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Health ministry to add 16 drugs as OTC under Schedule K of Drugs Rules, 1945

Gireesh Babu, New Delhi
Friday, May 27, 2022, 08:00 Hrs  [IST]

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.

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); and paracetamol tabs 500 mg (antipyretic).

The rest of the eight drugs include 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); and 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.

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.

 

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