Last Updated on December 31, 2023 by The Health Master
The expert panel of National Pharmaceutical Pricing Authority (NPPA) has rejected the application of Cadila Healthcare for retail price fixation of immunosuppressant tacrolimus prolonged release 3 mg, based on regulatory reasons.
A recent meeting by the multidisciplinary committee of experts, headed by Manmohan Sachdeva, advisor (cost), NPPA, observed that the product may require an approval from the Central Drugs Standard Control Organisation (CDSCO), and in the absence of such an approval, it cannot fix retail price to the product.
Based on the application from Cadila Healthcare for fixation of retail price, the Committee has earlier sought clarification from the CDSCO on the approval of the drug tacrolimus prolonged release hard gelatin capsule 3 mg and it has received clarification from the drug regulator on April 7, 2022.
The CDSCO clarified that they have not received any application of Cadila Healthcare Ltd for manufacture or import of the said prolonged release capsules.
The Committee also observed that according to the New Drugs and Clinical Trials Rules, 2019, the drug would continue to be a new drug.
“….after promulgation of New Drugs and Clinical Trials Rules, 2019, Cadila Healthcare Ltd would require specific approval from CDSCO to import/manufacture the formulation tacrolimus prolonged release hard gelatine capsule 3 mg in India,” it opined.
“Accordingly, the Committee decided to reject the application of Cadila Healthcare Ltd for retail price fixation of tacrolimus prolonged release hard gelatine capsules 3 mg since CDSCO has not given approval to Cadila Healthcare Ltd to import/manufacture the formulation…”, it added.
The extended release tacrolimus, which is sold under the brand Advagraf and others, is an immunosuppressive calcineurin inhibitor, used to prevent rejection in people who have received kidney transplant.
It may be noted that in the same meeting, the panel has decided not to fix the ceiling price of antifungal formulation clotrimazole 1% mouth paint, based on the drug regulator’s communication that it has not approved the formulation.
Zydus Healthcare has challenged the panel’s earlier decision to declare the antifungal formulation as scheduled formulation based on the Drugs (Prices Control) Order, 2013, to fix the ceiling price accordingly.
In a meeting held by the Committee on April 8, the experts noted that the Central Drugs Standard Control Organisation (CDSCO) has clarified that the formulation is not approved by its office.
“The Committee deliberated upon the matter in detail and is of the opinion that since clotrimazole 1% mouth paint is not approved by CDSCO, it cannot be categorised as scheduled formulation…,” said the Committee.
“Accordingly, the Committee decided that clotrimazole 1% mouth paint is not a scheduled formulation as per Explanation-I of DPCO 2013 and hence its ceiling price not to be fixed.”
The Expert Committee earlier noted that clotrimazole 1% drops, cream and mount paint are for local application and as such there is no significant difference between them. It then decided to obtain clarification from the CDSCO regarding the approval status of the formulation of mouth paint.
Zydus has raised objection arguing 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%.
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