Legal Obligation under CDSCO for obtaining a Wholesale Drug License
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Legal Obligation under CDSCO for obtaining a Wholesale Drug License - Meaning, Process, Documentation
The Central Drugs Standard Control Organisation along with state regulators are responsible for granting licenses for Specialized Categories of Critical Drugs such as blood and blood products,I.V fluids,Vaccine and Sera. Drugs Import License is required to Import Drugs into India by following government regulations.
CDSCO is the National Regulatory Authority (NRA) of India. In India, Import,Manufacturing,Sale and Distribution of Drugs is regulated under Drugs & Cosmetics Act 1940 and Rules 1945.
What is a Wholesale Drug License?
A Wholesale Drug License is required by the wholesalers who deals with Drug activities as in sale of drugs or pharmaceuticals. A Wholesale Drug License is granted by the Individual State Licensing Authority.
A Duly Notarized and Valid Copy of the Wholesale license for sale or distribution of drugs must be submitted under Drugs and Cosmetics Rules,1945 in the form 20B and 21B for obtaining the CDSCO Wholesale License.
Documents required in the CDSCO Wholesale Drug License process
Important documents required in the process are as follows:
- Covering Letter
- Duly filled application pertaining to wholesale drug license in Form 19
- TR6 Challan
- A Floor Plan (Detailed drawing of the premises precisely indicating the perimeter and area in a standard format)
- Proof of the ownership of the Premises
- Affidavit indicating the non-indulgence of the applicant with the criminal activities under the drug and cosmetic act, 1940
- Appointment letter of the applicant appointed as a full-time registered pharmacist
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