Menu
Guidelines and Procedures for Grant/Renewal of Loan Licence for manufacture of drugs other than Medical Devices for sale- Allopathic Drugs


Licencing Authority

  The Director of Drugs Control, Chennai-600006                                                                       

  1. 1. Covering letter addressed to the Director of Drugs Control, Chennai-600006, along with Rs.2/- court fee stamp for each licence.
    1. • To obtain loan licence for manufacture of drugs
        o other than those specified in Schedules C and C (1) and X - application in Form 24A
        o specified in Schedules C and C (1) excluding those specified in Schedule X- Application in Form 27A
        o Large Volume Parenterals/ Sera and Vaccines recombinant DNA (r-DNA) derived drug excluding those specified in Schedule X - Application in Form 27DA
        3. Fees of Rs. 7500/- per licence as Demand draft in Favour of the Director of Drugs Control, Chennai-6 with minimum of 10 products for each category of Schedule M and if exceeds, an additional fees Rs. 300/- per product shall be paid.
        4. Authorization of the signatory of the application form
        5. Details of the products applied
          a. List of products with composition (in quadruplicate)
          b. Copies of Drugs Controller General (India)'s approvals, if required.
          c. Specimen label.
          d. Therapeutic justification in case of patent and proprietary medicines.
          e. Method of manufacture of bulk drug along with specification of the intermediates and the Material Safety data sheet of each and every material used during manufacture and finished product
          f. Specification and method of analysis for Raw Materials and Finished Products.
          g. Brand name declaration in case of the products manufactured exclusively for the purpose of export.
          h. Stability data.
          i. Test Licences in Form 29.
          j. Consent letter from approved laboratory if applicable
          k. A CD containing the list of products applied along with formula in the given format.
        6. Applicant details:
        a. Document relating to constitution of concerned firm/ Company/ LLP and others.
        b. List of Directors/partners and their Bio-data with their residential addresses and Photo, in case of proprietorship, bio-data with their residential addresses and Photo of proprietor.
        c. Address/ ID proof of the applicant
        d. Copy of the request letter addressed to the Principal manufacturer and also Consent letter from the Principal manufacturer to avail their facilities
        7. Principal Manufacturer Details:
        Copies of the licences held by the Principal manufacturer along with their product endorsements similar to the proposed one applied by the applicant firm.
        8. Premises details:
        a. Licence in Form 20B and 21B if available or copy of any other drug licence held by the applicant
        b. Ownership document of the premises.
        c. Plan of the premises
        d. Rental agreement of the premises, if applicable
        9. Consent letter from approved laboratory, if applicable
        10. If the applicant provides the testing facility the details of Technical Personnel to be furnished:
        • List of Analytical Chemist along with their Bio-data, Passport size photo and photocopies of Qualification Certificate and experience certificate
        • Declaration of the Analytical Chemist.
        • Address proof and ID proof of the analytical Chemist
        11. In case of change of premises & change in constitution
        • Enclose original licence / Renewal Certificate if any with list of products permitted
        • Documents related to change in constitution like sale deed, Dissolution/Reconstitution deed, Amalgamation court order if it is Private Limited Company with board resolution & registration certificate from Ministry of Corporate Affairs and any other document pertaining to change in constitution.
        12. Any other document/particulars which is related to the above mentioned documents to verify the correctness of the particulars submitted by the applicant, if necessary.
        • Important Notes:
        • All the applications to be sent in,
        Original to
        o The Director of Drugs Control, Tamil Nadu, 359, Anna Salai, Chennai. 600 006.
        Copy to
        o The Deputy Drugs Controller (India)South Zone, Central Drugs Standard Control Organization, No. 26, Haddows Road, Shastri Bhavan Annexe Chennai -600 006>
        • In case of application for Form 28D, Applications to be sent in,
        Original to
        o The Director of Drugs Control, Tamil Nadu, 359, Anna Salai, Chennai. 600 006.
        Copy to
        o The Drugs Controller General (India), Central Licence Approving Authority Directorate General of Health Services, Food & Drugs Administration Bhawan, Kotla Road I.T.O, New Delhi-110 002.
        o The Deputy Drugs Controller (India)South Zone, Central Drugs Standard Control Organization, No. 26, Haddows Road, Shastri Bhavan Annexe Chennai -600 006
        Procedure Followed:
        1. The applicant has to submit the application, fees with Documents to be submitted to the Director of Drugs Control, Chennai-6.
        2. After the receipt of application, the file will be forwarded to the Assistant Director of Drugs control/ Senior Drugs Inspector/ Drugs Inspector/ Deputy Drugs Controller (India) within 5 working days, who in turn will resubmit the application with Inspection Report and all required documents within 25 working day
        3. If the file is in complete shape, the Licence will be issued within 30 working days otherwise further action will be taken on the file for processing again.
        Overall Processing Time:
        In case of Grant of Licence: 75 days
        Note: This process & procedure is not applicable in case of licence in Form 28D as it involves dual licencing procedure by State licencing authority and Central licencing approving authority.