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MDC invites Biological E to decide on exemption of Pneubevax 14 from DPCO pricing
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Gireesh Babu, New Delhi
February 21 , 2026
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The Multidisciplinary Committee of Experts (MDC), which advices the National Pharmaceutical Pricing Authority (NPPA) on pricing related matters, has invited Hyderabad-based Biological E in its next meeting to decide on the company's request for exemption of its 14-valent Pneumococcal Conjugate Vaccine (PCV), Pneubevax 14 from the pricing regulations.
The decision follows its observation that it requires some more clarifications and discussions regarding the eligibility of the vaccine to be exempted from the purview of Drugs Prices Control Order (DPCO), 2013, under Para 32 of the Order.
The Office of the Controller General of Patents, Designs & Trade Marks (CGPDTM) informed the Committee in its latest meeting, that majorly the formulation is covered under the claims for which patent has been granted. However, some clarifications/discussions are required from the company.
"Accordingly, the Committee deliberated upon the matter and decided to invite the company in the next MDC meeting," said MDC.
The request of Biological E Ltd was discussed in several meetings, including in December, 2024, and in March, April and July of 2025, and the Committee noted the response from the Department for Promotion of Industry and Internal Trade (DPIIT), under which the CGPDTM operates.
The Department informed that the strength of each serotype is different in granted claim 6 (of the patent) and composition mentioned in application filed to NPPA. The company mentioned the strength in application filed to NPPA as per the approval of the Drugs Controller General of India (DCGI).
The Patent Office 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”. Representatives of the Department also suggested getting the inputs/clarification of the applicant company in this regard for further examination of the claim.
Following this, the Committee directed to get the inputs/clarification of the applicant company in view of inputs of the DPIIT before taking the final decision in the matter. The company responded to the Committee's direction for inputs, and the Patent Office said that based on the inputs, said that the claims in the approved patent and the request for exemption from DPCO, are almost equivalent when the granted claims are read together.
It may be noted the decision on Biological E's request for exemption of Pneubevax 14 from DPCO has been pending 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.
Under Para 32 of the DPCO, 2013, the companies can apply for exemption from the drug price control measures for five years from the date of commencement of its commercial marketing by the manufacturer.
With the DPIIT appointing a representative to attend the MDC meetings, various applications pending with the Authority for exemption of patented drugs from DPCO for the specific time period have been taken up for decision making.
According to Biological E, developed specifically to prevent invasive pneumococcal diseases, Pneubevax 14 protects against infections caused by 14 different Streptococcus pneumoniae serotypes, including serotypes 22F and 33F—two strains not covered by some of the other PCVs.
Administered to infants from six weeks of age, the vaccine is designed to guard against serious diseases such as pneumonia, meningitis, and sepsis as part of the primary vaccination schedule.
In November, 2025, the company announced that the Vaccine received pre-qualification (PQ) status from the World Health Organisation (WHO). The PQ status from WHO enhances global access to the vaccine and strengthens supply security, particularly for children, said the company.
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