Category: Pharmaceutical & Healthcare

Compliances under Drugs Rules, 1945 [Part VIII, IX]

The Drugs Rules, 1945 were introduced under the Drugs and Cosmetics Act to standardize how medicines are manufactured, tested, and sold across India. They emerged during a period when the government sought stronger safeguards against unsafe or ineffective pharmaceuticals. The rules laid out scientific criteria for quality, labeling, storage, and distribution of medicinal products. By bringing regulatory clarity, they helped protect public health and support the growth of a structured pharmaceutical sector.

Compliances under Drugs Rules, 1945 [part VI, VII, VIII A ]

The Drugs Rules, 1945 were introduced under the Drugs and Cosmetics Act to standardize how medicines are manufactured, tested, and sold across India. They emerged during a period when the government sought stronger safeguards against unsafe or ineffective pharmaceuticals. The rules laid out scientific criteria for quality, labeling, storage, and distribution of medicinal products.

Compliances under Drugs Rules, 1945 [Part IV ]

The Drugs Rules, 1945 were introduced under the Drugs and Cosmetics Act to standardize how medicines are manufactured, tested, and sold across India. They emerged during a period when the government sought stronger safeguards against unsafe or ineffective pharmaceuticals. The rules laid out scientific criteria for quality, labeling, storage, and distribution of medicinal products. By bringing regulatory clarity, they helped protect public health and support the growth of a structured pharmaceutical sector.

Key Compliances under New Drugs and Clinical Trials Rules, 2019 [Chapter VIII, IX, X, XI ]

The New Drugs and Clinical Trials Rules, 2019 were notified by the Government of India on 19 March 2019 to replace parts of the earlier Drugs and Cosmetics Rules of 1945 and create a modern, transparent framework for regulating new drugs, investigational new drugs, clinical trials, bioavailability/bioequivalence studies, and ethics committees under the Drugs and Cosmetics Act, 1940

Key Compliances under New Drugs and Clinical Trials Rules, 2019 [Chapter V(Part B ), VI & VII ]

The New Drugs and Clinical Trials Rules, 2019 were notified by the Government of India on 19 March 2019 to replace parts of the earlier Drugs and Cosmetics Rules of 1945 and create a modern, transparent framework for regulating new drugs, investigational new drugs, clinical trials, bioavailability/bioequivalence studies, and ethics committees under the Drugs and Cosmetics Act, 1940.

Key Compliances under New Drugs and Clinical Trials Rules, 2019 [Chapter III, IV & V (Part A )]

The New Drugs and Clinical Trials Rules, 2019 were notified by the Government of India on 19 March 2019 to replace parts of the earlier Drugs and Cosmetics Rules of 1945 and create a modern, transparent framework for regulating new drugs, investigational new drugs, clinical trials, bioavailability/bioequivalence studies, and ethics committees under the Drugs and Cosmetics Act, 1940.

Key Compliances under Medical Devices Rules, 2017

The Medical Devices Rules, 2017 were issued under the Drugs and Cosmetics Act, 1940 to establish a dedicated regulatory system for medical devices in India. Prior to these rules, most devices were treated as drugs, creating gaps in licensing, quality control, and post-market oversight.

Clinical trial, Bio-availability & Bioequivalence Study of New Drugs & Investigational New Drugs

No person or institution or organisation shall conduct clinical trial of a new drug or investigational new drug,—

Form 25B: Licence to Repack for Sale or Distribution of Drugs

Form 25B is the licence issued under the Drugs and Cosmetics Rules, 1945, for the repacking of drugs intended for sale or distribution in India. It applies specifically to drugs other than those specified in Schedules C and C(1), and excluding Schedule X drugs.

All about Form 25 & Form 25F of Drugs Rules, 1945

Form 25 is the licence issued under the Drugs and Cosmetics Rules, 1945 for the manufacture for sale or distribution of drugs, excluding: