Health · Pharma & Biotech · 2 days ago
India drug regulator questions unapproved medicines in national formulary
India’s latest National Formulary of India lists several medicines that have not been approved by the country’s central drug regulator, the CDSCO.
The formulary is a reference guide for health professionals and students on prescribing, dispensing and giving medicines.
The Indian Pharmacopoeia Commission, which publishes the guide under the Union health ministry, released its seventh edition on September 21.
The Drug Controller General of India, who heads the CDSCO, has asked the commission to explain why the medicines were included.
The CDSCO was represented on the committee preparing the guide and had raised the issue during discussions.
The regulator said the discrepancy could have international implications, while the commission said it made efforts to exclude medicines that were not approved.
The regulator also raised concerns after stakeholders complained that the online edition was unavailable; the commission’s explanation is being sought.
The Drug Controller General of India has asked the Indian Pharmacopoeia Commission to explain why unapproved drugs appear in the latest National Formulary of India.
The seventh edition of the formulary was released on September 21.
The Economic Times identified at least five drugs or variants in the edition that it said were not approved by the Central Drugs Standard Control Organisation.
The Indian Pharmacopoeia Commission said it made the best possible efforts to exclude drugs not approved by the CDSCO.
The DCGI said the discrepancy could have international implications and required an urgent response.
- Who
- The Drug Controller General of India and the Indian Pharmacopoeia Commission.
- What
- The DCGI sought an explanation for unapproved drugs listed in the National Formulary of India.
- When
- The seventh edition was released on September 21; the DCGI sent a note in August.
- Where
- India.
- Why
- The DCGI flagged a discrepancy between drugs listed in the formulary and those approved by the CDSCO.
Drug Controller General of India
Indian Pharmacopoeia Commission
Inclusion of unapproved drugs
Drug Controller General of India
The DCGI sought the rationale for listing drugs not approved by the CDSCO and said the discrepancy may have international implications.
Indian Pharmacopoeia Commission
The IPC said it made the best possible efforts not to include drugs that are not approved by the CDSCO.
the discrepancy may have international implications and therefore requires an urgent response
the best possible efforts were made not to include drugs that are not approved by the CDSCO in NFI 2026
The DCGI sent a note to the IPC about unapproved drugs in the formulary.
The seventh edition of the National Formulary of India was released.
The DCGI wrote that the non-availability of the online version of NFI 2026 was a serious concern.
- Edition
- Seventh edition of the National Formulary of India
- Release date
- September 21
- Unapproved drugs identified
- At least five drugs or variants
- Methylene blue
- 10 mg/ml injection
- Flumazenil
- 0.1 mg/ml injection
- Alteplase
- 20 and 50 mg injection vials
Sources
Related news
Pilot trial tests support to limit weight regain after GLP-1 drugs stop
Dong-A launches three ibuprofen-based cold medicines
Experimental injection reduced visceral fat by 12% in early trials
FDA approves atezolizumab with chemotherapy for some stage III colon cancers
Review links drug company gifts to more and less appropriate prescribing
Brazil suspends Peptistrong supplement and orders all batches recalled
AstraZeneca blames trial design for failed bone disease drug study
Spain withdraws five erectile dysfunction supplements containing undeclared drugs
Baby Sleep Gripe Water Recalled After Alcohol Found in Testing
FDA Warns Amazon Over Unapproved Herpes Treatments
Possible Wrong Dose Raises Questions for PDE9 Drug Trials in Heart Failure
