How can a BAMS Doctor Start Ayurvedic Manufacturing Company?

One of our youtube viewer asked us about How a BAMS doctor can start Ayurvedic Manufacturing Company. Requirement for starting a ayurvedic manufacturing company is same as we have discussed in our article: How to start Ayurvedic Manufacturing Company?

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:

  1. 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.
  2. 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 Specifications:

Plant should compile with conditions as specify in Schedule T under Drug and Cosmetic act & Rules.

Documents Required:

  • Application Form (Form 24-D).
  • Prescribed Fees
  • 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.
  • Master Site Plan
  • Power Availability Certificate from Electricity Department.
  • List of Machinery/Lab. Equipments.
  • List of medicine to be manufactured.
  • Project Report.
  • 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:

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.

Machinery and Equipment:

All the machinery and its part used in ayurvedic manufacturing is made-up of stainless steel. Machinery are in SS-304 and contact part should be in SS-316. To know in detail about machinery read our article: List of machinery used in Pharmaceutical and Ayurvedic Sector.

Laboratory Equipment:

An Ayurvedic manufacturing unit either establish own testing laboratory or unit can get testing done at government approved laboratories. Complete detail of laboratory equipment know here

Hope above information is helpful to you…

Requirements for Ayurveda, Sidha and Unani Quality Control Section: Equipment, Area etc.

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.

Quality Control/Analytical Chemist: Quality control section will have a minimum of :

  • Expert in Ayurveda or Sidha or Unani medicine who possesses a degree qualification recognized under Schedule II of Indian Medicine Central Council Act 1970;
  • Chemist, who shall possess at least Bachelor Degree in Science or Pharmacy or Pharmacy (Ayurveda), awarded by a recognized University; and
  • Botanist (Pharmacognosist), who shall possess at least Bachelor Degree in Science (Medical) or Pharmacy or Pharmacy (Ayurveda) awarded by a recognized University

The quality control section shall have the following facilities:–

  • Area for Quality control section should be minimum of 150 sq. feet.
  • For identification of raw drugs, reference books and reference samples should be maintained.
  • Manufacturing record should be maintained for the various processes.
  • To verify the finished products, controlled samples of finished products of each batch will be kept till the expiry date of product for 3 years.
  • To supervise and monitor adequacy of conditions under which raw materials, semi- finished products and finished products are stored.
  • Keep record in establishing shelf life and storage requirements for the drugs.
  • Manufacturers who are manufacturing patent and proprietary Ayurveda, Siddha, and Unani medicines shall provide their own specification and control references in respect of such formulated drugs.
  • The record of specific method and procedure of preparation, that is, Bhavana, Mardana and Puta and the record of every process carried out by the manufacturer shall be maintained.
  • The standards for identity, purity and strength as given in respective pharmacopoeias of Ayurveda, Siddha and Unani systems of medicines published by Government of India shall be complied with.
  • All raw materials will be monitored for fungal, bacterial contamination with a view to minimize such contamination.

List of equipment required for Laboratory in Ayurvedic Manufacturing Units.

(Alternatively, unit can get testing done from the Government approved laboratory)

CHEMISTRY SECTION

  • Alcohol Determination Apparatus (complete set)
  • Volatile Oil Determination Apparatus
  • Boiling Point Determination Apparatus
  • Melting Point Determination Apparatus
  • Refractometer
  • Polarimeter
  • Viscometer
  • Tablet Disintegration Apparatus
  • Moisture Meter
  • Muffle Furnace
  • Electronic Balance
  • Magnetic Stirrer
  • Hot Air Oven
  • Refrigerator
  • Glass/Steel Distillation Apparatus
  • LPG Gas Cylinders with Burners. Water Bath (Temperature controlled)
  • Heating Mantles/ Hot Plates
  • TLC Apparatus with all accessories (Manual)
  • Paper Chromatography apparatus with accessories
  • Sieve size 10 to120 with Sieve
  • Shaker
  • Centrifuge Machine
  • Dehumidifier
  • pH Meter
  • Limit Test Apparatus

PHARMACOGNOSY SECTION

  • Microscope Binoculor
  • Dissecting Microscope
  • Microtome
  • Physical Balance
  • Aluminium Slide Trays
  • Stage Micrometer
  • Camera Lucida (Prism and Mirror Type)
  • Chemicals, Glassware etc