Skip to main content

Best Ayurvedic Company in India

How to sell Ayush (Ayurvedic, Unani and Siddha) Products in India?

Here we are going to talk about how you can do that if you want to sell Ayurvedic medicine in India. We talked a lot about: How can you start an ayush manufacturing company? How can you start a ayush marketing company? How can you do ayush products distribution? How can you start ayush retail store? But now comes the matter that if you want to sell Ayurvedic medicine , then in what way can you sell them. First, let's discuss about some regulatory requirements. Regardless of the Ayurvedic medicine that is available, then we include the entire AYUSH sector. Let's talk about the entire Ayush sector (Ayurvedic, Yoga & Naturopathy, Unani, Siddha and Homeopathy) . But keeping homeopathic medicine on the side, because license is required for homeopathic medicine. When it comes to manufacturing Ayurvedic medicine, Unani medicine, Siddha medicine, , it is regulated within the Drug and Cosmetic Act. The section of Ayurvedic Medicine is covered under this Act . Manufacturing of ayurve

How to start manufacturing unit of Bulk Drugs/API?

Starting manufacturing unit of Bulk drugs/active pharmaceutical ingredients requires almost same formalities as of pharmaceutical finished formulations manufacturing unit. Machinery and plant requirements vary in both cases. Bulk drug manufacturing unit is complex and requires more care as compare to finished pharmaceutical formulations manufacturing unit.

Manufacturing of bulk drugs are also regulated through Drug and Cosmetic Act & Rules in India. India is known as Pharmacy of World but we lack at bulk drug manufacturing level. We import approx 75% of raw material/bulk drug from other countries.

Plant specification is recommended under schedule M of Drug and Cosmetic act & rules. Schedule M Part 1 is dedicated to bulk drug manufacturing and provide detailed knowledge about premises, location and plant requirements and specifications. Download here: Drug and Cosmetic Act, 1940 and rules, 1945 as amended upto 31st December 2016 for referring Schedule M part 1.

Bulk Drugs/API is the biological active ingredient in a pharmaceutical drug. It is used in a finished pharmaceutical product (FPP), intended to be used for pharmacological activity

Requirements and License:

Machinery and Equipments:
  • SS and Glass Lined reactors having capacity 160 Ltr to 5000 Ltr
  • SS and MS Rubber Lined Centrifuges
  • Glass Assemblies
  • Tray dryer
  • Filters
  • Air Jet Mill
  • Sifter
  • Blender
  • Multi Mill
  • Packing area etc.

Laboratory Equipments:

  • TOC Analyzer
  • Gas Liquid Chromatograph
  • Total Organic Carbon analyzer
  • Ultra Pure Water purification system
  • Video Microscope
  • Fourier Transform Infra Red Spectrophotometer
  • Automatic Glass Ware Washing and Drying Machine
  • High Performance Liquid Chromatographs etc.

Qualification required for technical person for manufacturing:
  • A graduate in Pharmacy or Pharmaceutical Chemistry of a University established in India by law or has an equivalent qualification recognized and notified by the Central Government for such purpose] and has had at least eighteen months‘ practical experience after the graduation in the manufacture of drugs to which this licence applies; this period of experience may however be reduced by six months if the person has undergone training in manufacture of drugs to which the licence applies for a period of six months during his University course; or
  • A graduate in Science of 1[a University established in India by law or has an equivalent qualification recognized and notified by the Central Government for such purpose] who for the purpose of his degree has studied Chemistry 3[or Microbiology] as a principal subject and has had at least three years‘ practical experience in the manufacture of drugs to which this licence applies after his graduation; or
  • A graduate in Medicine of 1[a University established in India by law or has an equivalent qualification recognized and notified by the Central Government for such purpose] with at least three years‘ experience in the manufacture and pharmacological testing of biological products after his graduation; or
  • A graduate in Chemical Engineering of a University recognised by the Central Government with at least three years‘ practical experience in the manufacture of drugs to which this licence applies after his graduation; or
  • Holding any foreign qualification the quality and content of training of which are comparable with those prescribed in clause (a), clause (b), clause (c) or clause (d) and is permitted to work as competent technical staff under this Rule by the Central Government.

Qualification of technical person for laboratory:
  • A degree in Medicine or Science or Pharmacy or Pharmaceutical Chemistry of a University recognized for this purpose and shall have experience in the testing of drugs, which in the opinion of the Licensing authority is considered adequate.

