Approvals and registrations
The table lists typical approvals for a manufacturer or importer. Times are statutory targets where a rule states one, not guarantees.
| Approval or registration | Authority and portal | When needed and typical time |
|---|---|---|
| Medical device import licence | CDSCO; the Drugs Controller General (India) is the Central Licensing Authority | Before importing for sale. Apply in Form MD-14 through an authorised agent appointed by the overseas maker under a power of attorney. Licences stay valid until suspended or cancelled, subject to fees. |
| Medical device manufacturing licence | Class A and B: State Licensing Authority. Class C and D: CDSCO | Before production. Devices are classed by risk from A (low) to D (high). For Class C and D, inspection is due within 60 days of application if the data is satisfactory. |
| Clinical trials and test licences | CDSCO, under the New Drugs and Clinical Trials Rules 2019 | Before trials or test batches. Amendments notified on 20 January 2026 (G.S.R. 46(E)) cut the statutory timeline for test licences from 90 to 45 days. |
| Good manufacturing practice (revised Schedule M) | State drug regulators, with CDSCO | Applies to every drug plant. The extended deadline for MSMEs with turnover below ₹250 crore ended on 31 December 2025; CDSCO has asked states to inspect and act against non-compliant units. |
| Price control | National Pharmaceutical Pricing Authority (NPPA), Department of Pharmaceuticals | From launch. Under DPCO 2013, ceiling prices apply to scheduled formulations, drawn from the National List of Essential Medicines 2022; device trade margins are also rationalised. |
| Marketing code | Department of Pharmaceuticals | From launch. The Uniform Code for Pharmaceutical Marketing Practices 2024, notified on 12 March 2024, sets ethical norms for dealings with healthcare practitioners. |
| Government-route FDI approval | Competent ministry (Department of Pharmaceuticals for pharma), via the Foreign Investment Facilitation Portal | Before closing, for brownfield pharma above 74% or where a land-border-country beneficial owner holds over 10% or control. |
Sources: CDSCO, Medical Devices FAQs; Akashvani, 28 Jan 2026; CliniExperts, 2026; India Briefing, 2025; Business Standard, 8 Nov 2025; DoP Annual Report 2025-26; DPIIT FDI Policy 2020.
Who regulates what
- CDSCO (Central Drugs Standard Control Organisation) is the national regulator. Its head, the Drugs Controller General (India), is the Central Licensing Authority for device imports and for Class C and D device manufacturing. CDSCO also administers clinical trials and test licences under the New Drugs and Clinical Trials Rules 2019.
- State Licensing Authorities and state drug regulators license Class A and B device manufacturing and enforce revised Schedule M at drug plants, working with CDSCO.
- NPPA (National Pharmaceutical Pricing Authority), under the Department of Pharmaceuticals, fixes ceiling prices under DPCO 2013 for scheduled formulations drawn from NLEM 2022, and has rationalised device trade margins.
- Department of Pharmaceuticals owns the marketing code and is the competent ministry for Government-route pharma FDI.
- IRDAI verifies health insurers; see FDI rules.
Importers: the authorised agent route
An overseas device maker that wants to sell in India without a plant appoints an authorised agent in India under a power of attorney. The agent applies to CDSCO in Form MD-14 for the import licence, which stays valid until suspended or cancelled, subject to fees. The importer skips the manufacturing steps of the set-up roadmap but still faces price control and the marketing code from launch.
Manufacturers: licensing by device class
Devices are classed by risk from A (low) to D (high). The class decides the licensing authority:
| Class | Licensing authority | Inspection |
|---|---|---|
| A (low risk) | State Licensing Authority | No statutory target stated in the sources |
| B | State Licensing Authority | No statutory target stated in the sources |
| C | CDSCO | Due within 60 days of application if the data is satisfactory |
| D (high risk) | CDSCO | Due within 60 days of application if the data is satisfactory |
Check: The brochure states the class-to-authority split and the 60-day inspection target for Class C and D. Confirm the current classification of each product against the CDSCO device classification list before applying.
Drug plants: revised Schedule M and test licences
Every drug plant must meet revised Schedule M good manufacturing practice. The extended deadline for MSMEs with turnover below ₹250 crore ended on 31 December 2025, and CDSCO has asked states to inspect and act against non-compliant units. A new plant should be designed to revised Schedule M from the start; the Revamped Pharmaceutical Technology Upgradation Assistance Scheme supported upgrades at existing units for FY2024-25 to FY2025-26 (see central incentives).
Test licences for test batches and clinical trials come from CDSCO under the NDCT Rules 2019. The amendments notified on 20 January 2026 (G.S.R. 46(E)) cut the statutory timeline for test licences from 90 to 45 days; the health ministry expects at least 90 days saved in drug development.
Prices and marketing from launch
Before launch, check whether each formulation is a scheduled formulation under DPCO 2013. Ceiling prices set by the NPPA apply to those drawn from the National List of Essential Medicines 2022. Promotional activity must follow the Uniform Code for Pharmaceutical Marketing Practices 2024, notified on 12 March 2024, which sets ethical norms for dealings with healthcare practitioners; industry associations handle complaints.
Hospitals
A hospital operator needs no manufacturing licence, but state health and facility rules apply. The approvals and timelines page covers the general registrations every Indian entity needs.
What to check next
- Classify each device from A to D and identify whether the state authority or CDSCO licenses it.
- For imports, appoint an authorised Indian agent under a power of attorney before filing Form MD-14.
- Build any new drug plant to revised Schedule M; for an acquired plant, confirm its compliance status since the 31 December 2025 deadline.
- Plan drug development timelines around the 45-day test-licence target.
- Map the portfolio against NLEM 2022 for DPCO 2013 ceiling prices, and align promotion with UCPMP 2024.