer (搜索) drugs including ribociclib and abemaciclib from basic customs duty, bringing the total number of duty-exempt medicines to 129.
Seven additional rare diseases have been added to the duty exemption list for personal imports of medicines, expanding coverage under the National Policy for Rare Disease 2021.
Union Finance Minister Nirmala Sitharaman announced the launch of Biopharma Shakti (Strategy for Healthcare Advancement through Knowledge, Technology and Innovation) with an allocation of Rs. 10,000 crore over the next five years, marking a significant step toward establishing India as a global biopharmaceutical manufacturing hub. The initiative forms part of the government's broader strategy to scale up manufacturing in seven strategic and frontier sectors.
Comprehensive Biopharmaceutical Infrastructure Development
The Biopharma Shakti initiative will build a comprehensive ecosystem for domestic production of biologics and biosimilars. "Biologic medicines are key to longevity and quality of life at affordable costs. To develop India as a global Biopharma manufacturing hub, I propose the Biopharma Shakti with an outlay of Rs. 10,000 crore over the next 5 years," Sitharaman stated in her budget speech.
The strategy encompasses establishing a Biopharma-focused network with three new National Institutes of Pharmaceutical Education and Research (搜索) (NIPER) and upgrading seven existing ones. Additionally, the initiative will create a network of over 1,000 accredited India Clinical Trials sites to strengthen the country's research capabilities.
Regulatory Framework Strengthening
The budget proposes significant strengthening of the Central Drugs Standard Control Organisation (搜索) to meet global standards and approval timeframes through a dedicated scientific review cadre and specialists. This regulatory enhancement aims to streamline drug approval processes and align with international best practices.
Expanded Access to Critical Cancer Therapies
The Union Budget 2026-27 exempts basic customs duty on 17 critical drugs and medicines, particularly benefiting cancer (搜索) patients. The newly exempted drugs include ribociclib, abemaciclib, talycabtagene autoleucel (搜索), tremelimumab, venetoclax, ceritinib, brigatinib, darolutamide, toripalimab, serplulimab, tislelizumab, inotuzumab ozogamicin, ponatinib, ibrutinib, dabrafenib, trametinib, and ipilimumab.
With this addition, the total number of drugs exempted from basic customs duty has reached approximately 129, significantly expanding patient access to life-saving treatments.
Rare Disease Coverage Expansion
Seven additional rare diseases have been added to the exemption list for import duties on personal imports of drugs, medicines, and Food for Special Medical Purposes (FSMP). The newly included conditions are congenital hyperinsulinemic hypoglycemia (搜索) (CHI), familial homozygous hypercholestrolemia (搜索), alpha mannosidosis (搜索), primary hyperoxaluria (搜索), cystinosis (搜索), hereditary angioedema (搜索), and primary immune deficiency disorders (搜索). All seven diseases are part of the National Policy for Rare Disease (NPRD), 2021.
Healthcare Budget Allocation
The Union Budget 2026-27 allocated Rs. 1,06,530.42 crore to the Ministry of Health and Family Welfare, reflecting an increase of nearly 10% over the Revised Estimates of FY 2025-26. This enhanced allocation represents a cumulative increase of over 194%, translating into an additional Rs. 70,349.75 crore compared to the health budget of FY 2014-15.
Industry Response and Future Outlook
Rajiv Chhibber, Joint Forum Coordinator of the Association of Indian Medical Device Industry (搜索) (AIMED), commented that "policy steps such as rationalisation of duties on critical therapies including cancer (搜索) drugs and increased focus on assistive and patient-centric technologies reinforce the government's commitment to accessible and advanced healthcare."
The initiative positions India to transition from import substitution to global MedTech leadership while supporting national healthcare priorities. With continued policy-industry alignment, India aims to leverage global economic engagement through FTAs with key regions including Europe and other strategic partners.
Streamlined Regulatory Processes
The budget also addresses regulatory efficiency by proposing that approvals required for cargo clearance from various government agencies will be seamlessly processed through a single and interconnected digital window by the end of the financial year. Processes involved in clearance of food, drugs, plant, animal and wildlife products, accounting for around 70 percent of interdicted cargo, will be operationalized on this system by April 2026.