Date of Publication: 13-May-2026
INTELLIGENCE OVERVIEW:
Agency: CDSCO (India)
The Government of India has issued the Drugs (Second Amendment) Rules, 2026, introducing an important regulatory update by including Pregabalin under Schedule H1 of the Drugs Rules, 1945. The amendment will come into effect 180 days after publication in the Official Gazette.
Schedule H1 medicines are subject to stricter prescription and record-keeping requirements to support responsible use and strengthen monitoring practices. The inclusion of Pregabalin and its formulations reflects increasing regulatory focus on controlled dispensing and patient safety.
This regulatory change may have implications for pharmaceutical manufacturers, healthcare providers, pharmacies, and supply chain stakeholders, requiring updates to compliance processes and dispensing practices. Stakeholders should review the amendment and prepare for implementation within the specified transition period.
KEYWORDS: Pregabalin, Schedule H1, Prescription Drug,
REFERENCE: https://cdsco.gov.in/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=MTQyMDU=