Last Updated on January 14, 2024 by The Health Master
New Regulation on OTC Drugs
Download notification No. 393 (E) dated 25-05-2022, the link is given below: The pharmaceutical industry in the country is eagerly anticipating a favorable government response regarding the draft notification for the list of over-the-counter (OTC) drugs under Schedule K of Drug Rules 1945.
This new regulation lays down specific provisions for the regulation of these drugs in the country, offering an opportunity for the industry to promote self-care while maintaining patient health and safety and boosting pharmaceutical business and trade.
A new regulation circulated by the Union Health Ministry
On May 25, 2022, the Union health ministry circulated a notification, amending Schedule K of the Drugs Rules, 1945, which allows retailers to sell 16 specific drugs over the counter, provided they possess a valid license.
Industry’s Perspective
According to an industry official, the draft notification and suggestions from stakeholders aim not only to encourage self-care without compromising patient health and safety but also to enhance the pharmaceutical business and trade.
List of 16 Over-the-Counter (OTC) Drugs
The list of 16 OTC drugs includes the following:
- Povidone Iodine 5% w/v
- Chlorohexidine Gluconate 0.2%
- Clotrimazole 1% w/w cream and powder
- Oxymetazoline Nasal Solution 0.05%
- Sodium Chloride Nasal Spray 0.9%
- Diphenhydramine Capsules 25 mg
- Dextromethorphan Hydrobromide Lozenges 5mg
- Paracetamol Tabs 500 mg
- Diclofenac Ointment/Cream/Gel with 10 mg of Diclofenac Sodium per gram
- Ketoconazole Shampoo 2% w/v
- Benzoyl Peroxide 2.5 w/w
- Calamine Lotion
- Xylometazoline Hydrochloride 0.05% w/v
- Lactulose Solution 10gm/15ml
Conditions of the Draft Notification for OTC Drugs
As per the Drug and Cosmetic Rules, drugs defined under Schedule K are exempt from the provisions of Chapter IV and the regulations made under this act, subject to the conditions defined in the specific schedule.
The draft notification for OTC drugs outlines the following conditions:
- Retailers may sell the described drugs over the counter without any Registered Medical Practitioner’s (RMP) prescription, but only for a maximum duration of five days.
- If the symptoms persist beyond the five-day period, patients must consult a medical practitioner.
- The package size of the drug must not exceed the maximum daily dose prescribed for five days.
- Each pack must include patient information leaflets providing instructions on how to use the medicine.
Strict Compliance with Approved Indications
The draft notification also emphasizes that the indication claimed for each drug must align with the approval already granted by the licensing authority.
In conclusion, the pharmaceutical industry is looking forward to a positive government response to the draft notification for over-the-counter drugs, which has the potential to encourage self-care, ensure patient safety, and foster growth in the pharma business and trade sector.
The listed OTC drugs and the conditions of their sale without prescription provide opportunities for better access to essential medications while ensuring adherence to appropriate guidelines and regulations.
Disclaimer: This article contains information derived from Pharmabiz. Our team utilized an AI language model, to rewrite and present the news / article in a unique format.
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