How to set-up Testing Laboratory of Ayurvedic, Siddha and Unani drugs?

Approval for carrying out such tests of identity, purity, quality and strength of Ayurvedic, Siddha and Unani drugs as may be required under the provisions of these rules, on behalf of licensee for manufacture of Ayurvedic, Siddha and Unani drugs shall be granted in Form 48.

For setting up ayurvedic, siddha and unani medicines, one has to fulfill all criteria mentioned in Drug and Cosmetic Act & rules. Application for grand of approval of testing laboratory has to be submitted at AYUSH department of concern state.

Area Required:
Minimum area required for setting up Ayurvedic medicines laboratory is 800 Square feet.

Qualification Required:
Either owner or one of the employee should have minimum of degree in Chemistry, Botany, Ayurveda/Siddha/Unani/Bachelor in Pharmacy from a recognized University or equivalent, with experience for 2 years for carrying out tests or analysis as per the Ayurvedic, Siddha and Unani Pharmacopoeias.

Sections Required:
Sections should be with proper partitions
  • Chemistry
  • Pharmacognosy
  • Ayurveda, Siddha and Unani
  • Microbiology
  • Sample Room
  • Office-cum-Record Room
Premises Requirements:
  • The premises where the tests are carried out shall be well lighted and properly ventilated except where the nature of tests of any Ayurvedic, Siddha and Unani drug warrants otherwise. Wherever necessary, the premises shall be air-conditioned so as to maintain the accuracy and functioning of laboratory instruments or to enable the performance of special tests such as sterility tests and microbiological tests.
  • The applicant shall provide adequate space having regard to the nature and number of samples of drugs proposed to be tested.
Conditions For granting Testing Laboratory license for Ayurvedic, Siddha and Unani Tibb Medicines:

  • The premises shall compile with requirements mentioned in premises requirements.
  • The applicant shall provide adequate space having regard to the nature and number of samples of drugs proposed to be tested.
  • Separate section shall be provided with adequate minimum area
  • The applicant shall provide a list of persons who may be employed with him as experts, such as Chemist, Botanist and expert in Ayurveda/Siddha/Unani or Pharmacist who shall possess a minimum qualification as mentioned above
  • The applicant shall provide adequate equipment essential for carrying out tests for identity, purity, quality and strength of Ayurvedic, Siddha and Unani drugs as per pharmacopoeial standards or other available standards
  • List of equipment recommended check by clicking here

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