NPPA Seek Clarification From CDSCO On Approval Status Of Clotrimazole 1% Mouth Paint


New Delhi : The multidisciplinary committee of experts, under the National Pharmaceutical Pricing Authority (NPPA), has decided to seek clarification from the Central Drugs Standard Control Organisation (CDSCO) regarding the approval status of the antifungal formulation clotrimazole 1% mouth paint, as part of its efforts to fix ceiling price of the drug.

The Committee has earlier declared the drug as a scheduled formulation based on the Drugs (Price Control) Order, 2013 to fix the ceiling price accordingly, against which Zydus Healthcare has made a representation.

In the latest meeting, the Committee headed by Manmohan Sachdeva, advisor (cost), NPPA, noted that clotrimazole 1% drops, cream and mount paint are for local application and as such there is no significant difference between them.

It has also decided to obtain clarification from the CDSCO regarding the approval status of the formulation of mouth paint and to deliberate the issue further in the next meeting based on the inputs provided by the drug regulator.

Zydus has earlier raised objection against including the mouth paint under scheduled drug for ceiling price fixation, and informed the Committee that the PK and PD or efficacy profile of any mouth paint including clotrimazole 1% mouth paint is significantly different from that of a cream including clotrimazole 1% cream or for that matter, a drop including clotrimazole 1%.

Even though the Committee, in a meeting in January, this year, sought the company to provide published literature on significant differences in PK or PD of the mouth paint as against other formulations that leads to different outcome, the company has not submitted any published literature or significant difference, said the panel in its latest meeting.

In the latest meeting, held on February 25, the Committee deliberated upon matter in detail and reiterated its earlier stand taken in its 36th meeting held on October 11, 2021, that clotrimazole 1% mouth paint is a scheduled formulation based on Explanation 1 of DPCO, 2013.

The explanation in the DPCO, 2013 is that any dosage form of a medicine, other than the dosage form included in the Schedule, but in same strength and route of administration, which does not have significant difference in terms of pharmacokinetics or pharmacodynamics or efficacy-safety profile over the dosage form mentioned in the list shall 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.,” said the DPCO 2013.
This principle also applies to all other dosage forms, for example, oral liquid dosage forms, injectables, topical dosage forms etc., it added.

The committee’s observation is that the clotrimazole 1% drops, clotrimazole 1% cream and clotrimazole 1% passerby are scheduled formulations and ceiling price has been given for clotrimazole 1% lotion also.

The Committee has also earlier decided to get a clarification of approval of license status from the manufacturers and markets clotrimazole 1% mouth paint. It further noted that clotrimazole is a very old drug and the formulation clotrimazole 1% mouth paint has been in the market for a long time.

Clotrimazole pessary 100 mg has been listed in the National List of Essential Medicines (NLEM) 2015, for primary, secondary and tertiary healthcare levels. The mouth paint is used for treatment of fungal infections in the mouth and other fungal infections. The medicine works by binding with the inner surface of the mouth and will be gradually released into the saliva, later killing the fungi, according to online pharmacy stores.


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