Alcohol-based sanitizers are medicaments ?

Requirement of the definition of hand sanitizers under the Drugs & Cosmetics Act and Rules thereunder.

Cosmetics Hand sanitizer

The Suvarna Karnataka Chemists and Distributors Association (SKCDA) has requested the state drugs control department to clarify whether alcohol-based sanitizers are medicaments. The Association also asked for details of the hand sanitizers manufactured for sale across the 30 districts in the state.

In a communication to the Karnataka drugs controller, BT Khanapure, the Association has asked for particulars on the documents pertaining to applications, verifications, inspections and grant of license of manufacture for sale of alcohol-based hand sanitizers, gels and rubs under Forms 25, 25C and form 32.

Along with this, the SKCDA has also urged the state drugs control department to provide information from March 1, 2020 to May 31, 2020 of Form 25 for allopathy, Form 25C for homeopathy and Form 32 for cosmetics pertaining to alcohol-based hand sanitizers, gels and rubs that were granted licenses to manufacturers for sale. Besides, total number of licenses granted to market for sale along with the documents submitted by the applicants to manufacture these products. In addition, it also asked the department for names of the officers who verified and inspected the applications for grant of licenses to manufacture for sale.  

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“We also request you to indicate whether the applicant applied for the license to manufacture for sale in Form 25 and has complied with the conditions as per the Rule 71(1) to (7) of the Drugs & Cosmetics Act and Rules thereunder,” said V Harikrishnan, president, SKCDA.

Rule 71 reads, the applicant while applying for the license to manufacture for medicines furnish to the licensing authority evidence and data justifying that the patent or proprietary medicine contains the constituent ingredients in therapeutic and prophylactic quantities for which the medicines are recommended for use. The drugs also need to be assessed under the conditions of storage and whether it contain ingredients in such quantities for which there is therapeutic justification.

Rule 71 (7) license should comply with the requirements of the good manufacturing practices (GMP) laid down in the Schedule M.  There is also need to look into the details of the batch and quality reports submitted by the manufacturer till date who have availed of the licenses. This should be along with the details of the samples drawn by department where licenses are granted. Further, there is need for documents pertaining to officers of their applications under section 21 who have verified and inspected the documents and premises of the manufacturers.

Documents pertaining to the licensing authority of their notification under Rule 49 A who should be graduate in pharmacy or pharmaceutical chemistry or medicine with specialisation on clinical pharmacology or microbiology from a university established by law. He should have experience in manufacture and testing of 5 years.

“We request you to clarify whether alcohol based sanitizers are medicaments. Further we need the definition of hand sanitizers under the Drugs & Cosmetics Act and Rules thereunder,” said Harikrishnan.

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