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Cosmetics Manufacturing License procedure.pptx

The document outlines the procedures for obtaining a cosmetics manufacturing license in India. Key points include: 1. Premises must be inspected and approved according to area requirements specified for different categories of cosmetics. 2. An application with documents like product details, label drafts, equipment lists, and technical staff details must be submitted. 3. The licensing authority will inspect the premises and grant or reject the license. Licenses are valid for 5 years and must be renewed. 4. Additional categories or products can be added by following approval procedures including inspections.

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Cosmetics Manufacturing License procedure -What is Cosmetics? -Is it internal or external preparation? -Is there any therapeutic value of cosmetics? -If, yes whether they are classified as Drug? or Cosmeceuticals? -In India it is classified as Drug and Drug manufacturing License is to be obtained. -In USA it is classified as Cosmeceuticals &registration procedure to be followed.
Definition of Cosmetics “Cosmetic” means any article intended to be rubbed, poured, sprinkled or sprayed on, or introduced into, or otherwise applicated to, the human body or any part thereof for cleansing, beautifying, promoting attractiveness, or altering the appearance and includes any article intended for use as a component of cosmetic.
• Kanku used for tilak in forehead is a Cosmetic but it is used in puja is not cosmetic because it is not applied on the body of human being. • Similarly perfume sprayed on the body of human being is a cosmetics but it is sprayed on the handkerchief or room sprayer is not a cosmetic. • Similarly is case of Turmeric like Kanku.
Cosmetics Manufacturing License procedure (1)Approval of Plan of Premises (2)Submission of Application with documents to LA for grant of License (3)Inspection of Premises by Inspector & reporting to LA for taking action (4)Grant of license by LA (5) Renewal of License (6) Additional Product Permission (7) Addition of new Category in License (8) Technical Person approval
Approval of plan of Premises ( Area Requirements) 1) Manufacturing areas- As per Sch-M-II 2) Office- 10 SM 3) Workers Room-8 SM/Each sex 4) Raw material store-10 SM 5) Finish Product store-10 SM 6) Quarantine Room-10 SM 7) Packaging material store-10 SM 8) Bottle washing Room-10 SM 9) Bottle drying Room-10 SM 10) Packing & labeling Room-10 SM 11) Q.C.Laboratory-10 SM 12) Bonded Room for Alcohol -10 SM
6 Specific Area Requirements For Different Categories of Cosmetics (Sch: M-II) • Powders(loose,compact) section-15 sq.mt/each • Cream,lotion,etc.-25 sq.mt • Nail polish and nail lacquers (flameproof area)-15 sq. mt • Lipsticks and lipgloss-15 sq.mt • Depilatories-10 sq.mt • Eyebrows,eyelashes,eyeliners-10 sq mt
7 Kajal and surma- 10(basic)+ 5 (sterilisation) Aerosol-15 sq.mt Alcoholic fragrance solution-15 sq.mt Hair dyes-15 sq.mt Toothpaste and tooth powder-15 sq.mt.each(if black powder 15 sq.mt extra) Toilet soap-From basic-100 sq.mt (from nodules-50 sq.mt)
Submission of plan of Premises to LA for approval (Documents Required) 1) Forwarding letter address to LA 2) Original challan for Fee-Rs.100 3) 4 Copies of Plan- It includes the following -Key plan, -plan, -elevation, -end view, -Address of Premises & Sign. Of Auth. Person 4) Plan is scrutinized by Plan Committee & approved for construction of premises. 5) Premises is to be constructed as per approved plan, Machineries and equipments are to be installed, Technical Persons are to be employed, all documents are to be prepared and than application is to be submitted to LA for issuing License.
