What is FDA License for Manufacturing Products?
The company/distributor/independent agent to be an authorized Indian Agent for dealing with local/foreign drugs and cosmetics must have a manufacturing license from the Central Drugs Standard Control Organisations (CDSCO).
The application for the manufacturing drug License of medical devices in India is made according to Rule 27 to the State Drug Licensing Authority, CDSCO Zonal/Sub-zonal Office, and Drugs Controller General in India CDSCO (HQ).
Manufacturing of notified medical devices under the Central License Approving Authority (CLAA) for sale in India, a manufacturing drug license in form- 28 is required under Drugs and Cosmetics Rules. Rule 76 of Drugs and Cosmetics describes the information/data required for a grant of a manufacturing drug license.
Manufacture for sale of Disposable Hypodermic Syringes, Needles, and Disposable Perfusion sets and in-virto Diagnostic Devices are regulated by the concerned State Drug Licensing Authority.
Why this License is Required?
In order to make sure that food from the local market is hygienic, the Food and Drug Administration (FDA) Maharashtra will soon be issuing a notice to vendors in local markets to obtain a food safety license from the authority. Everybody who is dealing with food needs to have registration or license with us.
Check out the FDA License Video
Who can get FDA Manufacturing License?
Drug Products
Medical Devices
Cosmetics
Color Additives
Food
Beverages
Dietary Supplements
Labeling Products
Document Required for FDA Manufacturing License
Documents Checklist for FDA Manufacturing License (Maharashtra) for Drugs & Cosmetics
- Covering letter (with brief of company, categories of products, dosage forms proposed to manufacture)
- GRN generated by payment of fees through https://gras.mahakosh.gov.in/echallan
- Site Plan and layout of the building with name, address, scale, and measurements of the Area as per Schedule- T requirement (For Ayurvedic, Siddha, and Unani) & as per Schedule- M requirement (Allopathic Medicines) & as per Schedule- M - II requirement (For Cosmetics).
- Self-attested copies of documents pertaining to the possession of premises such as, Register ownership / rent / lease / allotment letter / Possession Letter, Tax Receipt, (Documents should be registered with appropriate Authority).
- Consent to establish from Maharashtra Pollution Control Board.
- Consent to estaList of Directors, Partners, Trustees ,along with ROC Copy Registered Partnership deed, Trust deed (As applicable)blish from Maharashtra Pollution Control Board.
Checklist of Documents for Grant of License
- A. Application in Form 24 & 27 (For Allopathic Medicine)
B. Application in Form 24-B (For Licence to Repack)
C. Application in Form 24-D (For Ayuverdic Medicine)
D. Application in Form 31 (For Cosmetics)
E. Application in Form 24-C (For Homoeopathic Medicine) - Challan of fees paid through https://gras.mahakosh.gov.in/echallan/.
- Specific power of attorney in favor authorized signatory for submitting application on behalf of the company.
- List Of Competent Technical Staff, With Their Qualification, Registration, Experience, Previous FDA Approvals, Etc.
- Appointment/Acceptance Letter of Competent Technical Staff of Manufacturing Section
- Appointment/Acceptance Letter of Competent Technical Staff of Testing Section.
- Section Wise List of Plant and Machineries
- Plan Layout of the Premises Approved By the Licensing Authority
- Consent To Establish & Consent To Operate From Maharashtra State Pollution Control Board
- NOC of Department of Industrial Safety & Health
- Details of Manufacturing Process, Process Flow Chart (For Bulk Drug).
- AHU Installation and Validation Certificate (Wherever Necessary).
- Water System Installation and Validation Certificate (Wherever Necessary).
Role of Shamkris and Process of FDA Manufacturing License
Shamkris adopts a results-oriented approach to compliance with mandatory licence requirements in the organization. A simple and guidance methodology help organisation to achieve licence in a timely manner and cost-effective. Shamkris support 100% in advisory, Guidance, Compliance with respect to license requirements to obtain approval.
The License process described below:
- Advisory for the document required
- Preparation of documents as per application & list of documents.
- Application File
- Inspection by the department if required
- Liason department
- License issued
- Applicable for 3 Years
- Renewal when due
Who can issue the FDA Manufacturing License?
FAQ
FDA stands for the Food and Drug Administration, a government agency responsible for the safety of food, dietary supplements, human drugs, vaccines, blood products and other biologicals, medical devices, radiation-emitting electronics, cosmetics, veterinarian products and tobacco products being sold or manufactured
Form-29 is a license to manufacture drugs for the purpose of Examination Testing and Analysis. The application made in Form-30, and the certificate is valid for one year.
Manufacturing license is a legal premise for a company to conduct manufacturing activities in Malaysia under the provision of the Industrial Coordination Act (ICA) 1975.