Health Ministry to Tighten Regulations on Prescribing and Selling Regulated Drugs

The CSR Journal Magazine

The Union Ministry of Health and Family Welfare has put forth a proposal to amend the Drugs Rules of 1945, with the aim of enhancing the oversight surrounding the sale of specific prescription medications. This initiative primarily focuses on drugs classified under Schedule H, Schedule H1, and Schedule X, all of which come with particular regulatory requirements due to the necessity for strict control over their distribution and sale.

This proposal is detailed in a Draft Gazette Notification numbered G.S.R. 791 (E), dated September 8, 2026. Among the notable recommendations is the mandatory installation of CCTV surveillance in medical stores. This measure aims to create a comprehensive record of transactions at pharmacies, thereby improving transparency in the sale of medicines that demand greater regulatory scrutiny.

The proposal has emerged in light of concerns regarding the unauthorised sale and access to Schedule H, H1, and X drugs, all of which are generally intended to be dispensed under particular conditions that necessitate a doctor’s prescription. The government is focused on strengthening the compliance mechanisms ensuring adherence to these regulations.

Survey Reveals Prescription Compliance Gaps

Furthermore, the survey raised questions about the availability of qualified pharmacist assistance at local chemists. Among 19,409 respondents, merely 31 per cent reported receiving assistance from a qualified pharmacist most of the time or always. This raises concerns regarding consumer safety and proper pharmaceutical guidance during medication purchases.

Moreover, the survey addressed consumer experiences regarding billing practices. Although 70 per cent of respondents reported receiving a printed GST bill, 26 per cent indicated that they did not receive any form of GST bill. This raises concerns about the standardisation of invoicing practices within the sector.

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