Licence For Cosmetics Manufacturing, Sale & Distribution in Uttar Pradesh

This article will take you through the process for obtaining the licence for  cosmetics as per the drugs and cosmetic act 1945 

The detailed process for obtaining license under the act are as follows-

• Manufacture on more than one set of premises (SECTION 137)

If cosmetics are manufactured on more than one premises, a separate application for each such premises shall be made and a separate licence obtained for each such premises.

Application for licence to manufacture cosmetics for sale (SECTION 138)

Application for grant of licence to manufacture any cosmetic for sale [shall be made up to ten items of each category of cosmetics categorized in Schedule MII to the Licensing Authority appointed by the State Government for the purpose of this Part (hereinafter in this Part referred to as the Licensing Authority) in Form 31 and shall be accompanied by a licence fee of rupees two thousand and five hundred and an inspection fee of rupees one thousand for every inspection thereof or for the purpose of renewal of licence.

• Application for loan licence to manufacture cosmetics.(section 138A)

Application for grant or renewal of a loan licence for the manufacture for sale of cosmetics [shall be made up to ten items of each category of cosmetics categorized in Schedule M-II in Form 31-A to the Licensing Authority and shall be accompanied by a licence fee of rupees two thousand and five hundred and an inspection fee of rupees one thousand for every inspection thereof].

‘loan licence’ means a licence, which a Licensing Authority may issue to an applicant who does not have his own arrangements to manufacture but who intends to avail himself of the manufacturing facilities owned by a licensee in Form 32.

• CONDITIONS TO BE SATISFIED BY MANUFACTURER FOR OBTAINING LICENCE

The manufacturer has to ensure that the production is done in the presence of a competent and qualified technical staff and at least one of the staff persons should possess the following educational requirements:

1. Diploma in Pharmacy approved by the Pharmacy Council of India under the Pharmacy Act, 1948; or

2. Is registered under the Pharmacy Act, 1948; or

3. Has passed the intermediate examination with one of the subjects as Chemistry or any other examination which is recognized by the Licensing Authority as equivalent to it.

• DOCUMENTS TO BE SUBMITTED FOR GRANT OF LICENCE

1. Application forms.

2. Challan of fee deposited.

3. Declaration form.

4. Key plan (Blueprint)

5. Site plan (Blueprint)

6. Basis of possession of the premises.

7. Proof of ownership of the premises, if rented.

8. Proof of constitution of the firm (Certified copy)

9. Affidavit of non-conviction of Proprietor/Partners/Directors under Drugs & Cosmetics Act, 1940.

10. Certified copy of Regn. Certificate of Delhi Pharmacy Council/Experience Certificate of the Registered Pharmacist/Competent person and qualification certificates.

11. Bio-data form.

12. Affidavit of Registered Pharmacist/Competent person regarding fulltime working with the firm duly attested by Notary.

13. Appointment letter of Registered Pharmacist/Competent person in charge, if employed person.

Process for filling online application for obtaining Licence for Cosmetics for state of uttar pradesh

1. Select Form of Licence as per product to be manufactured.

2. On the basis of the Licence Form, select the application Form to be applied.

3. Open http://fsdaup.gov.in and click on the Online registration for Drugs/Cosmetics Manufacturing icon.

4. You shall be directed to the website of Udyogbandhu. Click on Nivesh Mitra and register as an entrepreneur.

5. Fill out an online form, upload required documents and submit.

6. Submit one hard copy of the application form with documents in the office of Food Safety and Drug Administration for office record.

7. If you are applying for items to be approved by CLAA (Central Licence Approving Authority), submit an application copy to the Zonal Office of Central Drugs Standard and Control Organization (CDSCO) also.

8. A joint inspection of proposed premises shall be carried out by the Drugs Control Authorities on a pre-scheduled date under intimation to applicant.

9. In case any discrepancies are observed during the inspection, the applicant shall be given the opportunity to rectify the defects and deficiencies. The compliance report submitted by the applicant shall be verified by the local Drugs Inspector.

10. If the inspecting team has observed that the firm is complying with provisions as laid down in Drugs and Cosmetics Rules, 1945, the Licensing Authority shall issue the licence. The applicant may download a copy of the licence from Nivesh Mitra Portal.

11. In the case of CLAA items, the copy of the Licence is sent to Drugs Controller General (India) (DCGI) for approval. After approval by DCGI, the licence is finally issued by the Licensing Authority.

ENCLOSURE-     PDF CONTAINING DETAILS OF DOCUMENTS REQUIRED FOR OBTAINING MANUFACTURING LICENSE AS PER UP FOOD SAFETY AND DRUGS ADMINISTRATION WEBSITE. 

