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Hand sanitisers to be sold in licensed selling premises only: Maharashtra FDA

Earlier, Hindustan Unilever has sought clarification on the matter from Maharashtra FDA

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The Maharashtra Food and Drugs Administration (FDA) has clarified that hand sanitisers manufactured under allopathic drug manufacturing license should be sold in the licensed selling premises only.

JB Mantri, Joint Commissioner State Controller Maharashtra and State Drug Controlling authority said, “Hand sanitisers which are manufactured under ayurvedic and cosmetic manufacturing licenses are exempted from the purview of selling license. However, hand sanitisers manufactured under allopathic drug manufacturing license should be sold in the licensed selling premises only.”

On being queried whether a manufacturer who labels his product as ‘hand disinfectant’ will be allowed exemption under Schedule K, Mantri answered in the negative and said that the manufacturers will not be allowed to sell in that manner.

The aforesaid clarification from the Maharashtra FDA is a response to Hindustan Unilever’s (HUL) letter dated May 27, 2020, to its stockists and traders informing that under the Drugs & Cosmetics Act & Rules, sanitisers are exempted of sale license and can be stocked and sold without obtaining any selling license.

On May 20, the company had written a letter to the Maharashtra FDA informing about the sale of hand sanitisers by grocery shops without holding a sale license.

And later on May 27, 2020, Dr A Sivakumar, General Manager – Regulatory Affairs South Asia and Global Home Care, Hindustan Unilever issued a letter to its stockists and traders explaining the definition of the term “Drug”, which states that under the Drugs and Cosmetics Act & Rules of India.

The letter also explained that disinfectants are classified under section 3(b) (ii). It also assured them that the company manufactures its hand sanitiser under a drug manufacturing license with the primary ingredients of hand sanitiser; ethyl alcohol and isopropyl alcohol, well-known disinfectants.

The letter had justified that the term ‘disinfectant’ is applied to a chemical agent that destroys or inhibits the growth of pathogenic micro-organisms or which can kill all micro-organisms. Going by the above, it is evident that hand sanitiser is a ‘disinfectant’ and vide notification No. 1-20/60-D dated June 3, 1961, it is a drug under Section 3(b)(ii) of the Drugs & Cosmetics Act.

The letter further stated that hand sanitisers which are used to prevent the spread of disease are considered a dug (disinfectant) and exempted under 12 of Schedule K and therefore it can be stocked and sold without obtaining any selling license as required under Section 18(c) of the Act.

Speaking on the whole issue, Manmohan Taneja, Assistant State Drugs Controller, FDA, Head Quarter, Haryana, Panchkula explained, “The circular issued by Hindustan Unilever to its distributors is void ab initio. HUL has grossly erred in interpreting ‘hand sanitisers’ licensed as ‘drug’ on Form-25 and wrongly equated them with the ‘disinfectants’.”

He elaborated, “The contention of HUL that hand sanitiser is defined in section 3(b)(ii) of the ‘Drugs & Cosmetics Act'(in short ‘the Act’) holds no water. The ‘hand sanitiser’ is a medicine used for the prevention of disease in human beings. It will, therefore, fall within the ambit of Sub-clause (i). The substance referred to in Sub-clause (ii) is not meant for this purpose. Section 3(b)(ii) is stipulated as under:- such substances (other than food) intended to affect the structure or any function of the human body or intended to be used for the destruction of vermin or insects which cause disease in human beings or animals, as may be specified from time to time by the Central Government by notification in the Official Gazette. The purpose described in sub-clause (ii) is the destruction of vermin or insects which cause diseases in human beings or animals.

He further informed that the Oxford Advanced Learner’s Dictionary of Current English gives the following relevant meaning of the word ‘vermin’;
1. wild animals (e. g. rats, weasels, foxes) harmful to plants, birds and other animals.<