MTaI Statement on the Need to Revisit Price Cap on Knee Implants

 The Medical Technology Association of India (MTaI), a representative body of the domestic arm of global medical device makers, has expressed concern over the manner in which the NPPA has moved to cap the prices of knee implants.

Whilst we support the Government of India’s objectives to increase access to life-saving medical technologies in India, we are concerned over the hasty manner of decision-making to apply price controls, particularly by invoking Para 19 of the DPCO, which we find contrary to the goals of increasing patient access and creating an environment that encourages investments in India. Invoking Para 19 is intended for extraordinary circumstances only, and to address emergency and life-saving circumstances. While knee replacement surgery is an important procedure that can enhance quality of life, there is not an exigent emergency that warrants this approach. Invoking this authority also by-passes due involvement of NLEM and Medical Technology Assessment Board (MTAB), the latter of which is intended to develop evidence-based approaches to valuation of medical technologies.

MTaI has filed a detailed representation on 29th August 2017 with the NPPA requesting them to reconsider their decision of imposing price ceiling as well as highlighting some of the key issues currently faced by the manufacturers and importers of knee implant industry. Some of the key issues raised are as under:

  While fixing prices, the Authority has not considered appropriate categorization of the implants.

  While fixing prices for four of the major components of knee implants, in the original order the Authority has disregarded the service costs related to instruments.

  In the recent order on August 25th, as addendum to the original order, the Authority has mentioned knee implant ceiling prices to be inclusive of bone cement charges. Bone cement is a separate component not manufactured by all orthopedic knee manufacturers. This perhaps is the first time that the price of one drug is embedded into the price of another drug, when both the drugs are commercially available as packaged and finished goods of respective manufacturers, and governed separately under the D&C Act.

  Additional components used in revision surgery have not been considered.

The medical technology industry is committed to working with the Indian government to address the country’s public health challenges and unmet needs. We understand and support the Government of India’s objectives to increase access and affordability of life-saving medical technologies. As previously stated, we are very keen to partner with the Government of India and discuss how we can work together to address unmet healthcare needs in India and find solutions to improve standards of care for patients across the country.

 We urge the NPPA to re-think its decision to implement price controls on knee implants and refrain from additional price controls, and to have open dialogues with the industry to develop sustainable solutions.