INTRODUCTION
In India, the cosmetics sector has been developing at an exponential rate, particularly in urban regions. This is due to a variety of circumstances, including the influence of western culture, the desire to appear attractive, and so on. There is currently an extensive range of different sorts of cosmetic goods available on the market. Every cosmetic product contains a variety of chemicals; thus, it is critical for the country's government to safeguard customers' interests and verify that the items are safe to use. Previously, there were no tight rules for cosmetic items, but this has changed as people have become more aware of animal suffering and the detrimental consequences of chemicals in cosmetics. Countries are now enacting laws and policies to that effect, guaranteeing that strict measures are followed to ensure the safe use of these items. The Central Drugs Standard Organization (CDSCO), which is led by the Drugs Controller General of India, is the central authority in India for executing regulatory tasks relating to drugs and cosmetics. The Drugs and Cosmetics Act of 1940 and the Drugs and Cosmetics Rules of 1945 established it as a statutory authority. CDSCO's main purpose is to ensure the safety, efficacy, and quality of pharmaceuticals, cosmetics, and medical devices. Every state also has a state-level authority known as the State Drug Control Authority (SDCA), which is responsible for enforcing the Drugs and Cosmetics Act of 1940's laws. Under the Bureau of Indian Standards Act, 1986, the Bureau of India Standards is another governmental authority in India that has the jurisdiction to set standards for cosmetics.
Cosmetic regulations in India
As per the Drug and cosmetic act 1940, “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.” The Drugs and Cosmetics Act 1940 and Rules 1945, as well as the Bureau of Indian Standards' Labelling Declarations, govern cosmetic items in India (BIS). BIS establishes cosmetics standards for products covered by Schedule 'S' of the Drugs and Cosmetics Rules 1945. Skin Creams and Lipstick have also been specified by BIS in Indian Standards (IS) 6608:2004 and 9875:1990, respectively. Cosmetics comprising dyes, colours, and pigments other than those specified by the Bureau of Indian Standards (IS: 4707 Part 1 as amended) and Schedule Q are prohibited under Rule 134 of the Drugs and Cosmetics Rules. The use of lead and arsenic compounds in cosmetics for colouring is prohibited by Rule 145 of the Drugs and Cosmetics Rules. Rule 135 forbids the importation of cosmetics that have been coloured with a lead or arsenic ingredient. Cosmetics containing mercury compounds are prohibited by Rules 145 D and 135 A, respectively. Any cosmetic product imported into India must be prepared on Form COS-1 by the manufacturer or an India-based authorised agency to get the requisite Registration Certificate on Form COS-2, according to the Cosmetic Rules 2020. Aside from the demand for unique items, the market for novel cosmetic products is always buzzing. And the importance of Cosmetic Product Safety Assessment rules has grown as a result of this new segment of products, namely novel cosmetics. Manufacturers/importers must submit an application to the CDSCO in Form COS-12 to register a novel product in India, and the appropriate registration certificate can be obtained in Form COS-3. Given the rising demand for cosmetic items in India, the CDSCO is working tirelessly to streamline the regulations governing these products. It is safe to state that the CDSCO is striving to conform with worldwide cosmetic standards with the adoption of Cosmetic Rules 2020. As a result, firms entering the Indian market must be cautious when deciphering cosmetic product regulations to avoid any last-minute issues.
Restrictions on manufacture, sale and distribution of drugs & cosmetics
Manufacturing, sale, and, distribution of cosmetics that are not of standard quality are adulterated, misbranded, or spurious are forbidden under Section 18 of the Drugs and Cosmetics Act. The prohibition also applies to any patent or proprietary drug that is claimed to prevent, lessen, or cure any ailment or disease by any statement, device, or statement that comes with it, or that has any other adverse effect as defined by the act. The prohibition also applies to any cosmetic containing a substance that is dangerous when used according to the directions on the label, as well as any other drug or cosmetic that violates any provision of the chapter governing the manufacture, sale, and distribution of drugs and cosmetics. Under the limits on manufacturing, sale, or distribution clause, the terms spurious, misbranded, adulterated, or standard quality have the same meaning as under the requirements for the import of pharmaceuticals or cosmetics goods.
The Supreme Court held in Pratap Sharma Private Limited v. Union of India Writ Petition (C) Nos.3559 AND 4572/83 that if a drug does not meet the prescribed standards and has the potential to cause injury or endanger a person's life, the prohibition of that drug will be implied if it is not expressly prohibited under the Act, and the accused will be held liable.
Regulations for import of cosmetics
The Drugs and Cosmetics Rules 1945 have been changed, according to the Government of India's Gazette notification G. S. R 426 (E) dated May 19, 2010, and the new modification provides for registration of cosmetics imports into the country. All products imported for sale in India must now be registered with the CDSCO, or the Central Drugs Standard Control Organization, which has been designated as the licencing body for this purpose. The major goal of this registration requirement is to limit indiscriminate/illegal imports of cosmetics items by traders who are not responsible for their content and have no way to compensate customers who are dissatisfied with the quality. The major purpose of requiring import registration is to prevent the sale of substandard cosmetic items in India.
Recent developments
The Drugs and Cosmetics Bill, 2013, was submitted in 2013 to replace the current Drugs and Cosmetics Act, 1940, to create a comprehensive piece of legislation that would cover all areas of cosmetics and drugs. The bill was, however, withdrawn from the Rajya Sabha in 2016.
The Ministry of Health and Family Welfare issued Gazette notification G. S. R 718 (E) on October 13, 2014, amending the medicines and cosmetics rules to prohibit animal testing of cosmetics and the importation of animal-tested cosmetics into the country. India was the first country in South Asia to enact such a prohibition. Further clarifications were made in this regard, stating that the importer must get an official undertaking from the maker (legal/brand owner) stating that the cosmetic items were not tested on animals on or after November 12, 2014. This undertaking, along with the registration-related paperwork, shall be submitted to CDSCO by new applicants, and a copy of the undertaking must be produced at the ports for consignment clearance.
CONCLUSION
Despite the numerous disparities in cosmetics legislation among jurisdictions, each country shares a common goal: to safeguard consumers by ensuring that cosmetic goods are safe. Every regulatory system should have basic compliances in place for the benefit of consumers. We are all too aware that the Indian regulatory system has severe flaws when it comes to cosmetic regulations, as the requirements are numerous and complex, and there are multiple authorities involved, making the process of cosmetic product clearance laborious and time-consuming. The lack of application of CDSCO and BIS rules recommendations is a big issue. There is no consistency in the licence approval criteria, and there is variation in the interpretation of any given issue by different agencies. As a result, cosmetic laws and regulations must be standardised for product development, stability, safety, quality, and efficacy of cosmetics. As a result, there is a need to strengthen the legislation governing control standards and safety information for cosmetics in India to ensure that final cosmetic goods are safe.
REFERENCES
https://www.freyrsolutions.com/blog/cosmetic-product-regulations-in-india-an-overview
https://blog.ipleaders.in/legal-compliances-cosmetic-business-india