Sanjana Shikhar, 

B.A.L.L.B (Hons.) second year (3rd semester) 

Faculty of Law, Banaras Hindu University. 



Since a long time, the problem of drug adulteration and the creation of fake and sub-standard pharmaceuticals has posed a severe threat to the community's health. As a result, it was necessary to impose harsh punishments on anti-social elements who engaged in the manufacture or distribution of tainted or sub-standard pharmaceuticals, which may result in death in some circumstances. The Drugs and Cosmetics Act of 1940 was passed in order to preserve high standards of medical treatment. The Act governs the importation, manufacture, distribution, and sale of pharmaceuticals and cosmetics in the country. The Act defines a drug as "any article other than food designed to change the structure or function of the body of men or other animals for the purpose of diagnosing, curing, mitigating, treating, or preventing disease in men or other animals." It refers to any substance, vegetable, animal, or mineral, that is utilised in the composition or manufacture of medicines, or any substance that is used as a medicine. The term "cosmetics" refers to a product that is applied to the human body with the intention of adorning, maintaining, or purifying it.

 Before this Act of 1940, a law known as the Dangerous Drugs Act of 1930 was in effect. The Act of 1940 is in addition to, not in place of, the Act of 1930. The Central Government is authorised by the Drugs and Cosmetics Act to establish a Drugs Technical Advisory Board to advise the Central Government and the State Government on technical questions arising out of the administration of the Act, as well as to perform other duties as assigned by the Act. In the public interest, the Central Government has the authority to restrict the import of medications or cosmetics.

The Ministry of Health and Family Welfare notified the Cosmetic Rules 2020 (Rules) on December 15, 2020, in continuation of the authority granted to it under the Drugs and Cosmetics Act, 1940 (Act) to separately codify rules for efficient compliance. It should be noted that all licences issued prior to the notification of these Rules under the Drugs and Cosmetics Rules, 1945 (Old Rules) shall be valid until the expiry date or a period of 18 months from the date of notification of these rules.

Definition of Cosmetic

A 'cosmetic,' according to the definition established in the Drugs and Cosmetics Act of 1940, is any article that can be rubbed, poured, sprinkled, or sprayed on any portion of the human body. It could be introduced to/applied to any portion of the human body to clean, beautify, promote attractiveness, or change the appearance. The business had been controlled for a long time under the Drugs and Cosmetics Acts of 1940 and 1945, but in December of 2020, the Ministry of Health and Family Welfare announced the new and revised Cosmetics Rules, 2020. The new laws define and amend the rules governing the import, production, labelling, sale, and distribution of cosmetics in India separately. The 2020 Regulations, however, allow earlier granted licences under the 1945 rules to continue to be valid until their expiration date or a period of 18 months from the date of notification of Cosmetic Rules, 2020, for the sake of ease and a smooth transition.

The Cosmetic Rules, 2020

Cosmetics are divided into 11 broad product categories under the Seventh Schedule for the purpose of obtaining licence permits to manufacture for sale, according to the 2020 Rules: powders, skin powder for infants, creams, lotions, emulsions, pastes, cleansing milk, shampoos, pomade, brilliantine, shaving creams, hair oils, and so on. Lipsticks and Lip Gloss, Nail Polishes and Nail Lacquer Eyebrows, eyelashes, eyeliners, kajal, and surma are all examples of depilatories. Hair Dyes, Tooth Powders and Tooth Pastes, Toilet Soaps, Aerosol, Alcoholic Fragrance Solutions (Cologne), Hair Dyes, Tooth Powders and Tooth Pastes, etc. It goes on to describe the types of equipment to be used, the manufacturing surface area, the customised particular requirements, such as the use of exhaust fans, mixers, and storage tanks, as well as the premise, storage, and manufacturing guidelines that must be followed. According to the Eighth Schedule, openness must be maintained in terms of particulars that must be presented in manufacturing records.

Manufacture of cosmetics for sale or distribution

This is the same as the 1945 Rules, except there are new forms and applications with a lower fee. The Rules also require the applicant to provide a self-declaration confirming conformity with good manufacturing procedures, as well as another set of instructions. When production takes place at more than one location, the Rules require that each location obtain its own licence. In addition, similar to an import registration certificate, a manufacturing or loan licence must be valid in perpetuity, subject to payment of a retention fee within five years of the date of issuing of the licence.

