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Sanitizer business and its regulatory framework amidst COVID 19

April 28, 2020

By Rupin Chopra and Nishtha Das

The sudden outbreak of the novel COVID 19 virus has left a damaging impact all over the globe. The situation is such that even some of the developed countries are unable to find the cure for the virus and control its spread. As the virus can be transferred through human contact, almost all countries including the World Health Organisation (hereinafter referred to as ‘WHO’) is strictly recommending the use of face masks and hand rub sanitizers, along with social distancing, as a measure to curb the virus contamination.

Prior to the outbreak, India was a dormant market for hand sanitizers. However, the outset of the pandemic has resulted in an overwhelming, nationwide demand for hand sanitizers. While many businesses are struggling to survive, the sanitizer business is one of the few to have thrived during these difficult times. The frantic expansion of sanitizer market has attracted many entrepreneurs towards its development.

Also read: Equitable distribution and price control of hand sanitizers and face masks amid COVID-19

Licenses for sale/ manufacture/ distribution of sanitizers

As sanitizers fall within the definition of “Drugs” under the Drugs and Cosmetics Act, 1940, the license to sell/ manufacture/ distribute the same has to be obtained from the Licensing Authority as prescribed by the Government under the Drugs and Cosmetic Rules, 1945 (hereinafter referred to as ‘1945 Rules’).

The application for the sale/ stock/ exhibit or offer for sale has to be made in the prescribed relevant Form as provided under the 1945 Rules. The licensee has to submit the required details and has to follow the conditions attached with the license.

The application for manufacturing has to be submitted in accordance with the prescribed Form under the 1945 Rules along with the required documents including but not limited to plan of premises. As stated above, the license would further have to abide by the conditions attached to the license. For those entrepreneurs, who are not having manufacturing facility of their own, can obtain a loan license to manufacture the drug for sale. In this regard, they would have to provide a consent letter from the premises where such manufacturing is being carried out.

WHO guidelines for composition of sanitizers

With a view to safeguard the interests of the general public and to maintain the quality of sanitizers brought in the market, the WHO has recommended a certain composition of the sanitizers. As per the [1], applicable on India, handrubs with optimal antimicrobial efficacy usually contain 75 to 85% ethyl alcohol/ ethanol, isopropanol, or a combination of these products. Therefore the formulations advised by WHO either contain 75% v/v isopropanol, or 80% v/v ethanol.

Relaxation measures taken by the government in view of COVID 19

In view of the excessive demand for sanitizers, the Government has introduced relaxations for the sanitizer industry vide order dated March 19, 2020. The Central Government by way of this order has directed the State Governments to carry out the following actions.

  1. Permission on account of licensing and storage of Ethyl alcohol may be granted to the existing sanitizer industry without any quota restriction on supply of Ethyl alcohol. Ethyl alcohol is one of the major components in manufacturing of sanitizer.
  2. Ensuring easy procurement of Ethyl alcohol so that sanitizers can be obtained by producers at reasonable prices.
  3. Sanitizer industry to be motivated to increase working capacity for enabling enhanced production.
  4. As distillery members can also produce sanitizers in bulk, they are to be accorded with necessary permissions on priority basis.

Pursuant to the above, the Delhi Government has already eased the permission granted to all manufacturers of drugs and cosmetics in Delhi producing items based on ethanol up to June 30, 2020.

Ministry of AYUSH on licensing/approval/renewal process of sanitizers

Considering the crunch of time during the COVID 19 pandemic and subsequent need of sanitizers, the Ministry of AYUSH  has also rolled out a circular on April 02, 2020[2] on expediting the process for grant of approval/license/renewal of license for manufacturing sanitizers. The Government in this regard has directed the AYUSH  Licensing Authorities to complete the licensing/approval/renewal process expeditiously and dispose of the applications of the manufacturer’s maximum within a week’s time. However, the licensing/approval/renewal has to be in accordance with the terms of use of ingredients and permitted excipients, i.e. ingredient of medication.

[1] https://www.who.int/gpsc/5may/Guide_to_Local_Production.pdf

[2] https://www.ayush.gov.in/docs/124.pdf

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