Breaking news in the medical field comes from India, where the local Drugs Controller has given its stamp of approval to the first home-grown Class D Biomedical Device. Known as Cholederm, this low-cost solution promises rapid healing for skin wounds with minimal scarring.
As prescribed by the Medical Devices Rules, 2017, all medical devices are classified into four categories (Class A through Class D) according to their risk level. Class A carries a low risk; Class B is characterized by low to moderate risk; Class C has moderate to high risk, and Class D, like our new device, poses a high risk.
SCTIMST Introduces Tissue Engineering Scaffold
The Sree Chitra Tirunal Institute for Medical Sciences and Technology (SCTIMST) claims credit for developing this innovative technology. Operating under the Department of Science and Technology (DST), SCTIMST outpaced all other Indian institutions by creating the first Class D medical devices that satisfy Central Drugs Standard Control Organisation (CDSCO) requirements.
In particular, the team at SCTIMST developed an efficient method for constructing tissue engineering scaffolds from mammalian organs. While the concept of using animal-derived materials to advance wound care isn’t novel, this marks the first time that locally sourced technology has been used to create products of this caliber.
Cholederm’s Exceptional Healing Capabilities
In pre-clinical trials, Cholederm has shown great promise in healing various types of skin wounds, from burns to diabetic wounds, better and faster than existing market products. Its graft-assisted healing function is regulated by anti-inflammatory M2 type macrophages, which modulate or mitigate scarring reactions in different tissues.
Affordability and Market Potential of Cholederm
The Indian healthcare sector stands to benefit from the introduction of this affordable wound care product. Treatment costs are expected to drop substantially, from INR 10,000 before to a more manageable INR 2,000 or less. The competitive advantage that this technology offers on the international market cannot be overemphasized, as it opens the doors for income generation.
Next Steps: Dealing with Cardiac Injuries
Having achieved this significant milestone, the research team at SCTIMST has now turned its attention to creating injectable gel formulations of the scaffold. The primary goal is to make cardiac injury treatment easier and more effective, potentially revolutionizing the management of patients who have experienced myocardial infarction.
About CDSCO and Its Function
The CDSCO is the Central Drug Authority put in charge of performing functions assigned to the Central Government under the Drugs and Cosmetics Act, 1940. Operating under the Directorate General of Health Services, Ministry of Health & Family Welfare, Government of India, this National Regulatory Authority (NRA) oversees the approval of new drugs, clinical trials, and some licenses.
Unpacking the Role of the National Pharmaceuticals Pricing Authority (NPPA)
The NPPA is an autonomous body under the Department of Pharmaceuticals, Ministry of Chemicals and Fertilizers and was established in 1997. It has been tasked with revising prices of controlled bulk drugs and formulations, enforcing the availability and price regulations of medicines in the country, and monitoring the prices of decontrolled drugs to maintain reasonable levels. The prices are fixed/revised under the Drugs (Prices Control) Order (DPCO), 2013.
Last Modified: February 20, 2024