The Drug Controller General of India (DCGI) has sought an explanation from the Indian Pharmacopoeia Commission (IPC) after several medicines listed in the National Formulary of India (NFI) 2026 were reportedly found to lack approval from the Central Drugs Standard Control Organisation (CDSCO). The development has raised questions about regulatory verification and accuracy in an official reference used by doctors, pharmacists and other healthcare professionals.

The seventh edition of NFI 2026, released on September 21, 2026, contains 653 monographs, including 83 new monographs, 30 immunologicals and 42 fixed-dose combination monographs. Published by IPC, the formulary is intended to support the rational prescribing, dispensing and administration of medicines across India.

According to The Economic Times, at least five drugs or their variants listed in the latest edition were identified as not having CDSCO approval. These include methylene blue injection (10 mg/ml), flumazenil injection (0.1 mg/ml), folinic acid injection (3 mg/ml) and tablets (15 mg), pyridostigmine tablets (30 mg, 60 mg and 180 mg), and alteplase injection vials (20 mg and 50 mg). Officials cited in the report indicated that the number of potentially affected entries could be higher.

The DCGI reportedly raised concerns about the inclusion of these medicines and sought clarification from IPC regarding the rationale behind their listing. The report also states that the issue had been flagged during discussions on the preparation of the formulary, with the regulator emphasising the need for an urgent response because of possible implications for the wider regulatory ecosystem.

IPC has stated that efforts were made to ensure that medicines without CDSCO approval were not included. The commission is responsible for publishing official drug standards and the National Formulary, while CDSCO and state licensing authorities are responsible for regulatory decisions on drug approvals. Listing a medicine in a formulary should therefore not be interpreted as independent marketing authorisation.

The issue has also drawn attention to the availability of the digital edition of NFI 2026. According to the report, the DCGI raised concerns about the online version not being available, describing the matter as a serious concern for stakeholders who rely on the formulary as a clinical reference.

The development underscores the importance of accurate drug information, clear regulatory status and robust verification processes in official medical references. Any confirmed discrepancies may require clarification or corrective action to ensure that healthcare professionals can rely on the formulary for safe and rational medicine use.