Schedule H drugs are prescription medicines regulated under the Drugs and Cosmetics Rules, 1945, and they are sold only on the prescription of a Registered Medical Practitioner. For pharmaceutical manufacturers, marketers, distributors, pharmacies, and compliance teams, understanding Schedule H rules…
The control of high-risk medication is paramount to public health, and in India, this responsibility falls under the rigorous framework of Schedule X of the Drugs and Cosmetics Rules, 1945. As of late 2025, this classification represents the pinnacle of…
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…
Schedule-G drugs represent a crucial category within the regulatory framework of the Indian pharmaceutical industry, established under the Drugs and Cosmetics Rules, 1945. This schedule is designed to classify medications that, while essential for treating serious and chronic conditions, possess…
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…