India amends Drugs Rules 1945 to regulate cell and gene therapy products as new drugs
Cell and gene therapy developers, manufacturers and importers in India must now meet the new-drug approval, clinical-trial and licensing requirements under the 2019 Rules — the amended Drugs Rules 1945 regulate these products as new drugs
Change
The Ministry of Health & Family Welfare, on the recommendation of the Central Drugs Standard Control Organisation (CDSCO), has amended the Drugs Rules, 1945 to regulate Cell and Gene Therapy Products (CGTPs) as 'new drugs' under the New Drugs and Clinical Trials Rules, 2019, creating a uniform national framework for their approval, clinical trials, manufacture and import.
Why it matters
The amendment closes a regulatory gap by placing advanced cell-based and gene-based therapies on the same footing as new drugs, so their development, manufacture, import and marketing run through CDSCO's new-drug approval and clinical-trial regime rather than fragmented or ad-hoc oversight. For developers and manufacturers this establishes a single national standard and pathway; for the regulator it provides a consistent basis to assess the safety, quality and efficacy of these products. The framework applies uniformly across the country, replacing inconsistent treatment of these therapies across jurisdictions.
Implications
- — Cell and gene therapy developers and manufacturers in India must obtain the approvals required for a 'new drug' under the New Drugs and Clinical Trials Rules, 2019 — including CDSCO clinical-trial authorisation and marketing approval — before their products can be lawfully developed, manufactured or marketed under the amended framework.
- — Importers and sponsors bringing cell or gene therapy products into India must route them through the new-drug regulatory pathway administered by CDSCO, because the amendment regulates these products as new drugs nationwide rather than under fragmented state-level or ad-hoc treatment.
- — Manufacturers and developers of advanced therapies must apply a single national standard for the safety, quality and efficacy of cell and gene therapy products, replacing the previously inconsistent regulatory treatment with the uniform framework the amendment establishes.
Who is affected
- — Cell and gene therapy developers and manufacturers in India
- — Importers and clinical-trial sponsors of cell and gene therapy products
- — CDSCO and drug-regulatory functions administering the new-drug regime