Importer & Manufacturer | Source: CDSCO

Published On: 13-05-2026

Enforcement Date: 13 May, 2026

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

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.

On 13 May 2026, the Ministry of Health and Family Welfare issued G.S.R. 377(E), finalizing the Drugs (Second Amendment) Rules, 2026. The notification follows the draft rules published on 21 January 2026 under G.S.R. 54(E), inviting public objections and suggestions within thirty days. Copies of the draft were made available on 27 January 2026, and the Central Government considered all feedback received. Exercising powers under sections 12 and 33 of the Drugs and Cosmetics Act, 1940, and after consultation with the Drugs Technical Advisory Board, the Government amended the Drugs Rules, 1945. The amendment introduces a new entry in Schedule H1, adding Pregabalin as serial number 51. These rules will come into force 180 days after publication in the Official Gazette. The measure strengthens regulatory oversight of controlled substances, ensuring stricter monitoring and compliance in pharmaceutical distribution and prescription practices across India.

Applicable For: Importer & Manufacturer

Reference Number: CG-DL-E-21052026-272775 Notification Link

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

Importer | 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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Strengthening Enforcement against Unauthorized Promotion and Distribution of GLP-1 Based Drugs

Importer | CDSCO 22 May, 2026

The Central Drugs Standard Control Organization (CDSCO) has directed all State and Union Territory Drug Controllers to intensify enforcement against unauthorised promotion, illegal distribution, and misuse of GLP-1 based weight loss drugs such as semaglutide and tirzepatide products. Authorities have been asked to monitor online and offline sales channels, promotional activities, and ensure compliance with approved indications, labelling, and prescription requirements.

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