India’s drug regulator Central Drug Standard Control Organisation (CDSCO) is all set to be revamped into a world-class body.
With the rise in import alerts from the US Food and Drug Administration (USFDA), the government has geared up to increase the efficiency and quality of the pharma sector.
CDSCO regulates quality standards of drugs and is also responsible for the approval of new drugs. The ministry has floated the draft Cabinet note with an aim to upgrade the body at par with the world’s best health regulator, US Food and Drug Administration (US FDA).
“We have floated a Cabinet note on revamping CDSCO… For it to be upgraded into a world-class health regulator. The regulator will also be renamed as Central Drug Administration, which is as easy as Food and Drug Administration,” said a senior official of the health ministry. “The Cabinet may take up the proposal within July.”
The draft note also suggests that CDSCO should fall under the direct supervision of the health ministry as currently it falls under the Directorate General of Health Services (DGHS).
“We have set USFDA as the standard to upgrade and revamp the entire health system. Upgradation is a dynamic process and our aim is to adopt best international manufacturing practices,” said GN Singh, drug controller general of India (DCGI), who heads CDSCO.
New CDSCO is likely to have six arms divided into categories — drugs, cosmetics, medical devices, laboratories, new emerging areas and ayush.
The responsibilities of CDSCO include grants of import and export license, clinical trial approvals and permissions for marketing and manufacturing. State Food and Drug Administration (FDA) work with CDSCO in each state and is responsible for issuance of license to manufacture similar biologic in India apart from regulating the drug quality.