The Employees State Insurance Corporation (ESIC) on June 16, 2023, issued a notification to Prohibit the manufacture for sale, sale or distribution for human use of drug fixed dose combination.
The following has been stated namely: -
• 14 Fixed-Dose Combination of drugs has been prohibited for human use under Section 26A of the Drugs & Cosmetics Act, 1940 for manufacture for sale, sale or distribution. The table with the item name has been inserted in the notification.
• The items approved in DG ESIC RCs /CPSEs (Gem portal) are as under:
1. Chlorpheniramine Maleate + Codeine Syrup
2. Ammonium Chloride + Sodium Citrate + Chlorpheniramine Maleate (110mg+46mg+3mg+0.9mg) per 5ml Syrup
• lt is also instructed with regard to the cancelled items that:
i. The distribution and use of the said drugs should be stopped immediately.
ii. No supply to be received of above said drugs.
iii. Return back the existing stock of the said items to the manufacturers (Rate Contract Holders) and also the cost of the same has to be recovered from the firm.
This has come into force on June 16, 2023
[Notification No. U-25/12/banneddrug/2023-MedV (E-340288)]
