Guidelines and Procedures for Grant of Licence for Repacking of drugs for sale other than Medical Devices

The procedures are subjected to changes with respect to enclosed G.O. gazette notification
Licencing Authority
The Director of Drugs Control, Chennai-600006
Documents to be submitted
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-24B duly filled and signed by the applicant.
3. Fees of Rs. 700/- 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. 100/- per product shall be paid.
4. Authorization of the signatory of the application form
5. Details of the products applied
a. List of products (in quadruplicate)
b. Specimen label.
c. Therapeutic justification in case of patent and proprietary medicines.
d. Specification and method of analysis for Raw Materials and Finished
Products.
e. Brand name declaration in case of the products manufactured
exclusively for the purpose of export.
f. Stability data.
g. Test Licences in Form 29.
h. Consent letter from approved laboratory if applicable
i. 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 Competent person/ Analytical Chemist along with their Bio-data, Passport
size photo and photocopies of Qualification Certificate and experience certificate
• Declaration of the competent person /analytical Chemist.
• Address proof and ID proof of the Competent person/ analytical Chemist
8. Premises details:
a. Ownership document of the premises.
b. Plan of the premises- with details of partitions, measurements - Section wise
with location of machineries
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 change of premises & change in constitution
• Enclose original licence 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.
11. 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

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PROCESS FOR GRANT OF NEW PACKING LICENCE: Please visit the nearest Meeseva/ Office of Assistant
Controller, Legal Metrology/ www.meeseva.gov.in/ to the get the application for applying Grant of New
Packing License. Fill the application in detail. Please visit the nearest MeeSeva with the filled
application and other documents required for applying license. Please make sure that your online
application is filled without typo errors at Meeseva and get scanned the supporting documents in pdf
format (not exceeding 50kb) and photo in jpeg format (not exceeding 50kb) also register your mobile
number, so that you will receive the updates of your application. Make sure that the scanned documents
are attached to the appropriate options. Please get the acknowledgement from meeseva once your
online application is submitted after paying the fee. Please visit Office of Assistant Controller, Legal
Metrology with a set of photo copies including application and the get the date of inspection. You will
receive the date of inspection on your registered mobile. Physical original documents will be verified by
the Assistant Controller, Legal Metrology. Application has a time period of 60days for the process to
Grant/Reject(if failing on submission of required documents).

ATTACHMENTS TO BE SUBMITTED AT “MEE-SEVA” CENTER FOR GRANT OF NEW PACKING LICENCE:

1. Photographs of Proprietor - in case of Proprietorship Managing Partner - in case of Partnership firm

Managing Director - in case of Limited Company

2. Cross check whether the commodity for which packing licence applied is an item mentioned in
Schedule-II pf PC Rules 2011, if yes, check whether the sizes of packing indicated is in conformity with
sizes mentioned thereof.

3. Trade Licence/VAT registration

4. If applicant is an authroized signatory, proof thereto:

5. Registered partnership deed/articles of association as the case may be.

6. Sample copy of Label is to be crosschecked for compliance of declarations of PC Rules.

7.Aadhar card of the proprietor / Authorized signatory.