Understanding Legal Obligations for Obtaining a Wholesale Drug License under CDSCO:

The Central Drugs Standard Control Organisation (CDSCO) and state regulators are tasked with issuing licenses for specialized categories of critical drugs, including blood products, IV fluids, vaccines, and sera. To import drugs into India, a Drugs Import Licensemust be obtained, adhering to government regulations.

CDSCO serves as India's National Regulatory Authority (NRA). The import, manufacture, sale, and distribution of drugs in India are governed by the Drugs & Cosmetics Act of 1940 and the Rules of 1945.

What is a Wholesale Drug License?

A Wholesale Drug License is essential for wholesalers involved in the sale and distribution of pharmaceuticals. This license, granted by the State Licensing Authority, ensures compliance with drug regulations.

To obtain a CDSCO Wholesale Drug License, a duly notarized and valid copy of the wholesale license must be submitted according to the Drugs and Cosmetics Rules, 1945, using Forms 20B and 21B.

Legal Obligations for Obtaining a CDSCO Wholesale License

Legal obligations refer to the mandatory requirements set by the Central Drugs Standard Control Organisation (CDSCO) for obtaining a Wholesale Drug License. These include:

• Compliance with the standards set by the Drugs and Cosmetics Act of 1999.

• Operation within a designated area for drugs and cosmetics.

• Supervision by a certified pharmacist or competent person.

• The applicant must be a certified pharmacist with at least one year of experience in drug selling.

Procedure to Acquire a CDSCO Wholesale Drug License

1. Visit the CDSCO Registration Portal: Go to the CDSCO official website and register on the “SUGAM” portal by clicking ‘SIGN UP HERE’.

2. Fill in Details: Complete the ‘Applicant Registration Form’ with personal and organizational details.

3. Submit Documents: Provide the required documents for verification to authorize the Drug Import License.

4. Confirmation: Verify your registration by clicking the confirmation link sent to your registered email.

5. Approval: The application will be reviewed by CDSCO officials for license approval.

6. License Issuance: Upon successful verification, the Wholesale Drug License will be issued. CDSCO will conduct premises inspections to ensure compliance with storage, display, and sale regulations.

Documents Required for CDSCO Wholesale Drug License

Ensure to prepare and submit the necessary documentation as per the guidelines.

• Covering Letter

• Completed application for a wholesale drug license using Form 19

• TR6 Challan

• A detailed floor plan of the premises, clearly showing the perimeter and area in a standardized format

• Proof of the ownership of the Premises

• Affidavit confirming that the applicant has not been involved in any criminal activities related to the Drugs and Cosmetics Act, 1940

• Appointment letter for the applicant serving as a full-time registered pharmacist

Benefits of Acquiring a CDSCO Wholesale Drug License

1. Enhanced Reputation: A CDSCO Wholesale License demonstrates compliance with government regulations, boosting the company’s reputation.

2. Public Health Protection: CDSCO’s mission is to safeguard public health by ensuring the safety, efficacy, and quality of drugs.

3. Access to Indian Market: With India being a major pharmaceutical market, the CDSCO license facilitates entry into this expansive market.

Conclusion

The import, manufacturing, sale, and distribution of drugs in India are regulated under the Drugs & Cosmetics Act, 1940, and the associated rules. The Drug Controller General of India (DCGI) oversees these regulations within the Ministry of Health and Family Welfare. For wholesalers, obtaining a CDSCO Wholesale Drug License is a crucial step to operate legally in India’s vast pharmaceutical market.