Representation – Inputs on Innovation & R&D on the Draft Drugs, Medical Device & Cosmetics Bill 2022

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