NPPA Defers Price Exemption for Biological E's Pneumonia Vaccine, Seeks Patent Clarifications

New Delhi: The National Pharmaceutical Pricing Authority (NPPA) has deferred its decision on granting exemption under Para 32 (i, ii & iii) of the Drugs (Prices Control) Order, 2013 to Biological E Limited for its Pneumococcal Polysaccharide Conjugate Vaccine (PNEUBEVAX 14), seeking further clarifications from the company regarding patent claims and formulation details.

The matter was taken up during the 76th meeting of the Multidisciplinary Committee held on April 8, 2026. The matter has undergone extensive deliberations across multiple meetings of the Multi-Disciplinary Committee (MDC), including the 64th meeting held on 06.12.2024, 66th meeting on 03.03.2025, 67th meeting on 02.04.2025, 69th meeting on 03.07.2025, 75th meeting on 11.02.2026, and most recently the 76th MDC meeting.

During earlier deliberations, an officer nominated by the Department for Promotion of Industry and Internal Trade attended and submitted written inputs. It was highlighted that in Claim 1 submitted to the patent office, the strength of each serotype was not specified, whereas such strengths were mentioned in Claim 6. Further, the Office of the Controller General of Patents Designs and Trade Marks (O/o CGPDTM) observed that the strength of each serotype differed between the granted Claim 6 and the composition mentioned in the application submitted to NPPA.

The applicant mentioned the strength in the application filed to NPPA as per DCGI approval. O/o CGPDTM has also informed that “it is observed that the composition as specified in Row 4 of Form-1 dated 21/04/2023 and the claims granted by Indian Patent Office in this matter are almost equivalent when the granted claim 1 is read with claim 6.”.

Representative of O/o CGPDTM also suggested to get the inputs/clarification of the applicant company in this regard for further examination of the claim.

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

Accordingly, inputs were sought from the company. The company replied vide email dated 23.07.2025 and requested to refer to the claim 1, claim 6 and also the claim 3 as filed to the O/o CGPDTM. The inputs received from company were sent to O/o CGPDTM for comments on 01.08.2025. The O/o CGPDTM vide email dated 02.01.2026 provided the inputs stating that based on the comparisons of claim 3 and 6 granted by patent office, it is observed that the composition as specified in Row 4 of Form-1 dated 21.04.2023 and the claims granted by Indian Patent Office in this matter are almost equivalent when the granted claim 1 is read with claim 3 and 6.

In view of the above, the matter was deliberated in 75th MDC meeting held on 11.02.2026 wherein the representative from O/o CGPDTM stated that majorly the formulation is covered under the claims for which patent has been granted. However, some clarifications/ discussions are required from company. Accordingly, the Committee deliberated upon the matter and decided to invite the company in the next MDC meeting.

Accordingly, the matter was deliberated in 76th MDC meeting wherein the representative from the company was also present. The representative from O/o CGPDTM sought the clarification from the company regarding the composition of the formulation as mentioned in DCGI approval and the claims as approved by the Patent office.

The company was asked to clarify regarding the content of Absorbed onto Aluminium phosphate mentioned in strength as “< 75 mg” in the DCGI approval and “0.2 to 1 mg” mentioned in claim 5 submitted by the company.

After detailed deliberations, the Committee directed the company to submit written responses addressing all the queries raised during the meeting before a final decision on the exemption application is taken.