Facts for Prelims (FFP)
Source: TH
Context: The Sree Chitra Tirunal Institute for Medical Sciences and Technology (SCTIMST) has received approval from the Central Drugs Standard Control Organisation (CDSCO) for its advanced wound care product called Cholederm.
About Cholederm:
It is a Class D medical device made from the extracellular matrix of a pig’s gall bladder, tissue-engineered into membrane forms of the scaffold.
- Advantages: It has demonstrated faster healing of various skin wounds, including burns and diabetic wounds, in animal tests with minimal scarring. Cholederm is expected to reduce treatment costs and make advanced wound care more affordable.
- Significance: This development marks a significant milestone for indigenous development in the field of animal-derived medical devices, meeting all regulatory requirements.
About Medical devices:
Medical devices are instruments, apparatus, machines, or software used for diagnosing, treating, or preventing medical conditions. Medical devices are categorized into different classes based on their risk level, with Class A being low risk and Class D being high risk.
Class D medical devices are often complex and are used for critical medical procedures or treatments. Class D devices require strict regulation and undergo rigorous evaluation to ensure their safety and efficacy.
About CDSCO:
The Central Drugs Standard Control Organisation (HQ: New Delhi; under the Drugs and Cosmetics Act of 1940) is India’s national regulatory body for cosmetics, pharmaceuticals and medical devices. It is responsible for the approval of Drugs, Conduct Clinical Trials, and laying down the standards for Drugs.