List of Documents to be submitted for grant of manufacturing license of Bulk Drugs:
  • Introductory Covering Letter mentioning Name and address of plant and administration office
  • Application at prescribed Form and format
  • Prescribed Fee Receipt
  • Details of constitution of firm, partnership or Company
  • Documents related to Ownership of premises or Rent or Lease documents
  • Identity Proof of all Authorized persons, proprietor, partners and/or directors
  • Details of Technical Staff e.g. Manufacturing Chemist and Analytical Chemist with education documents and approval certificates which is applicable
  • List of machineries and laboratory equipments
  • Site Mater File
  • Blue print of Plant and layout of premises specifying installation of machinery and equipments
  • Design and Layout of HVAC system
  • List of bulk drugs to be manufactured in manufacturing unit
  • Water analysis report
  • NOC if required from other departments like health department, pollution department or fire department etc.
  • Factory Act Registration if applicable

Hope above information is helpful to you...
For any query and suggestion, mail us at pharmafranchiseehelp@gmail.com

Comments

Register your business at

Find pharmaceutical, cosmetics, nutraceutical, ayurveda and alternative medicine's distributors, franchise, suppliers query for free.

If you want to take distribution, franchise or associates with any pharmaceutical, cosmetic or ayush company then you can find it here...

Send Your Query

Popular posts from this blog

What are the Schedules under Drug and Cosmetic Act, 1940 & Rules 1945?

Schedules are the set of provisions for classifications of drugs, forms, fees, standards, requirements and regulations related to drugs and cosmetics under Drug and Cosmetic Act, 1940 and Rules, 1945. Here drugs includes pharmaceutical, Ayurvedic (including siddha), unani and tibb system of medicines, homeopathy etc. Schedules are divided alphabetically and named also alphabetically like Schedule A, Schedule B etc till Schedule Y. Schedule Z is proposed  but not implemented yet. Schedules are important part of Drug and Cosmetic Act 1940 & Rules, 1945 . Every schedule contains specific information as discussed below. Schedule A:  Schedule A  describes application forms and licenses types. Schedule B:  Schedule B  describes Fees for test or analysis by the Central Drugs Laboratories or State Drugs Laboratories Schedule B1: Schedule B1 describes fees for the test or analysis by the pharmacopoeial laboratory for indian medicine (plim) or the government analyst Schedule C: 

State Pharmacy Council, Its Constitution and Composition and Functions

State Pharmacy Council: State Pharmacy Council is constituted as per the Pharmacy Act, 1948 & State Pharmacy Rules, 1951. State Pharmacy Council is an authoritative council to regulate Pharmacy Act, 1948 & State Pharmacy Rules, 1951. State Pharmacy Council means a State Council of Pharmacy constituted under section 19, and includes a Joint State Council of Pharmacy constituted in accordance with an agreement under section 20 under the Pharmacy Act, 1948 & State Pharmacy Rules, 1951. State Pharmacy Council work under Pharmacy council of india . The State Pharmacy Council consists of the following: (i) Six members, elected from amongst themselves by registered pharmacists (ii) Five members, of whom three are persons possessing a prescribed degree or diploma in pharmacy or pharmaceutical chemistry or registered pharmacist, nominated by State Government (iii) One member, elected from amongst themselves by the members o

Schedule T: Good manufacturing practices for ayurvedic, siddha and unani medicines

Schedules:  Schedule A ,  Schedule B ,  Schedule C ,  Schedule D ,  Schedule E1 ,  Schedule F ,  Schedule G ,  Schedule H ,  Schedule H1 , Schedule I,  Schedule J ,  Schedule K ,  Schedule L1 ,  Schedule M ,  Schedule M1 ,  Schedule M2 ,  Schedule M3 ,  Schedule N ,  Schedule O ,  Schedule P ,  Schedule Q ,  Schedule R ,  Schedule S ,  Schedule T ,  Schedule U ,  Schedule V , Schedule W,  Schedule X ,  Schedule Y Schedule T (Rule 157): Schedule T describes the good manufacturing practices for ayurvedic, siddha and unani medicines The Good Manufacturing Practices (GMP) are prescribed as follows in Part I and Part II to ensure that: Raw materials used in the manufacture of drugs are authentic, of prescribed quality and are free from contamination. The manufacturing process is as has been prescribed to maintain the standards. Adequate quality control measures are adopted. The manufactured drug which is released for sale is of acceptable quality. To achieve the objectives