Food and Drugs Administration, Haryana, India. |
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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.
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