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GOVERNMENT OF INDIA
MINISTRY OF CHEMICALS AND FERTILIZERS
DEPARTMENT OF PHARMACEUTICALS
LOK SABHA
STARRED QUESTION NO. †*419
TO BE ANSWERED ON THE 20TH MARCH, 2026
Biopharma Shakti Scheme
†*419. Shri Bidyut Baran Mahato:
Smt. Aparajita Sarangi:
Will the Minister of CHEMICALS AND FERTILIZERS be pleased to state:
(a) the details of allocation and the proposed distribution of funds under the Biopharma Shakti
Scheme over the next five years, year-wise;
(b) the steps taken/proposed to be taken for establishment of recognized clinical trial sites in
the country including Chhattisgarh and the expected outcomes thereof;
(c) the steps taken to strengthen the regulatory framework, including capacity building of the
Central Drugs Standard Control Organization (CDSCO) for expeditious approval of biologics
and biosimilars; and
(d) the process likely to be followed to reduce import dependency and increase India's share in
the global biopharmaceutical market through the said scheme?
ANSWER
THE MINISTER IN THE MINISTRY OF CHEMICALS AND FERTILIZERS
(SHRI JAGAT PRAKASH NADDA)
(a) to (d): A statement is laid on the Table of the HouseStatement referred to in reply to the Lok Sabha Starred Question No. †*419 (19th
Position) for answer on 20.03.2026, raised by Shri Bidyut Baran Mahato and Smt.
Aparajita Sarangi, regarding “Biopharma Shakti Scheme”
With a view to strengthen the domestic biopharmaceutical sector and enhance global
competitiveness in biologics and biosimilars, the Government has announced the Biopharma
SHAKTI scheme with an outlay of ₹10,000 crore over five years with an objective to build a
globally competitive domestic ecosystem for biologics and biosimilars to support affordable
healthcare in India and enable India to emerge as a global biopharma manufacturing and
innovation hub. The contours of the scheme are under deliberation.
Under the scheme, it is envisaged to enable faster, globally credible approvals by strengthening
the CDSCO through creation of a dedicated Scientific Review Cadre of reviewers and specialist
positions for advanced fields like gene therapy. It is also envisaged to expand India’s clinical
research footprint by creating a nationally accredited network of 1,000 clinical trial sites under
ICMR.
The Biopharma SHAKTI initiative envisages to build the ecosystem for domestic production
of biologics and bio-similars. Further by supporting research and development, strengthening
clinical trial infrastructure and promoting collaboration between academia, research
institutions and industry, the Scheme seeks to encourage domestic innovation and
manufacturing capabilities in the biopharmaceutical sector. Such initiatives are expected to
contribute towards reducing import dependence over time and enhance India’s participation in
the global biopharmaceutical market.
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