What is Cholederm?

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What is Cholederm? Blog Image


Recently, 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.

About Cholederm:

  • It 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. 

Key facts about CDSCO

  • 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.
  • Under the Drugs and Cosmetics Act, CDSCO is responsible for -
    • Approval of Drugs.
    • Conduct Clinical Trials.
    • Laying down the standards for Drugs.
    • Control over the quality of imported Drugs in the country.
    • Along with state regulators, it is jointly responsible for the grant of licences to certain specialised categories of critical Drugs such as vaccines and sera, etc.
  • 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.
  • DCGI also sets standards for the manufacturing, sales, import, and distribution of drugs in India.


Q1) What are Over-the-Counter (OTC) Drugs?

These medications are available without a prescription and can be purchased directly from pharmacies or retail stores. They are typically used to treat common ailments such as cold and flu symptoms, allergies, pain relief, and acid reflux

Source: Drugs Controller approves first indigenously developed animal-derived tissue engineering scaffold for skin wounds healing