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.