NPPA Clarifies Anti Fungal Clotrimazole 1% Is A Scheduled Formulation Under DPCO

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New Delhi : The multidisciplinary committee of experts, under the National Pharmaceutical Pricing Authority (NPPA) has said that the anti fungal medication clotrimazole 1% mouth paint is a scheduled formulation based on the Drugs (Price Control) Order, 2013.

The matter of whether the particular strength of the medicine would fall under the Scheduled formulation was deliberated in detail by the Committee in its latest meeting held on October 11, at the NPPA office. It said that the Committee has decided that clotrimazole 1% 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.

The Committee, during the meeting, also recommended the retail price of metoprolol tartrate IP 25 mg + ivabradine hydrochloride equivalent to ivabradine 5 mg, and metoprolol tartrate IP 50 mg + ivabradine hydrochloride eq to ivabradine 5 mg from Ajanta Pharma at Rs. 15.46 per tablet and Rs. 17.74 per tablet, respectively.

It has also recommended the retail price for Sun Pharma’s cyclosporine IP 0.9 mg in 0.25 ml pack at Rs. 35.57 per pack, considering the calculations based on PharmaTrac data and recommendations of the Pranab Sen Committee Report.

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