The Union health ministry has exempted hand sanitizers from the requirement of sale license under the provisions of Chapter IV of the Drugs and Cosmetics (D&C) Act, 1940 and the provisions of the D&C Rules, 1945 for ensuring the easy availability of hand sanitizers in the interest of public and patient safety.
Several representations have been received requesting to exempt hand sanitizers from the requirement of sale license 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. The Central government considers it necessary that hand sanitizers are required to be made widely available to the public at large, according to the ministry’s notification.
A letter was also sent by the Maharashtra Food and Drug Administration (FDA) 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 litre bottle till June 30, 2020,” according to a senior FDA official.
An order was notified by the Government under the Essential Commodities (EC) Act for declaring the hand sanitizers as essential commodities up to June 30, 2020 by amending provisions of EC Act, 1955. An advisory was issued under the Legal Metrology (LM) Act. States could ask manufacturers to enhance production capacity of hand sanitizers, for making the supply smooth, while under the LM Act, the States could ensure sale of both the items at maximum retail price, as per the ministry’s notification.