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

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