Plans for India’s New Regulatory Agency

This fall, India has announced plans to replace its current Central Drugs Standard Control Organization (CDSCO) with a new agency, the Central Drugs Authority of India (CDAI). The government hopes that the CDAI will help centralize the product approval process and improve manufacturing quality supervision. Concerns of drug safety and ethical practices have motivated the government to plan these changes. The CDAI will focus on establishing a more transparent, efficient, and uniform system of drug regulation.

Under the CDAI, 10 new government divisions would be established in New Delhi. These divisions would be responsible for specific areas such as regulations, biotechnology products, imports, quality control, enforcement, legal and consumer affairs, medical devices/diagnostics, etc. Though Food and Drug Administrations at the State level would still be responsible for issuing drug sales licenses, the CDAI would eventually take over issuing manufacturing licenses after a five-year transition period.

Issues of efficiency and lack of resources have also prompted other plans for expansion.

The Drug Controller General of India will have two additional Drug Controllers working under him, and two new regional offices will be set up in Hyderabad and Chandigarh. In the past, drug approval processes would often come to a halt when the Drug Controller General was away or at Parliament. In addition, 114 new posts will be added to the current 82 posts. With more resources, the government hopes to streamline product approvals and improve quality control supervision.