CDSCO - Central Drugs Standard Control Organization
CDSCO is India’s national regulatory authority for drugs, medical devices, and cosmetics.
Who heads CDSCO?
DCGI - The Drug Controller General of India (DCGI) leads the CDSCO
Why do we need CDSCO?
CDSCO makes sure that medicines and medical devices in India are safe, effective, and meet quality standards. It is India’s equivalent to the US FDA or UK MHRA.
Functions of CDSCO:
Approval of new drugs or vaccines for marketing in India.
Regulates clinical trials by granting permission for trials that comply to the ethical and scientific standards.
Approves the License for the manufacturing and import of drugs from overseas.
Ensures safety and quality of drugs by setting standards, conducting inspections, and monitoring adverse drug reactions through PvPI Pharmacovigilance Program of India)
Regulates the safety and quality of medical devices.
Having a regulatory for each country is very much needed as that way the quality and safety of the drugs is ensured and maintained as well. There lies accountability among all the pharma companies under that particular regulatory authority. CDSCO is one such for India.
CDSCO plays a critical role in safeguarding public health in India by ensuring that drugs, vaccines, and medical devices are scientifically validated, safe, and effective before they reach the public. In a country with a large population, increasing disease burden, and rapid pharmaceutical growth, strong regulation is essential to prevent substandard or unsafe medicines from entering the market. The leadership of the DCGI ensures national oversight over clinical trials, approvals, imports, and manufacturing standards. Strengthening pharmacovigilance and transparency can further enhance trust in the healthcare system. Ultimately, CDSCO protects millions by ensuring that medical progress never compromises human safety.