Cholederm -UPSC Current Affairs

Description

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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.

PRACTICE QUESTION

Q. Consider the following statements.

a) 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.

b) 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.

Which of the statements given above is/are incorrect?

1. a only

2. b only

3. Both a and b

4. None of the above.

Correct Answer: None of the above.