NPPA Turns to Patent Office for Clarity on Drug Price Exemptions, Defers Intas, Biological E's Applications

During its meeting held in early December, the NPPA deferred decisions on exemption applications from Intas Pharmaceuticals and Biological E, pending further evaluation.

Intas Pharmaceuticals applied for an exemption for its antipsychotic formulation, Clozapine Extended Release Capsules (ranging from 12.5 mg to 200 mg). The company argued that the drug, developed through indigenous research and patented in India (Patent No. 437433, granted on July 5, 2023), qualifies for an exemption under Paragraph 32 of the DPCO 2013. This provision exempts drugs developed using a unique, indigenous process, patented under the Indian Patents Act, and not manufactured elsewhere.

Similarly, Biological E sought exemption for its Pneumococcal Polysaccharide Conjugate Vaccine (PNEUBEVAX 14), claiming that its novel development and patent status meet the criteria for exemption.

When reviewing the applications, the Committee recalled its decision from the 44th meeting of the MDC on August 4, 2022. At that time, the Committee had determined that various drug variants, such as extended-release and modified-release formulations, had been available in the market for a long time and were produced by several companies. As a result, these formulations could not be considered a "New Delivery System" eligible for exemption under Para 32 (iii) of the DPCO, 2013. Consequently, the Committee rejected Intas Pharmaceuticals' application for exemption from price control provisions for Clozapine Extended Release Capsules.

In response, Intas Pharmaceuticals reiterated that its formulation should be exempt from DPCO 2013, as it was developed using a new, indigenous process and patented under the Indian Patents Act, 1970. The company submitted the necessary DCGI approval, along with the patent certificate (Patent no. 437433), granted on July 5, 2023, including the complete specifications and claims on which the patent was granted.

The Committee also recalled its decision from the 61st meeting on August 14, 2024, which outlined that for matters related to exemptions under Para 32 of DPCO 2013, an officer from the Office of the Controller General of Patents, Designs & Trade Marks (CGPDTM), DPIIT, not below the rank of Deputy Controller, would be invited to participate in deliberations. The agenda for these deliberations would be sent in advance to CGPDTM. This decision was endorsed by the Authority during its 126th meeting on September 9, 2024.

Following this, the agenda for the subject matter was sent to DPIIT via a letter dated November 8, 2024, requesting the nomination of an officer to participate in the MDC meeting. A copy of the letter was also sent to CGPDTM, and reminders were issued on December 3 and December 5, 2024. However, no nomination has been received from DPIIT to date. As a result, the Committee decided to defer the agenda item and urged DPIIT to expedite the nomination process so that the matter can be discussed at the next meeting.

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In the case of Biological E, the Committee reiterated the same decision from the 61st meeting regarding the involvement of an officer from the CGPDTM. The agenda for deliberations was also sent to DPIIT on December 3, 2024, with a reminder on December 5, 2024. However, as with Intas Pharmaceuticals, no nomination has been received. Consequently, the Committee decided to defer this agenda item as well and emphasized the need for a suitable nomination from DPIIT to proceed.

Despite multiple communications, the Department for Promotion of Industry and Internal Trade (DPIIT) has yet to nominate an officer from the Patent Office to participate in these critical deliberations. As a result, both agenda items have been deferred, with the Committee stressing the importance of expert input before making any decisions.

Subsequently, the Committee decided;

“To defer the agenda item and requested that the matter may be pursued with DPIIT for the nomination of a suitable officer so that the matter can be deliberated in the next meeting.”