Grant of Drug and Cosmetic Manufacturing License in Own Premises

Food and Drug Administration Puducherry. Grants Own Manufacturing Licences for Drugs (Allopathy, Homoepathy, Ayurvedic, Siddha,Unani ) and Cosmetics in Forms 25, 28, 25B, 25C,25D and 32 The Administration also grants Licences for Blood & Blood products Vaccines & Sera in form 28C & 28D. However the said licences have also to be approved by Central Licensing Approving Authority i.e. Drug Controller General of India.

Procedure to obtain Drug Manufacturing licence (Fresh)

Stage 1
Approval of Layout Plan

For Approval of Lay out Plan the Applicant has to submit 3 Blueprint copies of plan to the concerned licensing Authority.(in case of Licenses for Blood Products and Vaccines Sera 4 Blue print copies of plan to be submitted) The plan should be as per the requirements prescribed for manufacturing premises in the Drugs and Cosmetics Act 1940. The prescribed requirements as per the Act for Layout plan are given in the checklist. The plan is scrutinized by panel of officers as per the requirements of the Drugs and Cosmetics Act 1940. If necessary the premises is inspected by the concerned Inspector before plan Approval. Finally after scrutiny and compliance as per requirements of the Act the layout plan is approved and a copy is given to the Applicant.

Stage 2
Application for grant of Own Manufacturing Licence The applicant has to make application in the requisite form ( 24,24B,24C,27,27C,27D) and pay Necessary fees. The fee can be paid through challan at State Bank of India (Main Branch), Puducherry, Karaikal, Mahe and Yanam under Head Account----0210-A MEDICAL AND PUBLIC HEALTH 04-PUIBLIC HEALTH (104) FEES & FINES LICENSE FEES UNDER PREVENTION OF FOOD ADULTARATION ACT 1954, DRUGS AND COSMETICS ACT 1940 FRESH/RENEWAL FOR THE YEAR

Documents to be attached along with the application form:

Receipt for the fees paid or challan, as the case may be or their attested copies. Copy of Approved layout plan of the manufacturing area. Documents viz. Rent receipt, purchase documents or its attested copies showing lawful possession of the premises List of machinery and equipments. Documents relating to the constitution of the firm viz. Partnership-deed, memorandum and article of association etc. Full particulars of the competent technical staff employed for manufacturing and testing of drugs and cosmetics along with copies of their educational qualifications and experience certificates approval letter as competent staff. The competent technical staff is required to furnish consent letter for full time employment with the applicant firm. List of Drugs Cosmetics in triplicate along-with undertaking to be submitted. In case, the application is for the products covered under Schedule C and C (I) category, then the details of stability data is required. If the products are covered under Patent and Proprietary definition, then the two copies of methods of Analysis of the products be supplied. Full name of the proprietor or the partners, as the case may be shall be provided in the application. In case of private or public limited concerns, full name of the Directors who sign the application and the authorized signatory, if any, shall be provided in the application .

Stage3
Inspection The application is scrutinized and premises inspected.

Stage 4
Grant of Licence If all conditions as prescribed by the act are complied license is granted

Procedure to Renew Drug Manufacturing licence Licenses in Forms 25, 25B, 25C,25D, 25F, 28, 28B,28C,28 D can be renewed.

Stage 1
Application for grant of Own Manufacturing Licence The applicant has to make application in the requisite form ( 24, 24B, 24C, 27, 27C, 27D)and pay Necessary fees as given in fee chart. The mode of payment of fees is same as fresh licence.

Documents to be enclosed along with application of renewal of licence :-

Copy of cash receipt or challan for payment of fees. Xerox copy of Licence /Previous renewal certificate. Xerox copy of the list of Drugs previously approved. List of Drugs along with names of proprietary medicines and dates of its approval (two copies). Full particulars of the competent technical staff appointed for manufacturing and testing along with their educational qualification and experience certificates.

Stage 2
Inspection The application is scrutinized and premises inspected.

Stage 3
Grant of Licence If all conditions as prescribed by the act are complied license is granted