DO HAND SANITIZERS REQUIRE A LICENSE TO BE SOLD IN STORES?

This article has been written by Samridhi Prakash from Symbiosis Law School, Noida.

BACKGROUND

Sanitization of hands is a trite official advice that has been repeated over time and again during the Covid-19 havoc that has resulted in a global tragedy. Hand sanitizers, which come in liquid, gel, or foam form, are chemicals that are applied to the hands to kill common germs. When the world saw an outbreak of clusters of pneumonia cases, later identified as the Coronavirus, resulting in a large number of deaths, governments, in consultation with their respective health departments and the WHO (World Health Organization), formalized a series of guidelines, primarily emphasizing the importance of personal hygiene and social distancing by the general public. Hand health is unquestionably important in preventing the spread of the infection. When hands are not noticeably dirty, the WHO recommends applying an alcohol-based hand rub for 20-30 seconds, using the right techniques.

STEPS TAKEN BY AUTHORITIES

Several governments throughout the world had recommended the use of ethyl alcohol or isopropyl alcohol-based hand rubs for hand hygiene in accordance with these standards. The WHO’s approval and government recommendations for alcohol-based hand sanitizers have clearly resulted in a surge in public demand in India and around the world. In response to the disconcerting increase in demand for hand sanitizers across the country, the Drug Licensing Authorities granted permission to manufacture these items in a record time of three days, not only to drug manufacturers, but also, strangely, to alcohol breweries and cosmetic manufacturers, all in an effort to alleviate the product’s shortage caused by an unexpected surge in demand. As a result, under the Essential Commodities Act of 1955, the Ministry of Consumer Affairs, Food and Public Distribution designated hand sanitizers as an “essential commodity” in March, 2020.

Hand sanitizers were exempted from the requirement of a sale license under the Drugs and Cosmetics Act, 1940, and the Drugs and Cosmetics Rules, 1945, by the Union Health Ministry in May, 2020. Several requests were submitted to the government, according to the official notification, to exempt hand sanitizers from the requirement of a sale license under the Drugs and Cosmetics Act. It has now been deduced from a number of circulars and instructions issued by Drug Inspectors across the country that the sale of hand sanitizers will be limited to dealers with drug licenses, limiting its sale to medical shops and chemists. This would have a significant impact on the supply and availability of such a vital item, especially when the urgent requirement is to ensure that sanitizers are available in every state, village, and town.

LEGISLATIVE PROVISIONS

Drugs and Cosmetics Act, 1940 & Drugs and Cosmetics Rule, 1945

The Drugs and Cosmetics Act of 1940 codifies the laws governing the manufacture, import, distribution, and sale of drugs and cosmetics. The manufacture, sale, and distribution of pharmaceuticals and cosmetics are covered in Chapter IV of the statute. According to Section 18(c) of the Act, no person, acting individually or on behalf of another, may manufacture any medication or cosmetic for sale, stock, distribution, or exhibition unless a license has been given for the purpose. When combined with the Rules, the Act mandates that every drug stocked or supplied in India be done so with a license. However, it is worth noting that the Rules explicitly provide for exemptions from the application of certain Act requirements to specific types of drugs.

In its wisdom, the legislature decided that certain items should be excused from the rigors of drug licensing under the Act for the purpose of stocking and selling. Insecticides are defined as compounds designed to be used for the extermination of vermin or insects that cause disease in humans or animals, according to entry 12 of Schedule K of the Rules. Disinfectants have an exception that allows them to be stocked and sold without the need for a drug license. It is worth noting, however, that such an exception is not uncommon. Several other medications, such as Oral Rehydration Salts, medicated dressings, and comparable treatments, currently have such exemptions. To include all chemical agents that destroy or impede the growth of pathogenic microorganisms, the term “disinfectants” had to be given a broader definition. Several items, including antiseptic lotions and sanitizers, will be included in a larger and more objective definition of disinfectants. Sanitizer has now received a global recognition as a disinfectant.

RELEVANT CASE LAWS

In Reckitt Benckiser v. State of Kerala, the Kerala High Court reviewed and recognized the disinfecting characteristics of specific formulations of antiseptic liquids containing alcohol, and approved their capacity to avoid the medication stocking and sale licensing requirements that disinfectants face. The court was summoned to determine whether or not ‘Dettol’ was a disinfectant, absolving it from Section 18 of the Drugs and Cosmetics Act, 1940. Dettol’s ability to be used for pre-operative skin preparation, antisepsis in midwifery, or on external lacerations such as cuts, stings, bites, and scratches for the same objective of eliminating microorganisms does not make it anything less than a disinfectant.

In the matter of Vijayakumar and Others v. Drug Inspector, the Andhra Pradesh High Court concluded that Savlon is a disinfectant for the purposes of the Act. It had been assumed that disinfectants were chemicals or mixtures of chemicals in appropriate quantities for destroying or rendering germs inactive.

GOVERNMENT NOTIFICATION DATED 27.07.2020

Every drug kept and sold in India must have a drug license, as per the provisions of the Drugs and Cosmetics Act, 1940. Hand sanitizer could formerly only be sold by licensed pharmacists and druggists. Hand sanitizers are not excluded from this rule. As a result, the entire supply chain for hand sanitizers, including shops, is required to sell them under the DCA’s stock and sale license. Mandatory licensing for selling and stocking hand sanitizers was waived by the Ministry of Health and Family Welfare on 27th July, 2020. Traders had approached the Ministry of Health and Family Welfare, seeking inclusion of hand sanitizers in Schedule K of the Drugs and Cosmetic Rules, 1945. The Centre was satisfied that hand sanitizers are an essential item in COVID, according to the directive.

The term “hand sanitizers” shall be included in the column “Class of Drugs” of Schedule K of the Drugs and Cosmetics, Rules, 1945, as per Section 26-B of the Drugs and Cosmetics Act, 1940. In India, hand sanitizers are more relevant and in demand than they have ever been. Manufacturers and marketers of hand sanitizers, on the other hand, must adhere to all applicable laws and regulations.

REFERENCES

S.O. 2451(E) – Exemption of hand sanitizer from sale license-Section 26B https://cdsco.gov.in/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=NjMzMA==

Drugs and Cosmetics Act, 1940

Drugs and Cosmetics Rule, 1945

Reckitt Benckiser v. State of Kerala, Crl. MC. No. 4997/2010, 2011

Vijayakumar and Others v. Drug Inspector, Crl. Petition. No. 3400/2005, 2005

Edited by Shivanshika Samaddar of National Law University, Delhi.