No ceiling price of clotrimazole 1% mouth paint

The multidisciplinary committee of experts, which was commissioned under the National Pharmaceutical Pricing Authority (NPPA), has finally decided not to fix the ceiling price of the antifungal formulation clotrimazole 1% mouth paint, based on the  National Pharmaceutical Pricing Authority (NPPA) ‘s communication that it has not approved the formulation.

The  National Pharmaceutical Pricing Authority (NPPA) declared the drug as a scheduled formulation based on the Drugs (Prices Control) Order, 2013, to fix the ceiling price accordingly in October 2021. That decision was challenged by Zydus Healthcare, which raised strong objections against including the mouth paint under the scheduled drug.

In a meeting held by the Committee on April 8, the experts also noted that the Central Drugs Standard Control Organisation (CDSCO) has clarified that its office does not approve the formulation.

“The Committee deliberated upon the matter in detail and is of the opinion that since CDSCO does not approve clotrimazole 1% mouth paint, it cannot be categorized as scheduled formulation…,” claimed the committee.

“Accordingly, the Committee decided that clotrimazole 1% mouth paint is not a scheduled formulation as per Explanation-I of DPCO 2013 and hence its ceiling price not to be fixed.”

The Expert Committee had earlier noted that clotrimazole 1% drops, cream, and mount paint are for local application, and as such, there is no significant difference between them. It then decided to obtain clarification from the CDSCO regarding the approval status of the formulation of mouth paint.

Zydus has raised objections arguing that any mouth paint’s PK and PD or efficacy profile, which includes clotrimazole 1% mouth paint, can be significantly different from that of another cream, including clotrimazole 1% cream or, for that matter, a drop which includes clotrimazole 1%.

Even though the Expert Committee had sought Zydus to provide published literature on significant differences in PK or PD of the mouth paint as against other formulations that led to a different outcome in a meeting in January earlier this year, the company has not managed to submit any published literature or significant difference, d the panel in one of its meeting.

The latest meeting was held on February 25. The Expert Committee had deliberated upon the matter in detail and had reiterated its earlier stand, which was taken in its 36th meeting held on October 11, 2021. It claimed that clotrimazole 1% mouth paint is a scheduled formulation based on Explanation 1 of Drugs (Prices Control) Order (DPCO), 2013.

The relevant explanation in the Drugs (Prices Control) Order (DPCO), 2013 is that any dosage form of any drug, other than the dosage form included in the Schedule, but in the same strength and route of administration, that does not have a significant difference in terms of its pharmacokinetics or pharmacodynamics or efficacy-safety profile over the dosage form as mentioned in the list shall also be considered as included.

“To elaborate, if a tablet is included, other dosage forms like conventional tablets and capsules are considered as included. However, such different dosage forms should be considered differently for purposes such as procurement policy, pricing, etc.,” explained the DPCO 2013.

This principle is also applied to all other dosage forms, such as the oral liquid dosage forms, topical dosage forms, injectables, etc.

The committee further observed that the clotrimazole 1% drops, clotrimazole 1% cream, and clotrimazole 1% passerby are also scheduled formulations, and a ceiling price has been given for clotrimazole 1% lotion also.

Clotrimazole Pessary 100 mg has also been listed in the National List of Essential Medicines (NLEM) 2015 for the primary, secondary, as well as tertiary healthcare levels. The mouth paint is often used to treat fungal infections in the mouth and other fungal infections. It works by binding with the inner surfaces of the mouth, and from there, it will be gradually released into the saliva, slowly killing the fungi.