Draft of Drugs Amendment Rules, 2022 adds new drugs for OTC retail sale

25th May, 2022
Draft of Drugs Amendment Rules, 2022 adds new drugs for OTC retail sale
Regulatory BodyCDSCO Product CategoryDrug for Importer & Manufacturer
Ministry of Health and Family Welfare has published a notification in the Gazette of India regarding the draft amendment in the D&C Rules, 1945 which has been enforced from 25th May 2022. 16 drugs have been added at S. No. 40 of Schedule K under Drugs and Cosmetics (D&C) Rules, 1945 which are allowed to be sold Over the Counter (OTC) with a valid license by retail shops.
Notable Products:Antiseptic and disinfectant agent, Mouth wash, Anti-fungal cream, Antihistaminic and Antiallergic drugs, Laxative, Lotions, Nasal Decongestant.
Applicable For:Importer & Manufacturer
Reference Number:CG-DL-E-25052022-236010
The Central Govt. in consultation with the Drugs Technical Advisory Board has amended the Schedule K of D&C Rules, 1945. This amendment is at draft stage and issued for public objections and suggestions. Any public opinion shall be received within the thirty days from issuance of this draft. According to the said amendment Over The counter (OTC) Drugs category has been added at S. No. 40 of Schedule K of D&C Rules 1945. At an initial stage sixteen (16) drugs have been allowed to be sold Over the Counter (OTC) by retail under a valid licence without any prescription from Registered Medical Practitioner (RMP). This list includes paracetamol 500mg, clotrimazole cream, Diclofenac ointment etc. which are commonly used medicines. The notice also mentions other extents and conditions of exemption for selling these OTC medicines: 1. The maximum duration of use and dosage should not exceed five days. 2. If the symptoms persist Registered Medical Practitioner consultation is essential. 3. Pack size should not exceed max dose recommended for 5 days. 4. Each pack of the drug must be accompanied by Patient Information Leaflet (PIL). 5. The indication claimed should be the same as already approved by the Licensing Authority under Rule 21 (b)