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Wed, Jul 09 2025
Shubham Bansal
In the pharmaceutical industry, some drugs require stricter control because of their sensitive nature, storage conditions, and higher risk of misuse. These drugs are categorized under Schedule C and C1 of the Drugs and Cosmetics Rules, 1945.
If you plan to wholesale such medicines, you must obtain a Form 21B Drug License. This blog explains what Form 21B is, who needs it, and why it is crucial for wholesale trade of specialized drugs.
Form 21B is a specific drug license issued to wholesalers who intend to sell, stock, exhibit, or distribute Schedule C and C1 drugs.
Schedule C and C1 include products such as:
Vaccines
Insulin
Sera
Injectable antibiotics
Other biological products requiring controlled storage
This license is granted by the State Drug Control Department and is mandatory for any business dealing in these specialized medicines.
You need to apply for Form 21B if your business involves:
Wholesale distribution of Schedule C/C1 drugs
Supplying specialized medicines to hospitals, clinics, or pharmacies
Stocking biological products requiring temperature-controlled storage
Examples of businesses requiring this license include:
Issuing Authority: State Drug Control Department
Applicable Drugs: All Schedule C and C1 drugs as defined under the Rules
Premises Requirements:
Personnel Requirements:
Validity: Typically issued for 5 years, renewable as per regulations
Record-Keeping: Mandatory maintenance of stock registers, purchase invoices, and sales records
It is mandatory to have Form 21B to wholesale Schedule C/C1 drugs in India.
Ensures that sensitive medicines are stored and handled safely.
Prevents counterfeit or improperly stored drugs from reaching patients.
Builds trust among hospitals, clinics, and healthcare providers.
Form 21B is a crucial license for any pharmaceutical business planning to wholesale vaccines, injectables, and other sensitive drugs. Compliance with licensing and storage requirements helps protect patient safety and supports smooth business operations.
If you are planning to start or expand a wholesale pharmaceutical business, understanding the importance of Form 21B is the first step toward meeting regulatory obligations.
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