Context: Recently, the Central Drugs Standard Control Organisation (CDSCO) put out a list of over 50 medicines that were either found to be spurious or ‘not of standard quality’, raising a furore.
What is CDSCO
- India takes pride in its pharmaceutical industry, being the largest global producer of generic medicines that benefit the global poor.
- However, the industry has faced challenges, including struggles to achieve scale and defamatory claims about the ineffectiveness and harm caused by Indian drugs.
- Quality concerns persist, with numerous drugs failing to meet standards, leading to substandard drugs in routine use and adverse events.
- Global regulators have raised issues with compliance, potentially damaging India's reputation. Recommendations include amending regulations, centralizing the drug regulatory system, enhancing transparency, and focusing on producing quality generics and innovative drugs.
About Central Drugs Standard Control Organisation (CDSCO)
- It functions as India's national regulatory body overseeing cosmetics, pharmaceuticals, and medical devices.
- The CDSCO is organized with the Drug Controller General of India (DCGI) overseeing pharmaceuticals and medical devices.
- It is assigned duties under Drugs and Cosmetics Act, 1940.
- The DCGI is situated within the Ministry of Health and Family Welfare and receives guidance from the Drug Technical Advisory Board (DTAB) and the Drug Consultative Committee (DCC).
- The CDSCO operates through zonal offices that conduct inspections prior to licensing, post-licensing inspections, post-market surveillance, and, if necessary, initiates drug recalls.
