Application for grant of license or loan license to manufacture cosmetics for sale or for

distribution.

(1) Any person who intends to manufacture cosmetics shall make an application for grant of a licence or loan licence to manufacture for sale or for distribution to the state Licensing Authority.

(2) Application under sub-rule (1) shall be made through an identified online portal in Form COS-5 for licence or in Form COS-6 for loan licence accompanied with a fee, as specified in the Third Schedule along with respective documents as specified in Part II of the Second Schedule. Provided further that till such time the online portal is not operational for this purpose, offline application in Form COS- 5 for licence or in Form COS- 6 for loan licence may be made for manufacturing of cosmetic referred to in sub-rule (2).

(3) In case of a new cosmetic, the applicant shall obtain prior permission in Form COS- 3 as provided in Chapter V from the Central Licensing Authority and no licence to manufacture any cosmetic shall be granted by the State Licensing Authority without such permission.

(4) In addition to the documents specified in part II of the Second Schedule, the applicant shall furnish

a self-declaration in Form COS-7 conforming compliance with Good Manufacturing Practices, requirements of premises, plants and equipment for manufacture of cosmetics as specified in the

Seventh Schedule.

(5) On receipt of the application under sub-rule (1) accompanied such fee and such documents as

provided in sub-rule (2) and (3), for grant of a licence or loan licence, the State Licensing Authority

shall grant a licence or loan licence within a period of forty-five days from the date application after

scrutiny of application and documents it is of the opinion that requirements of the Act and these rules

have been fulfilled: Provided where the State Licensing Authority considers that the applicant has not fulfilled the requirement of the Act and these rules, the same shall be conveyed to the applicant within forty-five days from the date the application has been made.

(6) On receipt of the licence or loan licence referred in sub-rule (5), the applicant may manufacture

cosmetics for sale or distribution, after uploading a copy of such licence on the website of the Central

Drugs Standard Control Organisation.

(7) The State Licensing Authority within thirty days from the date of grant of licence or loan licence,

shall inspect or authorise any other officer subordinate to such authority to inspect the site and verify the information given in self-certificate in Form COS-7 referred in sub-rule (4).

(8) Where the State Licensing Authority or any other officer authorised to do so fails to inspect and

verify the site of the licence or loan licence within the period referred in sub-rule (7), the licence or loan licence shall be deemed to be valid for all purposes.

(9) In case, it is found at the time of inspection that the self-certificate contained any false information, the Licensing Authority may, after giving the licensee an opportunity to show cause, the licence or loan licence may be cancelled: Provided that where the State Licensing Authority is of the view that deficiencies can be removed, the said authority may issue the directions to the holder of the licence or loan licence to stop the manufacturing till the requirements are complied with, and when it is complied with, it shall be informed to Licensing Authority by the applicant and the Licensing Authority if satisfied may issue the directions to restart the manufacturing within five working days of receipt of such compliance.

(10) In case, the original license or loan licence is defaced, damaged or lost, a duplicate copy of the

licence or loan licence may be requested for from the State Licensing Authority on payment of fee as

specified in the Third Schedule.

 Manufacture at more than one premises﹘ If cosmetics are manufactured at more than one premises, a separate application for each of such premises shall be made and a separate license obtained for each such premises.

 Form of license or loan licence to manufacture cosmetics for sale or distribution﹘ A license or

loan licence to manufacture cosmetics for sale or distribution shall be granted in Form COS- 8 and loan licence in Form COS- 9.

Conditions of license or loan licence for manufacture of cosmetics﹘

A license in Form COS- 8 shall be subject to the conditions stated therein and to the following other conditions, namely:﹘

(a) Manufacture of cosmetics shall be conducted under the direction and personal supervision of

competent technical staff consisting at least one person who is a whole-time employee and who

possesses any one of the following qualifications﹘

(i) holds a Diploma in Pharmacy approved by the Pharmacy Council of India under the

Pharmacy Act, 1948 (8 of 1948), or

(ii) is registered under the Pharmacy Act, 1948 (8 of 1948), or

(iii) has passed the Intermediate Examination with Chemistry as one of the subjects or an

examination recognised by the Licensing Authority as equivalent to it.

(iv) holds a bachelor’s degree in Cosmetic Technology from recognized university.

(b) The factory premises shall comply with the requirements and conditions specified in the Seventh

Schedule.

(c) The manufacturer shall either﹘

(i) provide and maintain adequate staff, premises, and laboratory equipment for testing the cosmetics manufactured, and the raw materials used for manufacture in such cosmetics, or

(ii) make arrangements with a laboratory approved by the Central Licensing Authority under

Chapter VIII of the rules and accredited by National Accreditation Board for Testing & Calibration Laboratories (NABL) for carrying out such tests.

(d) The applicant shall maintain documentary evidence for the following﹘

(i) documents in respect of the ownership or occupation on rental or other basis of the premises, specified in the application for license or in the license granted,

(ii) constitution of the firm, or

(iii) any other document that may be required for verifying the correctness of the statements made by the applicant or the licensee, while applying for or after obtaining the license as the case may be.

