DCGI Seeks IPC Explanation Over Unapproved Drugs in NFI 2026
New Delhi: The Drug Controller General of India (DCGI) has questioned the inclusion of several drugs or formulations lacking central regulatory approval in the latest edition of the National Formulary of India (NFI), a reference manual for medical and pharmaceutical professionals and students.
According to the news reported by ET, the DCGI has written to the Indian Pharmacopoeia Commission (IPC), the body under the Union Health Ministry responsible for publishing the formulary, seeking an explanation for including drugs not approved by the Central Drugs Standard Control Organisation (CDSCO), a senior government official said.
The seventh edition of the NFI was released on September 21. Another person familiar with the matter told ET that CDSCO, which was represented on the NFI core committee, had raised the issue during discussions on the document’s preparation. However, unapproved drugs were still included in the published edition.
He further added, "The issue was raised based on the CDSCO's position in the committee and as a final check the note was sent to IPC as it started its launch plans."
The same person told that, in its August communication, the DCGI described the IPC, the NFI and the commission’s other activities as integral to the country’s regulatory ecosystem. The communication cautioned that "the discrepancy may have international implications and therefore requires an urgent response".
At least five drugs or their variants listed in NFI 2026 were identified as not having received approval. These included methylene blue 10 mg/ml injection; flumazenil 0.1 mg/ml injection; folinic acid 3 mg/ml injection and 15 mg tablets; pyridostigmine 30 mg, 60 mg and 180 mg tablets; and alteplase 20 mg and 50 mg injection vials. People aware of the matter said there were several more such entries, ET reported.
An IPC official said the commission had made every possible effort to avoid including drugs without CDSCO approval in NFI 2026. The formulary provides authoritative guidance on prescribing, dispensing and administering medicines.
In a separate letter issued after the formulary’s publication, the DCGI said various stakeholders had complained about the unavailability of the online version of NFI 2026. The regulator described its non-availability as a "serious concern".
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