DRUG LICENSE

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ABOUT DRUG LICENSE

In the business of drugs & cosmetic, licensing is mandatory in India. This law comes under the Drug & Cosmetic Act 1940. This act ensures the end-to-end process manufacturing to sale of drugs in India. The act defines " drug " which is used for human beings or animals internally or externally. It involves all the substance in diagnosing to treatment process. It includes Ayurvedic and Unani drugs as well.

DOCUMENTS REQUIRED

  • Constitution of the firm (MOA/AOA)
  • Any ID proof of proprietor
  • Ownership documents or rental agreement in case of property is rented.
  • Site plan and key plan of the premises.
  • Proof of storage space like refrigerator, cold storage etc.
  • Affidavit from registered pharmacist
  • Proof of qualification - experience certificate - Appointment letter

ELIGIBILITY

  • Minimum Area Requirement
    • The carpet area should be 10sq ft. For wholesale or retail outlets. And minimum 15 sqft. area for combined wholesale and retail outlets.
  • Storage Facility • A drugstore or pharmacy must have air conditioner, sound ventilation system and refrigerator.
  • Technical Staff
    • Drug must be sold before a registered pharmacist or graduate with minimum 1 year experience in drugs or passed intermediate level with 4 years’ experience in drug sale marketing.