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Tue, Dec 30 2025
Raju Karn
In India, the sale, distribution, and manufacture of drugs and pharmaceuticals are strictly regulated to ensure the safety and quality of medicines. Any business dealing with drugs must obtain the appropriate drug license under the provisions of the Drugs and Cosmetics Act, 1940.
The licensing process involves applying for different forms, each catering to a specific type of drug activity. This blog explains the main types of drug licenses and the forms used for each purpose.
A drug license is an official permission granted by the State Drug Control Department or Central Drugs Standard Control (CDSCO), allowing an individual or entity to legally.
Drug licenses in India are categorized based on the nature of the business. Here are the most common types and their corresponding forms:
Purpose:
Allows the retail sale of drugs to end consumers.
Forms:
- Form 20 :General retail sale of allopathic drugs.
- Form 21: Retail sale of restricted drugs specified in Schedule C and C1 (e.g., biological products).
- Pharmacies
- Medical shops
Permits the sale of drugs to retailers, hospitals, and other institutions.
- Form 20B: Wholesale of general drugs.
- Form 21B: Wholesale of drugs listed in Schedule C and C1.Who Needs It:
- Wholesale distributors
- Stockists
- Supply chain companies
Purpose:Authorizes manufacturing of drugs, including repackaging and processing.
Forms:- Form 25: Manufacture of non-schedule C/C1 drugs. (e.g., Antibiotic tablets (not injectable), Non-biological formulations).
- Form 28: Manufacture of Schedule C and C1 drugs (e.g., vaccines, sera).Who Needs It:- Pharmaceutical manufacturers
- Repackaging units
Purpose:Issued when a manufacturer does not own a manufacturing facility but uses another manufacturer’s premises.
Forms:- Form 25A: For non-schedule drugs.
- Form 28A: For Schedule C and C1 drugs.
Purpose:Required to import drugs and raw materials into India.
Forms:- Form 10: License to import drugs.
- Form 41: Import license for new drugs and investigational drugs.
Purpose:Issued to entities that sell drugs without the supervision of a registered pharmacist, subject to restrictions.
Form:- Form 20A: Restricted license for general drugs.
Schedule C and C1 include biological products such as:- Sera
- Vaccines
- Insulin
- Other injectable preparations
These require stricter controls and specialized forms.
All licenses are issued under the Drugs and Cosmetics Act, 1940.
Applicants must meet infrastructure, storage, and personnel qualifications.
Licenses must be renewed periodically and displayed prominently on the premises.
Compliance with Good Distribution Practices (GDP) and Good Manufacturing Practices (GMP) is mandatory for relevant licenses.
Understanding the different types of drug licenses and forms is essential for any pharmaceutical business in India. Whether you plan to retail medicines, distribute to hospitals, manufacture formulations, or import products, the correct license ensures legal compliance and safeguards public health.