admin / 6th April, 2020

Regulations for Hand sanitizers and home drug deliveries by CDSCO in India

Regulation/Guidelines

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Summary:

Regulations regarding hand sanitisers and home deliveries of the drugs, along with the list of approved formulations for hand sanitisers

There is a huge demand for hand sanitizers with the increasing cases of COVID-19. To protect themselves against this novel virus and to prevent spreading the virus, everyone is using hand sanitizers. It has also become important to get the drugs and hand sanitizer delivered at our doorstep as it is not advisable to go outside. To support the home deliveries of drugs, including hand sanitizers and Schedule H drugs during this pandemic, Central Drugs Standard Control Organization (CDSCO) has come up with new regulations.

As per new CDSCO notification, a retail drug licensee can home deliver drugs, including hand sanitizers within the same district provided that Schedule H drugs are given on receipt of prescription physically or through e-mail.

What is the Right Composition for Manufacturing Hand sanitizer?

Hand sanitizers are products made for frequent use and they reduce the number of transient micro-organisms on intact skin. They are considered as OTC drugs and not categorized as Cosmetics if they contain any one of these chemicals viz. Ethanol, Ethyl Alcohol, Isopropyl Alcohol, as an active ingredient.

List of Hand Sanitizers approved by CDSCO including formulas of World Health Organization (WHO)
No.	Name	Purpose	Date of Approval
1.	Isopropyl Alcohol IP 45g +n-Propranol 30 g+Ethyl-hexadecyl-dimethyl ammonium- ethylsulphate 0.2g liquid each 100 gm		17.07.15
2.	Cetrimide 15% w/v +Chlorhexidine Gluconate 7.5% v/v +Isopropyl Alcohol 7.5% v/v Concentrate Solution	Cleansing of physically Contaminated wounds and for preoperative disinfection	09.02.09
3.	Each 100 ml contains: Iso propyl Alcohol IP …75% v/v Hydrogen Peroxide IP 0.125% v/v Glycerol IP…1.45% v/v Solution	Hand hygiene	07.07.2017
4.	Each ml of cutaneous solution contains: Chlorhexidine Gluconate Solution IP equivalent to Chlorhexidine gluconate …20 mg Isopropyl Alcohol IP……… 0.70ml	Disinfectant of the skin prior to invasive medical surgeries and sterilization of the device insertion sites.	22.03.2018
5.	Cetrimide 15% w/v + Chlorhexidine Gluconate 7.5% v/v +Isopropyl Alcohol 7.5% v/v Concentrate Solution	Cleansing of physically contaminated wounds and for pre-operative disinfection	09.02.09
6.	Isopropyl Rubbing Alcohol		IP 2018
7.	Ethanol (Denatured with 1% DEP) 10% w/w+2-Propanol IP 9%w/w +1- Propranol BP 6% w/w topical spray		17.07.15
8.	Isopropyl Alcohol IP 45g +n-Propranol 30 g+Ethyl-hexadecyl-dimethyl ammonium- ethylsulphate 0.2g liquid each 100 gm		17.07.15
9.	Ethanol(95%)IP 72.00%+Propylene Glycol IP 0.1.000%+Glycerine IP 0.1000%+Triclosan 0.3%+Aloes IP 0.007%+Vitamin E 0.007%+Carbopol 0.3% +2-Amino, 2-Methyl, 1-Propranol 0.2%+Fragrance 0.3%+purified water q.s. to 100.00% hand sanitizer		17.07.15
10.	2-Propranol IP 45g +1-Propanol IP 30 g +Ethyl-Hexadecyl-Dimethyl ammonium Ethylsulphate 0.2g per 100gm external liquid		17.07.15
11.	Ethanol (Denatured with 1% DEP) 10% w/w+2-Propanol IP 9%w/w +1- Propranol BP 6% w/w liquid		08.06.2016
12.	Propranol 50 gm+povidine iodine-1 gm in 100ml solution	For hygienic and surgical hand disinfection	19.11.07
13.	Propranol-18 gm+Ethanol(100%)-45gm in 100ml solution	For hygienic and surgical hand disinfection	19.11.07
14.	Propranol 1-ol 18 gm+Ethanol 100 % 45 gm/100ml solution	For hygienic and surgical hand disinfection	18.01.2010
15.	Industrial Methylated Spirit		IP 2010
16.	Surgical Spirit		IP 2011

Reference:

Examples of hand sanitisers/surgical hand disinfectant approved by CDSCO including the WHO formula for reference purposes.pdf. Available at:https://cdsco.gov.in/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=NTc4Mg==.Accessed on 31 st March, 2020.

Available at:https://www.scconline.com/blog/post/2020/03/27/covid-19-doorstep-delivery-of-drugs-allowed-only-on-receipt-of-prescription-physically-or-through-e-mail/.Accessed on 1 st April, 2020.