Why in the News
The Government has announced the Biopharma SHAKTI Scheme with an outlay of ₹10,000 crore (5 years) to strengthen India’s biopharmaceutical ecosystem and enhance global competitiveness.
What is Biopharma SHAKTI?
- A flagship initiative to:
- Promote biologics and biosimilars manufacturing
- Support R&D, clinical trials, and innovation
- Goal: Make India a global biopharma hub and ensure affordable healthcare
Key Objectives
- Build a self-reliant biopharma ecosystem
- Reduce import dependence
- Improve global competitiveness
- Promote innovation-driven manufacturing
Major Components of the Scheme
- Funding Support: Discovery Grant Fund and Equity Fund for drug development
- R&D Ecosystem
- Strengthening: National Institute of Pharmaceutical Education and Research (NIPER)
- Creation of a National Biopharma R&D Network
- Clinical Trials Expansion
- 1,000 accredited trial sites across India
- Led by Indian Council of Medical Research (ICMR)
- Manufacturing Boost
- Incentives for: Fermentation-based bulk drugs and Biopharma manufacturing inputs
- Devices & Packaging
- Develop ecosystem for: Drug delivery devices and Advanced packaging.
- Biosimilars & Biologics Production: Biosimilars (cost-effective versions of biologics) and Emerging biologics like gene therapies.
- Regulatory Strengthening: Strengthen Central Drugs Standard Control Organisation (CDSCO)
- Create scientific review cadre
- Faster and globally credible approvals
What are Biologics & Biosimilars?
- Biologics: Medicines derived from living organisms (e.g., vaccines, monoclonal antibodies)
- Biosimilars: Cheaper versions of biologics with similar efficacy
- Not identical (due to complexity of biologics)
- Must show no clinically meaningful differences in safety, purity, and effectiveness
| [2025] With reference to monoclonal antibodies, consider the following: 1. They are man-made proteins. 2. They stimulate the patient’s immune system to fight the specific disease. 3. They are produced using animal cells only. Select the correct answer using the code given below: (a) I and II only (b) II and III only (c) I and III only (d) All the three |