Application Submission to Lic.Autho.(Required documents) 1) Forwarding letter address to LA for obtaining License. 2) Form. No.-31 dully filled & signed by Auth. Person. 3) Form of Firms details dully filled & signed by Auth. Person 4) Original challan for lic. Fee as per requirements 5) Original plan of premises -1 copy 6) Document regarding possession of the premises 7) Document regarding constitution of the Firm(P/D,MOAA,TD etc) 8) List of Products-category wise-4 copies along with product details Form 9) Draft label of each product-3 copies 10) List of Machineries & Equipments-1 copy 11) List of Laboratory equipments-1 copy 12) List of approved Technical persons with their degree & experience certificates, appointment letter, acceptance letter -4 copies 13) Detail of method of analysis of products & Raw materials 14) Consent letter of Public Testing Laboratory
FORM 31 [See Rule 139] Application for grant or renewal of a1[licence to manufacture cosmetics for sale for distribution.] 1. I / We---------- (Name of person(s)) of --------- (Name of Company)hereby apply for grant / renewal of a licence to manufacture on the premises situated at…………( Address of Company) the following cosmetics:- 2. Name of Cosmetics………(As per list attached). 3. Names, qualifications and experience of technical staff employed for manufacture and testing………(As per list attached). 4. A fee of rupees ……2500+1000(IF).has been credited to Government under head of account…0210 etc… Date……………………….. Signature……………………. Note:—The application should be accompanied by plan of the premises.
[FORM 31-A [See Rule 138-A] Application for grant or renewal of loan1[ licence to manufacture cosmetics for sale or for distribution] 1. I / We------- (Name of person(s …of (Name of company)…………………..hereby apply for grant / renewal of a loan licence to manufacture cosmetics for sale on the premises situated at… …………( Address of Company) ………………………………….C/o… …………( Address of own Company) ………………………................…….the following cosmetics:-- 2. Names of Cosmetics… ………(As per list attached). ……………………………………. 3. The names, qualifications and experience of the expert shall actually connected with the manufacture and testing of the specified products in the manufacturing premises. ………(As per list attached). 4. I /We enclose a) A true copy of a letter from me / us to the manufacture concern whose manufacturing capacity is intended to be utilized by me / us. b) A true copy of a letter from the 2manufacturing concern that they agree to lend the services of their competent technical staff, equipment and premises for the manufacture of each item required by me / us and that they shall maintain the registers of raw materials and finished products separately in this behalf. c) Specimen of labels, cartons of the drugs proposed to be manufactured. 5. A fee of Rs2500+1000(IF)…………………………………..has been credited to Government under the head of account…0210 etc…………………………………………….. Date………………………… Signature…………
FORM 32 [See Rule 140] [Licence to manufacture cosmetics for sale or for distribution] Number of Licence and date of issue……………………………. 1 (Name of company)………………….. is hereby licensed to manufacture on the premises situated at …………( Address of own Company ……………………..the following cosmetics under the supervision of the following technical staff:-- a) Names of cosmetics. ………(As per list attached). b) Names of technical staff ………(As per list attached). 2. Enter here the name and address of the manufacturing concern where the manufacture will be actually carried out and also their licence number. 2. The licence shall be in force from…1/5/2012………………………….to……30/4/2017………………. 3. The licence is subject to the conditions stated below and to such other conditions as may be specified in the Drugs and Cosmetics Rules, 1945. Date………………………….. Signature………………. Designation……………..
Conditions of Licence 1. This licence and any certificate of renewal in force shall be kept on the approved premises and shall be produced at the request of an Inspector appointed under the Drugs and Cosmetics Act, 1940. 2. Any change in the expert staff named in the licence shall be forthwith reported to the Licensing Authority. 3. If the licensee wants to manufacture for sale of additional items he should apply to the Licensing Authority for necessary endorsement to the licence as provided in rule 138 (3). This licence shall be deemed to extend to the cosmetics so endorsed. 4.The licensee shall inform the Licensing Authority in writing in the event of any change in the constitution of the firm operating under the licence. Where any change in the constitution of the firm takes place, the current licence shall be deemed to be valid for a maximum period of three months from the date on which the change takes place unless, in the meantime, a fresh licence has been taken from the Licensing Authority in the name of the form with the changed constitution.
FORM 32-A [See Rule 139-B] Loan [Licence to manufacture cosmetics for sale or for distribution] 1. Number of Licence and date of issue 2 (Name of company)………………….. ………………………………..of… …………( Address of Company …………………………..is hereby granted a loan licence to manufacture the following cosmetics on the premises situated at …………( Address of own Company …………………….C/o… Name of own company …………………………………under the direction and personal supervision of the following technical staff: - a) Names of technical staff. ………(As per list attached). b) Names of cosmetics. ………(As per list attached). 3. The licence shall remain in force from…1/7/2012………………to…30/6/2017……….. 4. The licence is subject to the conditions stated below and to such other conditions as are specified in the rules for the time being in force under the Drugs and Cosmetics Act, 1940. Date……………………… Signature…………… Designation………..
