Compliance with respect to cosmetics
With lot of multinational companies in cosmetics sector coming to India, market is full of various cosmetic and personal care products. For this Ministry of Health and Family Welfare came with regulations for registration of the cosmetics products in India. But during the review of the application process submitted for registration of cosmetic products various compliance related issues is observed by Central Drugs Standard Control Organisation (CDSCO).
Summing below the various compliance related issues in the application for registration of cosmetics in India:
- Covering Letter
Improper information about the purpose of the product example –
- New registration certificate
- Package size, amendment
- Change in the address of the Indian authorized agent, or importer, or manufacturer or any additional documents etc.
- Form 42
- Inadequate Name and address of the Indian agent, Legal manufacturer & Actual Manufacturing Premises, Category of the Product not put in a manner as per the Cosmetic guidelines in India.
- Full name of the of the Cosmetics with Brand name & Variant with Pack size is not clear.
- If the products are to be imported in bulk, the actual pack size for import in bulk quantity is not mentioned.
- Signature & Stamp with Name & Designation of Indian agent or Manufacturer are not given in original.
- Schedule D- III
- The name & address of the Indian authorized agent, legal manufacturer & actual manufacturing site information not matching with Form 42.
- The name of the cosmetic with brand name and variants with pack size not matching with Form 42.
- Undertaking which is not duly signed and stamped by Indian agent or manufacturer.
- The list of countries where market authorization or import permission or registration was granted is not mentioned properly.
- Incomplete data in Schedule D-III as some columns is not filled up.
- Authorization of agent by manufacturer (Power of Attorney)
- The validity of Power of Attorney which is not mentioned.
- Name & address of the Indian agent, Legal manufacturer & actual manufacturing premises not according to Form 42.
- Name of the Cosmetic with Brand Name & Variant with Pack size not correlating with Form 42.
- Not co-jointly signed, stamped and dated with name & designation of the signatory by both Indian agent & the manufacturer.
- All the pages of Power of Attorney including product list not notarized and not authenticated from the country of origin.
- Power of Attorney is found to be not intact.
- Payment of fees with TR-6 Challan
- TR-6 challan without challan number, date of payment and bank realisation stamp.
- TR-6 challan not submitted in original.
- Fees paid in INR are not mentioned in terms of USD.
- Amount of USD paid not correlating with the category of products proposed as per column 3 of the guidelines.
- TR-6 challan which is not mentioning Head of Account.
- Fees paid apart from Bank of Baroda.
- TR 6 challan without complete information of applicant name or address, categories for which fees are paid etc.
- Product Composition data or Ingredients of the product
- The Product composition list is not submitted for all the proposed products.
- The list of ingredients for all the products not submitted with exact concentration of each ingredient.
- The product composition information containing ingredients with concentration more than the prescribed limit of BIS.
- Product composition data containing substances which is not complying composition of cosmetic products as per Annexure A of IS 4707 (Part 1&2): 2009 of BIS.
- Product Composition data which is not duly signed/stamped by competent quality control person from the manufacturer.
- The product composition data which is not from the real manufacturer of the product.
- Free Sale Certificate (FSC)
- The Free sale Certificate which is not issued from country of origin of the products.
- The original or authenticated copy of Free Sale Certificate issued by the national regulatory authority or other competent organizations from country of origin which is not submitted for all the applied products.
- The validity of Free sale Certificate is not mentioned properly.
- The FSC does not clearly indicate that the proposed products are freely sold in the country of origin.
- The name of the cosmetics along with Brand name and variants which are not correlating with Form 42 & Power of Attorney.
- Free sale certificate found to be tampered.
- Chemical Information of Cosmetics
- The test Protocol for testing of Cosmetics and specification of the product is not submitted.
- The test report including the amount of Mercury, Lead, Arsenic & Other Heavy metals with limits not complying BIS is not provided.
- The test report which is not duly signed by competent quality control person from the manufacturer of the cosmetic product.
- Labels or Package insert of Proposed Products
- The submitted Label or package insert of the products which is not legible and not in English Language.
- The name of the cosmetics, package size & name or address of the manufacturer not correlating with that of Form 42.
- The Label of the proposed products without batch number manufacturing license number, expiry date not complying with Rule 148 of Drugs & Cosmetics Rules 1945.
- The Labels containing phrases or claims that may appear to attract the definition of the drug. For example, affects the structure or any function of the human body, treatment, drug facts, dermatologist recommended etc.
- The label does not mention cautions and instructions for certain ingredients (e.g. p- Phenylenediamine, fluoride content) as per requirement of Drugs & Cosmetic Rules 1945.
- The submitted labels are not signed/ stamped by manufacturer or its authorized agent.
- Heavy Metal Declaration –
Heavy Metal undertaking not complying with BIS and Indian regulation and not issued from the legal or real manufacturer.
- Soft Copies –
Soft copies of the information about the Product name along with Category, Pack size and actual manufacturing site in MS Word / MS Excel not submitted.
- Manufacturing License
- If the proposed products are imported in bulk for repacking or relabelling in India, notarized copy of manufacturing license or repackaging license issued by the State Licensing Authority not submitted.
- The above documents in English translation not duly signed by the qualified translator –
In short, Companies and individuals who manufacture or market cosmetics have a legal responsibility to ensure the safety of their products. So, preparing the documents in a fair way can lead to better compliance in respect of regulatory review of the registration process.
- Non-Compliances Observed During Review Process of Applications for Registration of Import of Cosmetics.pdf. https://cdsco.gov.in/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=MzQxMA – Accessed on 02.03.2019.