NPPA Panel Recommends 5-Year Price Control Exemption for Intas' Clozapine ER Capsules

New Delhi: The National Pharmaceutical Pricing Authority (NPPA) Multidisciplinary Committee (MDC) has recommended granting an exemption from price control under Para 32(ii) of the Drugs (Prices Control) Order (DPCO), 2013 to Intas Pharmaceuticals Private Limited for its formulation Clozapine Extended Release Capsules (12.5 mg/25 mg/50 mg/100 mg/200 mg). The recommended exemption period is five years from the date of commencement of commercial production in India.

This came after the Multidisciplinary Committee (MDC) of the National Pharmaceutical Pricing Authority (NPPA) reviewed the application Application by M/s Intas Pharmaceuticals Private Limited for exemption from the provisions of Drug Price Control Order 2013 under Para 32 (ii & iii) for the formulation “Clozapine Extended Release 12.5 mg/ 25 mg/ 50 mg/ 100 mg/200 mg capsule.”

The Committee recalled that Intas Pharmaceuticals had earlier applied for exemption under para 32(iii) for the same formulations. The matter was deliberated in 44th MDC meeting held on 04.08.2022 wherein the Committee deliberated that different variant of a drug like extended release, modified release of a drug was in the market since a considerable period and also manufactured by a number of companies.

Hence, it could not be considered as a 'New Delivery System' qualifying for exemption under Para 32 (iii) of DPCO, 2013. Accordingly, the Committee rejected the application of M/s Intas Pharmaceuticals Limited for exemption from the provisions of Drug Price Control Order 2013 under Para 32 (iii) for the formulations "Clozapine Extended Release Capsules 12.5mg/ 25mg / 50mg / 100mg / 200mg".

Subsequently, the company, vide its letter dated 07.10.2024 stated the "Clozapine Extended Release Capsules 12.5mg/ 25mg / 50mg / 100mg / 200mg" are being produced in the country by a new process through indigenous research and development and are patented under the Indian Patent Act, 1970. The company submitted the patent certificate No. 437433 titled “Extended Release pharmaceutical composition of Clozapine”.

The matter was deliberated in the 69th meeting of MDC held on 03.07.2025. Representatives of O/o DPIIT attended the meeting and provided their written inputs on the subject matter. It has also been informed that “the granted claim is significantly distinct from the claim submitted by the applicant to NPPA. Similarly, considerable differences are observed between the complete specification and dependent granted claims 2-4.

Therefore, it is observed that the applicant has submitted a different complete specification and claim set to the NPPA on 30.10.2024, which is significantly distinct from the granted complete specification and claims”. Representative of O/o DPIIT also suggested to get the inputs/clarification of the applicant company in this regard.

Accordingly, the Committee, after deliberations, directed to get the inputs/clarification of the applicant company in view of the inputs of the DPIIT before taking the final decision in the matter.

In response, the applicant, via mail dated 22.07.2025 stated that they had inadvertently submitted the wrong claim documents and requested to reconsider the revised claim documents submitted on 23.04.2025. Accordingly, revised claim documents were sent to the O/o CGPTDM.

In response, O/o CGPTDM submitted their inputs on the revised claim documents as follows: “It has been found that, subject-matter as submitted by applicant company before NPPA, and the subject-matter that is approved by DGCA i.e. “Clozapine Extended Release 12.5 mg/25mg/50mg/100mg/200 mg Capsule”, fall within the scope of granted Claim 1 of the patent application”.

Accordingly, based on the inputs received from O/o CGPTDM, the matter was deliberated in75th MDC meeting.

The committee noted,

"The company has already launched the said formulations in 2025. In the meeting representative from the O/o CGPDTM reiterated that the applied formulation falls within the scope of the granted claims of the patent application.

Accordingly, the committee recommended to grant exemption for the formulations Clozapine Extended Release 12.5 mg/ 25 mg/ 50 mg/ 100 mg/200 mg capsule under Para 32(ii) of DPCO, 2013 to M/s Intas Pharmaceuticals Private Limited for a period of 5 years from the date of the commencement of commercial production in the country."