Conditions of Licence 1. This licence and any certificate of renewal in force shall be kept on the approved premises and shall be produced at the request of an Inspector appointed under the Drugs and Cosmetics Act, 1940. 2. Any change in the technical staff shall be forthwith reported to the Licensing Authority. 3. If the licensee wants to manufacture for sale additional items he should apply to the Licensing Authority for the necessary endorsement to the licence as provided in rule 138-A (5). This licence shall be deemed to extend to the cosmetics so endorsed.
FORM 33 [See Rule 141] Certificate of renewal of loan licence to manufacture Cosmetics for sale 1. Certified that licence no………………granted on the…………………………to…………………for the manufacture for sale of the following cosmetics at the premises situated at………………has been renewed from…………………..and shall expire on………………………….. 1. Names of cosmetics 2. Names of technical staff Date………………………… Signature…………………….. Designation…………………..
FORM 33-A [See Rule 141-A] Certificate of renewal of loan licence to manufacture Cosmetic for sale 1. Certified that loan licence No………………granted on the……………to…………………………for the manufacture for sale of the following cosmetics at the premises situated at C/o…………………………………has been renewed from……………………….to…………………. 1. Names of cosmetics. 2. Names of technical staff. Date………………………… Signature………………….. Designation………………..
Form 32 is granted or renewed, the following conditions shall be complied with by applicant: (1) The manufacture shall be conducted under the direction and personal supervision of a competent technical staff consisting of at least one person who is a whole time employee and who possesses any one of the following qualifications: (a) holds a Diploma in Pharmacy approved by the Pharmacy Council of India under the Pharmacy Act, 1948 (8 of 1948), or . (b) is registered under the Pharmacy Act, 1948 (8 of 1948), or (c) has passed the Intermediate Examination with Chemistry as one of the subjects or an examination recognized by the Licensing Authority as equivalent to it
(2) The factory premises shall comply with the requirements and conditions specified in Schedule M- II. (3) The applicant shall either-- (i) provide and maintain adequate staff, premises and laboratory equipment for testing the cosmetic manufactured, and the raw materials used in the manufacture; or (ii) make arrangements with some institution approved by the Licensing Authority under Part XV (A) of these rules for such tests to be regularly carried out in this behalf by the institution.
Conditions of licence—A licence in Form 32 shall be subject to the conditions stated therein and to the following other conditions, namely:— (a) the licensee shall provide and maintain staff, premises and equipment as specified in rule 139. (b) The licensee shall comply with the provisions of the Act and the Rules made there under and with such further requirements, if any, as may be specified in any rules to be made hereafter under Chapter IV of the Act. (b-1) the licensee shall keep records of the details of each batch of cosmetic manufactured by him and of raw materials used therein as per particulars specified in Schedule U(1) and such records shall be retained for a period of three years. (c) The licensee shall test each batch or lot of the raw materials used by him for 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.
(d) The licensee shall allow any Inspectors appointed under the Act to enter with or without prior notice any premises where the manufacture of a substance in respect of which the licence is issued is carried on, to inspect the premises and to take samples of the manufactured products under a Receipt. (e) 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 the Rules made thereunder have been complied. (f) The licensee shall maintain an Inspection Book in Form 35 to enable an Inspector to record his impression and the defects noticed. [Provided that clauses (b -1) and (c) shall not apply to the manufacture of soap and the procedure for testing of raw materials and the records to be maintained by the manufacturer of soap shall be such as are approved by the Licensing Authority.
