Guidelines and Procedures for Grant/ Renewal of Licence for manufacture of Homeopathic Drugs under Drugs and Cosmetics Rules 145

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.
    • 2. Application in Form-24C duly filled and signed by the applicant.
      3. Fees of Rs. 300/- as Demand draft in Favour of the Director of Drugs Control, Chennai-6.
      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. Specification and method of analysis for Raw Materials and Finished Products.
        f. Consent letter from approved laboratory if applicable
        g. 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
      7.Technical Personnel Details:
      • List of manufacturing Chemists/ Analytical Chemist along with their Bio-data, Passport size photo and photocopies of Qualification Certificate and experience certificate
      • Declaration of the manufacturing Chemist/analytical Chemist.
      • Address proof and ID proof of the manufacturing Chemist/ analytical Chemist
      8. Premises details:
      a. Ownership document of the premises.
      b. Plan of the premises
      c. Rental agreement of the premises, if applicable
      9.Details of Machineries/Equipments:
      • List of machineries and equipments, AHU's, and water system provided Section wise for the manufacturing.
      • List of analytical instruments and equipments for analysis.
      • The photocopies of purchase invoices with the details like production capacity, make etc. wherever applicable
      10. In case of renewal
      • Enclose latest Renewal Certificate with list of products permitted
      • Details of the drugs to be renewed/not renewed in the given format.
      11. In case of change of premises & change in constitution
      • Enclose latest Renewal Certificate 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,
      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
      In case of renewal of Licence: 120 days