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Requirement of drug license for sale of Ayurvedic Medicines

Query: Dear Mr Ajay Kamboj , I have read your blog: How to start ayurvedic medicine store? and How to start ayurvedic wholesale and distribution? on the subject matter. it is very helpful. In this regard I have a query that on what basis the licensing authority inform that license for sale of Ayurvedic Medicines is not required. I mean any written rule for this. Response: Government only describes the rules for which a license is required. If any product doesn't require any license then you will not find any written rule for it. It's understood. Ayurvedic medicines are regulated through drug and cosmetic act . In drug and cosmetic act, only conditions and license type of manufacturing license of ayurvedic medicine is described. Distribution and sale license is not described or mentioned. So there is no requirement of a sales license for ayurvedic medicines. For explanation, a llopathic medicines require license for all business that is manufacturing, sale, purchase, stock,

How to start Unani Medicine Manufacturing Company?



For starting Unani Medicines manufacturing unit and get unani medicine manufacturing licence, you should have minimum of 1200 square feet covered premises with specifications mention under schedule T (Good manufacturing practice of Ayurvedic, Siddha and Unani system of medicine) of drug and cosmetic act & rules. You can divide your premises into partition depend at dosage form, you want to manufacture at unani manufacturing unit.

Along with above mentioned space criteria, you have to fulfil technical staff requirement mentioned below:

For manufacturing chemist:

A person should be either
  • A degree in Unani system of medicine, as the case may be, conferred by a University, a State Government or Statutory Faculties, Councils and Boards of Indian Systems of Medicines recognized by the Central government or a State Government for this purpose, or
  • A diploma in Unani system of medicine granted by a State Government for this purpose, or
  • A graduate in Pharmacy or Pharmaceutical Chemistry or Chemistry or Botany of a University recognized by the Central Government with experience of at least two years in the manufacture of drugs pertaining to the Unani systems of medicines, or
  • A Vaid or Hakim registered in a State Register of Practitioners of indigenous systems of medicines having experience of at least four years in the manufacture of Unani drugs, or
  • A qualification as Pharmacist in Unani systems of medicines, possessing experience of not less than eight years in the manufacture of Unani drugs as may be recognized by the Central Government.

For Analytical Chemist:

A person should be either graduate in pharmacy or chemistry or pharmaceutical chemistry or botany etc.

Machinery required:

Machinery required depend at dosage form you want to manufacture at manufacturing unit. Most commonly used machineries are as follow:

Laboratory:

A unani manufacturing unit require to have either own internal laboratory for testing and quality of herbs and finished goods or can tie-up with any outside government approved laboratory for this purpose. Check out detail about laboratory equipments here

Documents required for applying Unani drugs manufacturing license:

  • Form
  • Fee receipt
  • Firm detail (proprietorship/partnership/company registration etc)
  • Premises possession proof (rent agreement/ownership proof)
  • Technical staff detail with their qualification and experience certificates copy
  • Blue print of premises/Site master file
  • List of machineries and laboratory equipments
  • Unani drugs list to be manufactured at premises
  • Electricity Bill copy
  • NOC if applicable
  • Other documents if asked by authorities

Procedure for applying Unani drugs manufacturing licence:
  • Complete all requirements
  • Visit to State AYUSH licensing authority office
  • Submit your licensing file
  • After submission AYUSH office will inspect your premises with compliance with required conditions mentioned in Schedule T (GMP:AYUSH) of Drug and Cosmetic Act & Rules
  • If all conditions are satisfy, manufacturing license number will be issued to you
  • If not satisfy, your applicable will be sent back for amendments


Hope above information is helpful to you....

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