49 Corrigendum to the letter dated 11.04.2025 on manufacturing and marketing of unapproved FDCs 2025-Sep-10 433 KB
In force — no superseding record on file.
File No. 4-01/2023-DC (Misc. 3) Government of India Directorate General of Health Services Central Drugs Standard Control Organization
pl
(FDC Division)
==> picture [17 x 29] intentionally omitted <==
----- Start of picture text -----<br> To,<br>----- End of picture text -----<br>
All State/ UT’s Drugs Controllers
FDA Bhawan, Kotla Road New Delhi-110002 Date: armeerten 10 SEP 205%"
Subject: Manufacturing and marketing of unapproved FDC’s -regarding.
Sir/ Madam,
Please refer to the letter issued by this office vide File No. 4-01/2023-DC (Misc. 3) dated 11.04.2025 on the subject cited above.
In this regard, it may be mentioned that one of the FDCs namely Voglibose 0.2 mg and Metformin Hcl (as SR form) 500mg (at S.No. 31) has been found to be approved by CDSCO and the same was also recorded by Hon’ble High court, Delhi during the hearing on 14.07.2025.
Accordingly, the FDC i.e Voglibose 0.2 mg and Metformin Hcl (as SR form) 500mg (at S.No. 31) stands excluded from the list of unapproved FDCs in letter dated 11.04.2025.
Yours Faithfully,
\ Quy jeev_ Si aghuvanshi) Drugs Controjler General (India)
Copy forwarded to:-
-
All Zonal/Sub Zonal Offices of CDSCO
-
US (D), Ministry of Health and Family Welfare, NirmanBhawan, New Delhi. 3. Website of CDSCO
Page 1 of 1
Verbatim extracted text (OCR/PDF). Older scans and tables may show extraction artifacts — verify against the original for anything you act on.
No analysis generated for this document yet (analysis runs over brief docs + on-demand). Run build_analysis.py --ids 24623 --apply.