(e) The licensee shall comply with the provisions of the Act and the rules made thereunder and with

such further requirements, if any, as may be specified in any rules to be made hereafter under Chapter

IV of the Act.

(f) The licensee shall keep record of the details of each batch of cosmetic manufactured by him and of

the raw materials used therein as per particulars specified in the Eighth Schedule and such records shall be retained for a period of three years after the date of expiry of the batch.

(g) A license in Form COS- 9 shall be deemed to have been cancelled or suspended, if the license issued, in Form COS- 8, in respect of manufacturing facilities is cancelled or suspended.

(h) The licensee shall test each batch or lot of the raw materials used for manufacturing the cosmetics

and also each batch of the final product and shall maintain records or registers showing the particulars

in respect of such tests. The records or registers shall be retained for a period of three years from the

date of manufacture.

(i) The licensee shall allow an Inspector appointed under the Act to enter with or without prior notice

any premises where the manufacture of a substance in respect of which the license is issued, is carried

on, to inspect the premises and to take samples of the manufactured products for which a receipt shall

be issued in Form COS- 10.

(j) The licensee shall allow an Inspector to inspect all registers and records maintained under these

rules and shall supply to the Inspector such information as he may require for the purpose of

ascertaining whether the provisions of the Act and rules made thereunder have been complied with.

(k) The licensee shall maintain an Inspection book in Form COS-11 to enable an Inspector to record

his impression and the defects noticed; The manufacturer shall inform the Licensing Authority within thirty days, in writing, in the event of change in labelling or composition or testing, or specification or in documentation of any of the cosmetic pertaining to this license along with an undertaking that the products comply with standards laid down bythe Bureau of Indian Standards as referred in the Ninth Schedule.

(l) The licensee shall inform the Licensing Authority in writing in the event of any change in the

constitution of the firm operating under the license. Where any change in the constitution of the firm

takes place, the current license shall be deemed to be valid for a maximum period of six months from

the date on which the change takes place unless, in the meantime, a fresh license has been taken from

the Licensing Authority in the name of the firm with the changed constitution.

(m) In case of change in name or address of a manufacturer, after grant of licence or loan licence

under sub-rule (5) of rule 23, an application for amendment shall be made to state Government for

prior approval from Licensing authorities for the said changes in manufacturing license within a period of sixty days from the date of such change. Provided that clauses (c) and (d) shall not apply to the manufacture of soap and the procedure for testing of raw materials and the records to be maintained by a manufacturer of soap shall be such as are approved by the ―Licensing Authority.

 Grant or refusal of license—

(1) If the Licensing Authority, after such further enquiry, if any, as he

may consider necessary, is satisfied that the requirements of the rules under the Act have been complied with and that the conditions of the license, loan licence and the rules under the Act shall be observed, he shall grant a license in Form COS-8 or Form COS-9 as the case may be.

(2) If the Licensing Authority is not so satisfied, he shall reject the application and shall inform the

applicant of the reasons for such rejection and of the conditions which must be satisfied before a license can be granted or renewed and shall supply the applicant with a copy of inspection report.

 Further application for licence or loan licence after rejection. —If within a period of six months

from the rejection of an application for a licence or loan licence, the applicant informs the State Licensing Authority that the requirements laid down in the Act and these rules have been fulfilled and

deposits a fee as specified in the Third Schedule, the State Licensing Authority may, after causing

further scrutiny, and on being satisfied that the requirements for grant of licence or loan licence have

been complied with, issue a licence in Form COS-8 or Form COS- 9.

 Appeal to the State Government. —Any person who is aggrieved by the order passed by the

Licensing Authority refusing to grant a license under this Chapter may within ninety days from the date of receipt of such order, appeal to the State Government and the State Government may, after such enquiry as considered necessary, and after giving the said person an opportunity for representing the case, pass such order as it thinks fit.

Validity of licence ﹘

(1) A licence or loan licence issued in Form COS- 8 or Form COS- 9 shall remain valid in perpetuity, subject to payment of licence or loan licence retention fee as specified in the Third Schedule before completion of the period of five years from the date of its issue, unless, it is suspended or cancelled by the State Licensing Authority.

(2) If the licensee fails to pay the required licence or loan licence retention fee on or before the due date as referred to in sub-rule (1), the licence or loan licence holder shall, in addition to the licence or loan licence retention fee, be liable to pay a late fee calculated at the rate of two per cent.of the licence or loan licence retention fee for every month or part thereof within one hundred and eighty days and in the event of non-payment of such fee during that period, the licence shall be deemed to have been cancelled.

 Inspection for verification of compliance﹘

(1) The premises licensed for manufacturing cosmetics

shall be inspected by Inspector appointed by the Central Government and State Government to verify

the compliance with the conditions of licence and the provisions of the Act and these rules, not less than once in three years or as needed as per risk-based approach.

(2) The inspectors appointed by the Central Government shall, when so required by the controlling

officer or the Central Licensing Authority, carry out special inspection of the identified manufacturing

facilities for ensuring compliance with the provisions of this Act and Rules thereunder.