Business Plan for Manufacturing Unit

• Search Premises for Manufacturing Unit (Rented or Owned)
• Choose a Company Name
• Apply for Manufacturing License Number
• Apply for GST Number
• Apply for  the products approval along with Manufacturing License Number File
• After approval is attained start manufacturing of Ayurvedic/Sidha/Unani Medicines
• Last but not the least Start Selling Products

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Requirements For Manufacturing Licence For Ayurvedic Products

Documentation and Procedure of Ayurvedic Manufacturing Unit (The requirement may vary from state to state or area to area.)

• Application on prescribed Form 24-D.
• Prescribed Fees as mentioned
• Subject to the conditions of Rule 157 being fulfilled the license will be issued Form 25-D which will be valid for a period of —– years from date of issue.
• Requirements of schedule ‘T’ are to be fulfilled for which the Departmental Inspection Team will conduct the inspection and submit its report on the prescribed Performa.
• Documents in respect of competent technical staff consisting of at least one person, who is a whole-time employee and who possesses the qualifications as mentioned below as competent person staff section.
• Site Plan of the premises.
• An Attested copy of No Objection Certificate from the Pollution Control Board is to be obtained.
• Power Availability Certificate from Electricity Department.
• List of Machinery/Lab. Equipments.
• List of medicine to be manufacture.
• Project Report.
• Ownership proof or rent agreement

 The Inspection team will come and inspect the premises to check the Location and surroundings of the unit, buildings, water supply, disposal of container’s cleaning, Stores, raw material, packing material, finished goods store, working space, Health, clothing sanitation and hygiene of workers, medical services, and equipment’s, quality control section etc. to see and satisfy themselves that all the compliances are made.

Area Required For Starting Ayurvedic Manufacturing Unit

The Area Requirement is depending upon the number of sections you want to start. And Minimum area required under drug and cosmetic act is 1200 square feet. But, if unani medicines are manufactured in same premises additional 400 square feet area is required. Section wise partition is required as per the dosage form. For example,in case for the tablet/capsule section, you have to partition minimum of 100 square feet, and for liquid section, you require minimum of 150 square feet of area.

Machinery and Equipment Required For Ayurvedic Medicine & Herbal Manufacturing Unit

All the machines required for manufacturing are in SS-304 and contact part in SS-316. The  List of machineries used in Ayurvedic Sector are:

Liquid & oil section

• High speed mixer for tank
• S. S. tank- 200 liter/500 liter/1000 liter capacity with wheel and cover lid
• Liquid filling machine double head
• P.P. cap sealing machine
• Liquid filtration unit
• Tables

Capsule/Tablet section

• Air compressor
• Air conditioner
• Blister packing machine
• Capsule filling machine zero number
• Capsule Loader zero number
• Tablet Punching Machine
• Dehumidifier
• Sifter
• Mass mixer
• Multi mill
• FBD
• Double cone blender

Miscellaneous Equipment

• Batch printing machine
• RO plant
• Lab equipment
• Balances- 200gm, 30kg, 100kg

Laboratory Equipment Required For Ayurvedic Medicine & Herbal Manufacturing Unit

An Ayurvedic manufacturing unit can either establish its testing laboratory unit or get the testing done at government-approved laboratories.

Competent Person/ Staff Qualification For Manufacturing

The manufacture of Ayurvedic along with Siddha  and Unani drugs shall be done under the direction and supervision of  the competent technical staff which consist of at least of one person, who is a whole-time employee and who possesses the minimum of any of the following qualifications, i.e:-

• Either  a degree-holder or a diploma holder of Ayurveda or Ayurvedic Pharmacy, Siddha or Unani system of medicines,  conferred by a University, a State Government or Statutory Faculties, Councils, and Boards of Indian Systems of Medicine recognized by the Central Government or a State Government for this purpose,
• Or a graduate degree in Pharmacy or Pharmaceutical Chemistry or Chemistry or Botany of a University that is recognized by the Central Government with an experience of at least two years in the manufacture of drugs about the Ayurvedic or Siddha or Unani system of medicine,
• Or a Vaid or Hakim registered with the State Register of Practitioners of Indigenous Systems of Medicines having experience of at least four years in the manufacture of Siddha or Unani drugs,
• Or a qualification as a Pharmacist in Ayurveda including Unani systems of medicine or Siddha, and possessing an experience of not less than eight years in the manufacture of Ayurvedic or Siddha or Unani Drugs as that may be recognized by the Central Government.

Competent Person Staff For Laboratory

A minimum of the following qualifications is required for Laboratory laboratory-competent person:

• A graduate in Pharmacy or Pharmaceutical Chemistry or Chemistry or Botany from a University recognized by the Central Government

There is such a regulation by which commercial manufacturing of ayurvedic medicines is regulated. The Manufacturers have to take a prior license from the State Drug Controlling Authority.