Last Updated on July 29, 2020 by The Health Master
The Department of Health and Family Welfare, under the Ministry of Health Family Welfare (MoHFW), has issued a notification exempting hand sanitisers from the requirement of sale license.
As per the notification issued by the health department, “The Central Government considers that it is necessary that hand sanitisers are required to be made widely available to the public at large; therefore, in the exercise of the powers conferred by section 26B of the Drugs and Cosmetics Act, 1940 (23 of 1940), it directs that the drug, namely, hand sanitiser 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 Drugs and Cosmetics Rule 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 sanitisers.”
The reactions to this news are mixed, stakeholders seek clarity on the classification as well as the definition of hand sanitisers under the Drugs and Cosmetics Act 1940.
Harish Jain, Secretary, Karnataka Drugs and Pharmaceutical Manufacturers Association said, “The gazette notification by the Central Government is a much-anticipated move and will go a long way in the nation’s fight against COVID-19. The move will make sanitisers accessible to the general public easily. Sanitisers were only one in the trinity of sanitiser, mask and social distancing (SMS), which was of restricted distribution.”
He continued, “It is the duty of the industry to make hand sanitiser available to every nook and corner of the country and also maintain high quality standards befitting the high standards of the pharma industry.”
However, the All India Organisation of Chemists and Druggists (AIOCD) had earlier made representations to the Prime Minister as well as Health Minister, Health Secretary, Chemical and Fertilizer Minister, Pharma Secretary and the DCGI requesting each authority to not allowing hand sanitisers to be sold at any place or without a sale license. In its letter to government authorities, the association pointed out that sanitisers also contains drugs like chlorhexidine, hydrogen peroxide, isopropyl alcohol, glycerol, ethanol (95 per cent), propylene glycol etc., which needs to be bought and sold on licences premises. And when a hand sanitiser is sold from a pharmacy store there is government machinery to control and check the quality.
Reacting on the central government notification of allowing the sale of hand sanitisers without a sale licence, Rajiv Singhal, General Secretary, AIOCD commented, “It is not a wise decision of the government to allow the sale of hand sanitiser without the sale licence, especially during the pandemic situation when the quality of hand sanitiser needs to be taken into consideration. Reportedly, there are already many substandard and harmful sanitisers containing methanol, which is hazardous to human health. With this permission, now there will be no control over the quality of sanitisers, which will be available at every nook and corner. Therefore, now AIOCD is concerned that when sanitisers are sold on the roads without any sort of quality control, the health of common citizens will be in great danger in this COVID situation. And there are high possibilities of a rise in substandard or impure sanitisers which will defeat the purpose of avoiding COVID-19 infection.”
Dr GL Singhal, Retired Drug Controller of Haryana responded, “By exempting sell license under Schedule K for hand sanitisers, especially without defining such products statutorily, we are opening a Pandora’s box. It would be cumbersome for drug regulators to ensure the quality of such products, which is crucial in this pandemic period. Monitoring and ensuring the availability of quality products would be a challenging task for drug regulators.”
V Harikrishnan, President, Suvana Karnataka Chemists and Distribution Association said, “We welcome the move initiated by the Central Government by exempting the sale of hand sanitiser as it will certainly ensure accessibility. However, we would like to have clarity on whether alcohol-based hand sanitizers and rubs are medicaments or disinfectants? The primary function of alcohol-based hand sanitisers and rubs are for preventive measures (hand hygiene) and not for therapy or prophylactic use (cure or preventive) as the product does not contain any active pharmaceutical ingredients (API) which are used for treating ailments or diseases. Therefore, we need to have a clear definition of hand sanitisers, whether is it a drug or a disinfectant and how does it work; as care, cure or prevention?”
He also informed that the association has written a letter to the DCGI, including the PMO, Health Minister, the Health Secretary of Department of Pharmaceuticals seeking clarification with regards to hand sanitisers classification under GST and its definition. “So far, we have not yet received any clarification from the government authorities on this, but we are hopeful that the government will look into the matter on a priority and respond to our query, which will give us a clear understanding about the product’s classification as well as definition.”