New Delhi: The Drug Controller General of India (DCGI) has formed an expert panel to determine whether over-the-counter (OTC) healthcare products, such as Dettol and Savlon, will continue to enjoy exemptions under “antiseptics" and “disinfectants".
Under clause 12, schedule K of the Drugs and Cosmetics Rules, “substances intended to be used for destruction of vermin or insects, which cause disease in human beings or animals, like insecticides and disinfectants" can be stocked, exhibited and sold without a licence.
“At present Dettol, Savlon and other similar products fall under clause 12, schedule K of Drugs and Cosmetics Rules and, hence, no sale licence is applicable. However, the matter has been referred to a subcommittee for examination. The experts will also see if these products can be considered under the OTC category, or no-prescription products, and will clarify on the existing exemption to these products from the sale licence," said a senior government official, requesting anonymity.
On 1 February, DCGI S. Eswara Reddy, who is also the chairman of Drugs Consultative Committee (DCC), formed a subcommittee of experts, and mandated them to submit the report within three months. “The subcommittee will hold its first meeting in the first week of April," said a second official, also requesting anonymity.
Dettol, which contains active ingredients such as chloroxylenol, terpineol and absolute alcohol, is popular as a first-aid product.
“Ensuring the safety and effectiveness of OTC healthcare antiseptics is a priority for the Central Drugs Standard Control Organization (CDSCO), which is also in the process of bringing in more clarity on medicines and products that can be sold without prescription," said the first official.
In 2017, the US Food and Drug Administration (FDA), in a similar move, barred the use of 24 ingredients in OTC antiseptic products such as handwashes and surgical hand scrubs.
“The step was taken not only because these products were an important component of infection control strategies in healthcare settings, but also because of the role these products may play on contributing to antimicrobial resistance, if they were not manufactured or used appropriately," then FDA commissioner had said.
Emailed queries to Reckitt Benckiser (India) Ltd, which makes Dettol, and ITC Ltd, which has acquired Savlon from GlaxoSmithKline, did not elicit any response till press time.