The regulation of therapeutic goods, that is drugs and therapeutic devices, varies by jurisdiction. In some countries, such as the United States, they are regulated at the national level by a single agency. In other jurisdictions they are regulated at the state level, or at both state and national levels by various bodies, as is the case in Australia. The role of therapeutic goods regulation is designed mainly to protect the health and safety of the population.
Regulation is aimed at ensuring the safety, quality, and efficacy of the therapeutic goods which are covered under the scope of the regulation. In most jurisdictions, therapeutic goods must be registered before they are allowed to be marketed. There is usually some degree of restriction of the availability of certain therapeutic goods depending on their risk to consumers.
Therapeutic goods in the United States are regulated by the U.S. Food and Drug Administration (FDA), which makes some drugs available over the counter at retail outlets and others by prescription only. The possession of some substances is prohibited by scheduling under the Controlled Substances Act, under the joint jurisdiction of the FDA and the Drug Enforcement Administration (DEA).
Medicines in India are regulated by CDSCO - Central Drugs Standard Control Organization Under Ministry of Health and Family Welfare. Headed by Directorate General of Health Services CDSCO regulates the Pharmaceutical Products through DCGI - Drugs Controller General of India at Chair. Under Retail and Distribution:- Drugs classified under 5 heads 1. Schedule X drugs – Narcotics 2. Schedule H and L – Injectables, Antibiotics, Antibacterials 3. Schedule C and C1- Biological Products-example Serums and Vaccines Under Manufacturing Practice 1. Schedule N List of the equipment for the efficient running of manufacturing wing,
Qualified personnel 2. Schedule M
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Regulation is aimed at ensuring the safety, quality, and efficacy of the therapeutic goods which are covered under the scope of the regulation. In most jurisdictions, therapeutic goods must be registered before they are allowed to be marketed. There is usually some degree of restriction of the availability of certain therapeutic goods depending on their risk to consumers.
Therapeutic goods in the United States are regulated by the U.S. Food and Drug Administration (FDA), which makes some drugs available over the counter at retail outlets and others by prescription only. The possession of some substances is prohibited by scheduling under the Controlled Substances Act, under the joint jurisdiction of the FDA and the Drug Enforcement Administration (DEA).
Medicines in India are regulated by CDSCO - Central Drugs Standard Control Organization Under Ministry of Health and Family Welfare. Headed by Directorate General of Health Services CDSCO regulates the Pharmaceutical Products through DCGI - Drugs Controller General of India at Chair. Under Retail and Distribution:- Drugs classified under 5 heads 1. Schedule X drugs – Narcotics 2. Schedule H and L – Injectables, Antibiotics, Antibacterials 3. Schedule C and C1- Biological Products-example Serums and Vaccines Under Manufacturing Practice 1. Schedule N List of the equipment for the efficient running of manufacturing wing,
Qualified personnel 2. Schedule M
Click here to browse books on Pharmaceutical Regulations