Department of Health and Family Welfare vide notification dated the 25th May, 2022 has provided that the following drugs to be sold Over-The-Counter (OTC) by retail under the valid license:
(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)
Sale by retail Over-The-Counter without prescription of a Registered Medical Practitioner (RMP) shall be 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.
