Exempt FMCG distributors from getting licence for household antiseptic disinfectants: KKCCI

The Kalyana Karnataka Chamber of Commerce and Industry (KKCCI) has urged the Union Ministry of Health and Family Welfare to do away with the requirement for getting wholesale licence for stocking and distribution of antiseptic disinfectants for household use.

In a representation addressed to the Director (Drugs Regulation), Ministry of Health and Family Welfare, New Delhi, KKCCI president Sharanabasappa M. Pappa and secretary Shivaraj V. Inginshetty pointed out that the draft Drugs (Amendment) Rules 2025 notified on October 16 may cause unnecessary confusion and compliance burden for distributors of Fast Moving Consumer Goods (FMCG).

The chamber noted that FMCG wholesalers and distributors have been “the supply chain backbone of various household items, mainly soaps, bodywashes, deodorants, shampoos, talcum powders, washing powders, floor cleaners, edibles like biscuits, atta, candies, etc.”

It added that during the COVID-19 pandemic the demand for disinfectants and antiseptics had risen sharply and distributors had worked against all odds to ensure that these essential hygiene products reached every corner of the country.

Referring to earlier amendments to the Drugs and Cosmetics Rules, the chamber said that the inclusion of antiseptic liquids for household use in Schedule K under the Drugs (Second Amendment) Rules 2022 has “unintentionally resulted in taking away the business of disinfectants with antiseptic properties from the FMCG distributors and wholesalers who previously did not need such licence.”

It argued that imposing drug-like licensing conditions such as refrigeration and supervision by a competent authority on these products is unnecessary.

“As part of the general conditions for obtaining a wholesale licence, the wholesaler is required to comply with conditions like refrigeration in warehouse/godown/storage area and supervision of a competent authority. However, when it comes to products such as these antiseptic disinfectants, these requirements are not only superfluous but also an unnecessary luxury since they are not required for storage and distribution of these products,” the chamber said.

KKCCI further observed that the new draft rules, which sub-classify antiseptics into for household use and for hospital and other uses can lead to overlapping regulation and confusion.

The chamber requested that the Centre consider removing the licensing requirement for antiseptic disinfectant products meant for household use, provided manufacturers continue to hold valid manufacturing licence.

“The requirement for wholesale licence for antiseptic disinfectant products/household antiseptic liquids be done away with, as long as manufacturing licence continues to remain,” the chamber appealed in its representation.