Cholederm

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Context

• Cholederm, has won the approval of the Central Drugs Standard Control Organisation (CDSCO) as a Class D medical device.

Cholederm

• Cholederm is a wound healing material derived from the extracellular matrix of de-cellularised gall bladder of pig and tissue engineered as membrane forms of scaffold.
• Cholederm healed different types of skin wounds including burn and diabetic wounds in rats, rabbits or dogs faster than similar products currently available in the market, with minimal scarring.
• Researchers said that the scaffold modulated or mitigated the scarring reactions in subcutaneous, skeletal-muscle and cardiac tissues and that it had the ability to mitigate fibrotic scarring in rats suffering experimental myocardial infarction.

Significance

• Given the stringent requirements that have to be met under the 2017 Medical Devices Rules, the development of animal-derived Class D medical devices was not considered to be an easy or practical proposition.

Class D: Class D device includes In vitro diagnostics (IVD) that detect or are exposed to life-threatening transmissible agents or transmissible agents and infectious diseases with a high risk of propagation.

• The CDCSO approval for Cholederm is thus a milestone achievement.
• Though the concept of using animal-derived products for manufacturing advanced wound care material is not new, Cholederm is the first indigenously developed product to meet all regulatory requirements.
• However, indigenous technology was so far not available for fabricating quality products that satisfy the requirements of the Drugs Controller General. Therefore, such products were imported making them expensive.
• It is expected that with the introduction of Cholederm to the Indian market, the treatment cost can be reduced from Rs 10,000/- to Rs 2,000/- making it more affordable to the common man. 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.

https://www.thehindu.com/news/national/drugs-controller-approves-first-indigenously-developed-animal-derived-tissue-engineering-scaffold-for-skin-wounds-healing/article66964779.ece