Quality and ingredients of cosmetics

The Rules have set in place certain mandates in order to ensure that consumer behaviours are safe. Manufacturers must include all chemicals in their products, including those with a concentration of less than 1%, so that consumers may make more informed decisions. The Rules prohibit the importation and manufacture of cosmetics that do not meet the required levels of safety and quality. Certain raw materials (as defined in Annex A of Indian Standard IS 4707 Part 2) are also forbidden from being used in cosmetics. Cosmetics containing dyes, hues, and pigments other than those permitted by BIS are forbidden from entering the country.

Types of cosmetic license in India

The permits required to start and run a cosmetic business in India are divided into two categories, depending on the nature of the business.

1. Manufacturing 

2. Importing

The Central Licensing Authority is in charge of overseeing cosmetics imports in collaboration with state licencing authorities, while the State Licensing Authorities are in charge of overseeing the manufacture, sale, stock, exhibit, or offer for sale and distribution, as well as granting approval for various tests.

Requirements for getting a license of cosmetic business

For manufacturing, they must submit an application to the state licencing authority via an online/offline portal in the specified form, along with the requisite fees and documents, as outlined in Section 23. Furthermore, the producer must ensure that the production process is observed by a competent and certified technical team. At least one member of staff should be present, with the necessary educational background. As required by Section 26 of the Rules, they must have one of the following qualifications.

The staff must have a Diploma in Pharmacy that has been authorised by the Pharmacy Council of India under the Pharmacy Act, 1948; or the staff can be registered under the Pharmacy Act, 1948; or the staff can be registered under the Pharmacy Act, 1948. The employees must pass the intermediate test with Chemistry as one of the courses, or any other examination recognised by the Licensing Authority as comparable, or a bachelor's degree in Cosmetic Technology from a recognized university.

The manufacturer must also keep documentary evidence of ownership or rental records, the firm's constitution, and appropriate employees and laboratory equipment on hand at all times.

Inspection before granting license

The Licensing Authority must order an inspection of the entire process of the operations before awarding or refusing the licence. The State Government appoints inspectors under Section 21 of the Act. The inspectors are then expected to provide the Licensing Authority with a thorough report on the operations. The Licensing Authority will then decide whether or not to award the licence.

Even for existing licenced manufacturers, inspectors are required to visit the premises of the site at least once every three years to his satisfaction and write full findings to the supervising officer. They have the authority to file charges in the event of a breach and to collect samples for testing and assessment based on reasonable suspicion. They keep a record and provide CLSA with copies from time to time, and they can conduct inquiries as part of any complaint investigation.

Requirement for testing of cosmetic sample

One of the important components for ensuring consumer safety is the quality verification of items using the sample testing technique. It must meet all of the requirements for the registration of imported cosmetic products, as well as satisfy the maker, buyer, and customer. It is carried out by the inspector, who is empowered under Section 22 of the Act.

It is important to remember that the Cosmetics Rules, 2020, as well as the Drugs and Cosmetics Act, 1940, apply to any product that is manufactured or imported. The Drugs and Cosmetics Act of 1940 is a punitive statute that spells out the offences and consequences for violating it while keeping consumer safety in mind.

With the 2020 Rules, the provisions have become even more strict and explicit in terms of the safety precautions that must be followed. Under the 1940 Act, any cosmetic that does not comply with the Rules in terms of colours, labels, or imitation is classified under Section 9C as misbranded cosmetics and Section 9D as spurious cosmetics. Section 10 lists the cosmetics that are prohibited if they are misbranded or of poor quality.

If any of the Act's regulations or laws relating to cosmetics are not followed in situations of import, Section 13 lays out the penalties, which include imprisonment and a fine cap. The Act's Section 27A deals with penalties for violating the manufacture and selling provisions.


As a result, we can see that the new Rules 2020 have ensured consumer safety at every step. There are certain fundamental regulatory compliances in place for the users' advantage. The laws, for example, require extremely visible packaging and ingredient labelling restrictions. Mention any potentially toxic substances, as well as the composition of raw materials utilised and any unfavourable effects that may occur – all of which places the burden of proof on the consumer and their decision to use the product. Furthermore, proper licence numbers, production batches, and the company's contact information have been provided for the user's convenience in the event that they wish to contact them.

Though there is always room for improvement, the revised Rules demonstrate that they are an effective effort to maintain control standards and safety information, particularly for consumers.







6.        6. Drugs and Cosmetics Rules, 1945

7.     7. Cosmetic Rules, 2020

8.     8. Drugs & Cosmetics Act, 1940

9.     9. Pharmacy Act, 1948