Manufacturer & Exporter | Source: CDSCO

Published On: 10-09-2025

Enforcement Date: 10 September, 2025

Corrigendum to the letter dated 11.04.2025 on manufacturing and marketing of unapproved FDCs

The CDSCO has issued a corrigendum to its earlier letter dated 11.04.2025, clarifying that the Fixed Dose Combination (FDC) of Voglibose 0.2 mg and Metformin HCl (SR) 500 mg is approved. This correction follows a Delhi High Court observation and removes the FDC from the list of unapproved combinations previously circulated.

On 10th September 2025, the Central Drugs Standard Control Organization (CDSCO) issued a corrigendum to its earlier communication dated 11th April 2025 concerning unapproved Fixed Dose Combinations (FDCs). The update specifically addresses the FDC listed at Serial No. 31—Voglibose 0.2 mg and Metformin Hydrochloride (as Sustained Release) 500 mg. It has now been confirmed that this combination is approved by CDSCO and was acknowledged as such by the Hon’ble Delhi High Court during proceedings on 14th July 2025. Consequently, this FDC has been officially excluded from the list of unapproved combinations. The corrigendum has been circulated to all State and UT Drug Controllers, Zonal CDSCO offices, and relevant stakeholders, and is also available on the CDSCO website.

Applicable For: Manufacturer & Exporter

Reference Number: File No. 4-01/2023-DC (Misc. 3) Notification Link

Revised Regulatory Guidelines For Sampling Of Drugs, Cosmetics & Medical Devices By Drugs Inspectors Of Central & State Drug Authorities

Manufacturer | CDSCO 29 May, 2026

On 9 February 2024, CDSCO issued regulatory guidelines for sampling of drugs, cosmetics, and medical devices by central and state inspectors. The framework standardizes sampling plans, risk‑based product selection, rural and urban coverage, timelines for testing, and centralized monthly reporting of NSQ/Spurious products. It mandates uniform methodology, database monitoring, and public alerts, ensuring stronger surveillance and safeguarding public health.

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BE-NOC Prior Intimation (System of Notification for certain category of new drugs for conduct of “BA-BE Studies” for export purpose under Chapter V, NDCT Rule, 2019) and procedure for obtaining CT-16 application on NSWS Portal

Importer | CDSCO 29 May, 2026

CDSCO issued a notice introducing an interim procedure for submitting standalone Form CT16 applications via the NSWS portal due to system linkage issues with Prior Intimation applications (Form CT05). Applicants importing Reference Listed Drug(RLD)/ Investigational Medicinal Product (IMP) for BA/BE studies for export must submit specified documents. This step ensures continuity of regulatory processes while maintaining compliance with NDCT Rules, 2019.

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2026.05.13 G.S.R. 377(E)_Notification for amendment in Schedule H1 for inclusion of Pregabalin and its drug formulations

Importer | CDSCO 29 May, 2026

On 13 May 2026, the Ministry of Health and Family Welfare finalized amendments to the Drugs Rules, 1945, adding Pregabalin under Schedule H1. Following public consultation on the January draft, the rules will come into force 180 days after publication in the Official Gazette.

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