Regulatory guide · Drugs and Cosmetics Rules, 1945 Written by Darshan Singh, M.Sc. (Organic Chemistry), 23+ years in pharmaceutical QA, QC and drug regulatory affairs · Published 15 February 2023 · Updated 4 October 2026 On this pageWhich routeWhat changedSample…
Last verified: 8 August 2026 Schedule H is the list of drug substances under the Drugs and Cosmetics Rules, 1945 that may be sold by retail in India only against the prescription of a Registered Medical Practitioner. This page carries…
Drugs Rules, 1945 — India Schedule X drugs list — all 16 substances, the XRx label rule and every licence form The short answer Schedule X to the Drugs Rules, 1945 specifies 16 substances — six barbiturates, five CNS stimulants,…
For pharmaceutical manufacturers in India, complying with Schedule M – the cornerstone of Good Manufacturing Practices (GMP) – has long been the game. But the winds of change have blown, ushering in a revised Schedule M, promising a more robust…
What are the key features of Revised Schedule M for manufacturing companies? Ministry of Health and Family Welfare, Government of India, issued a notification regarding the implementation of revised Schedule-M 2024 by all pharmaceutical formulation companies in India. The initial…
The pharmaceutical industry is a heavily regulated industry. Here are lots of certification concepts applicable to the quality of products. GMP and GLP are two popular existing certifications that stand for Good Manufacturing Practice and Good Laboratory Practice respectively. Similarly,…
Schedule M area requirements: the short answer Schedule M area requirements are set per dosage form, not per plant: a minimum manufacturing area and a separate minimum ancillary area for each category of manufacture. The most-quoted figures are 60 m²…
Drugs Rules, 1945 — India · updated August 2026 Schedule G drugs list: the red-box label, the prescription gap, and the plan to abolish it Schedule G is the schedule most reference material still gets wrong. The caution text changed…
Regulatory position last verified: 23 August 2026, based on notifications published up to that date, including draft G.S.R. 745(E) of 19 August 2026 · Reviewed by Darshan Singh, 23 years in pharmaceutical QC, QA and drug regulatory affairs In brief…