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FDA/DRUG License

India’s drug industry is primarily regulated by the drugs and cosmetics act of 1940. The administration of drugs in Maharashtra is vested with the food and drug administration of the state.

Infrastructural Requirements

A retail or wholesale operational unit for drugs can be established in a carpet area of 10 square meters and must include a separate and exclusive entrance on the other hand, an outlet operated for both retail and wholesale purposes must be established a carpet area of 15 square meters and must include a separate and exclusive entrance.

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Procedure

How to get the license

The medical facility must include a refrigerator for the storage of certain vaccinations and medicines. Apart from this; cupboards, racks and other pertinent utilities are required for the storage of drugs.

Fresh application of retail/wholesale license – documents required

  • Application form in form 19 (for retail license), form 21 (for wholesale license), form 19b (for retail homeopathic license), form 20c (for wholesale homeopathic license), form 19c (for retail and wholesale license of schedule x drugs), and form 19a (for retail restricted license). For the awareness of the applicants, these forms need not be signed by all partners given its statutory nature
  • Photo id (for proprietorship firms).
  • Scanned pdf of the partnership deed and the receipt of the registration fee paid to the registrar of companies (for partnership firms).
  • Documents of trust registration issued by the charity commissioner
  • Huf deed (for Huf’s).
  • Deed and registration certificate of the society (for societies).
  • Letter from the head of department of the government.
  • List of the proprietor/partner/director/trustee, etc.
  • Proof of identity of the concerned applicants.
  • Rental/lease agreement of the proposed premise (conditions apply).
  • Proof of ownership of the premise.
  • No objection certificate (for societies, residential premises leased by cidco, mhada or similar government/semi government agencies).
  • Layout of the building.
  • Proof of installation of cold storage facilities.
  • Appointment letter and acceptance letter of the pharmacist, along with his/her residential proof.
  • Registration certificate (for retail license).
  • Self-declaration of the pharmacist (for retail license).
  • Qualification certificate (for whole sale license).
  • Experience certificate of the pharmacist (for whole sale license).
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