From The Economic Times · Vikas Dandekar · · 40s
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.
In brief
India's National Formulary includes drugs not approved by central drug regulator, prompting DCGI to seek IPC's rationale. The National Formulary of India 2026 lists drugs unapproved by CDSCO, with DCGI demanding explanation from Indian Pharmacopoeia Commission. Originally reported by The Economic Times.
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”
The one thing
The National Formulary of India 2026 lists drugs unapproved by CDSCO, with DCGI demanding explanation from Indian Pharmacopoeia Commission.
