Food and Drugs Administration, Haryana, India. |
Email ID: fdazone@gmail.com
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Last Updated on October 10, 2021 by The Health Master
FAQs on Sanitizer, N95 Mask & Digital Thermometer
Q. 1. Is disinfectant covered under Drugs and Cosmetics Act 1940 ?
Ans: Yes, Disinfectant is covered u/s 3 (b) of the Drugs and Cosmetics Act 1940. There is another category of disinfectant which is provided under Medical Devices Rules 2017 (for their intended use of disinfection of medical devices)
Q. 2. Has Govt fixed rate of sanitizer ?
Ans: Now, no rate is fixed for Sanitizer.
(Previously, Govt. of India have recently notified the retail prices for sanitizers vide notification S.O.1197 (E) dated 21st March 2020. As per this notification retail price is Rs. 100/ per 200 ml of bottle of sanitizer.) To download the notification, click here.
Q. 3 Whether the “disinfectant” which is manufactured under MD Rules 2017 (for their intended use of disinfection of medical devices) is also covered under this notification?
Ans: No. Disinfectants manufactured for disinfection of medical devices under MD Rules 2017 are not covered by this notification. As these are not hand sanitizer.
Q. 4. Is Ethyl Alcohol and its preparation comes under DPCO?
Ans; Ethyl Alcohol is a scheduled drug as per the list of drugs given in Schedule-I attached to DPCO 2013 therefore it is a price controlled or scheduled drug. Any formulation containing Alcohol as an ingredient would be covered under the definition of ‘New Drug’. If any person manufacture such formulations (alcohol containing formulations) then its prior approval of price from NPPA is mandatory under Para 15 of DPCO.
Q. 5. Is Harpic like products comes under DPCO 2013?
Ans; As per the composition labeled on the product ‘HARPIC’ it does not mention any drug which is included in Schedule 1 of DPCO 2013, hence it is not a Scheduled drug.
Latest notifications – DPCO /NPPA
FAQs – On DPCO: Drugs (Prices Control) Order, 2013
Q. 6. Is Mask N95 comes under DPCO 2013?
Ans: Now, no rate of N 95 Mask is fixed.
(Previously, Govt had fixed the retail price of N 95 Masks.)
Q. 7. Is Digital Thermometer a medical device?
Ans; Yes. As per notification No. S.O. 5980 (E) dated 03-12-2018 (To download the notification, click here) issued by the Govt. Of India it has been notified as medical device under Category B of Medical Device Rules 2017 However Govt. has further notified vide notification No. S.O. 4671 (E) dated 27-12-2019 (To download the notification, click here) that licensing provision for manufacturing and sale of the said medical device is effective from 1.1.2021. DCGI has given relaxation in the implementation of said notification for next 6 months from the issue of this order vide letter no. 292 dated 28.12.2019.
Q. 8 For which alcohol (Ethanol, Isopropyl Alcohol, Propanolol etc) permission is required from Excise Department?
Ans; Ethyl Alcohol and Extra Neutral Alcohol (ENA) etc.
Q. 9 What are various monographs of alcohol given under IP 2018?
Ans; IP 2018 provides monographs for
- Alcohol 95%
- Absolute Alcohol (99%)
Q. 10 What is ENA?
Ans; Extra Neutral Alcohol is food grade alcohol and basically raw material for preparation of alcoholic beverages such as whisky and wine.
Q. 11 What is Denatured alcohol (DNA)?
Ans; Ethyl Alcohol is mixed with some other chemical (dye pyridine, methanol etc) make it unfit for human consumption. It is used as solvent only
Q. 12 What is the mechanism of action of sanitizer containing IPA ?
Ans; IPA present in the sanitizer (IPA 70%, water 30%) destroys the protein of cell membrane of bacteria /virus.
Q. 13 Can Hand Sanitizer be sold at grocery shop ?
Ans: Yes. Govt has issued notification in this regard under section 26-B of the Drugs and Cosmetics Act.
Q. 14 Can Hand Cleanser / Hand Rub / Hand Wash be sold at grocery shop ?
Ans: Hand cleanser / Hand Rub / Hand Wash manufactured under cosmetic license do not require license for sale and these can be sold at grocery shop.
Difference between Sanitizer and Disinfectant
Licensing procedure for Medical devices
Latest Notifications: Medical Devices
Classifications of Medical Devices under the provisions of MDR 2017
FAQs on Medical Devices Rules, 2017
FAQs – on Blood Pressure Monitoring Devices
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