Sanitizer Business and its Regulatory Framework amidst COVID-19

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The article has been written by Pragyna Panigrahi a 1st-year student of Amity Law School, Amity University Chhattisgarh.

INTRODUCTION:-

The COVID-19 pandemic is considered as the most crucial global health calamity of the century and the greatest challenge that the humankind faced since the 2nd World War. In December 2019, a new infectious respiratory disease emerged in Wuhan, Hubei province, China and was named by the World Health Organization as COVID-19. The name COVID-19 ‘CO’ stands for ‘corona’ ‘VI’ stands for ‘virus’ and ‘D’ stands for ‘disease’ and 19 represents the year of its occurrence. As far as the history of human civilization is concerned there are instances of severe outbreaks of diseases caused by a number of virus. According to the report of the World Health Organization (WHO as of April 18,2020), the current outbreak of COVID-19, has affected over 2,164,111 and killed more than 146,198 people in more than 200 countries throughout the world. Till now there is no report of any clinically approved antiviral drugs or vaccines that are effective against COVID-19. It has rapidly spread around the world, posing enormous health, economy, environment and social challenge to the entire human population. The corona virus outbreak is severely disrupting the global economy. Almost all the nations are struggling to slowdown the transmission of the disease by testing and treating patients, quarantining suspected persons through contact tracing, restricting large gathering maintaining complete or partial lock down etc.

As the virus can be transferred through human contact, almost all the countries including the World Health Organization 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 business are struggling to survive, the sanitizer businesses 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.

LICENSES FOR SALE/ MANUFACTURE/ DISTRIBUTION OF SANITIZERS

As sanitizers fall within the definition of “Drugs” under the Drugs and Cosmetic 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.

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.

Material required to Manufacture Hand Sanitizers:-  Beaker, Filter funnel, Filter paper, Foil paper, paper tape, packaging bottle, analytical weighing balance, Lavender oil, glycerin, camphor, wild spinach, garlic, turmeric, Ethanol, distilled water.

Documents Required For Hand Sanitizer Manufacturing License:-

  • Incorporation/ Proprietary/ other form of business
  • Area of the manufacturing unit should be not less than 600 sqft.
  • DMR act compliance’s must be followed by all manufactures.
  • Technical officer (BMS doctor)
  • Technical officer (BMS with Bio.)
  • Product information (the composition of products)
  • Directors (related to the herbal domain) will be more preferable

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, applicable on India, hand sanitizers with optimal antimicrobial efficiency 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 the 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 order has directed the state government 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 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 cost.
  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 permission on priority basis.

According to the above, the Delhi Government has already eased the permission granted to all manufacturers of drugs and cosmetic in Delhi producing item 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 2, 2020 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 compete the licensing/ approval/ renewal process expeditiously and dispose of the applications of the manufacturer’s maximum within a week’s time. [1]

References-

[1] https://www.mondaq.com/india/operational-impacts-and-strategy/943038/sanitizer-business-and-its-regulatory-framework-amidst-covid-19-

https://www.sciencedirect.com/science/article/pii/S0048969720323998

https://www.corpseed.com/service/Hand-Sanitizer-Manufacturing-License

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