REQUIREMENTS

1. Affidavit attested by Public Notary:-

i. Of Proprietor of the applicant firm, if the firm is proprietorship firm.

ii. Of all the partners, if the firm is a partnership firm.

iii. Of the person duly authorised by the Board of Directors of the Private Limited or Limited Company.

iv. Of the person duly authorised by …………………………………….. of the Co‑
operative society.

Note: No format is prescribed in the Drugs and Cosmetics Act and Rules for such an affidavit. The affidavit should include particulars regarding position and authority of the authorised applicant in the firm/Company/Co-operative Society.

2. If the applicant Company is a Private Limited or Limited Company, copy of minutes of the Board of Directors regarding authorization of person for the purpose of application for grant of licence and day to day responsibility. And if the applicant is a Co-operative Society then…………………………………………………………………

3. List of Board of Directors of Private Limited or Limited Company with full names and addresses of all directors. In case of Partnership firm list of names and addresses of all partners.

4. Attested copy of registration certificate from District Industries Centre if the applicant firm is a Small Scale Unit. Attested copy of certificate of incorporation issued by Registrar of Companies it is Private Limited or Limited Company. Attested copy of registration certificate issued by the Registrar of Firms, Societies and Chits if the firm is a partnership firm or a Co-operative Society.

5. Copy of Partnership Deed in case of Partnership firm.

6. Address proof of the authorised applicant/proprietor ( copy of voter I.D., Driving licence, ……………………………………..)

7. Affidavit of the person responsible for day to day working and for any violation of laws pertaining to Drugs.

8. Documents related to Manufacturing Chemist Employed (not applicable if the licence is required on Form 37 for a testing laboratory):

i. Affidavit duly attested by Public Notary ( a sample of format for affidavit is enclosed ad Annexure-III)

ii. Attested copies of educational qualification certificates, experience certificates.

iii. Attested copy of letter of approval by State Drugs Controller.

iv. Copy of consent letter, appointment letter, joining letter.

v. Medical examination certificate from a registered medical particular including eye fitness certificate .

vi. Four photographs per applied licence (e.g. for licence on Form-25 and 28, 8
photographs shall be required.

vii. Address proof

9. Documents related to Analytical Chemist Employed:

i. Affidavit duly attested by Public Notary (a sample of format for affidavit is enclosed as Annexure-III)

ii. Attested copies of educational qualification certificates, experience certificates.

iii. Attested copy of letter of approval by State Drugs Controller

iv. Copy of consent letter, appointment letter, joining letter.

v. Medical examination certificate from a registered medical practitioner including eye fitness certificate

vi. Four photographs per applied licence (e.g for licence on Form-25 and 28, eight photographs shall be required)

vii. Address proof

10. Attested copy of consent of Approved testing laboratory for testing of those raw materials and finished products which require sophisticated instruments for analysis

11. Three copies of Plan of Premises showing all the sections and dimensions.

12. Documentary proof of ownership or rental basis of the proposed premises. Copy of rental agreement is case of rented premises. Attested copy of ownership proof of rented premises from landlord.

13. Copy of No Objection Certificate from Pollution Control Board. In case of renewal of licence attested copy Air and Water Consent from Pollution Control Board (not applicable if the manufacturing unit is exempted for the same).

14. Copy of test report of water from a Government Approved Laboratory regarding its potability and freedom from pathogenic microorganisms.

15.  For formulation required to approved on licence, the details of each formulation on the following format:

16. List of manufacturing machineries and equipments provided (All the machineries and equipments, including Air conditioning and Air Handling Units, as prescribed under Schedule-M/M-I (for homeopathic drugs)/ M-II(for manufacture of Cosmetics)/M-III(for the manufacture of Medical Devices)of the Drugs and Cosmetics Rules.

17. List of Testing instruments and equipments provided.

18. List of general utilities provided viz boiler, fire fighting equipments, Effluent treatment plant, insect control equipment provided.

19. Attested copy of certificate issued by the Chief Controller of Explosives, Govt. of India under Indian Explosives Act for manufacturing units meant to manufacture medicinal gases to be filled into cylinders, units wgerein any inflammable/ explosive substance is to be used.

20. Copy of certificate from Fire Officer of the District.

21. Attested copy of certificate issued under India Boilers Act if the manufacturing unit is going to use Boilers of capacities not exempted under the said Act.

22. Copies of medical examination certificates of staff employed.

23. Photocopy of all approved items if application is being made for renewal of licence.

NOTE: For renewal of above mentioned drugs/cosmetics manufacturing licences, the application shall be made in the same form which is mentioned in column-3 of Table-1 along with documents as mentioned in para-2, 12, 13, 14, 16, 17, 18, 19, 20, 21, 22 and 23 above.

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