Importer & Manufacturer | Source: CDSCO
Published On: 31-10-2025
Enforcement Date: 31 October, 2025
G.S.R 810( E) Dated 31.10.2025 Corrigendum to G.S.R 587( E) Dated 27.08.2025 regarding Draft Notification for application of unapproved drugs for conduct of BA BE studies for export purpose under NDCT Rules 2019
The Ministry of Health and Family Welfare has issued a corrigendum to its draft notification under G.S.R. 810(E), dated 31st October 2025. The sample size condition in para 2, proviso no. 3, has been revised from “not more than 48” to “not more than or equal to 18.” Stakeholders can submit objections or suggestions within 15 days to the Directorate of Drugs.
On 31st October 2025, the Ministry of Health and Family Welfare released a corrigendum under G.S.R. 810(E) concerning its earlier draft notification (G.S.R. 587(E), dated 27th August 2025).
The amendment modifies the sample size requirement in para 2, proviso no. 3, changing the limit from “not more than 48” to “not more than or equal to 18.”
This change significantly impacts compliance requirements for stakeholders involved in drug regulation and testing. The government has invited objections and suggestions from the public within 15 days of publication.
Submissions should be addressed to the Director (Drugs), Ministry of Health and Family Welfare, Room No. 407, A Wing, Nirman Bhawan, New Delhi – 110011, or emailed to drugsdiv-mohfw@gov.in.
This corrigendum emphasizes the government’s commitment to refining regulatory standards for better quality control.
Applicable For: Importer & Manufacturer
Reference Number: CG-DL-E-04112025-267384
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