Industry awaits positive govt response on draft notification on OTC drugs
The pharmaceutical industry in the country is waiting for the positive government response on the suggestions on the draft notification about the list of over-the-counter (OTC) drugs under Schedule K of Drug Rules 1945 and laid down specific provisions for its regulation in the country.
On May 25, 2022, the Union health ministry had circulated a notification by revising Schedule K of the Drugs Rules, 1945 that permits retailers to sell 16 specific drugs over the counter with a valid license.
“The draft notification and the suggestions from the concerned stakeholders is aimed at not only promoting self-care without compromising patient health and safety but also helping boost the pharma business and trade,” according to an industry official.
The list of 16 OTC drugs include 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 and lactulose solution 10gm/15ml.
As per the Drug and Cosmetic Rules, the drugs defined under Schedule K shall be free from the provisions of Chapter IV and the regulations made under this act to the extent and subject to the condition defined in that specific schedule.
As per the conditions of the draft notification for OTC drugs, these described drugs can be sold over the counter by retailers without any Registered Medical Practitioner’s (RMP) prescription only if the maximum duration of treatment or use is no longer than five days. If the symptoms do not go away when using the medication, the patient should consult a medical practitioner.
Additionally, the package size of the drug must not exceed the maximum daily dose prescribed for five days and each pack must come with patient information leaflets that explain how to use the medicine.
The draft notification also clarifies that the indication claimed should be the same as that already approved by the licensing authority for each drug.
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