Panacea Biotec Limited has disclosed significant regulatory developments following an inspection by the National Centre for Public Health and Pharmacy, Hungary (NCPHP) at its subsidiary's Baddi manufacturing facility. The company made this disclosure under Regulation 30 of SEBI listing requirements on February 05, 2026.

NCPHP Inspection and Timeline

The NCPHP conducted an inspection of Panacea Biotec Pharma Limited's (PBPL) Baddi facility in Himachal Pradesh from January 26, 2026 to January 31, 2026. Following the inspection, NCPHP issued a "Statement of non-compliance with Good Manufacturing Practice" dated February 03, 2026, which was received by PBPL on February 04, 2026.

GMP Certificate Revocation and Product Supply Impact

NCPHP determined that the Baddi facility does not comply with GMP requirements as outlined in Directive (EU) 2017/1572, resulting in the revocation of all valid GMP certificates issued by NCPHP. The regulatory authority has proposed halting supplies of non-vital products, with an exception for patients currently on treatment with oncology products.

Importantly, the company clarified that PBPL is not supplying any oncology-related products in European Union markets. NCPHP officials did not observe any behavior or manufacturing processes that would pose risks to the quality of products already released.

Limited Financial Exposure to EU Markets

The regulatory action's financial impact appears contained given Panacea Biotec's limited European exposure. During FY 2024-25, PBPL's revenue from European Union markets contributed around 0.32% of the total consolidated net revenues of Panacea Biotec Limited.

Corrective Measures and Re-inspection Plans

Panacea Biotec has committed to maintaining the highest standards of quality and compliance. The company is implementing comprehensive corrective and preventive actions (CAPA) and plans to request a re-inspection at the earliest opportunity to restore the GMP certificates. The company is conducting ongoing risk-benefit assessments in coordination with relevant regulatory agencies, particularly considering that their EU export products are vital for patients undergoing long-term immunosuppression or anti-viral therapy.

Panacea Biotec Limited has achieved a significant milestone in its dengue vaccine development program by completing the enrollment of study participants for the Phase III clinical trial of DengiAll. The pharmaceutical company announced that it has successfully enrolled 10,335 participants in this critical phase of clinical testing for its tetravalent dengue candidate vaccine.

Stock Performance and Market Response

Panacea Biotec shares demonstrated strong market response to the announcement, gaining 7% following the completion of enrollment news. The positive stock performance reflects investor confidence in the company's vaccine development capabilities and the potential market opportunity for DengiAll in addressing India's dengue challenge.

Clinical Trial Progress and Participant Details

The Phase III clinical trial represents a major advancement from the company's earlier announcement when the trial was initially launched in collaboration with the Indian Council of Medical Research (ICMR). The completion of enrollment marks a crucial step in the vaccine development process, transitioning from participant recruitment to the active monitoring phase across India.

Two-Year Monitoring Phase and Vaccine Design

Following the completion of enrollment, Panacea Biotec will now commence a comprehensive two-year monitoring period for each participant. During this phase, the company will track participants who have received either the investigational medicinal product (the vaccine) or a placebo. The primary objectives include examining the vaccine's efficacy in preventing dengue infection and assessing its immunogenicity profile.

DengiAll uses live, weakened strains of all four dengue virus serotypes DEN1, DEN2, DEN3 and DEN4 in a single dose formulation. This comprehensive approach targets all dengue virus variants, which is crucial for effective protection against the disease.

Market Entry and Global Context

DengiAll is positioned to become India's first indigenous single-shot dengue vaccine, representing a significant breakthrough in the country's public health infrastructure. The company expects the vaccine to enter the Indian market by 2027, subject to successful completion of the clinical trial and regulatory approvals.

Industry Challenges and Competitive Landscape

Dengue vaccine development has historically been challenging across the global pharmaceutical industry. Sanofi had withdrawn its dengue vaccine Dengvaxia from the Philippines following safety concerns and later discontinued its manufacture due to low demand. Studies had shown that Dengvaxia increased the risk of severe dengue in individuals who had not been previously infected.

Other global efforts are also underway in the dengue vaccine space. Japanese drugmaker Takeda introduced its dengue vaccine Qdenga in 2022, while the Butantan Institute in Brazil has developed the Butantan DV vaccine, which is yet to enter commercial production.

Health authorities continue to stress that preventing mosquito bites remains the primary line of defence against dengue, even as vaccine research progresses. The successful completion of enrollment demonstrates Panacea Biotec's execution capabilities in conducting large-scale clinical trials and positions the company for the next critical phase of vaccine development.