ICH Guidelines: Purpose, Participants, and Process

1. Introduction The pharmaceutical industry is one of the most regulated industries worldwide. Medicines and medical products must be safe, effective, and of high quality before reaching the public. To achieve these goals across diverse regions and regulatory frameworks, a unified approach to drug development and approval is essential. Historically, drug manufacturers had to fulfill … Read more

Offences and Penalties in Drug and Cosmetic Regulation (Drugs and Cosmetics Act, 1940)

Introduction The Drugs and Cosmetics Act, 1940, along with the Drugs and Cosmetics Rules, 1945, governs the import, manufacture, distribution, and sale of drugs and cosmetics in India. The Act ensures that only safe, effective, and high-quality drugs and cosmetics reach consumers. It contains strict provisions for offences and penalties to prevent the manufacture, sale, … Read more