Drug Manufacturing Licence

Government of India has made it mandatory to obtain Manufacturing License for all those who want to deal in the business of manufacturing drugs. The license covers all sorts of medicines such as Ayurvedic, Allopathic, Unani, and Cosmetics products as well. The State Licensing Authority is responsible to issue the license and at the same time monitor different license such as Drug Sales License, Drugs Manufacturing License for Ayurvedic, Allopathic, and Cosmetics etc. These state government authorities also conduct regular inspection of the sale department, manufacturing unit and at the same time protect drugs manufacturing unit from malpractice.

Form-28 is required under Drugs and Cosmetics Rules to apply for Manufacturing License. Rule 76 of Drugs and Cosmetics provides the information related to issue of manufacturing license. State Drug Licensing Authority regulates manufacturing for sale of disposable hypodermic syringes, disposable hypodermic needles, disposable perfusion sets and in-vitro diagnostic devices.

Documents required for obtaining manufacturing drug license

• Passport size photograph

• Identity proof

• Address proof

• Evidence for depositing the application fees

• Application form, Filled and signed

• Self-attested copy of the registered plant layout

• Utility bill as the certified office proof, in case of owned land

• Rent agreement, if applicable

• No-objection Certificate from Landlord (in case of rented property)

• Educational background, experience letter of the registered pharmacist

• Invoice of Refrigerator for business purpose

• Invoice of the purchase of Air-Conditioner

Additional Documents Required In Case Of Partnership Firm

• Partnership Deed

• List of all Partners

Additional Documents Required In Case Of Private And Public Limited Company

• Certificate of Incorporation

• Memorandum of Association

• Article of Association

• Appointment of the concerned and authorized person who will be responsible for daily operations.

• Copy of the board resolution regarding the authorized person who will be responsible for the day to day operations.