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Welcome to GPC India - Regulation

ICMSR (India REACH)

India released the fifth draft of the Chemical (Management and Safety) Rules (ICMSR) on August 24, 2020. The ICMSR will regulate Substances, Substances in Mixture, Substance in Articles and Intermediates that are manufactured, imported, or placed in the Indian Territory. ICMSR is also known as India REACH.  

Notification is required for all substances that are in quantity above 1 Tonne Per Annum (TPA). Additionally, only substances that are listed in "Priority Substances Required to be Registered" in Schedule II of the ICMSR need to be registered. 

 

The ICMSR (India REACH) is expected to be notified to WTO in 2022 and come into force after 60 days of notification. India REACH will require Indian manufacturers and importers to comply with the regulation which includes notification and substance registration. For foreign manufacturers, they may appoint an Authorized Representation (AR) on their behalf to comply with the ICMSR (India REACH).  

 

BIS Certification

The BIS in BIS Certification stands for Bureau of Indian Standards. The establishment of a national standards body in India is based on the Bureau of Indian Standards Act established in 2016.  

The aims of the BIS Act include harmonious development of the activities of standardization, conformity assessment and quality assurance of goods, articles, processes, systems, and services. The responsible authority is the Bureau of Indian Standards

BIS certification is required by every manufacturer (Indian or foreign) of those who are manufacturing products under Compulsory Certification. 

Product certification includes two schemes: 

  • Product Certification Schemes: Scheme 1 - Indian Standards Institution (ISI)
  • Scheme 2 - Compulsory registration scheme (CRS). 

The list of products that requires BIS certification is constantly being extended. See our summary on BIS Mandatory Product list: for Scheme II and Scheme II.  

For non-Indian manufacturers to comply with BIS certification, Authorized Indian Representative (AIR) can be appointed to assist the application process, including:  

  1. Documentation and application submission  
  2. Factory inspection by Indian auditor 
  3. Provision of test samples by the AIR and execution of the tests 
  4. Marking and labelling of products with the standard or ISI marks for BIS certification 

 

Drug and Cosmetics Act, 1940

Cosmetic is defined under section 3(aaa) of the Drugs and Cosmetics Act, 1940 as, 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. 

Under the provisions of Drugs and Cosmetics Act, 1940 and Rules made there under, the manufacture of cosmetics is regulated under a system of inspection and licensing by the State Licensing Authorities appointed by the respective State Governments, while the import of cosmetics is regulated under a system of registration by the Central Licensing Authority appointed by the Central Government. The Drugs Controller General (India) functions as the Central Licensing Authority who grants the Import Registration Certificate and regulates the import of cosmetics into India vide Gazette notification G.S.R 763(E) under the provisions of Drugs and Cosmetics Act, 1940. 

The Cosmetics Rules, 2020

With the recent increase in awareness about safety and healthcare regulatory bodies around the globe started improving and advancing their regulations and policies to safeguard the health of their citizens. Following the trend Indian regulatory body who watch-over the safety of the cosmetics in the country – Central Drug Standard Control Organization (CDSCO) came up with new Cosmetics Rules. The Cosmetics Rules have been published through an official gazette notification on 15th Dec, 2020 and are effective since the same date in the whole country.

In the Cosmetics Rules, 2020, the cosmetics' definition remains the same.However, the concept of "New cosmetic" is introduced for the first time. It is defined as ‘a cosmetic that contains a novel ingredient that has not been used anywhere in the world or is not recognized for use in cosmetics in any national or international literature’.

These new rules mandate importers/ manufactures of a ‘new cosmetic’ to make an application and seek an approval from the Central Licensing Authority (CLA) before such a ‘new cosmetic’ could be imported or manufactured in India.The application should be accompanied with requisite data on safety and effectiveness. Further, the manufacturer must comply with IS 4011:2018 standards for testing the safety of the ‘new cosmetic’. 

The Cosmetics Rules, 2020 streamline the process of import registration of cosmetics. Along with the rules, the CDSCO (Central Drug Standard Control Organization) has issued frequently asked questions (FAQs) and guidance document for grant or retention of registration certificate (RC) or license for import or manufacture of cosmetics in the country.

To guide manufacturers in the formulation and labelling of their cosmetics, the Cosmetics Rules, 2020 includes the Ninth Schedule which defines the Indian Standards that cosmetics (in their finished forms) need to respect and the Tenth Schedule which list the colorants permitted in cosmetics (Part I - IS 4707) and in soaps.

Form Purpose
Cos-5 Application to obtain cosmetics manufacturing license 
Cos-7 Self- certificate compliance for GMP
Cos-8 Cosmetics Manufacturing license
Cos-10 Form for sampling
Cos-12 Application for new cosmetics
Cos-15 Seizure Form
Cos-16 Fair-price Form
Cos-17 Memorandum to Govt. Analyst
Cos-18 Non-Disposal Form
Cos-19 Govt. Analyst Test Report
Cos-22 Application for grant of testing of cosmetics
Cos-23 License for testing laboratory for cosmetics

 

The cosmetic products need to be registered on the SUGAM portal. To help the manufacturers, the authorized agent or the importers gather the right information to upload on the portal, an Excel sheet listing all the information needed is available to download on the portals’ website. Registration submission requires :

  • Product's category
  • Name of the product
  • Brand
  • Size
  • Variants
  • Bulk (yes or no)
  • Kit (yes or no)
  • Name of the kit
  • Address of the premises of the manufacturer
  • Name of the country where the product has been manufactured
  • Instructions

GPC can :

  • Review your formulation
  • Test the physic-chemical properties of your product
  • Test the microbiology of your product
  • Review your label
  • Review your claims
  • Perform a safety assessment
  • Register your product
  • Perform regulatory monitoring
  • Give regulatory consulting

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