Central Drugs Standard Control Organization hand written notes pdf

Save (0)



CDSCO stands for Central Drugs Standard Control Organization, which is the national regulatory body of India under the Ministry of Health and Family Welfare. It was established in 1961 to regulate the import, manufacture, sale, and distribution of drugs and medical devices in India.

The primary functions of CDSCO include:

1. Approving new drugs and medical devices for sale in India and ensuring their safety, efficacy, and quality.

2. Monitoring the manufacture, distribution, and sale of drugs and medical devices in the country.

3. Issuing licenses and certificates to manufacturers, importers, and distributors of drugs and medical devices.

4. Formulating and implementing regulations and guidelines for clinical trials, pharmacovigilance, and quality control of drugs and medical devices.

5. Conducting inspections and audits of drug manufacturing facilities and laboratories to ensure compliance with regulatory norms.

6. Taking legal action against violators of the drug regulations and ensuring consumer protection.

CDSCO has several divisions, including the Drugs Controller General of India (DCGI), which is responsible for the regulatory control of drugs in India, the Medical Device Division, which regulates the import, manufacture, and sale of medical devices, and the Pharmacovigilance Program of India (PvPI), which monitors adverse drug reactions in the country.

CDSCO plays a crucial role in ensuring the availability of safe and effective drugs and medical devices to the citizens of India. It works in close collaboration with other national and international regulatory agencies to maintain high standards of drug and device regulation.