Synopsis: The Drugs Control Administration has urged the Centre to withdraw the sale licence exemption granted for ethanol-based hand sanitisers, introduced as part of combating COVID-19, since some people have been using them as a substitute for alcohol.
Hand sanitisers, widely used during the COVID-19 pandemic to maintain hand hygiene, have now come under regulatory scrutiny in Andhra Pradesh after the state Drugs Control Administration (DCA) found that some people were allegedly using ethanol-based sanitisers as a substitute for alcohol.
The DCA has written to the Drugs Controller General of India (DCGI), seeking withdrawal of the sale licence exemption for ethanol-based hand sanitisers that was introduced during the COVID-19 pandemic.
DCA Director General P Arun Babu said there was a need to regulate the sale of ethanol-based hand sanitisers in view of their alleged misuse.
“Some people are using ethanol-based hand sanitisers as a substitute for alcohol. Therefore, there is a need to regulate their sale,” Babu said in the statement issued by the Andhra Pradesh Health Department on Friday, 4 September.
The Centre had issued S.O. 245(E) on 27 July 2020, exempting hand sanitisers from the requirement of a sale licence to ensure their easy availability during the pandemic.
Babu said the exemption, introduced during an emergency situation, was now being misused.
“The exemption given during COVID-19 for the storage and sale of sanitisers is being misused by some people,” he said.
The department said the issue came to the attention of drug control officials after reports emerged that people in Vijayawada were consuming ethanol-based hand sanitisers instead of alcohol.
Following this, DCA officials conducted inspections and raids at retail medical shops in the city. They found that some shops had been selling ethanol-based sanitisers in unusually large quantities.
Officials seized bills from Sai Venkateswara Pharmacy and Surgical in Patamata, Vijayawada. According to the records, the shop had purchased and sold around 33,586 bottles of 100 ml sanitiser containing 70% v/v ethanol over approximately one-and-a-half years.
The department has initiated licence cancellation proceedings against three retail sales outlets in connection with the matter.
The findings follow concerns over high-volume sanitiser sales in Vijayawada. A recent inspection of three medical shops had found that nearly 75,000 bottles were sold over three years, with officials suspecting that some of the products could have been purchased for consumption as a cheap alternative to alcohol.
However, the department’s latest statement specifically cites the 33,586 bottles recorded in the bills of one shop and does not state that all sanitisers sold were consumed.
State asks Centre to remove exemption
The DCA said the COVID-era exemption continues to remain in force even though the emergency circumstances under which it was introduced have changed.
“The continuation of the exemption given during COVID-19 even after four years is creating an opportunity for the misuse of ethanol-based sanitisers,” the department said.
The state has now asked the Centre to review S.O. 245(E) and withdraw the sale licence exemption for ethanol-based hand sanitisers.
The department also pointed out that ethanol-free hand sanitiser alternatives are available in the market, reducing the need for ethanol-based products to enjoy the same regulatory exemption.
Babu urged the Centre to take necessary steps to withdraw the exemption for the storage and sale of ethanol-based hand sanitisers, keeping public interest in mind.
The move could bring ethanol-based liquid sanitisers under tighter regulatory oversight and make it more difficult for retail outlets to sell such products in large quantities without scrutiny.