Hand Sanitizer has become part and parcel of our lives. These liquid gel sanitizers are available everywhere. From the biggest of the Pharmacies, General Stores and the smallest of the Kirana shops have stocked these for the benefit of the general public. Post COVID -19, especially after the WHO's insistence, Hand Sanitizers have gained prominence and is found in every nuke and corner from large cities to the smallest villages. Such has been the impact of the humble Hand Sanitizer. The importance of the Hand Sanitizer can be understood from the fact, the Government of India has brought these into the ambit of Essential commodities Act so as to ensure that the same is available round the clock without any difficulty.
Prior to Covid – 19, Hand Sanitizer was a product of the affluent. Very few used it. Very few companies and Multinationals produced, marketed and sold it. After the Pandemic, the market has been flooded with the several products of different nature and claiming to kill all germs upto 99.9%. Such has been the colossal impact of Hand Sanitizer, the Government had to intervene and cap the prices.
Interestingly, the Government of Maharashtra came out with a letter dated 29.5.2020 issued through the Food & Drugs Administration, that stated that only a valid license holder under the Drugs and Cosmetic Act and its Rules can distribute and sell the Hand Sanitizer. The Government's response was apparently to a query from a leading manufacturer of whether they (as a license holder to manufacture) can sell these products to small kirana shop owners (obviously ones without the license) who will ensure that Hand Sanitizer has the last mile reach.
Therefore the question is whether these small time shopkeepers would have to obtain a license to stock and sell hand sanitizer in their shops in light of Food & Drugs Administration dicta. This piece will examine the law surrounding Hand Sanitizers.
The World Health Organization and Governments across the world has been repeatedly urging the use of Hand Sanitizer to prevent the spread of nCovid-19. According to Britannica.com, Hand Sanitizer is a cleansing agent, hand antiseptic, hand rub, agent applied to the hands for the purpose of removing common pathogens (disease-causing organisms). It is a simple means of infection control. In fact, if one looks at the ingredients provided for in the label, one can find Ethanol and Hyrodgen Peroxide as the mainstay ingredients. According to, Kathleen A. Baxter, “ Analysis of Alcohol-Based Hand Sanitizer Delivery Systems: Efficacy of Foam, Gel, and Wipes Against Influenza A (H1N1) Virus on Hands,” American Journal of Infection Control , few drops of these rubbed over the fingers and hand surfaces thoroughly for a period of 30 seconds would effectively reduce populations of Viruses, bacteria and fungi. In fact Hand Sanitizers are made of Alcohol-based products and typically contain between 60 and 95 percent alcohol, usually in the form of ethanol, isopropanol, or n-propanol. At those concentrations, alcohol immediately denatures proteins, effectively neutralizing certain types of microorganisms, according to U.S. Centers for Disease Control and Prevention Vessel Sanitation Program, “ OPRP—General Information on Hand Hygiene,”.
The Drugs and Cosmetics Act, 1940 read with the Drugs and Cosmetic Rules 1945 mandates that every drug, manufactured, stocked or sold, exhibited in India must be done so under a license unless, the said drug is exempted. The object of The Drugs and Cosmetics Act, 1940 was to regulate the import, manufacture, distribution and sale of drugs and cosmetics. ‘Drug' is defined under Section 3(b) and the said section has 4 sub clauses and sub clause (1) talks of ‘medicines', while sub-clause (ii) and (iii) talks of ‘substances' and sub clause (iv) talks of ‘devices'. Therefore the conclusion one could arrive at is that a ‘Drug' would not only constitute just medicines but also substances and devises.
Therefore the logical question that arises is whether Hand sanitizer would fall within the meaning of Drug as contemplated in Section 3(b). Our Supreme Court in Chimanlal Jagjivan Das Sheth v. State of Maharashtra, (1963) concluded that a ‘substance' as stated under Section 3(b) of the Drugs and Cosmetics Act is beyond those that can be classified as “Medicine” and a substance can even be a ‘thing' that can be used for any treatment. Hence borrowing this understanding, a Hand sanitizer would conclusively fall within the meaning of a Drug, as a substance.
The next question is of who all should obtain license under the act for the purposes of dealing with the drug. Section 18(c) of the Drugs and Cosmetics Act 1940 makes it very clear that license should be applied for ‘Manufacture for sale, Distribution, sell or stock or exhibit of offer, for sale of any drug'. This Section has also to be read with Part VI - Rules 59 to 66A and Part VII - Rules 71 to 84B of the Drugs and Cosmetics Rules 1945. A perusal of these rules would make it clear that not only the manufacturer but also to stock, exhibit or offer sale or distribute have to obtain the appropriate license under different forms as prescribed (For eg. Relevant forms, for this opinion, would be Form 19A and Form 25 of Schedule A of the Drugs and Cosmetics Rules 1945).
