There is an urgent need to ensure citizens are enabled to access quality healthcare, especially medicines in India. In order to improve accessibility and affordability, Government must consider major changes in the pricing policy of medicines in our country. We have observed in the past that the government with stringent price control has denied the citizens access to quality medicines and the choice for medical practitioners to prescribe medicines with better outcomes and value for money. We must innovate and bring global best practices with India. Centric Approach to encourage adoption of the most appropriate pricing mechanism. Trade Margin Rationalization (TMR) is a step in the right direction. TMR in principle could improve access and affordability however, it is imperative to ensure the mechanism of calculating TMR should not impact access to patients. TMR is a mode of price regulation by way of capping trade margins in the supply chain. This is the difference between the price to trade by manufacturers and price to patients i.e., Maximum Retail Price. Therefore, there should be clear objectives for any proposed policy intervention to provide quality and affordability and avoid distrust and disruption in the market. While the primary aim of rationalisation of trade margins should be to help consumers, it should also allow rationalised and reasonable profits for all the players in the supply chain starting from manufacturers, importers, distributors, and wholesalers & retailers, creating an enabling environment for the industry to grow and flourish in the interest of the consumers. As we all know, India today is seen as the pharmacy of the world only because we assure quality along with competitiveness on pricing and availability. A well-balanced policy to implement TMR will bring in affordability and accessibility to the latest innovative drugs and pave way for cutting-edge molecules into the Indian market, undoubtedly with focus on patient safety. It will also act as a catalyst for foreign direct investment in India and help in overcoming challenges in providing access to innovation, quality, and affordable healthcare in the country. Besides, it will create opportunities to increase investment in research and development. TMR is a mode of price regulation by way of capping trade margins in the supply chain. This is the difference between the price to trade by manufacturers and price to patients i.e., Maximum Retail Price. Therefore, there should be clear objectives for any proposed policy intervention to provide quality and affordability and avoid distrust and disruption in the market. While the primary aim of rationalisation of trade margins should be to help consumers, it should also allow rationalised and reasonable profits for all the players in the supply chain starting from manufacturers, importers, distributors, and wholesalers & retailers, creating an enabling environment for the industry to grow and flourish in the interest of the consumers. As we all know, India today is seen as the pharmacy of the world only because we assure quality along with competitiveness on pricing and availability. A well-balanced policy to implement TMR will bring in affordability and accessibility to latest innovative drugs and pave way for cutting edge molecules into the Indian market, undoubtedly with focus on patient safety. It will also act as a catalyst for foreign direct investment in India and help in overcoming challenges in providing access to innovation, quality and affordable healthcare in the country. Besides, it will create opportunities to increase investment in research and development. The government’s recognition of TMR as a fair and balanced approach to ensure reasonable prices to the consumers is greatly appreciated. However, to not asphyxiate the patients in these trying times, a rational and transparent implementation of the approach is paramount. We as consumers have constantly supported innovative and research based interventions in the healthcare delivery system and thus wholeheartedly support the implementation of TMR that “follows ethical and reasonable margin”. We cannot forget the consequences of TMR on 42 oncology drugs notified on February 27, 2019, while implementing the proposed TMR, we only hope our concerns are not lost this time while framing the New TMR for NEW INDIA. We are now entering the AMRIT KAAL for the next 25 years, we should consider a comprehensive TMR for all non-scheduled drugs and not a myopic vision, which will compromise access to quality medicines. We also propose that for computation of ‘Net Sales Realization’, the New TMR should only include such commercial sales which are managed by profit making entities and not include government sales at low tender prices, physician sample, samples for training of healthcare professionals, charity, research supplies, supplies under Patient Assistance Programs (PAPs), etc.. As there is no trade channel involved, no margin can be calculated in case of such distribution. As we all know, Government has already provided several incentives for supplies under PAPs with the goal of improving access to drugs and to ensure initiation and continuation of essential treatments. The objective is to support the patients to comply with the therapy and improve the clinical benefit that patients should have on account of the therapy. Supplies under PAPs are also made after reversal of the Input Tax Credit (ITC) under Section 17(5)(h) of the CGST Act, 2017. Further, no output GST is attracted by the supplies under PAPs as these are considered as ‘Free supplies to unrelated persons’ under section 7(1) of the CGST Act. Inclusion of such non-commercial supplies for calculation will result in unviable pricing for the industry, which in turn may impact patients’ accessibility to quality drugs. Going ahead with this mode of implementation of TMR, will defeat the very objective of bringing in an alternative balanced pricing regime for drugs. Prof. Bejon Kumar Misra, Founder & Director, Patient Safety & Access Initiative of India Foundation. Source: ET Health