Antifungal Clotrimazole 1 percent is scheduled formulation under DPCO 2013: NPPA

New Delhi: In line with the Drug (Prices Control) Order, 2013, the National Pharmaceutical Pricing Authority (NPPA) Committee, at its recent Multidisciplinary Committee meeting, has clarified that Clotrimazole 1% mouth paint is a scheduled formulation.

This came during the 36th meeting of the Multidisciplinary Committee of Experts held on 11.10.2021 where the issue of whether the Clotrimazole 1 percent mouth paint would fall under the Scheduled formulation was discussed.

Clotrimazole is a synthetic, imidazole derivate with broad-spectrum, antifungal activity. It is used primarily in the treatment of skin, oral and vaginal candida infections. Clotrimazole inhibits biosynthesis of sterols, particularly ergosterol, an essential component of the fungal cell membrane, thereby damaging and affecting the permeability of the cell membrane. This results in leakage and loss of essential intracellular compounds, and eventually causes cell lysis.

Glenmark Pharmaceuticals sells clotrimazole 1 percent W/V under the brand name CANDID MOUTH PAINT. Apart from that, there are products on the market such as Mankind's NUFORCE MOUTH PAINT 15ML LOTION, Lupin's CANAZOLE 15ML LOTION, and Bayer Pharmaceutical's CANESTEN 15ML LOTION, all of which contain Clotrimazole 1 percent W/V.

The DPCO 2013 says the "National List of Essential Medicines" means the National List of Essential Medicines, 2011 published by the Ministry of Health and Family Welfare as updated or revised from time to time and included in the first schedule of this order by the government through a notification in the Official Gazette.

Furthermore, as per DPCO 2013, "scheduled formulation" means any formulation, included in the First Schedule, whether referred to by generic versions or brand names. 

In view of the above, at the recent Multidisciplinary Committee of Experts meeting, the committee decided that Clotrimazole 1% mouth paint is a scheduled formulation based on explanation I of DPCO 2013.