The Suvarna Karnataka Chemists and Distribution Association (SKCDA) has sought clarification from the State drug controllers about the procedures followed by the authority in granting manufacturing as well as sale licenses to manufacturers of hand sanitisers in the State. It has written a letter to the drug controlling authority with a request for detailed data pertaining to applications, verifications, inspections and grant of license for manufacture and sale of alcohol-based hand sanitisers, gels and rubs.
In its letter to the state drug controllers, the association has requested for details of documents submitted by the applicants through hard copies as well as soft copies. It also wants details of the total number of licenses granted for manufacture for sale of alcohol-based hand sanitisers, gels, rubs by the drug controller department of Karnataka through in Form 25 (Allopathic), Form 25C (Homoeopathic) and Form 32 (Cosmetic). It has also asked for details like batch and quality reports submitted till date by manufacturers who have been granted permission to manufacture for sale licenses for hand sanitisers in the state. It also wants to know that if the applicant applied for the license to manufacture for sale through form 25, has the applicant adhered to the condition specified in Rule 71 (1) to (7) of Drugs and Cosmetics Act 1940 and Rules thereunder.
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Besides this, it has also sought the details of the officers who have verified and inspected the applications for the grant of licenses to manufacture for sale of alcohol-based hand sanitisers, gels and rubs in form 25, form 25C and form 32 (01.03.2020 to 31.05.2020) of their appointment under section 21 gazetted and date of notification published in the official gazette.
V Harikrishna, President, SKCDA said, “The objective is getting detailed information pertaining to the classification of alcohol-based hand sanitisers and rubs. Are they drugs or disinfectants?”
He added, “Earlier, we wrote to different government authorities seeking the definition and classification of hand sanitisers. So far, we have not received any communication from them. We would like to have an understanding of the granted manufacturing for sale licenses for hand sanitisers are based on what assessment and classification. Hence, we have written a letter to the State drug controller requesting these details along with complete submitted documents by the applicants and details of the batch and quality report of the granted product. We have also sought details of officers who have granted the respective licenses with documents pertaining to their appointment notification.”
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Summing up, he said, “Once we get the requested data from the State FDA, we will be able to understand whether the given licenses justify that manufacturers should pay 18 per cent GST on hand sanitisers as addressed and classified by the GST Council categorising it as ‘disinfectant’ or are they liable to pay only 12 per cent GST as they have received the manufacture for sale licenses for hand sanitisers as a drug.”
The association informs that it had written a similar letter earlier to the DCGI office requesting similar details.
Source: Express Pharma