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Biopharma SHAKTI Strategy with ₹10,000 Cr Outlay to Boost Biosimilars Using Non-Animal Methodologies (NAMs)

Target:UPSC GS-IIIMPSCSSC GATeachingPrelims HighMains MediumStatic GK Link
25 Mar 2026
~2 min
Source: The Hindu
Key Data:₹10,000 crore2006 Northwick Park Tragedy2026 Union Budget
Bodies:CDSCOCPHMSDBTICMR
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What This Article Covers

1.Biopharma SHAKTI is a ₹10,000 crore strategy announced in the 2026 Union Budget to boost domestic biologics and biosimilars.

2.It promotes Non-Animal Methodologies (NAMs) like organoids and organ-on-chip, which are more predictive than animal models for complex biologics.

3.Key challenges include regulatory clarity from CDSCO, patent evergreening, and translating academic NAM research into industry-ready applications.

The Big Picture
Prelims · HighMains · Medium

The 2026 Union Budget's Biopharma SHAKTI strategy, with ₹10,000 crore, aims to boost domestic biologics and biosimilars production. It promotes Non-Animal Methodologies (NAMs) like organ-on-chip to overcome the unreliability of animal testing, a shift critical for India's pharmaceutical innovation and regulatory modernization.

Exam Lens

Quick Exam Facts From News

Biopharma SHAKTI Outlay₹10,000 crore
Announced In2026 Union Budget
Regulatory Body for BiosimilarsCentral Drugs Standard Control Organisation (CDSCO)
Tragedy Highlighting Animal Model Failure2006 Northwick Park Tragedy

1-Minute Revision

  • ›Biopharma SHAKTI Outlay: ₹10,000 crore
  • ›Announced In: 2026 Union Budget
  • ›Target this Data: ₹10,000 crore outlay for Biopharma SHAKTI.
  • ›Target this Nodal Body: Central Drugs Standard Control Organisation (CDSCO) for biosimilar approvals.
  • ›Target this Event: 2006 Northwick Park Tragedy highlighting animal model failure.

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Practice exam-style questions, track your score, and strengthen your recall.

Q1Static LinkageEasy

Which regulatory body in India grants approval for biosimilars before they are commercialised, as mentioned in the article?

Q2Statement-basedHard

Consider the following statements regarding Biopharma SHAKTI and Non-Animal Methodologies (NAMs):

1. Biopharma SHAKTI is a strategy announced in the 2026 Union Budget with an outlay of ₹10,000 crore to boost domestic biologics.

2. Non-Animal Methodologies (NAMs) include animal models that are genetically modified to better replicate human biology.

3. A 2024 study in 'Cell' reported using a breast cancer-on-chip model to study the effectiveness of CAR T-cell therapy against solid tumours.

Which of the statements given above is/are correct?

Q3Data-centricMedium

What is the total financial outlay announced for the Biopharma SHAKTI strategy in the 2026 Union Budget, as per the article?

Q4Application/ImpactMedium

What is a primary challenge associated with 'patent evergreening' in the context of biosimilars, as discussed in the article?

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