regular-article-logo Thursday, 08 June 2023

Centre proposes over-the-counter sales of 16 classes of drugs

The change will potentially allow retail shops to sell such OTC formulations without the need for buyers to show prescriptions from doctors

G.S. Mudur New Delhi Published 27.05.22, 02:46 AM
Representational image.

Representational image. Shutterstock

The Union health ministry has proposed over-the-counter sales of 16 classes of medicines, including the anti-fever paracetamol, an anti-bacterial acne formulation, anti-fungal creams, nasal decongestants, an analgesic cream formulation and anti-allergy capsules, among others.

A gazette notification released by the ministry on Wednesday sought public responses to a proposed amendment to the national drug rules to allow the 16 formulations “to be sold over-the-counter (OTC) by retail under valid licence”.


The change will potentially allow retail shops to sell such OTC formulations without the need for buyers to show prescriptions from doctors. These medicines are currently available mainly through retail chemists or hospital pharmacies.

But the OTC sales will be allowed only under the conditions that the maximum duration of treatment or use should not exceed five days and that if the symptoms do not resolve, the patient should consult doctors. The pack size should not exceed the maximum doses recommended for five days and each packet should be accompanied by a patient information leaflet.

The move to introduce an OTC class of medicines in India comes in a landscape where many chemists and pharmacies continue to sell restricted medicines, including antibiotics or fixed-dose combinations of medicines, without insisting on prescriptions despite government strictures.

The Indian Association of Dermatologists had over four years ago complained to the central drug regulatory agency about dangerous skin creams laced with steroids being sold without doctors’ prescriptions that had contributed to “an epidemic of superficial fungal infections”.

“But nothing has changed on the ground — steroid-containing creams continue to be sold without prescriptions,” said Abir Saraswat, a Lucknow-based dermatologist and a member of an association panel that had urged a government crackdown.

But, Saraswat said, the plan to introduce OTC formulations could help as it might allow consumers to learn to differentiate between drugs that can be bought without doctors’ prescriptions and those that require prescription.

“We never had anything labelled as OTC. Let us hope the introduction of some OTC medicines is followed up by authorities on getting tough on medicines that need to be sold only on prescriptions,” Saraswat told The Telegraph. “The rules already exist — they just need to be enforced.”

The proposed OTC formulations include providone iodine, an antiseptic disinfectant, chlorohexidine mouthwash, clotrimazole antifungal cream and dusting powder, dextromethorphan hydrobromide cough lozenges, diclofenac analgesic cream, benzoyl peroxide anti-acne cream, diphenhydramine anti-allergic capsules, paracetamol 500mg tablets, three nasal decongestants, two anti-dandruff formulations, calamine antiseptic lotion and two laxative formulations.

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