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Industry seeks clarity in regulations for sale of hand sanitisers

Opposing views prevail on the inclusion of hand sanitisers under Schedule K of Drugs and Cosmetics Rules, 1945

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Several ambiguities in the rules for the sale of hand sanitisers in the country have been noticed by the industry stakeholders and the authorities in the country.

For instance; on April 27, 2020, the Uttar Pradesh FDA issued an order allowing the sale of hand sanitisers at a grocery store, general store and medical stores. On May 18, 2020, the Commissioners of Aurangabad and Nagpur also issued a circular informing about the permission to sell hand sanitisers at grocery shops and supermarkets by obtaining a sale license.

Sanjay Kale, Joint Commissioner, FDA-Aurangabad said, “To prevent the misuse of hand sanitisers in the public, we have issued a circular informing about the given regulatory guidelines. And as per section 20, 20 (a) and 20 (b) of the Drugs and Cosmetics Act 1940 it is allowed to sell the product without the supervision of qualified pharmacists. Considering the given provision in the law, we have asked the sellers to get a license from the state FDA for the sale of hand sanitisers at the supermarket and grocery stores.”

He also pointed out that though there is no mention of hand sanitisers in the Schedule-K of the Drugs and Cosmetic Act of 1945, we treat it as a Schedule K product.

On the other hand, S W Deshpande, Former Joint Commissioner of FDA Maharashtra and Advocate Founder of PHARMALEX explained, “In my opinion, hand sanitisers are disinfectants and are entitled to exemption under entry 12 of Schedule K and do not require a license to stock and sale it. This view is supported by the Kerala High Court judgment in the State of Kerala v/s Reckitt Benckiser India Ltd 2011(2) Drugs Cases (DC) 9. Despite this Judgment, officers in the FDA Maharashtra and also most of the officers in India are of the view that hand sanitisers are required to be stocked and sold under sale license. A few officers in FDA Maharashtra have issued circular to this effect. There is pending prosecution in Haryana filed after Kerala High court judgment against the distributor for selling hand sanitisers without a license. I am of the opinion that the DCGI should examine this issue in consultation with the Health and Law Ministry so that one view is taken and uniformly implemented throughout the country.”

The industry is also unsure about the regulations. The Federation of Pharma Entrepreneurs (FOPE), has requested authorities to bring them under Schedule K of the Drugs and Cosmetics Act, 1945.  B R Sikri, Chairman, FOPE said, “Hand sanitation has become a prime requirement for containment of COVID-19. Therefore, our request to the DCGI is that all kinds of hand sanitisers should be included in Schedule K of the Drugs & Cosmetics Rules, 1945 for widespread availability. This will be in the public interest and leave no ambiguity in the supply chain of hand sanitisers.”

Harish Jain, Secretary, Karnataka Drugs and Pharmaceutical Manufacturers Association commented, “Pharma industry manufactures hand sanitisers as per the composition approved by the DCGI and recommended by the WHO. This composition of minimum 70 per cent + alcohol is the only scientifically proven composition which is effective against COVID-19. It is imperative that it is made available across every nook and corner of the country for the benefit of the masses and to augment our fight against COVID-19. That’s why it is required to quickly bring it under Schedule K to remove the legal impediment in this fight.”

Nipun Jain, Partner, Pharmchem said, “It should be brought into the ambit of Drugs and Cosmetics Act. Since it is applied to human skin, proper manufacturing and monitoring of quality are very essential.” He also points out that, if such products are made in unhygienic conditions without proper testing then the quality will be doubtful and will not serve the purpose at large.

Thus, clarifying the regulations for the sale of sanitisers is a priority since it is a first-line defence against the coronavirus-infection. The World Health Organisation (WHO) has informed that alcohol-based hand disinfectants play a major role in preventing COVID-19 infection. The Centres for Disease Control and Prevention (CDC) has also recommended the use of hand sanitisers that contains at least 60 per cent alcohol.

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