New Delhi : The expert panel of National Pharmaceutical Pricing Authority (NPPA) has once again rejected the application by Intas Pharmaceuticals Ltd for exemption from the provisions of Drug Price Control Order (DPCO) 2013, for various strengths for its antipsychotics formulation Clozapine extended release capsules.
The company submitted a representation following the rejection of the application by the Multi Disciplinary Committee (MDC) of experts in a previous meeting on August 4, 2022.
However, after deliberating the representation and related matters, in a latest MDC meeting, the Committee deliberated on the matter and “reiterated its decision taken in the 44th meeting of the Multidisciplinary Committee of Experts held on August 4, 2022.”
The company has approached the Authority seeking exemption from the provisions of DPCO 2013, under Para 32 (iii) for the formulations Clozapine extended release capsules 12.5 mg/25 mg/50 mg/100 mg and 200 mg.
Under Para 32(iii) of the DPCO, 2013, the provisions of the price control order are not applicable to a manufacturer producing a new drug involving a new delivery system developed through indigenous research and development for a period of five years from the date of its market approval in India, provided that the provisions of the paragraph shall apply only when a document showing approval of such new drugs from the central drug regulator is produced before the government.
The Multidisciplinary Committee of Experts, under the NPPA, deliberated upon the application in detail and opined that the different variants of a drug like extended release, sustained release, modified release or a drug are in the market since a considerable period and also manufactured by a number of companies.
“Hence, it cannot be considered as ‘a new delivery system’ for qualifying for exemption under Para 32 (iii) of DPCO, 2013,” it observed.
“Accordingly, the Committee decided to reject the application of Intas Pharmaceuticals Ltd for exemption from the provisions of Drug Price Control Order 2013 under Para 32 (iii) for the formulations ‘Clozapine extended release capsules 12.5 mg/ 25 mg/ 50 mg/ 100 mg/ 200 mg’,” said the Committee in the minutes of its 44th meeting.
Clozapine is an antipsychotic medicine to treat schizophrenia and schizoaffective disorders in people who are not responding to or not tolerating other medicines. The drug acts by modulating the action of chemicals that affects thoughts in the brain.