but this article is specific for Bachelor of Ayurveda, Medicine and Surgery (BAMS) doctors.
An Ayurvedic Manufacturing unit requires two technical persons to handle overall manufacturing and quality. For manufacturing, a manufacturing chemist is required and for quality control, an analytical chemist is required. BAMS doctors are pre-approved manufacturing chemists for Ayurvedic manufacturing Unit under drug and cosmetic act. So they only require analytical chemist as another technical person.
(In case of Siddha and Unani Medicines, technical person related to Siddha and Unani will be required)
Application for licence to manufacture Ayurvedic (including Siddha) or Unani drugs:
An application for the grant or renewal of a licence to manufacture for sale any Ayurvedic (including Siddha) or Unani drugs shall be made in Form 24-D to the Licensing Authority along with prescribed Fee.
Subject to the conditions of Rule 157 under Drug and Cosmetic Act & Rule being fulfilled, a licence to manufacture for sale any Ayurvedic (including Siddha) or Unani drugs shall be issued in Form 25-D. The licence shall be issued within a period of three months from the date of receipt of the application
Plant should compile with conditions as specify in Schedule T under Drug and Cosmetic act & Rules.
Application Form (Form 24-D).
Requirement of schedule ‘T’ are to be fulfilled for which Departmental Inspection Team will conduct the inspection and submit its report on the prescribed Performa.
Technical Persons qualification documents. One is of BAMS doctor and One is of Quality section as discussed above.
Power Availability Certificate from Electricity Department.
List of Machinery/Lab. Equipments.
List of medicine to be manufactured.
Ownership proof or rent agreement
AYUSH department team will inspect premises as per norms prescribed in Schedule T. If all requirements are fulfilled, manufacturing license will be issued.
Area Required for setting up manufacturing unit is 1200 Square feet covered area with separate cabins or partitions for each activity. If Unani medicines are manufactured in same premises an additional area of 400 sq. feet will be required. You can read in detail at our article: How much Area required to start ayurvedic manufacturing plant.
Every Ayurvedic, Sidha and Unani manufacturing unit is required to set-up own quality control section or testing should be done through government approved testing laboratory. Tests should be conducted at per Ayurveda, Sidha and Unani pharmacopoeial standard. If tests are not available, tests should be performed under in-house specification or other information available. Work of quality control section is to verify all the raw materials, monitor in-process quality checks and control the quality of finished product being released to finished goods store/warehouse. Preferably for such quality control there will be a separate expert.