REGULATORY REQUIREMENTS FOR THE APPROVAL OF NARCOTIC DRUGS AS PER CDSCO IN INDIA IN COMPARISON WITH CANADA

Narcotic drugs, derived largely from the opium poppy, have powerful pain-relieving effects but also carry a high risk of addiction. Therefore, most countries place strict controls on the manufacturing, trading, and use of these drugs. This report examines the regulatory frameworks governing narcotic drugs in India and Canada, alongside the international classification set out by the 1961 UN Single Convention. India relies on the NDPS Act, along with specialized bodies such as the CBN and NCB, working alongside the general regulator, CDSCO. Canada regulates narcotics mainly through Health Canada and the CDSA, using a single permit-based system under the Narcotic Control Regulations. The comparison highlights how each country licenses the manufacturing, import, export, and sale of narcotic drugs, and what these differences reveal about their regulatory approaches.