Cholederm

Indian Drugs Controller approves first indigenously developed animal-derived tissue, named cholederm

• Cholederm is a wound healing material derived from the extracellular matrix of de-cellularised gall bladder of pig.
• It is a Class D Biomedical Device material.
• Indigenous one – It is the first indigenously developed product to all statutory requirements of the Central Drugs Standard Control Organisation.
• Developer – Sree Chitra Tirunal Institute for Medical Sciences and Technology (SCTIMST), an autonomous institution of the Department of Science and Technology (DST).
• Advantages – The treatment cost can be reduced making it more affordable to the common man.
• Cholederm healed different types of skin wounds including burn and diabetic wounds faster than other products with minimal scarring.
• Moreover, the technology for recovering extracellular matrix from the gallbladder is not available to others and it gives a fair chance for competition in the international market.

The Central Drugs Standard Control Organisation (CDSCO)

• The CDSCO is the national regulatory body for pharmaceuticals and medical devices in India.
• Ministry – Ministry of Health & Family Welfare, Government of India is the National Regulatory Authority (NRA) of India.
• Headquarters – New Delhi
• Under the Drugs and Cosmetics Act, CDSCO is responsible for approval of drugs, conduct of clinical trials, laying down the standards for drugs, control over the quality of imported drugs in the country.
• CDSCO along with state regulators, is jointly responsible for grant of licenses of certain specialized categories of critical drugs such as blood and blood products, I. V. fluids, vaccine and sera.
• The Drug Controller General of India (DCGI), which is an organ of the CDSCO, is responsible for approving and licensing of drugs and medical devices