Steps for starting Pharmaceutical manufacturing company.

Pharmaceutical sector is regulated under Drug and Cosmetic Act & Rule, 1940. From manufacturing to retailing, every activity is regulated under this act and separate license is required for conducting every type of activity.

For setting up pharmaceutical manufacturing unit, you will require to take manufacturing license number for it. If you want to manufacture medicines then you will require medicine manufacturing license. If you want to manufacture medical device then you will require manufacturing license for medical devices. If you want to manufacture pharmaceutical raw material/ Bulk Drugs and active ingredients then you will require related license. Similarly separate licenses will be required for cosmetics, surgical equipments, disposable syringes etc.

Manufacturing licenses is granted by State Drug Control Office generally situated at capital region of concern state. You have to apply for manufacturing license to State Drug Control Office. But before applying for granting of manufacturing license, you have to fulfill all criteria and requirements required for setting up pharmaceutical manufacturing unit.

Requirements for Setting-up pharmaceutical manufacturing unit: 
  • Building and Plant
  • Two Technical Persons (One is approved for Manufacturing process and One is for Analytical Operations)
  • Machinery and Equipments for manufacturing processes and analytical operations
Building and Plant: The building(s) used for the factory shall be designed, constructed, adapted and maintained to suit the manufacturing operations so as to permit production of drugs under hygienic conditions. They shall conform to the conditions laid down in the Factories Act, 1948. Plant should compile with the specification describe under Schedule ‘M’ of Drug and Cosmetic Act & Rule.

Technical Persons: Technical persons shall possess desired qualification and experience in specific manufacturing type i.e. medicine, medical device, active ingredients etc.

The manufacture shall be conducted under the active direction and personal supervision of competent technical staff consisting at least of one person who is a whole-time employee and who is:
  • 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; or
  • A graduate in Science of 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 as a principal subject and has had at least three years practical experience after his graduation; or
  • A graduate in Chemical Engineering or Chemical Technology or Medicine of a University established in India by law or has an equivalent qualification recognized and notified by the Central Government for such purpose with general training and practical experience, extending over a period of not less than three years after his graduation; or
  • Holding any foreign qualification the quality and content of training of which are comparable with those prescribed in above three and is permitted to work as competent technical staff under this Rule by the Central Government.
Provided that the Licensing Authority may, in the matter of manufacture of disinfectant fluids, insecticides, liquid paraffin, medicinal gases, non-chemical contraceptives, plaster of Paris and surgical dressings, for the manufacture of which the knowledge of Pharmaceutical Chemistry or Pharmacy is not essential, permit the manufacture of the substance under the active direction and personal supervision of the competent technical staff, who, although not having any of the qualifications included above , in the opinion of the Licensing Authority, adequate experience in the manufacture of such substances.

The analytical operations shall be conducted under the active direction and personal supervision of competent technical staff consisting at least of one person who is a whole-time employee and who is:
  • 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.

Machinery and Equipments: Each type of manufacturing requires different type of machineries. Medicine manufacturing unit require different type of machineries where as bulk drugs manufacturing requires different types of machinery. Medical device manufacturing will require different types of machinery and equipments.
Licenses required for setting up pharmaceutical manufacturing unit: 
Read about procedure, details and documents required for particular license, click at particular license type above. 

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Hope above information is helpful to you…

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