Central Drug Standard Control Organisation

Central Drug Standard Control Organisation

The Central Drugs Standard Control Organisation (CDSCO) is the national regulatory body for Indian pharmaceuticals and medical devices, and serves parallel function to the European Medicines Agency of the European Union, the PMDA of Japan, the Food and Drug Administration of the United States and the Medicines and Healthcare products Regulatory Agency of the United Kingdom.

The Central Drugs Standard Control Organization (CDSCO) is the Central Drug Authority for discharging functions assigned to the Central Government under the Drugs and Cosmetics Act. CDSCO has six zonal offices, four sub-zonal offices, 13 port offices and seven laboratories under its control.

The vision and mission of CDSCO is To Protect and Promote public health in India and to safeguard and enhance the public health by assuring the safety, efficacy and quality of drugs, cosmetics and medical devices respectively.

Under the Drugs and Cosmetics Act, CDSCO is responsible for approval of New Drugs, Conduct of Clinical Trials, laying down the standards for Drugs, control over the quality of imported Drugs in the country and coordination of the activities of State Drug Control Organizations by providing expert advice with a view of bring about the uniformity in the enforcement of the Drugs and Cosmetics Act.

Cosmetics

As per the Drugs and Cosmetics Act, 1940 and Rules 1945 made, the manufacture of cosmetics is regulated under a system of inspection and licensing by the State Licensing Authorities appointed by the respective State Governments while the import of cosmetics is regulated under a system of registration by the Licensing Authority appointed by the Central Government. The Drugs Controller General (India) functions as the Licensing Authority who grants the registration certificate and regulates the import of cosmetics in India. To know more about our services, click https://cliniexperts.com/india-regulatory-services/cosmetic/

Medical Device

The Central Drug Standards Control Organization (CDSCO) is India’s main regulatory body for medical devices. The Drug Controller General of India (DCGI) is the key official within the CDSCO. The DCGI is responsible for the approval of the manufacturing of medical devices.

It is important to have a CDSCO license to the medical devices’ manufacturers and medical devices seller according to the Indian regulatory body. Each nation as its very own committed overseeing body under the ministry of health to take care of each part of medical devices. The CDSCO is responsible for regulating the registration and sale of notified medical devices in India. To know more about our services, click https://cliniexperts.com/india-regulatory-services/medical-device/

Drugs

The Central Drugs Standard Control Organisation (CDSCO) is the National Regulatory Authority (NRA) of India under Directorate General of Health Services, Ministry of Health & Family Welfare, Government of India establish India to evaluate safety, efficacy and quality of drugs. CDSCO is responsible for approval of New Drugs, Conduct of Clinical Trials, laying down the standards for Drugs, Control over the quality of imported Drugs in the country, coordination of the activities of State Drug Control Organizations by providing expert advice, during uniformity in the enforcement of the Drugs and Cosmetics Act. To know more about our services, click https://cliniexperts.com/india-regulatory-services/drug/

Biologicals

Biological products, or biologics, are medical products. Many biologics are made from a variety of natural sources (human, animal or microorganism). Like drugs, some biologics are intended to treat, prevent or diagnose diseases and medical conditions. Biological products include Vaccines, Blood and blood products for transfusion and/or manufacturing into other products, allergenic extracts, which are used for both diagnosis and treatment (for example, Allergy shots), Human cells and tissues used for transplantation (for example, tendons, ligaments and bone), Gene and cellular therapies, Tests to screen potential blood donors for infectious agents such as HIV.

CDSCO is responsible for grant of NOC for issuance of Form 29 (manufacture of drugs for the purpose of Examination, test or analysis of vaccines, r-DNA products, Stem cells and Cell based products, Blood & Blood Products, Veterinary vaccines), approval of Clinical Trials in human and Field Trials in animals, grant of Marketing Authorization, grant of Registration Certificate, Import License and Test Licence in Form 11, approval of Form 28-D Licensing under CLAA Scheme for human and veterinary vaccines, rDNA products and blood products, issuance of Export NOC and Permission under Rule 37 for human and veterinary vaccines and rDNA products. To know more about our services, click https://cliniexperts.com/india-regulatory-services/biologicals/

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