Inspection of Premises by Inspector & Report to LA Inspection of Premises by Inspector is carried out for verification of- 1) Areas of Premises 2) Documents 3) Machineries & Equipments 4) Laboratories Equipments 5) Technical Persons requirements 6) Other requirements if any as per law - Detail report of inspection is submitted to LA by Inspector along with his recommendations for grant/rejection/compliance of License. -LA grant/reject application for License. - License granted is valid for 5 years from the date of grant. -License granted is to be renewed for another period of 5 years. -New License is to be obtained in case of change in constitution of the Firm within three months. -Separate License is to be obtain for change of Premises. -New category can be added in existing License by following prescribed procedures
Renewal of license If a person applies for the renewal of license after expiry but within six months of such expiry, the fee payable for the renewal of such license shall be [rupees two thousand five hundred plus an additional fee at the rate of rupees four hundred per month or part thereof in additional to an inspection fee of rupees one thousand.]
Procedure for addition of new category in existing License • New plan showing old and new category is to be submitted for approval to LA as discussed earlier. Plan is approved by plan committee. Premises is to be constructed for new category as per new plan, Machineries and equipments are to be installed, Technical Persons are to be employed, all documents are to be prepared and than application is to be submitted to LA for granting new category of cosmetics. The following documents are to be submitted to LA. 1) Forwarding letter address to LA 2) Original challan for Fee of products as per requirements 3) Original new plan of premises -1 copy 4) List of Products-category wise-4 copies along with product details Form 5) Draft label of each product-3 copies 6) List of Machineries & Equipments-1 copy 7) List of Laboratory equipments-1 copy 8) List of approved Technical persons-4 copies 9) Detail of method of analysis of products & Raw materials 10) Copy of original License
Inspection of new category by Inspector & Report to LA • Inspection of Premises by Inspector is carried out for verification of- 1) Areas of new category 2) Documents 3) Machineries & Equipments 4) Laboratories Equipments 5) Technical Persons requirements 6) Other requirements if any as per law - Detail report of inspection is submitted to LA by Inspector along with his recommendations for grant/rejection/compliance of new category along with products included. -LA grant/reject application for new category along with products included. - Validity of new category & products is up to validity of original License.
Procedure for additional product permission in existing License • License fee shown above is for 10 items of each category of Cosmetic. • For additional item –Rs. 100 per item is required in case of Cosmetics-(Maxi.Rs-3000). 1) Application is to be made to LA for obtaining permission for additional items with- 2) List of Products-category wise-4 copies along with product details Form 3) Draft label of each product-3 copies 4) Detail of method of analysis of products & Raw materials 5) Copy of original License
27 Approval of Technical Person by LA • For getting approval of TP for particular section an application along with documents is to be made to LA by concern manufacturer if degree & experience is as per Rules. • Documents are-(1) Appointment letter of TP (2) Acceptance letter of TP (3) Copy of Degree Certificate of TP (4)Experience Certificate of TP (5) Forms of TP dully filled with. • Verification of Degree , experience is carried out by an Inspector & report is submitted to LA. • LA is approving TP for concern section if report is OK. • Approval given by LA is valid for all Manu. Units.
PROCDURE FOR LOAN LICENCE (Drugs to be manu. in other’s premises) • Application form-31A along with fee (challan) • Form-1,2,3 Properly filled &sign by appli. • Copy of Manu.licences of own firm • Copy of wholesale licenses • Other documents as discussed earlier regarding product & premises • Licenses are granted by LA. • Validity of lic. Is for 5 years from the date of grant. • In case of any change in the constitution new license is to be obtained within three months.
Conditions of license in Form 32-A.- (a) A license in Form 32-A shall be deemed to be cancelled or suspended, if the license owned by the licensee, in Form 32, whose manufacturing facilities are cancelled or suspended, as the case may be under these Rules. (b) The licensee shall comply with the provisions of the Act and these rules and with each further requirements, if any, as may be specified from time to time in Chapter IV of the Act, provided that where such further requirements are specified in the rules, these would come into force four months after publication in the Official Gazette.
(b-1)the licensee shall keep records of the details of each batch of cosmetic manufactured by him and of raw materials used therein as per particulars specified in Schedule U (1) and such records shall be retained for a period of three years. (c) The licensee shall test each batch or lot of the raw materials used by him for the manufacture of the cosmetics and also each batch of the final product and shall maintain records of registration 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.
