Alcohol-Based Hand rubs and sanitizers- regulatory requirements and uncertainties

Last Updated On: June 11, 2020, 6:17 p.m.
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ALCOHOL BASED HAND RUBS AND SANITIZERS

Due to the COVID-19 virus pandemic, there was a sudden demand for manufacturers and marketers to sell hand sanitizers containing ethanol or isopropyl alcohol as an active ingredient.

World Health Organisation has to told that hand hygiene is very important to protect from the prevention of this virus. WHO has recommended the use of an alcohol-based hand rub for 20-30 seconds using appropriate technique.

Due to regulatory uncertainties, there is a required to have drug licenses for the stock, sale, and determining or controlling of the price which is a barrier for running these operations.

Thus, the manufacturers and marketers are forced of exploring an alternative option to overcome these uncertainties by manufacturing hand sanitizers as ayurvedic medicine.

The Drug Licensing Authorities have started granting a license to manufacture ABHRs in a record time of three days to drug manufacturers, even to alcohol distilleries and cosmetic manufacturers to ensure a steady and sufficient supply of hand sanitizers and hand rubs.

 

However, The manufacturer and marketers are facing many challenges due to this regulatory uncertainties, they have been listed one by one the below segment.

  1. Making claim related to COVID-19
  • The Scientific Laboratory data proves that the claim recommended by WHO i.e ABHRs in the concentration of 30% v/v can inactive the COVID-19 virus in 30 seconds.
  •   If any manufacturer or marketer wishes to put a generic COVID-19 virus-related claim on its label, it may need to first obtain prior permission from DCGI who may decide to treat the ABHR as an untested ‘new drug’ and require the manufacturer to submit supporting laboratory data for its own formulation before it is permitted to make any COVID-19 virus-related claim. This is because the Scientific Laboratory has not been endorsed by the DCGI. Any claim in the absence of DCGI will make the manufacturer liable for prosecution.
  1. Drug license for stock and sale
  •        The Drugs and Cosmetics Act, 1940 (DCA) directs that every drug stocked or sold in India must be sold under a license unless the drug, or the person stocking or selling the drug, is exempt by law from this requirement but there is no exemption for ABHRs.
  •  The entire supply chain, including retailers of ABHRs, are required to sell them under a stock and sale license under DCA.
  • It is not possible to meet the current demand for ABHRs through existing distribution and retail channels that have stock and sell licenses for drugs. Therefore, there is an expectation that ABHRs should be sold through general FMCG distribution and retail channels.

Remedies which has also lead to face challenges:

  • The only legal way is to position ABHRs as Disinfectants. As there is an exemption for stocking or selling Disinfectants without any Drug License.
  • The industry is awaiting an official clarification on this issue. The central drug regulator, the Drugs Controller General of India (DCGI), is currently reviewing the regulatory positioning of hand sanitizers, including ABHRs, as ‘disinfectants’ and availability of exemption from drug stock and sale license to them. Until DCGI takes a final position, some State-level Drug Licensing Authorities may accept ABHR’s claim of disinfectants and allow them to be stocked and sold by the distributors and retailers without drug licenses.
  • Manufacturers and marketers are manufacturing ABHRs under as an ayurvedic drug that is made under an ayurvedic drug manufacturing license, or as a cosmetic that is made under a cosmetic manufacturing license.
  • There are significant challenges faced by the ABHRs by stocking or selling it as an ayurvedic drug or Cosmetic Drug.
  • State Governments in India have prescribed a limit on alcohol content, stating that alcohol used in the manufacture of antiseptic solutions should not contain alcohol in excess than is necessary for the preservation of ayurvedic ingredients.
  • ABHRs are sold as cosmetics, it is not possible to make any ‘drug’ claim on it. It is not possible to claim on the label that the ABHR ‘kills’ germs, as it would mean that the product is not for the cosmetic application but for medicinal application.
  1. Status as new drugs of India:
  • WHO recommended two formulations of ABHRs Ethanol 80% (v/v) or Isopropyl alcohol 75% (v/v), Glycerol 1.45% (v/v) and Hydrogen peroxide 0.125% (v/v). 
  • Under New Drugs and Clinical Trial Rules, 2019 (NDCTR), a formulation is deemed to be a “new drug” for four years from the date of its first approval. Therefore, the WHO recommended formulations are to be currently treated as ‘new drugs’ for regulatory purposes in India until 2021.
  • When any drug is classified as a ‘new drug’, the manufacturer will have to face two consequences. First is to take prior permission from the central drug regulator, DCGI, to obtain a manufacturing license. Second, it is that after the manufacturing license is granted, the manufacturer is supposed to undertake post-marketing surveillance and submit periodic safety update reports (PSURs) to DCGI.
  1. Price Control of Hand sanitizers
  • The Drug (Prices Control) Order, 2013 DPCO regulates the prices and distribution of ABHRs containing ethyl alcohol 70% (v/v) since 2013.  
  • The current price ceiling on 70% ethyl alcohol solution is 0.56 Rupees per ml, which translates into 112 Rupees for 200 ml. All other ABHRs are restricted from increasing their maximum retail price by more than 10% in between twelve months.
  • As mentioned earlier hand sanitizers can be manufactured as ayurvedic or cosmetic. Ayurvedic formulations are not regulated for the price by DPCO to a great extent and cosmetics are not regulated for price at all.
  • To overcome these challenges, the Indian Government has notified The Essential Commodities Order, 2020, thereby classifying “hand sanitizers” as an essential commodity until June 30th, 2020. Due to this, all hand sanitizers including drug, ayurvedic medicine, cosmetics, and the raw material used in them have decided to limit price control and have become amenable to the jurisdiction of respective State Governments.

 

  1. Putting Government Logo for endorsement in the fight against Covid-19 virus
  • World Health Organization, putting the name or official seal or emblem of the Government of India or of any State or of a Department of any Government without prior permission of the Central Government is an offense under the Emblems and Names (Prevention of Improper Use) Act, 1950.
  1. Getting the label right
  • More than one active ingredient falls in the category of ‘fixed-dose combinations’ (“FDCs”).
  • Every FDC is required by law to state the composition on the label first, followed by its brand name. In the case of the WHO recommended formulae described earlier, the name of the active ingredients must appear prominently on the label, and simply writing “hand sanitizer” or “hand rub“ may not be enough.
  1.  Focusing on getting the quality aspects right
  • The manufacturer of ABHRs is obligated by law to produce the standard quality of Hand sanitizers.
  • In case a drug is found to be not of standard quality, the liability lies with the manufacturer and not the marketer.
  • But from March 1st 20121, the marketers will also be responsible for the quality of the drug.
  • The agreement between marketers and manufacturers will play an important role in the determination of liability. 

                                    

ABHRs in-demand in India than ever before due to the pandemic condition. However, manufacturers and marketers of ABHRs should be careful about compliance with laws and regulations, because any oversight today may lead to strict regulatory action in the future.

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