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The Central Drugs Standard Control Organisation (CDSCO) is India's national regulatory body for cosmetics, pharmaceuticals and medical devices. It serves a similar function to the Food and Drug Administration (FDA) of the United States or the European Medicines Agency of the European Union .
Schedule H is a class of prescription drugs in India appearing as an appendix to the Drugs and Cosmetics Rules, 1945 introduced in 1945. These are drugs which cannot be purchased over the counter without the prescription of a qualified doctor. The manufacture and sales of all drugs are covered under the Drugs and Cosmetics Act and Rules.
The center doesn't actually test drugs itself, although it does conduct limited research in the areas of drug quality, safety, and effectiveness standards. As of the end of 2013, the FDA and its predecessors had approved 1,452 drugs, though not all are still available, and some have been withdrawn for safety reasons. [5]
Covidien Receives FDA 510(k) Clearance for Nellcor™ Pulse Oximetry Motion Claims Nellcor pulse oximeters only FDA 510(k)-cleared oximeters compliant with ISO 80601-2-61 BOULDER, Colo.--(BUSINESS ...
The drug is FDA-approved for prevention of heartworm in dogs and cats, [4] although it is less potent against heartworms than ivermectin. [citation needed] The substance is often combined with other parasiticides to achieve a broader spectrum of action. Such products include: [citation needed] Milbemax and Interceptor Plus (with praziquantel)
The Drugs and Cosmetics Rules, 1945 are the rules which the government of India established for the implementation of the Drugs and Cosmetics Act, 1940. These rules classify drugs under given schedules and present guidelines for the storage, sale, display and prescription of each schedule. [1] [2]
The Food and Drug Administration's recommendations apply to pulse oximeters, which are clip-on devices used in hospitals and medical clinics to ensure patients are getting enough oxygen. The FDA said it wants companies to conduct larger studies and include more patients from different racial groups.
Schedule X is a class of prescription drugs in India appearing as an appendix to the Drugs and Cosmetics Rules introduced in 1945. These are drugs which cannot be purchased over the counter without a valid prescription of a Registered Medical Practitioner (RMP). Also, the retailer has to preserve the prescription for a period of two years. [1]