(d) 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 license is issued is carried on, to inspect the premises and to take samples of the manufactured products under a receipt. (e) 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 the rules made there under have been compiled. (f)The licensee shall maintain an Inspection Book in Form 35 to enable an Inspector to record his impressions and the defects noticed.
Conditions for the grant or renewal of a license in Form 32 Before a license in Form 32 is granted or renewed, the following conditions shall be compiled with by applicant: (1) The manufacture shall be conducted under the direction and personal supervision of a competent technical staff consisting of at least one person who is a whole time employee and who possesses any one of the following qualifications: (a) holds a Diploma in Pharmacy approved by the Pharmacy Council of India under the Pharmacy Act, 1948 (8 of 1948), or . (b) is registered under the Pharmacy Act, 1948 (8 of 1948), or (c) has passed the Intermediate Examination with Chemistry as one of the subjects or an examination recognized by the Licensing Authority as equivalent to it.
Continued [(2) The factory premises shall comply with the requirements and conditions specified in Schedule M- II. (5) The applicant shall either-- (i) provide and maintain adequate staff, premises and laboratory equipment for testing the cosmetic manufactured, and the raw materials used in the manufacture; or (ii) make arrangements with some institution appro ved by the Licensing Authority under Part XV (A) of these rules for such tests to be regularly carried out in this behalf by the institution.
Conditions of licence A license in Form 32 shall be subject to the conditions stated therein and to the following other conditions, namely:— (a) the licensee shall provide and maintain staff, premises and equipment as specified in rule 139. (b) The licensee shall comply with the provisions of the Act and the Rules made there under and with such further requirements, if any, as may be specified in any rules to be made hereafter under Chapter IV of the Act. 3(b-1) the licensee shall keep records of the details of each batch of cosmetic manufactured by him and of raw materials used therein as per particulars specified in Schedule U(1) and such records shall be retained for a period of three years. (c) The licensee shall test each batch or lot of the raw materials used by him for 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.
(d) The licensee shall allow any Inspectors 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 under a receipt. (e) 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 the Rules made there under have been complied. (f) The licensee shall maintain an Inspection Book in Form 35 to enable an Inspector to record his impression and the defects noticed. [Provided that clauses (b -1) and (c) shall not apply to the manufacture of soap and the procedure for testing of raw materials and the records to be maintained by the manufacturer of soap shall be such as are approved by the Licensing Authority.]
. Further application after rejection.- Application is to be made to LA within a period of six months from the rejection of an application for a license, the applicant informs the Licensing Authority that the conditions laid down have been fulfilled and deposits an inspection 1[a fee of rupees two hundred and fifty], the Licensing Authority may, if, after causing further inspection to be made, he is satisfied that the conditions for the grant of license have been complied, with issue a license in Form 32, Form 32-A or Form 33.
Appeal to the State Government Any person who is aggrieved by the order passed by the Licensing Authority refusing to grant or renew a license under this Part 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 into the matter as is considered necessary and after giving the said person an opportunity for representing the case, pass such order as it thinks fit.]
Prohibition of manufacture of cosmetics Prohibition of manufacture of cosmetics containing colours other than those prescribed.- No Cosmetic shall be manufactured which contains Dyes, Colours and Pigments other than the one specified by the Bureau of Indian Standards (IS: 4707 Part I as amended) and Schedule Q. The permitted Synthetic Organic colours and Natural Organic colours used in the Cosmetic shall not contain more than : (i) 2 parts per million of arsenic calculated as arsenic trioxide. (ii) 20 parts per million of lead calculated as lead. (iii) 100 parts per million of heavy metals other than lead calculated asthe total of the respective metals.]
144-A. Prohibition of manufacture of cosmetics containing Hexachlorophene.—No cosmetic containing Hexachlorophene shall be manufactured. [Provided that in the case of soaps hexachlorophene may be used in concentrations not exceeding one per cent weight by weight. Provided further that the following cautionary note shall be printed and shall appear in a conspicuous manner on the wrapper of package of each soap, namely:- “Contains hexachlorophene – not to be used on babies”.] 145. Use of Lead and Arsenic compounds for the purpose of colouring cosmetics prohibited.—The use of Lead and Arsenic compounds for the purpose of colouring cosmetics is prohibited.