Address : Casaheb,
- B-4 Spaze It Park, Sohna Road, Gurgaon, Haryana, 122018
- Phone +91-9717076556
- anup@casaheb.in
Drug License Requirements in India
- Manufacturing License
- Application Submission
- Document Verification
- Inspection
- License Issuance
- Sale License:
Types of Drug Licenses
1
Manufacturing License:
Required for entities involved in the production of
drugs and cosmetics. This license is issued by the State
Drug Control Authority.
3
Import License
Necessary for importing drugs and cosmetics into India.
This license is issued by the Central Drugs Standard
Control Organization (CDSCO).
Understanding Drug License Requirements in India
In India, the pharmaceutical industry is stringently regulated
to ensure the safety, efficacy, and quality of drugs available
to the public. A Drug License is an official authorization
granted by the regulatory authority, permitting individuals or
entities to manufacture, distribute, or sell pharmaceutical
products. Obtaining this license is mandatory for operating
any business related to pharmaceuticals within the country.
Key Requirements for Conversion
- The firm should have a valid partnership deed rQualified Personnel: The presence of a registered pharmacist for retail sales or a competent individual with a degree or diploma in pharmacy for wholesale operations is mandatory.
- Premises: The business premises must comply with the prescribed space requirements and storage conditions to ensure drug safety and efficacy. .
Application Process
Application Submission
Submit the duly filled application form along with the
requisite fees to the respective State Drug Control
Authority.
Document Verification
Provide necessary documents, including proof of premises,
identity and address proof of the applicant, qualification
proof of the registered pharmacist or competent person, and
affidavits as required.
Inspection
The Drug Inspector conducts a thorough inspection of the
premises to verify compliance with the regulatory standards.
License Issuance
Upon satisfactory inspection and verification, the authority
issues the drug license, authorizing the commencement of
business operations.
Good Storage Practices
Maintain appropriate storage conditions to preserve drug
quality.
Record Maintenance
Keep accurate records of all transactions related to the
sale, purchase, and distribution of drugs.
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