16 drugs including Diclofenac, Clotrimazole going to be OTC
New Delhi: By amending Schedule K of the Drugs Rules, 1945, through a recent Gazette Notification, the Ministry of Health and Family Welfare (MoHFW) has issued draft certain rules allowing specific drugs to be sold Over-The-Counter (OTC) by retail under the valid licence.
As per the draft rules, the list of 16 medicines to be sold over-the-counter (OTC) by retail under a valid licence includes Povidone Iodine 5% w/v solution, Clotrimazole cream, Clotrimazole dusting powder, Dextromethorphan Hydrobromide Lozenges, Diclofenac ointment/cream/gel, Diphenhydramine Capsules, Paracetamol tabs 500 mg, Sodium Chloride Nasal spray, Oxymetazoline nasal solution 0.05%, Ketoconazole shampoo 2% w/v, Lactulose solution 10gm/15ml.
According to the Drug and Cosmetics Rules, the drugs specified in Schedule K shall be exempted from the provisions of Chapter IV of the Act and the Rules made thereunder to the extent and subject to the conditions specified in that Schedule.
This came in exercise of the powers conferred by sub-section (1Central Government proposes) of section 12 and subsection (1) of section 33 of the Drugs and Cosmetics Act, 1940 (23 of 1940) and in consultation with the Drugs Technical Advisory Board is hereby published for information of all persons likely to be affected thereby and notice is hereby given that the said 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;
The gazette also added, "Objections and suggestions which may be received from any person within the period specified above will be considered by the Central Government;"
"Objections and suggestions, if any, may be addressed to the Under Secretary (Drugs), Ministry of Health and Family Welfare, Government of India, Room No. 434, C Wing, Nirman Bhavan, New Delhi - 110011 or emailed at drugsdiv-mohfw@gov.in." the notice further added.
As per the proposed amendment;
In the Drugs Rules, 1945, in Schedule K after serial no. 39 and entries relating thereto, the following serial number and entries shall be inserted, namely:
| Class of Drugs | Extent and conditions of Exemptions |
| "40. The following drugs to be sold Over-The-Counter (OTC) by retail under the valid licence: 1. Povidone Iodine 5% w/v solution Composition: Povidone Iodine 5% w/v (Antiseptic and disinfectant agent) 2. Chlorohexidine Mouth wash Composition: Chlorohexidine Gluconate 0.2% (For the treatment of gingivitis) 3. Clotrimazole cream Composition: Clotrimazole 1% w/w cream (Antifungal) 4. Clotrimazole dusting powder Composition: Clotrimazole 1%w/w powder (Antifungal) 5. Dextromethorphan Hydrobromide Lozenges (5mg) (Cough) 6. Diclofenac ointment/cream/gel Each gram of gel contains 10 mg of diclofenac sodium (equivalent to 11.6 mg of diclofenac diethylammonium) (Analgesic) 7. Diphenhydramine Capsules 25 mg (Antihistaminic/Antiallergic) 8. Paracetamol tabs 500 mg (Antipyretic) 9. Sodium Chloride Nasal spray – 0.9% (Nasal Decongestant) 10. Oxymetazoline nasal solution 0.05% (Nasal Decongestant) 11. Ketoconazole shampoo 2% w/v (Anti dandruff) 12. Lactulose solution 10gm/15ml (Laxative) 13. Benzoyl peroxide 2.5 w/w (Antibacterial for acne) 14. Calamine Lotion (Anti septic) 15. Xylometazoline hydrochloride 0.05% w/v (Nasal decongestant) 16. Bisacodyl tablets 5mg (Laxative) | The provisions of Chapter IV of the Act and Rules thereunder to provide that these drugs can be sold by retail Over-The-Counter without prescription of a Registered Medical Practitioner (RMP), subject to the following conditions, namely:— a. The maximum duration of treatment/use should not exceed five days. b. If the symptoms do not resolve the patient should consult Registered Medical Practitioner. c. Pack size may not exceed the maximum doses recommended for five days. d. Each pack of the drug may be accompanied with Patient Information Leaflet (PIL). e. The indication claimed should be same as already approved by the Licensing Authority under Rule 21(b) for the categories mentioned.‖
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To view the Gazette notification, click on the link below:
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