Schedule X drugs are a special category of prescribed medicines in India governed by the Drugs and Cosmetics Act of 1940 and the Rules of 1945. Retailers cannot sell these drugs without a valid prescription from a registered medical practitioner. Additionally, prescriptions must…
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 are classified in various Schedules on the basis of their category and the potential for addiction, abuse, and other medical uses. Similarly, Schedule-G drugs are Schedule drugs that are advised to be used only after a prescription. These are…
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…
Schedule H is a category of prescription drugs declared by CDSCO in India. These drugs are subject to regulation and restrictions on the sale and distribution without a valid prescription. The CDSCO established Schedule H to prevent the misuse and…