New Delhi, 16-10-2025 — India’s drug regulator (CDSCO) has invited stakeholder comments on whether and how to “ensure a level playing field” when several applicants file for approval of the same new drug and only the first applicant bears the cost of local clinical trials while later applicants obtain approval on bioequivalence (BE) alone. The notice flags that this creates a cost gap between the first and subsequent applicants and seeks views to “remove the discrepancy” and encourage development. Submissions are requested within 30 days of the circular.
What the CDSCO Notice Says: New Drug Approval
Under India’s New Drugs & Clinical Trials Rules, 2019, local clinical trials are generally required for new drugs approved elsewhere (with waivers possible). When multiple Indian applicants file for the same new drug, CDSCO may permit trials/BE for more than one sponsor. In practice, the first applicant often completes the trial and wins new drug approval; subsequent applicants can then be cleared with chemistry/pharma data and BE only.The agency is working on solutions to restore balance.
How Major Regulators Deal with "First vs. Subsequent" Applicants: Global Drug Approval Systems
| Jurisdiction | Is local clinical trial normally required for follow-ons? | Incentive for “first generic”? | Innovator data/market protection (baseline) | Notes & sources |
| United States (FDA) | No (ANDA relies on BE to RLD) | Yes: 180-day Hatch-Waxman exclusivity for first-to-file Para IV; separate 180-day CGT exclusivity for drugs with limited competition. | Separate frameworks (e.g., 12 yrs for biologics; various exclusivities). | FDA guidance on 180-day exclusivity; FDA CGT explainer. |
| EU/EEA (EMA) | No; BE-based generics | No first-generic exclusivity | “8+2+1” (8 yrs data + 2 yrs market + possible +1 yr) | EMA material and Article 14(11) Reg. 726/2004. (Note: reforms are under negotiation). |
| United Kingdom (MHRA) | No; BE-based generics | No first-generic exclusivity | EU-style data & market exclusivity transposed to UK law; NI follows EU rules. | MHRA guidance on DME and RMPs post-Brexit. |
| Canada (Health Canada) | No; BE-based generics (after “no-file” window) | No first-generic exclusivity | 8 years data protection + 6-month pediatric; 6-year “no-file” for follow-ons. | Health Canada guidance & register. |
| Australia (TGA) | No; BE-based generics | No first-generic exclusivity | 5 years protection for new active ingredient under Therapeutic Goods Act s25A. | TGA guidance/Act references. |
| Japan (PMDA/MHLW) | Generics cannot be approved during originator re-examination window | No first-generic exclusivity | Re-examination (typically 6–8–10 years depending on category) creates de facto exclusivity. | PMDA/Japan materials on re-examination. |
| South Korea (MFDS) | Historically via re-examination; from Feb 21, 2025 a formal data-protection regime applies | No first-generic exclusivity | Up to 10/6/4 years depending on drug type (e.g., 10 for orphan; 6 for new drug). | Law-firm summaries; MFDS pages. |
| China (NMPA) | BE-based generics; draft rules propose structured data exclusivity | Draft includes protection for first-to-market generics in China | Up to 6 years data exclusivity proposed (draft for comments, 2025). | NMPA draft summaries (status: proposed, not final). |
| Singapore (HSA) | No local trials; strong reliance pathways (Abridged/Verification) + BE for generics | No first-generic exclusivity | EU-/US-style reliance on reference agencies; no separate data-exclusivity statute for generics | HSA evaluation/BE guidance. |
| South Africa (SAHPRA) | No local trials; BE-based generics | No first-generic exclusivity | No statutory data-exclusivity; generics proceed on BE & quality | SAHPRA BE guidance; expert overview noting absence of data exclusivity. |
| ICH E5 / E17 (global good practice) | Encourages accepting foreign data with bridging (E5) and well-designed MRCTs (E17) | — | — | Benchmark guidance often used to justify waivers to duplicative local trials. |
Why India’s Debate Is Different: Drug Approval Cost Discrepancy
India’s situation arises because local clinical trials can be required before first approval of a new drug, even if approved abroad. When multiple Indian companies apply at once, the first applicant may run the trial while Others depend on BE to secure approval as “subsequent” applications lowering their regulatory drug approval cost discrepancy relative to the first mover.
By comparison, the US/EU/UK/Canada/Australia typically reserve regulatory exclusivities for innovators (data/market protection), not for the first generic. Only the US offers a time-limited reward to the first generic (180-day exclusivity), designed to spur patent challenges not to compensate for running local trials (which aren’t required for generics).
Asia examples show two models: Japan uses a re-examination period (up to ~10 years) that blocks generics; Korea moved in 2025 to a formal data-protection regime that runs independently of re-examination. China has drafted measures proposing up to 6 years of data exclusivity (including protection for the first-to-market generic) but these are not yet final.
What policy levers others use (menu India could study)
- Reward the first generic (U.S. model): A short, automatic exclusivity (e.g., 180 days) for the first approved “subsequent applicant” could offset first-mover costs.
- Strengthen reliance on global trials (ICH E5/E17): Broader, criteria-based waivers or bridging could reduce duplicative local trials while preserving safety for India-specific sub-populations.
- Clarify data/market protection (EU/UK/Canada/Australia models): Exclusivity applies to innovators, not generics; it prevents regulatory reliance on the originator’s data for a fixed period, after which all generics (not just first-movers) can file/launch per BE rules.
- Hybrid options (Korea/China trajectories): Time-bound data protection tied to category (orphan, pediatric, “new drug”, etc.) and independent of post-marketing surveillance, with clear start/stop triggers and transparency.
How to respond
Stakeholders have 30 days from issuance to comment to CDSCO (emails listed in the circular). The agency says it will deliberate the issue with stakeholders and other departments before a decision.
References
- United States (FDA): Guidance: 180-Day Generic Drug Exclusivity · Competitive Generic Therapies (CGT) overview · CGT guidance (PDF). U.S. Food and Drug Administration+2U.S. Food and Drug Administration+2
- EU/EEA (EMA): Glossary: Data exclusivity (“8 years”) · Data exclusivity / market protection explainer (slides). European Medicines Agency (EMA)+1
- United Kingdom (MHRA): Reference Medicinal Products (DME rules) · Biosimilars guidance (confirms 8+2). GOV.UK+1
- Canada (Health Canada): Guidance: Data Protection under C.08.004.1 · Register of Innovative Drugs. Government of Canada+1
- Australia (TGA): Explainer: Data protection scheme (notes 5-year protection & s.25A) · Therapeutic Goods Act 1989, s.25A. Therapeutic Goods Administration (TGA)+1
- Japan (PMDA/MHLW): “Matters related to re-examination period” (English PDF) · Re-examination (PMDA page, JP). PMDA+1
- South Korea (MFDS): Guideline on Re-Examination of New Drugs (English page) · (Update: new data-protection regime from Feb 21, 2025—law-firm summary) Kim & Chang overview. mfds.go.kr+1
- China (NMPA — draft policy): Ropes & Gray: Draft “Implementation Measures for Drug Trial Data Protection” (overview). ropesgray.com
- Singapore (HSA): Evaluation routes (overview) · Generic applications: BE & SRP Q&A · Abridged route for new drugs. HSA+2HSA+2
- South Africa (SAHPRA): Quality & Bioequivalence Guideline · Biostudies (BE) guideline PDF. SAHPRA+1
- ICH (global good practice): ICH E5 (R1): Ethnic factors / bridging · ICH E17: Multi-Regional Clinical Trials (PDF). European Medicines Agency (EMA)+1