Drug & Cosmetic License (CDSCO)

What is Drug & Cosmetic License (CDSCO)?

Get your CDSCO or State Drug Control licence before manufacturing, selling, or importing drugs or cosmetics — covers pharma, Ayurvedic products, and devices.

The Drugs and Cosmetics Act 1940 is the primary legislation governing the manufacture, distribution, sale, and import of drugs and cosmetics in India. The Act is administered through a two-tier regulatory structure: the Central Drugs Standard Control Organisation (CDSCO), headed by the Drugs Controller General of India (DCGI), exercises jurisdiction over import licenses, new drug approvals, clinical trials, and standards-setting; while the State Drug Control Authorities (SDCAs), each headed by a State Drugs Controller, issue manufacturing and retail or wholesale distribution licenses within their respective states. Understanding which authority has jurisdiction over a particular activity is the first step in any licensing exercise. The Act draws a fundamental distinction between drugs and cosmetics. Drugs include all medicines for internal or external use in the diagnosis, treatment, mitigation, or prevention of disease in human beings or animals, including substances used in the manufacture of such medicines, and medical devices as defined under the Medical Devices Rules 2017. Cosmetics are articles intended to be rubbed, poured, sprinkled, or sprayed on, or introduced into, or otherwise applied to, the human body for the purpose of cleansing, beautifying, promoting attractiveness, or altering the appearance, excluding soap. Different schedules of the Act and Rules apply to different sub-categories of drugs, and the applicable schedule determines the minimum manufacturing area, qualified person requirements, equipment standards, and record-keeping obligations. For pharmaceutical manufacturers, the cornerstone requirement is Good Manufacturing Practice (GMP) compliance as prescribed in Schedule M of the Drugs and Cosmetics Rules 1945. Schedule M was substantially revised in 2023 and aligns Indian GMP standards more closely with World Health Organization (WHO) GMP norms. A manufacturing license (Form 25 for allopathic formulations, Form 28 for bulk drugs) is issued by the State Drugs Controller after an inspection of the manufacturing premises confirms Schedule M compliance. The qualified person requirement mandates that manufacturing operations be supervised by a competent technical staff member, who must hold a degree in pharmacy, medicine, science (with specific subjects), or an equivalent qualification as specified in Schedule M. Wholesale distribution licenses (Form 20-B for drugs, Form 21-B for restricted drugs) and retail sale licenses (Form 20 for drugs, Form 21 for prescription drugs) are issued by the State Drugs Controller for businesses that stock and sell drugs without manufacturing them. Retail chemists must additionally comply with the conditions prescribed in Schedule H (prescription-only drugs that can only be sold on a valid prescription), Schedule H1 (drugs requiring additional recording of prescription details), and Schedule X (habit-forming drugs subject to strict quantity controls and record-keeping). For cosmetics, a manufacturing license under Form 32 and a wholesale dealer's license under Form 42 are required. Imported cosmetics require an import license under Form 43, which is issued by CDSCO. Since 2023, cosmetic imports are required to comply with the Cosmetics Rules 2020, which align with ASEAN Cosmetic Directive standards and require listing on the SUGAM portal before import. Ayurvedic, Unani, and Siddha (ASU) drugs are regulated under Chapter IV-A of the Act and the Drugs and Cosmetics Rules applicable to ASU drugs, with licensing by the State Drugs Controller using distinct forms and with oversight in many states by a separate Ayurvedic Drug Controller. Common pitfalls include applying to the wrong authority (central versus state), failing to meet the minimum area requirements specified in Schedule M or the Cosmetics Rules before applying for inspection, employing a qualified person who does not meet the educational qualification criteria for the specific drug category being manufactured, and omitting to obtain a No Objection Certificate from the local municipal body and the Pollution Control Board before the drug authority inspection. Many businesses also underestimate the time required to obtain Good Manufacturing Practice certification from CDSCO, which is required for export and for demonstrating equivalence to overseas regulators. Professional assistance is essential because the drug licensing framework is complex, highly technical, and subject to frequent amendments. Our team includes regulatory affairs specialists who work directly with State Drug Controllers and CDSCO, ensuring that your application is complete, your premises meet inspection readiness standards, and your qualified person arrangements are legally correct before any inspector visits.

How It Works

1. 1

   Regulatory scoping and license identification

   We identify the correct license forms and authorities based on your product category (allopathic drug, ASU drug, cosmetic, medical device), activity type (manufacture, wholesale, retail, import), and state of operation, and review your premises and qualified person arrangement against the applicable schedule requirements.

2. 2

   Premises and infrastructure readiness assessment

   We conduct a pre-inspection review of your manufacturing or storage premises against Schedule M (for drug manufacturers) or the Cosmetics Rules (for cosmetic manufacturers) and provide a gap analysis report with specific remediation actions before the official inspection.

3. 3

   Qualified person verification and documentation

   We verify that your proposed technical staff member meets the educational and experience criteria prescribed in Schedule M or the applicable rules for the specific drug category, and compile the supporting educational and experience documentation.

4. 4

   Application compilation and filing

   We prepare the prescribed application form (Form 24, 25, 28, 32, or equivalent), compile all supporting documents, arrange for payment of the prescribed license fee, and file the application with the State Drugs Controller or CDSCO as appropriate.

5. 5

   Inspection coordination and representation

   We coordinate the premises inspection by the Drug Inspector, accompany the inspection team, respond to any observations raised during the inspection, and submit the compliance report within the prescribed timeline.

6. 6

   License receipt, renewal planning, and ongoing compliance

   Upon grant of the license we collect the license certificate, brief your team on record-keeping requirements under the applicable schedules, set up a renewal calendar, and advise on post-licensing obligations including adverse drug reaction reporting and recall procedures.

Government Fees (Indicative — state-specific schedules apply)

Professional Fees