National Formulary of India lists drugs not approved by CDSCO, DCGI seeks explanation from IPC

The Drug Controller General of India (DCGI) has flagged the discrepancy in a communication to the Indian Pharmacopoeia Commission, a body under the union health ministry that publishes the reference document. It has sought the rationale for the inclusion of drugs that are not approved by the Central Drugs Standard Control Organisation (CDSCO), a senior government official told ET.

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The 7th Edition of the NFI was released on September 21. The CDSCO, which was represented on the NFI core committee, had raised the issue while discussions were happening on the preparation of the document, but unapproved drugs still found their way into it, said another person aware of the matter. “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 person said.

In the note sent in August, the DCGI said the Indian Pharmacopoeia Commission (IPC), NFI and all other activities of the IPC formed an integral part of the regulatory ecosystem of the country and that “the discrepancy may have international implications and therefore requires an urgent response”, according to the person.

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When contacted by ET, an official from the Indian Pharmacopoeia Commission said the best possible efforts were made not to include drugs that are not approved by the CDSCO in NFI 2026.

ET’s email seeking comment to the DCGI, who heads the CDSCO, went unanswered.The National Formulary of India is an authoritative guide to prescribing, dispensing and administering medicines.

ET found that at least five drugs or their variants in NFI 2026 were not approved. These were 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. There are many more, according to people aware of the matter.

In a letter sent after the publication of the reference manual, the DCGI said various stakeholders had complained about the non-availability of the online version of NFI 2026. It termed the non-availability as a “serious concern”.