At this Juncture it would be pertinent to refer Part XI of the Drugs and Cosmetics Rules 1945 – Rule 123 – Exemptions. It would be useful to extract the same, which is as follows, "123. The drugs specified in Schedule K shall be exempted from provisions of Chapter IV of the Act and the rules made thereunder to the extent and subject to the conditions specified in that schedule." This would mean that all drugs specified in Schedule `K' shall be exempted from the provisions of Chapter IV of the Act and the Rules made thereunder, to the extent and subject to the conditions specified in that schedule. Schedule K lists out 35 items which are exempted from Chapter IV of the Drugs and Cosmetics Act 1940. For the purposes of this Article, item 12 would be of great relevance and the same is extracted as follows, 12. Substances intended to be used for destruction of Vermin or insects which cause disease in human beings or animals, viz. Insecticides and Disinfectants. A closer look would reveal that the above description (item 12) is similar to the wordings of Section 3(b) (ii) of the Drugs and Cosmetics Act 1940 (Definition of Drug), extracted supra. Therefore the intention of the legislature seems to be that those substances as defined under 3(b)(ii), which specifically fall within item 12 of Schedule K are exempted from the provisions of the Act, to the extent as provided for. Item 12 very clearly exempts the following: Those “Substances” intended to be used for “destruction of Vermin” or insects which cause disease in “human being” or animals, viz. Insecticides and Disinfectants. Therefore there is an exemption under the Act for “Disinfectants”.
Now the moot question is whether a Hand Sanitizer would fall within the definition of a “Disinfectant”. It is here that the Food & Drugs Administration in Maharashtra comes out with an answer that a Hand Sanitizer is not a Disinfectant and hence even the smallest shop should obtain license to sell the Hand Sanitizers as according to them Hand Sanitizer is not an Exempted item within item 12 -Schedule K of the Act.
The word Disinfectant has not been defined anywhere in the Act or the Rules. However the Hon'ble SC in Bombay Chemical (P) Ltd. v. CCE, (1995) had an opportunity to consider the meaning of the word “disinfectant” from the context of Central Excise Rules and concludes that a Disinfectant is a Substance used to disinfect or to destroy germs of infectious and contagious diseases and is commercially produced chemical liquid that destroys germs. Therefore giving an ordinary, natural and popular construction and applying the above ratio, a Hand Sanitizer would fall within the meaning of Disinfectant and as a Substance. Therefore from the above it is clear that a “Disinfectant” is a substance (liquid) used to disinfect or to destroy germs of infectious and contagious diseases. Extending the same interpretation as stated above, Hand Sanitizer would fall within the meaning of Disinfectant and as a Substance within the meaning of 3(b)(ii) and the same meaning has to be given to the word “Disinfectant” found in item 12 of Schedule K, by which a substance which destructs vermin which causes disease in human viz. would be a Disinfectant.
Further reference can also be had to a Judgment of the Kerala High Court Reckit Benckiser (India) Ltd. v. State of Kerala, (2011). In the said case, the question that arose was whether ‘Dettol' is a Disinfectant within the meaning of Item `12 of Schedule K of the Drugs and Cosmetics Rules 1945 (similar to our facts and circumstances). The Kerala High Court after taking into account other precedents and authorities, ultimately holds that Dettol is indeed a Disinfectant within the meaning of Item 12 - Schedule K. The Kerala High Court in a very captivating fashion would have said that the function of a ‘Disinfectant' which is is destruction of micro organisms particularly on inanimate objects, but that does not mean that a Disinfectant could be used only on inanimate objects and the moment it could be used on animate objects also, it ceases to be a ‘Disinfectant' and became an ‘Antiseptic'. Its use on animate objects is only external with the same purpose - destruction or making inert micro organisms”. What can de deduced from the above, is , that Alcohol based Hand Sanitizer is used to disinfect externally and hence would fall within the meaning and ambit of ‘Disinfectant' as given in Item 12 – Schedule K. Therefore the letter dated 29.5.2020 issued by the FDS, Govt of Maharashtra asking all those who deal with Hand Sanitizer to obtain license under the Drugs and Cosmetic Act is not correct and valid and any insistence would be contra to the law laid down as stated supra.
Further in addition, the fact that Hand Sanitizer are brought within the Essential Commodities Act shows the intent and purpose of the Government. The Intention was to ensure round the clock availability and easy access to Hand Sanitizers to all classes of People and not simply restrict only to Licensed Pharmacists. The Government wants Hand Sanitizers to be available at every nook and corner and expects the smallest of shops also to have the same so that the availability is easy and not cumbersome and also to prevent hoarding.
Originally published by NR Associates, June 2020
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