Schedule X is a special category of prescribed medicines in India, outlined in the Drugs and Cosmetics Act of 1940 and the Rules of 1945. These drugs cannot be sold by retailers without a valid prescription from a registered medical practitioner. Furthermore, records of prescriptions must be maintained for two years post-sale, and a sale […]
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 and globally aligned quality management system. Buckle up, because this blog post dives deep into
Unveiling the New Standard: A Deep Dive into Revised Schedule M 2023 Read More »
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 gazette notification was published on 09th October 2018, and then objections and suggestions were sought
Important key points about revised Schedule-M 2024 Read More »
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, GxP stands for Good x (variable) Practices. It reflects that the company does all practices
What is the concept of GxP? Read More »
Besides making efforts for promoting the pharmaceutical industry in India with the help of the PLI Scheme the Government is inducing the controversial rule of holding marketers responsible for the quality of products along with manufacturers of products. A specific agreement for marketing format is to be done before manufacturing any pharma product. Also Read:
Agreement For Marketing format Pharma companies 2021! Read More »
Pharmaceutical companies are a highly regulated industry in India, it’s not easy to start a manufacturing company like other non-regulated industries. The construction of the building requires a high level of guidance following the Schedule-M norms. The layout of the plant should be as prescribed in the Schedule-M of Drug and Cosmetic Act 1945. There
Pharma plant required area according to Schedule-M Read More »
