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,…
In 2021, India introduced pivotal regulatory changes to strengthen accountability in the pharmaceutical sector. Through amendments to the Drugs and Cosmetics Act, 1940 and its 1945 Rules, the Ministry of Health and Family Welfare mandated stricter oversight of third-party manufacturing arrangements. Central…
Revised Schedule‑M (2023–2025) doesn’t skim details. It now demands specific space allocations—e.g., 150 m² basic plus 100 m² ancillary for small volume injectables; 250 m² basic and 150 m² ancillary for large-volume parenterals using Form‑Fill‑Seal tech Laafon Galaxy Pharmaceuticals The Health Master+1. This is about…
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…
Overview In 2014, the Govt. of India introduced a new Schedule of prescription drugs to control the misuse of prescription drugs, which is called Schedule H1 Drug List. It contains medications that contain Opioids, Sedatives molecules, stimulants, and substances that…