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Cholederm : Class D Medical Device

Cholederm : Class D Medical Device

An advanced wound care product developed by the Sree Chitra Tirunal Institute for Medical Sciences and Technology (SCTIMST), named Cholederm, has won the approval of the Central Drugs Standard Control Organisation (CDSCO) as a Class D medical device

  • Cholederm is a wound healing material derived from the extracellular matrix of the de-cellularised gall bladder of pigs and tissue engineered as membrane forms of a scaffold.
  • It healed different types of skin wounds including burn and diabetic wounds in rats, rabbits or dogs etc. faster than similar products currently available in the market
  • It is the first indigenously developed product to meet all regulatory requirements.
  • The scaffold modulated the scarring reactions in subcutaneous, skeletal-muscle and cardiac tissues.
  • It is the Central Drug Authority for discharging functions assigned to the Central Government under the Drugs and Cosmetics Act of 1940.
  • It works under the Ministry of Health & Family Welfare.

Drugs Controller General of India (DCGI):

  • DCGI is the head of the department of the CDSCO of the Government of India responsible for approval of licences of specified categories of drugs such as blood and blood products, IV fluids, vaccines and sera in India.