Manufacture of Drugs for Test Examination and Analysis

Learn the legal process for manufacture of drugs for test examination and analysis under Indian drug laws and regulatory provisions. Manufacturing drugs for non-commercial purposes, such as testing, examination, and analysis, is allowed under specific conditions: Key Provisions: Purpose-Specific Manufacturing: Drugs must be used strictly for clinical trials, research, or quality analysis, not for commercial … Read more

Manufacture of New Drug

Understand the approval process and legal requirements for manufacture of new drug under Indian regulations and the Drugs and Cosmetics Act. Manufacture of New Drug The manufacture of new drugs—not previously approved or registered—requires stringent regulations to ensure safety and efficacy. Key Provisions: Clinical Trials: Comprehensive clinical trials are required to establish safety and efficacy, … Read more

Conditions for Grant of Manufacturing License

Understand the conditions for grant of manufacturing license under drug laws in India, including legal requirements and compliance rules. Obtaining a license to manufacture drugs in India involves adhering to specific conditions designed to maintain high manufacturing standards: Conditions for Grant of Manufacturing License Infrastructure and Facilities: Adequate manufacturing facilities, storage areas, and equipment as … Read more

Prohibition of Manufacture and Sale of Certain Drugs

Learn about the prohibition of manufacture and sale of certain drugs in India, and the legal restrictions under the Drugs and Cosmetics Act Prohibition of Manufacture and Sale of Certain Drugs The Act prohibits the manufacture and sale of specific categories of drugs to safeguard public health. Prohibited Drugs: Adulterated Drugs: Drugs containing harmful substances … Read more

Offences and Penalties (Related to Import)

Explore offences and penalties related to import under drug laws in India, including key violations and legal consequences. Offences and Penalties (Related to Import) The Act imposes strict penalties for violations related to the import of drugs and cosmetics to ensure safety and compliance. Key Offences and Penalties: Unauthorized Import: Importing drugs without a license … Read more

Objective of the Drugs and Cosmetics Act 1940

Explore the main objective of the Drugs and Cosmetics Act, 1940 and understand its role in regulating drug and cosmetic safety in India. Objectives The Objective of the Drugs and Cosmetics Act, 1940 (hereafter referred to as “the Act”) is one of the primary legislations in India aimed at regulating the import, manufacture, distribution, and … Read more

Drugs and Cosmetics Act 1940 and Rules 1945

Explore the key provisions of the Drugs and Cosmetics Act, 1940 and Rules, 1945 for drug regulation, safety, and legal compliance in India. Introduction to Drugs and Cosmetics Act 1940 and Rules 1945 The Drugs and Cosmetics Act, 1940 and Rules, 1945 regulates the import, manufacture, distribution, and sale of drugs and cosmetics in India. … Read more