India drafts new drugs law to tighten pharma and medical-device oversight
The proposed Drugs, Medical Devices and Cosmetics Bill, 2026 would replace the 1940 law, strengthen the DCGI, establish dedicated device oversight and enable faster approvals, recalls and tougher action on counterfeit or substandard drugs.
What happened
Government of India · India plans a new Drugs, Medical Devices and Cosmetics Bill, 2026 to replace the 1940 law, strengthen the DCGI, create dedicated device
Key facts
- 86-year-old law
- Drugs and Cosmetics Act of 1940
- Draft Drugs, Medical Devices and Cosmetics Bill, 2026
- Boards to meet at least once every six months
- Nominated members to serve three years
Why this matters
Pharma and healthcare buyers may find stronger rationale to acquire device-regulatory, quality-control, serialization and compliant distribution capabilities ahead of the bill’s potential enactment.
What to watch
- Publication of the final bill text and whether medical devices receive a separate regulator, registration pathway or dedicated enforcement unit.
- Scope of expanded DCGI powers over inspections, recalls, online pharmacies, advertising, imports and supply-chain records.
- Rules for device classification, registration timelines, clinical evidence, quality-management standards and importer liability.
- Mandatory serialization, track-and-trace, e-prescription, batch-record retention or pharmacist documentation requirements.
- Enforcement actions against counterfeit or substandard drugs, especially raids, license suspensions, recalls and online marketplace takedowns.
- Industry feedback from pharmacy associations, domestic generic-drug makers, device importers and hospital groups.
- Parliamentary timetable, implementing rules, transition periods and state-level enforcement capacity.
- Audit supplier licenses, product registrations, batch-level traceability and recall clauses across drug, OTC, diagnostic and medical-device assortments.
- Prioritize direct sourcing from established manufacturers and authorized importers; reduce exposure to brokers and unverified secondary-market inventory.
- Build recall playbooks covering store-level quarantine, customer notification, reverse logistics, digital prescription records and regulator reporting.
- Increase quality-assurance capacity for private-label healthcare products, including vendor audits, stability testing, labeling review and adverse-event escalation.
- Model margin exposure from potential device registration costs, import compliance, product withdrawals and working-capital increases from tighter inventory controls.
- Use compliance credibility in consumer messaging and institutional sales pitches, emphasizing authenticated sourcing and recall readiness.