NPPA seeks clarifications regarding ceiling price fixation of Clotrimazole mouth paint

This came during the 38^th meeting of 'Multidisciplinary Committee of Experts' meeting which was held on 24.01.2022 through video conference.

In this meeting, the committee examined the representation of Zydus Healthcare Ltd and noted Clotrimazole 1% drops, Clotrimazole 1% cream and clotrimazole 1% passerby have scheduled formulations, and ceiling price has been given for clotrimazole 1% lotion and related to the ceiling price fixation of the mount paint formulation.

The committee earlier declared the drug as scheduled formulation under the DPCO, 2013.

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.

However, the company claims that the PK and PD or efficacy profile of any mouth paint containing clotrimazole 1% is significantly different from that of a cream containing clotrimazole 1% or a drop containing clotrimazole 1%.

Clotrimazole is a very old drug and the formulation clotrimazole 1% mouth paint has been in the market for a long time noted in the report published after the meeting.

"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.

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 the 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.

On October 11 the Committee met to discuss whether the particular strength of the medicine would fall under the Scheduled formulation. Based on Explanation I of DPCO, 2013, the Committee determined that clotrimazole 1 percent mouth paint is a scheduled formulation.

According to the DPCO, 2013, any dosage form of a medicine other than the dosage form included in the Schedule, but in the same strength and route of administration, does not have a significant difference in terms of pharmacokinetics, pharmacodynamics, or efficacy-safety profile over the dosage form mentioned in the list is considered included.