India's No.1 PU & Degree With Integrated IAS & IPS(UPSC/PSC) Training College.
Cholederm : Class D Medical Device
News: The Central Drugs Standard Control Organisation (CDSCO) has approved Cholederm, an innovative wound care product created by the Sree Chitra Tirunal Institute for Medical Sciences and Technology (SCTIMST), as a Class D medical device.
Cholederm is a tissue-engineered, membrane-based scaffold used to treat wounds that is made from the extracellular matrix of decellularized pig gall bladders.
It treated various skin wounds, such as burn and diabetic wounds, in rats, rabbits, or dogs more quickly than competing medications now on the market.
It is the first locally created product to satisfy all legal standards.
In subcutaneous, skeletal-muscle, and cardiac tissues, the scaffold controlled the scarring responses.
It is the Central Drug Authority and is responsible for carrying out duties entrusted to it by the 1940 Drugs and Cosmetics Act.
The Ministry of Health and Family Welfare oversees its operations.
India’s Drugs Controller General (DCGI):
In India, the licences for specific types of medications like blood and blood products, IV fluids, vaccines, and sera must be approved by the head of the department of the CDSCO.
