DRUG  LICENSE

To make sure that people don't abuse or misuse medications and other medical supplies, access to them needs to be controlled. Therefore, under the medicines and Cosmetics Act of 1940, drug licenses are required for all pharmacists, wholesalers, retailers, producers, distributors, dealers, and importers of medicines, cosmetics, ayurveda, Siddha, and Unani drugs.

TYPES OF DRUG LICENSE

Manufacturing License– License issued to a business that manufactures drugs inclusive of allopathic/homoeopathy medicines.

Sale License – License issued for the sale of drugs. It has the following bifurcations: – Wholesale Drug License – Retail Drug License

• Wholesale License – A drug wholesaler must obtain a wholesale licence. Wholesale means the sale of the drug to a person/retailer to further sell it.
• Retail License – A retail license is required for the retail sale of drugs. A retail sale means the sale of drugs or cosmetics for the consumption of the end consumer. Retailers can sell it to a dispensary, hospital, educational, medical, or research institute. Retailers engaged in pharmaceuticals, cosmetics, stand-alone pharmacists, ayurvedic shops, etc

DOCUMENTS REQUIRED

• Constitution of the entity, Memorandum of Association (MOA), Articles of Association (AOA) for a company, partnership deed, LLP agreement in case of partnership and LLP.
• ID proof of partner/director/proprietor.
• Documents related to premises – Copy of ownership documents of property or rental agreement and NOC (No Objection Certificate) from the owner of the rented premises as the case may be.
• Site plan and key plan of the premises.
• Copy of Board resolution permitting obtaining of a license.
• Proof of availability of storage space as cold storage, refrigerator, etc.
• Copy of challan as proof of depositing fee.
• Affidavit regarding non-conviction of proprietor/partner/director and the firm.
• The affidavit from the registered pharmacist/competent person.
• Cover letter with name and designation of the applicant
• Declaration form in a prescribed format
• Applicant’s qualification certificate
• For a pharmacist at a retail sale:
  • Proof of qualification
  • Registration of local pharmacy council
  • Appointment letter
• For a pharmacist at a wholesale sale:
  • Proof of qualification
  • Experience certificate
  • Appointment letter

 STEPS INVOLED IN THE PROCESS

- Visit the respective drug controlling authority website

- Filing of application

- Upload documents

- Visit by drug inspector

- Grant of the drug license