Date: 30-Jul-2020

Health Ministry Exempts Sale License For Hand Sanitizers Under D&C Act To Ensure Its Availability

In order to ensure easy availability of hand sanitizers in the interest of public and patient safety, the Union health ministry has exempted hand sanitizers from the requirement of sale licence under the provisions of Chapter IV of the Drugs and Cosmetics (D&C) Act, 1940 and the provisions of the D&C Rules, 1945.

As per the ministry’s notification, several representations requesting to exempt hand sanitizers from the requirement of sale licence under the provisions of Chapter IV of the D&C Act, 1940 and the provisions of the D&C Rules, 1945 for stocking or sale of the drug have been received. The Central government considers it necessary that hand sanitizers are required to be made widely available to the public at large.

The Maharashtra Food and Drug Administration (FDA) had earlier sent a letter to the Central Drugs Standard Control Organisation (CDSCO) to allow exemption of sale license for hand sanitizers. “Exemption of sale license for hand sanitizers will not only make it available but also will offer competitiveness to the manufacturers in producing sanitizers at an affordable price. More so, as there is now no price control on hand sanitizers as the government had capped the maximum retail price (MRP) of hand sanitizer at Rs. 500 per lite bottle till June 30, 2020,” according to a senior FDA official.

In view of COVID-19 pandemic, hand sanitizers were either not available with most of the vendors in the market or were available with great difficulty at exorbitant prices. Now, therefore, in exercise of the powers conferred by section 26B of the D&C Act, 1940 (23 of 1940), the Central government, hereby directs that the drug, namely, hand sanitizer shall be exempted from the requirement of sale licence for its stocking or sale under the provisions of Chapter IV of the Drugs and Cosmetics Act, 1940 and the Drugs and Cosmetics Rules, 1945, subject to the condition that provisions of condition (17) of Rule 65 of the said Rules are complied with by the person stocking or selling hand sanitizers.

Government had notified an order under the Essential Commodities (EC) Act to declare hand sanitizers as essential commodities up to June 30, 2020 by amending provisions of EC Act, 1955. It had also issued an advisory under the Legal Metrology (LM) Act. Under the EC Act, after discussions with the manufacturers, states could ask manufacturers to enhance production capacity of hand sanitizers, to make the supply chain smooth, while under the LM Act, the States could ensure sale of both the items at maximum retail price.  

The states were also advised to give publicity of state helplines for registering complaints by the consumers of hand sanitizers. The consumers could also register their complaints in this matter with the national consumer helpline number 1800-11-4000, online complaints at www.consumerhelpline.gov.in, department’s website www.consumeraffairs.nic.in, dsadmin-ca@nic.in and dirwm-ca@nic.in, secy.doca@gov.in