Govt: Draft notification to add 16 drugs as OTC under Schedule K of Drugs Rules

Objections and suggestions which may be received from any person within the period will be considered by the government.

The Health Master

May 28, 2022

2210

Govt of India Gazette of India Notification — Gazette of India

Table of Contents

Last Updated on January 6, 2024 by The Health Master

Download notification No. 393 (E) dated 25-05-2022, link given below: The Union health ministry will soon be adding various strengths or delivery forms of 16 drugs, including antipyretic drug paracetamol 500 mg, analgesic diclofenac in ointment format, among others, as over-the-counter (OTC) drugs under Schedule K of Drugs Rules, 1945.

Download notification No. 393 (E) dated 25-05-2022

The move is to add them under a single serial number 40, after the recently added serial number 39 for anticeptic liquid for household use.

The drugs that will be part of the OTC list, according to this, include:

Povidone Iodine 5% w/v solution composition: Povidone iodine 5% w/v (antiseptic and disinfectant agent);
Chlorohexidine mouth wash composition: Chlorohexidine gluconate 0.2% (for the treatment of gingivitis);
Clotrimazole cream composition: Clotrimazole 1% w/w cream (antifungal);
Clotrimazole dusting powder composition: Clotrimazole 1%w/w powder (antifungal);
Dextromethorphan hydrobromide lozenges (5mg) (cough);
Diclofenac ointment/cream/gel each gram of gel contains 10 mg of diclofenac sodium (equivalent to 11.6 mg of diclofenac diethylammonium) (analgesic);
Diphenhydramine capsules 25 mg (antihistaminic/antiallergic);
Paracetamol tabs 500 mg (antipyretic).

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Sodium chloride nasal spray – 0.9% (nasal decongestant);
Oxymetazoline nasal solution 0.05% (nasal decongestant);
Ketoconazole shampoo 2% w/v (anti dandruff);
Lactulose solution 10gm/15ml (laxative);
Benzoyl peroxide 2.5 w/w (antibacterial for acne);
Calamine lotion (anti septic);
Xylometazoline hydrochloride 0.05% w/v (nasal decongestant);
Bisacodyl tablets 5mg (laxative).

Based on the provisions of Chapter IV of the Drugs and Cosmetics Act and Rules these drugs can be sold by retail OTC without prescription of a Registered Medical Practitioner (RMP), subject to certain conditions.

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The conditions are that the maximum duration of treatment/use should not exceed five days and if the symptoms do not resolve the patient should consult Registered Medical Practitioner.

The pack size may not exceed the maximum doses recommended for five days. Each pack of the drug may be accompanied with Patient Information Leaflet (PIL).

The indication claimed should be same as already approved by the Licensing Authority under Rule 21(b) for the categories mentioned in the list.

A draft rule has been notified by the Ministry in this direction. It has also issued a notice along with the notification that the draft rules shall be taken into consideration on or after the expiry of a period of thirty days from the date on which the copies of the Gazette of India containing these draft rules are made available to public.

Objections and suggestions which may be received from any person within the period will be considered by the government.

Conditions

The conditions mentioned in the draft notification say that:

The specified drugs can be sold by retail over the counter without prescription of a registered medical practitioner only if the maximum duration of treatment or use does not exceed five days and if the symptoms does not resolve, patients consult a doctor.

Another condition stipulates that the pack size of the drug should not exceed the maximum dose recommended for five days and each pack is accompanied with patient information leaflet.