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:
All about Form 28A & Form 28DA of Drugs Rules, 1945
Loan licences for drugs under Sch C & C(1), excluding Sch X, LVPs, Sera, and r-DNA drugs, must be in Form 28A.
All about Form 25A of Drugs Rules, 1945
Form 25A is the licence to manufacture drugs other than specified in Sch X, C and C(1) for the purpose of sale or distribution in India, issued under the Drugs and Cosmetics Rules, 1945.
General Condition of licences under Drugs Rules, 1945
Licences in Forms 20, 20A, 20B, 20F, 20G, 21 and 21B shall be subject to the conditions stated therein and to the following general conditions:—
Licenses to Import Drugs in India
The import of drugs in India is strictly regulated to ensure quality, safety, and efficacy. Central to this regulatory framework is the requirement for an import license, which must be obtained prior to bringing drugs into the country
Form 41: Registration Certificate under Drug Rules
Under the Drugs and Cosmetics Act, 1940, registration under Form 41 is a mandatory requirement for establishments involved in manufacturing, importing, or wholesaling drugs. This registration once issued serves as confirmation that the premises meet the prescribed quality,
Drugs and Cosmetics Act, 1940
The Drugs and Cosmetics Act, 1940 was enacted to regulate the import, manufacture, distribution, and sale of drugs and cosmetics in India. The Act aims to ensure the safety, efficacy, and quality of drugs and cosmetics, preventing substandard, adulterated, or misbranded products from reaching consumers. It also sets standards for labeling, packaging, and advertisement of drugs and cosmetics to protect public health.