MANUFACTURING OF COSMETICS & LEGAL COMPLIANCES REVOLVING AROUND IT

What Are Cosmetics?

Cosmetics are generally classified as beauty products that enhances and enriches the natural body of its consumers wherein, according to section 3 (aaa) of Drugs and Cosmetics Act it means any article intended to be rubbed, poured, sprinkled or sprayed on, or introduced into, or otherwise applied 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.

REGULATORY BODIES AND GOVERNING STATUTES:

1. REGULATORY BODIES:

Cosmetics in India are majorly regulated by G.O.I through:

1. Bureau of Indian Standards (BIS)
2. State Foods and Cosmetics Administration (SFCA)
3. Central Cosmetics standard Control Organisation (CDSCO)
4. Drug Controller General

• GOVERNING STATUTES:

A list of statutes that lays down procedural and substantive laws with respect to cosmetics are listed here in under;

1. Drugs and Cosmetics Act 1940
2. Drugs and Cosmetics Rules 1945
3. The Packaged Commodity Rules 2011
4. Legal Metrology Act 2009
5. Drug Control Act

1. MANUFACTURING COSMETICS!!!

1. Essentials

To manufacture cosmetics, a Licence is to be obtained from the licencing authority, that has been appointed by the state government.

1. Application form is to be dully filled and submitted withstanding to a licence fee @Rs. 2500/-*, in addition to an inspection fee of Rs. 1000/-*
2. 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:
3. Holds a Diploma in Pharmacy approved by the Pharmacy Council of India under the Pharmacy Act, 1948; or
4. Is registered under the Pharmacy Act, 1948; or
5. Has passed the intermediate examination with Chemistry as one of the subjects or any other examination as recognized by the Licensing Authority as equivalent to it.

• General Requirements for Manufacturing Cosmetics:

1. LOCATION AND SURROUNDINGS.  (non-residential area and hygienic) (10 – 150 square feet variable, pertaining to cosmetics.)
2. BUILDINGS (walls to be 6 feet erected; flooring to be smooth and washable)
3. WATER SUPPLY (potable quality)
4. DISPOSAL OF WATER (suitable arrangements for waste water)
5. HEALTH, CLOTHING AND SANITARY REQUIREMENTS OF THE STAFF
6. MEDICAL SERVICES (First Aid)
7. WORKING BENCHES (for the operation of cosmetics)
8. ADEQUATE FACILITIES (for washing and drying of containers)

• MANUFACTURING RECORDS:
• Maintaining of manufacturing records is mandatory as per Drugs and Cosmetics Act, non-compliance to which shall attract a penalty in addition to imprisonment.
• Particulars that are to be mentioned in manufacturing Records:

Serial number; Name of the product; Batch size; Batch number; Name of all ingredients; Quantities used; Actual production; Packaging particulars indicating the size and quantity of finished packings; and Signature of the expert staff responsible for the manufacture.

• MANUFACTURER’S RESPONSIBILITY:
• A manufacturer is responsible to ensure Rationality; Safety; Ensure Quality and Quantity of the various excipients used in formulation of the cosmetics.
• Manufacturer shall continue to provide and maintain the premises, equipment and staff as at the time of grant of license.
• Manufacturer shall test each batch of raw material before its use in the manufacture of cosmetic.
• Manufacturer shall to test each batch of finished cosmetics.
• Manufacturer shall maintain records of raw materials, manufacturer of each batch of cosmetic and their testing.

• COSMETICS THAT ARE NOT TO BE MANUFACTURED/SOLD:

With regard to the guidelines laid under Drugs and Cosmetics Act 1940 and Rules 1945 certain cosmetics are neither to be manufactured, nor to be sold; such cosmetics are disclosed here in under;

1. Cosmetic that are Misbranded
   1. Cosmetic that are Spurious
   1. Cosmetic that are Adulterated
   1. Cosmetic that are Unlicensed
   1. Cosmetic that are Prohibited
   1. Cosmetic that are Patented or Proprietary, wherein, ingredients used can’t be disclosed.

• LABELLING REQUIREMENTS FOR COSMETICS:

1. Name, manufacturing address and pin code is to be mentioned over the drug.
2. Net contents and Ingredients are to be specified.
3. Directions of use are to be mentioned, if any.
4. Names and net content of ingredients are to be specified, if consists of any hazardous ingredient
5. Quality standards are to be specified in accordance with Bureau of Indian standards.
6. Distinctive batch number followed after letter B, in addition to manufacturing license number followed by letter M; to be specified on label.

• LICENCES & DOCUMENTS REUIRED TO ACQUIRE LICENCE:

1. LICENCES:
2. License on form 32 is issued for manufacture/ sale distribute of cosmetics. (Form no 31)
3. License on form 32-A is issued for loan license for manufacture/ sale distribute of cosmetics. (Form no. 31-A)
4. License on form 37 is issued for grant or renewal of approval for carrying out tests on drugs/cosmetics or raw material used in the manufacture thereof on behalf of licenses for manufacture for sale of drugs/cosmetics. (Form no. 36)

• DOCUMENTS MANDATORY TO BE ANNEXED WITH APPLICATION:

1. Certain documents are necessary to be annexed while applying for the licence with regard to the clearance and No Objection Certificate. A list of such documents necessary is tagged herein’

“Application forms; Challan of fee deposited; Declaration form; Key plan (Blue print); Site plan (Blue print); Basis of possession of the premises. Proof of ownership of the premises, if rented; Proof of constitution of the firm (Certified copy); Affidavit of non-conviction of Proprietor/Partners/Directors under Drugs & Cosmetics Act, 1940; Certified copy of Regd. Certificate of Pharmacy Council/Experience Certificate of the Registered Pharmacist/Competent person and qualification certificates; Bio-data form; Affidavit of Registered Pharmacist/Competent person regarding fulltime working with the firm duly attested by Notary; Appointment letter of Registered; Pharmacist/ Competent person in charge, if employed”