# NFI Lists Unapproved Drugs, DCGI Demands Explanation

> India's National Formulary includes drugs not approved by central drug regulator, prompting DCGI to seek IPC's rationale.
- Title: NFI Lists Unapproved Drugs, DCGI Demands Explanation
- Summary: India's National Formulary includes drugs not approved by central drug regulator, prompting DCGI to seek IPC's rationale. The National Formulary of India…
- Keywords: national formulary of india, cdsco, dcgi, indian pharmacopoeia commission, methylene blue injection, flumazenil injection, folinic acid injection, pyridostigmine, alteplase, NFI, Lists, Unapproved
- Source: The Economic Times — https://economictimes.indiatimes.com/industry/healthcare/biotech/healthcare/national-formulary-of-india-lists-drugs-not-approved-by-cdsco-dcgi-seeks-explanation-from-ipc/articleshow/134840736.cms
- Author: Vikas Dandekar
- Published: 2026-10-09T18:18:00+00:00
- Read time: 1 min
- Topics: national formulary of india, cdsco, dcgi, indian pharmacopoeia commission, methylene blue injection, flumazenil injection, folinic acid injection, pyridostigmine, alteplase
## NFI 2026 Includes Unapproved Drugs
The National Formulary of India 7th edition lists drugs not approved by CDSCO.

> 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
## DCGI Flags Discrepancy with IPC
DCGI has sought rationale for inclusion of unapproved drugs in NFI from IPC.

> the discrepancy may have international implications and therefore requires an urgent response
## Specific Unapproved Drugs Listed
Methylene blue 10 mg/ml injection and other variants are unapproved in NFI 2026.

> methylene blue 10 mg/ml injection; flumazenil injection 0.1 mg/ml; folinic acid injection 3mg/ml and 15 mg tablet; pyridostigmine 30, 60 and 180 mg tablets; and alteplase 20 and 50 mg injection vials
## DCGI Demands Urgent Response
DCGI requires IPC to address international implications of unapproved drugs in NFI.

> the discrepancy may have international implications and therefore requires an urgent response
## Key takeaway

The National Formulary of India 2026 lists drugs unapproved by CDSCO, with DCGI demanding explanation from Indian Pharmacopoeia Commission.