Hand sanitisers have assumed a crucial role in our day-to-day life in the post-COVID era. As per Section 3(b) of the Drugs and Cosmetics Act, 1940 (“Act”) and the Drugs Rules, 1945 (“Rules”), the definition of drug includes substances (other than food) intended to be used for the destruction of vermin or insects that cause disease in human beings or animals. Since sanitiser is a substance used to destroy vermin or insects, hand sanitiser is a ‘drug’ under the Act. 

HEALTHCARE REGULATIONS: LICENCES FOR HAND SANITISER

The license to sell, manufacture or distribute hand sanitisers has to be obtained from the licensing authority as prescribed by the government under the Rules. The Act and the Rules require that every drug manufactured, stocked, sold, and exhibited in India must procure a license unless the concerned drug is exempted. The Central Drugs Standard Control Organisation (CDSCO) is the licensing and regulatory authority for activities related to drugs.  

Earlier, the Act and the Rules did not provide for hand sanitisers as one of the exempted drugs under Rule 123 of the Rules read with Schedule K. Due to the increased demand and need for hand sanitisers during the COVID-19 pandemic, hand sanitisers have become readily available in the fast-moving consumer goods healthcare market, and even small shops are selling them. However, most shops did not have appropriate licenses under the Act and the Rules to sell hand sanitisers. Due to the COVID-19 pandemic creating a lot of noise from traders to include hand sanitisers in Schedule K of the Rules, the Centre, through a notification dated 27 July 2020, made an exception and included hand sanitisers under this category. Thus, a sale licence for hand sanitisers under the Act is not required anymore in India. 

HEALTHCARE STANDARDS AND LABELLING OF SANITISERS

Section 16, read with the Second Schedule of the Act, states that ‘substances intended to be used for the destruction of vermin or insects which cause disease in human beings or animals’ are required to follow the standards as may be prescribed. Further, the Rules state that the standards for identity, purity and strength shall be those specified in the edition of the Indian Pharmacopoeia for the time being in force. Such standards include minimum alcohol content and being free from harmful chemicals or contaminants. The World Health Organisation (WHO) has recommended additional foreign standards. Both manufacturers and marketers are liable for the standard quality of hand sanitisers under the Act. 

The labelling of hand sanitisers is also an essential aspect of its legal compliance requirements. Some contents that must be mandatorily included: 

• A correct statement of the net contents in terms of weight, measure, volume, number of units of contents, and number of units of activity, as the case may be, and the weight, measure and volume are to be expressed in the metric system.
• The name of the manufacturer and the address of the premises of the manufacturer where the hand sanitiser has been manufactured. 
• A distinctive batch number i.e. the number by reference to which details of the particular batch from which the substance in the container is taken are recorded.

In addition to the above-mentioned labelling requirements, hand sanitisers must also meet legal compliance under the Legal Metrology (Packaged Commodities) Rules, 2011. 

HAND SANITISER AS AN ESSENTIAL COMMODITY IN HEALTHCARE

To ensure that there was no misuse of the pricing of hand sanitisers, the central government has notified hand sanitisers as an essential commodity under the Essential Commodities Act 1955. Further, the prices of hand sanitisers, i.e. alcohol-based hand rubs containing 70% ethyl alcohol, are regulated under the Drug (Prices Control) Order, 2013 (“DPCO”). Other alcohol-based hand rubs are also restricted from increasing their maximum retail price by more than 10% within twelve months. Notably, the prices of sanitisers manufactured as ayurvedic drugs or cosmetics are not regulated. Additionally, through the Fixation of Prices of Masks (2 ply and 3 ply), Melt Brown Non-Woven Fabric and Hand Sanitisers Order, 2020, hand sanitisers were categorised as an essential commodity, and it was provided that the maximum retail price of hand sanitisers for a 200ml bottle could not be more than INR 100. However, this order was only applicable only until 30 June 2020. Thus, hand sanitisers are presently being price-controlled as per the DPCO.  

CONCLUSION

Hand sanitisers have become an integral component of every household and their healthcare practices. The healthcare law around hand sanitisers in India is comprehensive and evolving. It covers various aspects of their manufacture, sale, and usage. The primary objective of these regulations is to ensure the safety and efficacy of hand sanitisers, thereby safeguarding public health. Manufacturers and sellers are required to adhere to the stringent guidelines, including the licensing requirements, legal compliance with the standards for hand sanitisers and correct labelling. 

¹ Section 18(c), Drugs and Cosmetics Act, 1945 read with Part VI and Part VII, Drugs Rules 1945.
² https://iris.who.int/bitstream/handle/10665/331846/WHO-2019-nCoV-IPC_WASH-2020.3-eng.pdf
³ Rule 84-E, the Drugs Rules 1945
4 Rule 96, the Drugs Rules 1945