Indian Drug And Cosmetics Policy: Where Is The Place For Hemp Based Products?

Hemp based cosmetics are setting their place in the Indian market. There are hemp based cosmetic products containing CBD oil (cannabinoid), hemp oil, skin care products etc. available in the market. As the law surrounding hemp in India is unclear and still under development, hemp based products still raise questions in mind about the legality, procurement, manufacture, sell, assemble and all other things around it.

Researchers postulate that CBD has potential use in cosmetics as an anti-acne and anti-inflammatory agent.

As a result, there is a significant research activity being conducted on rodent models, human skin organ cultures and so on. There is a rising interest in the use of CBD-infused oil in cosmetics formulations for skin and hair care. Hemp based cosmetics contain phytonutrients in the form of CBD. Phytonutrients are the driving force of innovation in skin research because they can protect the skin against harmful exogenous and endogenous agents and can help in redemption of skin and aging health.

Hemp based medicines and cosmetics are covered under the Drugs and Cosmetics Act, 1985 with the inclusion of Ayurvedic and Unani drugs. The Ayurvedic and Unani drugs include hemp based medicines which are formed, available and strictly administered as per the formulations described in the authoritative books. Indian law makers have very cautiously drafted the drug policy to provide effective pharmaceuticals and cosmetics with no compromise on the quality of the products. The Drugs and Cosmetics Act, 1940 along with Drugs and Cosmetics Rules, 1945 is enacted to regulate the import, manufacture, distribution and sale of drugs, cosmetics and medical devices, to ensure their safety, efficacy, prescribed quality standard and conduct of clinical trials and for matters connected therewith or incidental thereto.

Laws are amended from time to time to bring changes according to the current requirements. The amendments are the changes or improvements in the current law. These changes are made with a progressive approach to include and exclude relevant rules and regulations. Changes come with growing knowledge, research and global development. The Drugs and Cosmetics Act, 1940 has been amended various times depending upon the current requirements. The Act has been amended as Drugs (amendment) Act, 1964 (13 of 1964) to include Ayurvedic and Unani drugs, the enactment of Narcotics Drugs and Psychotropic Substances Act, 1985 (NDPS Act, 1985), recently notified Cosmetics Rules, 2020 and many more earlier made amendments.

An Insight On Cosmetics Under The Drugs And Cosmetics Act, 1940

The definition of cosmetics is defined under section 3 (aaa) ― cosmetic 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 and includes new cosmetics. Under the provisions of Drugs and Cosmetics Act, 1940 and Rules made there under, with respect to cosmetics, there are two licensing authorities appointed at central and state level:

1. The Central Government regulates 

  • the import of all categories of cosmetics;
  • coordination with the State Licensing Authorities for registration; and
  • the Drugs Controller General of India functions as the Central Licensing Authority.

2. The State Government regulates

  • the manufacture for sale and distribution of all categories of cosmetics;
  • sale, stock, exhibit or offer for sale or distribution of all categories of cosmetics;
  • grant of approval to the laboratory which applies for carrying out tests on cosmetics and their raw materials under Chapter VIII of the Cosmetics Rules, 2020; and 
  • the State Drugs Controller by whatever name is called or any person delegated to perform the duties of the Licensing Authority appointed by the Government of the State or Union Territory functions as the State Licensing Authority.

Import And Manufacture Of Cosmetics

Import and manufacture of cosmetics are guided by the central and state government respectively. For a cosmetic to be imported into India, the product has to be registered under the rules laid down by the Central Licensing Authority. Any article falling within the definition of cosmetic is required to be registered along with pack size, variant(s) and manufacturing premises before its import into the country.

As per rule 39 of the Cosmetics Rules, 2020 for a cosmetic to be imported or manufactured it has to comply with:

  • the specifications prescribed in the Ninth Schedule;or
  • any other standards of quality and safety applicable to it;and
  • other provisions under the rules.

The power to determine grant or refusal of license to manufacture is with the State Licensing Authority. For manufacture of a cosmetic, the State Licensing Authority is required under law :

  • to order an inspection of the whole premises where the operations are to be carried out;
  • the inspectors are required to submit a detailed report for all the compliances;
  • a competent authority and qualified technical staff has to be appointed by the manufacturer under whose presence the production is done.

What Are The Conditions To Be Fulfilled To Obtain An Import And Manufacturing License For Cosmetics?

Indian hemp based Drug And Cosmetics Policy
Photo by Daria Shevtsova from Pexels

Import Of Cosmetics In India

The power to grant or refuse an application for import of cosmetics in India is vested with the Central Licensing Authority. A cosmetic intended to be imported in India needs to be registered on the online portal of the Central Government under Form COS-1 either by :

  • the manufacturer himself; or
  • by his authorised agent; or
  • the importer in India; or
  • by the subsidiary in India authorised by the manufacturer.

Along with the Form COS-1, information and undertaking needs to be furnished as per the requirements mentioned in Part I of Second Schedule of the Cosmetics Rules, 2020. On perusal of the documents and requirements, the Central Licensing Authority on being satisfied, may grant or refuse the application within 6 months and the reasons shall be recorded in writing.

Manufacture Of Cosmetics In India

The power to grant license for manufacture of cosmetics for sale or distribution is vested with the State Licensing Authority. A license to manufacture a cosmetic for sale or distribution shall be made under Form COS – 5 to the State Licensing Authority either through online or offline mode, as available. The manufacturer has to submit :

  • information and declaration required as per Part II of Second Schedule of the Cosmetic Rules, 2020.
  • a self-certificate of compliance of Good Manufacturing Practices (GMP) as specified in Form COS-7.

The rule does not mention the time limit for grant/refusal of license application by State Licensing Authority. It says that on further enquiry the license may be granted or rejected. In case an application is rejected, the applicant would be informed of the reason and a copy of the inspection report would be provided to him.

Loan License To Manufacture In India

Another license that can be granted with respect to cosmetics is a loan license to manufacture cosmetics. A loan license to manufacture is under Rule 3 (p) of the Cosmetics Rule, 2020 stating a licence granted by the State Licensing Authority under rule 25, for manufacturing a cosmetic, to a person who intends to utilize the manufacturing site of another licensee for manufacturing the cosmetic manufactured by the licensee at that site. To obtain a loan license an application under Form COS – 6 needs to be made to the State Licensing Authority, along with the same requirements as mentioned above for application to manufacture a cosmetic.

Though hemp based products are on their way to gain popularity in the Indian market but there are still questions regarding the legality of the products. Hemp based cosmetics available in India find their way through the laws which are still under interpretation. As the hemp industry is growing globally with developing laws by Indian states, the vagueness surrounding the subject is getting more clarity. We hope to have better and clear hemp policies and laws in India in the coming years.

Pallavi S. Maheshwari
Pallavi S. Maheshwari
Advocate working towards social upliftment and sustainable development. Here to gather knowledge and write.

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