FAQs – on Glycerin (Pharma Industry)

FAQs - on Glycerin (Pharma Industry)

Picture: Pixabay
Deputy State Drugs Controller |
Food and Drugs Administration, Haryana, India. |
Email ID: fdazone@gmail.com
Lalit Kr. Goel

Last Updated on September 21, 2021 by The Health Master

FAQs – on Glycerin (Pharma Industry)

Q1.      Whether Glycerin is a drug or cosmetic?

Ans:    Glycerin has dual use. It can be used as drug, cosmetic and food.

Q2:      Whether Glycerin is officially in any pharmacopoeia?

Ans:    Yes, it is official in IP and USP.

Q3:      Whether Glycerin IP can be used in food and cosmetics?

Ans:    Yes, as IP book is a standard of products for specifications and testing.

Q4:      Is any reference / document / data of dual use of API of Glycerin as the drug, food, and cosmetic?

Ans:    Yes, as per DCG(I) letter dated 05.07.2019 regarding the dual use of APIs.

Q5:      Whether oral Glycerin can be manufactured under form 25?

Ans:    Yes, Oral Glycerin is official in IP and can be manufactured in Oral Liquid Section only.

Q6:      Can Glycerin be manufactured in external section or for repack?

Ans:    Glycerin can be manufactured in external section if for external use only and can be repacked the same under repacking license.

Q7:      Can Glycerin product manufactured as drug claim as beauty product?

Ans:    No, it comes under the definition of cosmetics.

Q8:      What are the contaminations detected in Glycerin?

Ans:    Di-ethylene Glycol (DEG)

Q9:      What are the main instruments required for testing DEG in Glycerin?

Ans:    Gas Chromatograph is required to detect presence of DEG in Glycerin.

Q10:    When this test of DEG was introduced in IP?

Ans:    This test was introduced after JJ Hospital, Bombay tragedy in early 1980 wherein many died due to containing DEG as contamination in Glycerin.

Q11:    Name the Commission which conducted enquiry of JJ Hospital, Bombay tragedy?

Ans:    Lante Commission.

Q12:    What are the precautions for the person dealing in manufacturing of Glycerin?

Ans:    They should get Glycerin tested for contamination like DEG in their product.

FAQs – On ‘Good Night’, ‘All Out’, ‘Hit’ and ‘Harpic’

FAQs – on Ranitidine tablets and injections in India

FAQs – On Narcotic Drugs, Brand Names of drug (G.S.R. no. 828 (E) 

For informative videos by The Health Master, click on the below YouTube icon:

YouTube Icon

For informative videos on Medical Store / Pharmacy, click on the below YouTube icon:

YouTube Icon

For informative videos on the news regarding Pharma / Medical Devices / Cosmetics / Homoeopathy etc., click on the below YouTube icon:

YouTube Icon

For informative videos on consumer awareness, click on the below YouTube icon:

YouTube Icon
YouTube Icon