AMCHAM Medical Device Committee submitted recommendations to use TMR from PTD as a pricing mechanism to make medical devices more affordable for the patients. AMCHAM recommendations also suggested Therapeutic /Price band approach. Recommended to have a detailed industry consultations separately to evolve a suitable methodology for identifying products which need to go for TMR. Recommendations also highlighted that TMR should not applied on B2B products like capital equipment, IVD Bulk reagents and others sold to labs and hospitals which are not billed to the consumers. Regarding Percentage of TMR – supported the DoP report of the committee on High Trade Margin in the sale of Drugs. TMR should have a graded margin depending upon product category. Creation of a legal provision to incorporate TMR from PTD, Stents should also be considered for TMR based pricing, IPDMS instead of Paper format and well documented guidelines on how to calculate the PDT and PTS to avoid confusions were additional points submitted as recommendations
Medical Device Committee submitted the observations and shared inputs /suggestions to improve the Research development of Medical Devices”. Submitted recommendations pertaining Standards of Medical Devices – AMCHAM industry members believes that this is a very pragmatic approach and hope that emphasis will be laid on horizontal QMS standards and onus will be on the innovative medical Device Companies to establish compliance with functional standards based on Essential Principles of Safety and performance of medical devices, rather than dogmatic old product standards which stifles innovation. Another submission was about Transitory Provisions & Repeal and Savings. AMCHAM welcomes the move on continuation of Nineth Schedule Rules, namely: The Medical Devices Rules, 2017 & The New Drugs and Clinical Trials Rules, 2019. These Rules are created after detailed consultation and conforms to the best practices. Regarding non-compliance with quality standards –submitted recommendation to draft a Standard Operating Procedure on Causality Analysis for adverse events before proceeding with such clauses. The proposed act should define a proper mechanism to do the causality analysis of any adverse event on patient, before establishing whether the drugs, /devices are indeed spurious or adulterated or misbranded. Give our full support to work closely with regulators – to ensure patient safety and compensation but also to eliminate the harsher clauses which may deter launch of differentiated technologies.”
AmCham-AdvaMed provided comments on the new medical device rules to the Ministry of Health & Family Welfare (MoHFW) on 29th December 2016. (This document is not for public disclosure).