The promise of lenacapavir
Regulatory challenges
- The Central Drugs Standard Control Organisation (CDSCO) must evaluate and approve the generic versions for domestic sale and export, which involves validating data, inspecting plants, and assessing safety and efficacy.
- Once India approves, issuing a Certificate of Pharmaceutical Product (CPP) or moving towards WHO pre-qualification will allow recipient countries to rely on Indian assessments, speeding up imports and local approvals.
- Scaling injections requires cold-chain storage, trained health workers, and monitoring systems — all of which take time to set up.
- Robust global trial data is already available, which could allow Indian regulators to waive the need for local trials.
How long could approval take?
- Data submission and review (6–12 months): Indian firms must file manufacturing and stability data for CDSCO review.
- Plant inspections (6–12 months): Inspectors verify Good Manufacturing Practices (GMP).
- Domestic approval and CPP issue (up to 1 year): CPPs are needed before export.
- WHO pre-qualification (12–24 months): This enables automatic reliance by 115 countries.
- Commercial launch (2027 target): On standard timelines, rollout is expected around 2027 — but acceleration by CDSCO or WHO could cut years.
Delays could cost lives
Keeping costs low
- Gilead Sciences has waived royalty payments for licensed generics in 115 countries, removing a major cost barrier.
- With potentially millions of users worldwide, manufacturers can spread fixed costs like factory setup, quality checks and regulatory filings over large volumes, driving down per-dose costs.
- Organisations such as Unitaid, the Gates Foundation and the Clinton Health Access Initiative (CHAI) are providing funding and technical assistance for technology transfer, approvals and scale-up.
- India’s strong generics industry, lower labour costs and established manufacturing base make large-scale affordable production feasible.
National programme inclusion
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