NPPA Committee Asks Intas to Clarify Patent Discrepancy in Clozapine ER Pricing Plea
New Delhi: The Multidisciplinary Committee (MDC) of Experts under the National Pharmaceutical Pricing Authority (NPPA) has asked Intas Pharmaceuticals Pvt. Ltd. to furnish clarifications over alleged inconsistencies in the patent details submitted for Clozapine Extended Release (ER) 12.5 mg/25 mg/50 mg/100 mg/200 mg capsules.
The company had applied for exemption under Paragraph 32 (ii & iii) of the Drugs (Prices Control) Order, 2013 (DPCO, 2013). The application was first reviewed during the 64th MDC meeting held on December 6, 2024, but was deferred pending further examination and input from the Department for Promotion of Industry and Internal Trade (DPIIT).
At the 66th MDC meeting on March 3, 2025, a representative of DPIIT informed the committee that the application forwarded by NPPA was “at an advanced stage of examination.” The committee then “requested that the comments may be shared with NPPA by 15th March 2025 so that the matter may be deliberated in [the] next meeting for early disposal.”
However, during the 67th MDC meeting on April 2, 2025, no representative from DPIIT was present, and no comments were submitted. The committee again deferred the agenda and directed to pursue the matter with DPIIT for early inputs.
The matter was revisited during the 69th MDC meeting held on July 3, 2025, where a DPIIT representative finally attended and submitted written inputs. These highlighted a significant discrepancy between the patent claims submitted by Intas to NPPA and those granted by the Indian Patent Office.
Quoting the official minutes: “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 30th October 2024, which is significantly distinct from the granted complete specification and claims.”
In view of these discrepancies, the MDC has now directed that “the inputs/clarification of the applicant company [be obtained] before taking the final decision in the matter.”
