NPPA panel seeks clarification on license status from manufacturers of clotrimazole 1% mouth paint

New Delhi, January 31, 2022:

The multidisciplinary committee of experts, under the National Pharmaceutical Pricing Authority (NPPA), has said that it would desire to get a clarification of approval of license status from the manufacturers and markets of antifungal medication clotrimazole 1% mouth paint, in connection with fixation of ceiling price for the drug under the regulation.

This comes after it has declared that it is a scheduled formulation based on the Drugs (Price Control) Order, 2013.

The decision was taken while considering a representation of Zydus Healthcare Ltd related to the ceiling price fixation of the mount paint formulation, after the NPPA meeting referred the matter to the multidisciplinary committee for examination.

The committee, in its meeting held on January 24, 2022, examined the company’s representation and noted 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.

According to the DPCO explanation, it has provisions to include the formulations which have no significant difference in terms of pharmacokinetics (PK) or pharmacodynamics (PD) under the same schedule, based on which the Committee earlier declared the drug as scheduled formulation Kunder the DPCO, 2013.

However, the company said 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%.

“…the company may be requested to provide published literature on significant differences in PK or PD of clotrimazole 1% mouth paint viz a viz other formulations that leads to different outcomes,” said the committee.

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.

“Accordingly, the Committee desired that clarification of approval of license status may be obtained from the manufacturer(s)/marketer(s) of clotrimazole 1% mouth paint for further deliberation in the matter,” concluded the expert committee.

The Committee, in a meeting held on October 11, deliberated the matter of whether the particular strength of the medicine would fall under the Scheduled formulation. The Committee decided that clotrimazole 1 percent mouth paint is a scheduled formulation based on the Explanation I 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.

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 medical stores, companies including Mankind Pharmaceuticals and Dabur India are selling clotrimazole 1 per cent in the market at present. Pharmabiz