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The Multidisciplinary Committee of Experts (MDC) of the National Pharmaceutical Pricing Authority (NPPA) has recommended granting exemption to Intas Pharmaceuticals' antipsychotic drug clozapine extended release in certain strengths from the drug pricing norms of Drugs Prices Control Order (DPCO), 2013 for a period of five years after identifying that the company has a patent for the formulations.
The recommendation for exemption of the formulation clozapine extended release 12.5 mg/ 25 mg/ 50 mg/ 100 mg/200 mg capsule from the drug price regulation for the limited timeframe follows an assurance from the Office of the Controller General of Patents, Designs & Trade Marks (CGPDTM) that the applied formulation falls within the scope of granted claims of patent application.
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 CGPDTM has also submitted that the formulation, approved by the Central Drugs Standard Control Organisation (CDSCO), falls within the scope of granted claim 1 of the patent application of the company.
Interestingly, the application for exemption has been pending with the MDC from August, 2022, and it was rejected soon with the Committee observing 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 and it could not be considered as a 'New Delivery System' qualifying for exemption under Para 32 (iii) of DPCO, 2013.
Subsequently, the company in a letter in October, 2024 informed the Committee that the formulation is being produced in the country by a new process through indigenous research and development and is patented under the Indian Patent Act, 1970. The company submitted the patent certificate No. 437433 titled “Extended release pharmaceutical composition of clozapine”.
Again, decision on various applications including Biological E's request for exemption of Pneubevax 14 and Intas' request for clozapine extended release, was held up for some time, owing to delay from the DPIIT in nominating an eligible representative from the patent office to consider the industry requests for exemption of patented drugs from price control for patented drugs under Para 32.
The application was deliberated in the 69th meeting of MDC held in July, 2025, and the representative of the Department for Promotion of Industry and Internal Trade (DPIIT), under which the CGPDTM operates, attended the meeting and provided their written inputs on the matter.
However, the DPIIT informed that the granted claim is significantly distinct from the claim submitted by the applicant to NPPA. Similarly, considerable differences were observed between the complete specification and dependent granted claims 2-4. It observed that the applicant has submitted a different complete specification and claim set to the NPPA, which is significantly distinct from the granted complete specification and claims submitted that the MDC should seek clarification from the company on this.
The company, in July, 2025, informed that they had inadvertently submitted wrong claim documents and requested to reconsider the revised claim documents submitted in April, 2025.
It was following this, the CGPTDM informed the MDC that the formulation in the application to NPPA and the Claim 1 of the patent application are the same and the applied formulation falls within the scope of granted claims of the patent application.
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