Legal Framework
Drug License Registration in India is governed by the Drugs and Cosmetics Act, 1940 and the Drugs and Cosmetics Rules, 1945. These laws regulate the import, manufacture, distribution, and sale of drugs to ensure public health and product quality. Licenses are issued by the CDSCO and respective State Drug Authorities, with mandatory compliance to GMP and GDP standards.
Types of Drug Licenses
Retail Drug License (RDL)
For direct sale to consumers through pharmacies or medical stores.
Wholesale Drug License (WDL)
For bulk sale to hospitals, institutions, and retailers.
Manufacturing License
Issued to pharmaceutical manufacturers with GMP compliance.
Loan License
For businesses that market drugs manufactured by third parties.
Import License
Required to import pharmaceutical products or medical devices into India.
Test License
Allows testing of drugs for R&D, education, or quality assurance purposes.
Medical Device License
Required for sale or manufacture of regulated devices post-2020 notification.
Eligibility Criteria
Applicants must appoint a qualified pharmacist (B.Pharm/D.Pharm), have proper premises (10–15 sq.m.), refrigeration units for sensitive drugs, and business registration. Experience requirements apply for wholesale licenses.
Registration Procedure
- Submit online application via Sugam portal or state authority.
- Upload documents: identity proofs, qualification, premises proof, etc.
- Undergo site inspection by Drug Inspector.
- Receive license if compliance is satisfactory within 20–60 days.
Legal Compliance & Renewal
Drug licenses are valid for 5 years. Renewal must be filed 6 months before expiry. Violations like absence of pharmacist, poor storage, or sale of expired drugs can lead to cancellation under Section 22 and 27 of the Act. Manufacturing licenses require additional audits and documentation.
Policy & Technological Reforms
- Medical Devices Rules 2020: Extended coverage to diagnostic equipment.
- Sugam Portal: Centralized licensing system improving transparency.
- Track & Trace: Barcode-based drug traceability now mandated for exports.
- Antibiotic Control: Tighter norms for Schedule H and X drugs.
Challenges in Implementation
Discrepancies in state-wise procedures, lack of rural infrastructure, inspector corruption, and inefficient monitoring mechanisms remain persistent issues. Harmonizing standards and enhancing digitalization are key for smooth operations.