Ayurvedic (including Siddha) or Unani Drugs manufacturing License and Testing Laboratory

To manufacture for sale of Ayurvedic (including Siddha) or Unani Drugs, manufacturing license is required which is known as Ayurvedic (including Siddha) or Unani Drugs manufacturing License. A manufacturing license has a unique number which is known as manufacturing license number.

Every manufacturing unit is required to have a testing laboratory for carrying out tests on Ayurvedic, Siddha and Unani drugs or raw materials used in the manufacture.

Types of applications and Licenses:
  • Form 24D: Application for the grant / renewal of a licence to manufacture for sale of Ayurvedic/ Siddha or Unani drugs
  • Form 24E: Application for grant or renewal of a loan licence to manufacture for sale Ayurvedic (including Siddha) or Unani Drugs
  • Form 25D: Licence to manufacture for sale of Ayurvedic (including Siddha) or Unani drugs
  • Form 25E: Loan License to manufacture for sale Ayurvedic (including Siddha) or Unani Drugs
  • Form 26D: Certificate of renewal of licence to manufacture for sale of Ayurvedic / Siddha or Unani drugs
  • Form 26E: Certificate of renewal of loan licence to manufacture for sale of Ayurvedic / Siddha or Unani Drugs
  • Form 47: Application for grant or renewal of approval for carrying out tests on Ayurvedic, Siddha and Unani drugs or raw materials used in the manufacture thereof on behalf of licensees for manufacture for sale of Ayurvedic, Siddha and Unani drugs
  • Form 48: Approval for carrying out tests or analysis on Ayurvedic, Siddha and Unani drugs or raw materials used in the manufacture thereof on behalf of licensees for manufacture for sale of Ayurvedic, Siddha and Unani drugs
  • Form 49: Certificate of renewal for carrying out tests or analysis on Ayurvedic, Siddha or Unani drugs or raw materials used in the manufacture thereof on behalf of licensees for manufacture for sale of Ayurvedic, Siddha or Unani drugs
  • Form 50: Report of test or analysis by approved Laboratory

Condition of Ayurvedic (including Siddha) or Unani Drugs manufacturing License:
  • Manufacture and testing of Ayurvedic (including Siddha) or Unani drugs should be carried out in premises fulfilled criteria laid down in schedule T.
  • Manufacture and testing of Ayurvedic (including Siddha) or Unani drugs should be carried out under supervision of full time competent technical staff.


Qualification of Competent Staff for manufacture of Ayurvedic (Including siddha) or Unani Drugs: Manufacture of Ayurvedic (including Siddha) or Unani drugs to be conducted under the active direction and supervision of full time competent technical staff that possess either of following qualifications:
  • A degree in Ayurveda or Ayurvedic Pharmacy, Siddha or Unani system of medicine
  • A diploma in Ayurveda, Siddha or Unani system of medicine granted by a State Government for this purpose
  • Graduate in Pharmacy or Pharmaceutical Chemistry or Chemistry or Botany with two years experience in drugs pertaining to the Ayurvedic or Siddha or Unani systems of medicines
  • A Vaid or Hakim registered in a State Register of Practitioners with at least four years in the manufacture of Ayurvedic or Siddha or Unani drugs
  • A qualification as Pharmacist in Ayurvedic (including Siddha) or Unani systems of medicines, with at least eight years of experience

Qualification of Competent Staff for testing of Ayurvedic (Including siddha) or Unani Drugs:
Testing of Ayurvedic (including Siddha) or Unani drugs to be conducted under the active direction and supervision of full time competent technical staff that possess either of following qualifications
  • Minimum of graduation in Pharmacy or Chemistry or Pharmaceutical chemistry or Botany etc.

Related:

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