How medicines and medical devices get approved in India

The Drugs Controller, India, as the Central Licencing Authority, grants permission to import or manufacture a new drug that contains a molecule not yet approved in India. The rules give a 90 working day target for the decision. A separate import or manufacturing licence is needed after the permission.

Full application, new active substance · target 90 days · verified October 3, 2026

A drug already approved for some claims needs new permission before it is marketed with a new indication, dosage form, route of administration or strength. The application includes local clinical trial results unless waived.

Full or mixed application, known active substance · target 90 days · verified October 3, 2026

A fixed dose combination of two or more drugs is a new drug when the drugs are combined for the first time or the ratio changes. It needs permission from the Central Licencing Authority, with data from Table 1, 2 or 3 of the Second Schedule as fits the case.

Full or mixed application, known active substance · target 90 days · verified October 3, 2026

Drugs made abroad need a registration certificate for the foreign manufacturing site and each drug, and the importer needs an import licence. The foreign maker or its authorised agent in India applies to the licensing authority appointed by the central government. The rules set a nine month limit for issuing the certificate when the file is complete.

Other route · verified October 3, 2026

The Central Licencing Authority can waive the local clinical trial for a new drug already approved and marketed in countries it has specified. The countries named are the United States, the United Kingdom, Japan, Australia, Canada and the European Union. The waiver is used for five categories of drugs, and the applicant commits to a Phase IV trial in India.

Reliance route, abridged review · target 90 days · relies on AU, CA, EU, GB, JP, US · verified October 3, 2026

Accelerated approval can be granted for serious or life threatening conditions, rare diseases, diseases of special relevance to India, or unmet medical needs. Approval may rest on a surrogate endpoint, or on Phase II data when efficacy is remarkable. Post marketing trials then confirm the clinical benefit.

Conditional or accelerated approval · target 90 days · verified October 3, 2026

A sponsor can ask for an expedited review when clinical safety and efficacy are established even if not all trial phases are complete. The drug must treat a serious, life threatening or rare disease and offer a significant advantage. Orphan drugs and drugs for disaster or defense use can also qualify.

Priority or accelerated review · verified October 3, 2026

The rules define an orphan drug as one for a condition that affects not more than 500,000 people in India. Orphan drugs pay no fee for clinical trial applications, can use the expedited review, and can have the local trial or Phase IV requirement relaxed.

Orphan or rare disease designation · target 90 days · verified October 3, 2026

A medical officer of a government hospital or government medical institution can import a new drug not approved in India but approved in its country of origin, to treat a patient with a life threatening or seriously disabling disease or an unmet need. The authority decides within 90 days.

Early or compassionate access · verified October 3, 2026

When a government hospital doctor prescribes a new drug that is still in clinical trial in India for a patient with a serious or life threatening disease and no satisfactory therapy, a manufacturer can ask to make a limited quantity. The ethics committee recommends first, and the authority decides within 90 days.

Early or compassionate access · verified October 3, 2026

A similar biologic is shown to be similar in quality, safety and efficacy to an approved reference biologic through a step by step comparison. The Review Committee on Genetic Manipulation oversees development up to preclinical data, and the drug regulator handles clinical trials and marketing approval. Quality data cannot be shortened.

Biosimilar application · target 90 days · verified October 3, 2026

A drug stays a new drug for four years after its first approval in India. During that time, another company that wants to import or make the same drug needs permission from the Central Licencing Authority. The data set is shorter and centers on quality and bioequivalence.

Generic application · target 90 days · verified October 3, 2026

Drugs that are no longer new drugs, including generics and nonprescription products, are made under a manufacturing licence from the State Licensing Authority where the factory is located. The site must meet the good manufacturing practice rules in Schedule M. For some oral generics, bioequivalence results are required.

Generic application · verified October 3, 2026

Vaccines are always new drugs in India, so each vaccine needs permission from the Central Licencing Authority. Domestic makers also need a manufacturing licence from the State Licensing Authority with approval of the Central Licence Approving Authority. Each lot is released by the Central Drugs Laboratory in Kasauli before sale.

Full application, new active substance · target 90 days · verified October 3, 2026

Cell or stem cell derived products and gene therapy products are always new drugs. They follow the new drug permission rules, with the same 90 working day decision limit. Gene and cellular therapy products approved in the specified reference countries are one of the categories that can get a local trial waiver.

Full application, new active substance · target 90 days · verified October 3, 2026

All classes of medical devices and in vitro diagnostics made abroad need an import licence from the Central Licensing Authority. An authorised agent in India applies on the online portal. The rules set a nine month limit for the decision. Devices with a free sale certificate from Australia, Canada, Japan, the European Union, the United Kingdom or the United States are licensed without a clinical investigation.

Device: registration or licence with the regulator · relies on AU, CA, EU, GB, JP, US · verified October 3, 2026

Makers of Class A and B devices and IVDs in India apply to the State Licensing Authority on the online portal. A registered notified body audits the site against the quality management system rules. For Class B, the audit comes before the licence. For Class A, the licence comes first and the audit follows within 120 days.

Device: conformity assessment by a certification body · verified October 3, 2026

Makers of Class C and D devices and IVDs in India apply to the Central Licensing Authority on the online portal. The authority checks the documents within 45 days, inspects the site within 60 days of the application, and decides within 45 days of the inspection report.

Device: registration or licence with the regulator · target 45 days · verified October 3, 2026

Class A devices that are not sterile and have no measuring function are not licensed. The maker registers them by uploading device details and self-certifications on the online system. No fee is charged for the registration number.

Device: premarket notification · verified October 3, 2026

A device with no predicate device on the Indian market needs permission from the Central Licensing Authority after a clinical investigation. The authority decides within 120 days, extendable by 30 days. The clinical investigation can be skipped when the device is approved in the United Kingdom, the United States, Australia, Canada, Japan or the European Union and has been marketed there for at least two years.

Device: premarket approval by the regulator · relies on AU, CA, EU, GB, JP, US · verified October 3, 2026

A new IVD needs permission from the Central Licensing Authority, usually after a clinical performance evaluation. The authority decides within 90 days, extendable by 30 days. Class A IVDs may not need clinical performance data.

Device: premarket approval by the regulator · verified October 3, 2026