On August 3rd, ICMR organized a meeting chaired by Dr. Rajiv Bahl, Secretary DHR and DG, ICMR, Dr. N.S. Chatterjee, Head Discovery Research Gorup, ICMR, and Prof Y.K. Gupta, Vice Chairman, SNCM in New Delhi. Expert cardiologists like Dr. Sandeep Singh, Dr. Rakesh Yadav, Dr. Sanjay Bansal, Dr. Neeraj Pandit, Dr. Ajay Mahajan and Dr. Paul attended the meeting. Industry members shared their suggestions through presentations. AMCHAM was represented by Mr. Prashant Sharma from Medtronics.
Industry members addressed the importance of clinical evidence in categorization of stents. Some of the points deliberated included the following:
- A robust post market surveillance program should be followed to meet regulatory requirements.
- Industries invest heavily in generating clinical evidence proving product quality, efficacy, and patient safety throughout the lifecycle of DES.
- Due to wide market access of various DES in India there is a strong need for stent categorization based on clinical evidence.
U.S. companies recommended that:
- Stringent assessment based on clinical evidence needs to be in place for market approval of new DES.
- RCT evidence is recommended to categorize DES based on proven efficacy, and patient safety.
- Robust post market surveillance program by continuous monitoring of safety of new DES entering in market should be ensured.
- To improve patient safety by monitoring adverse events, industry to register under Materio vigilance Programme MvP.
The Committee Chair suggested as a conclusion on how to categorize stent:
- In their internal meeting with DCGI, DCGI may consider what could be the appropriate method of giving approval to coronary stents.
- Requested the cardiologist groups and cardiologists present to write an article sharing their suggestions / inputs to get approval on coronary stents, on international standards and to share the available data.
- Post Market Surveillance Study through private public partnership through ICMR.
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