National Pharmaceutical Pricing Authority, NPPA has rejected the application of Intas Pharmaceuticals for exemption from the provisions of Drug Price Control Order, DPCO, 2013 under Para 32 (iii) for the formulations Clozapine Extended Release Capsules.
The expert committee of NPPA had received application from Intas Pharmaceuticals for 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
The expert committee by NPPA, deliberated upon the matter and said that the different variants of a drug like extended release, sustained release, modified release of 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.
Clozapine is a psychiatric medication and is the first atypical antipsychotic. It is primarily used to treat people with schizophrenia and schizoaffective disorders who have had an inadequate response to other antipsychotics or who have been unable to tolerate other drugs due to extrapyramidal side effects.
