Government is planning to tap the trade margin at 65% In case of the orthopaedic Implant. This means that the difference in price between the first point of sale, i.e the price at which the manufacturer sells to the distributor and the MRP cannot be more than 65%.

New Delhi: In the light of the recent faulty hip implant case, Orthopaedic Implant Manufacturers Association(OIMA) an association of 65 companies indigenously manufacturing orthopaedic devices has now written to the Prime Minister asking for a level playing field.

"The recent issue of faulty hip implants supplied by a multinational, Johnson & Johnson, has confirmed that despite giving all sops to multinationals, sometimes even at the cost of indigenous manufacturers, it is not a guarantee that a product of multinationals would be of great quality." the association wrote in the letter.

The association consists of 65 member companies that manufacture screw and plates, Total Hip Replacement, Total Knee Replacement, Spine implant, Arthroscopy Implants, External Fixator which treats patients of Trauma, bone degeneration.

Orthopaedic Implant Manufacturers Association(OIMA) knocked the door of PM on the dispute of orthopaedics implant capping up to 65%, which considers the first point of sale as a manufacturer in case of domestic implants and distributors in case of imported products. This, the association pointed out was causing them a huge disadvantage and demanded a level playing field to compete with foreign manufacturers.

The National Pharmaceutical Pricing (NPP) Authority announced price caps on orthopaedic implants used in knee replacement surgeries, bringing the price of the basic model of implants down by 65% in August 2017.

Government is planning to tap the trade margin at 65% In case of the orthopaedic Implant. This means that the difference in price between the first point of sale, i.e the price at which the manufacturer sells to the distributor and the MRP cannot be more than 65%.

“For the Indian manufacturers, the first point of sale is the manufacturer, whereas, for foreign multinationals or importers of foreign implants, the first point of sale is the first distributor in India, and hence for them the first sale price is not the price at which they import the implant, but their selling price to the first distributor after adding their cost, without any cap, claimed on education, awareness and R&D,” the letter added

Asking for a level playing field, the association drew the attention to the following demands

• Tender qualification for all Indian drug licence holders for tenders floated by local, state and central government to ensure fair competition and fair price amongst all, whether they be the smallest entrepreneur or the biggest. Presently, many govt. institutions impose unreasonable conditions that have no bearing on product quality in order to have a very high level of turnover, which leads to monopolization by one or two companies.


• In continuation with the Hon'ble Prime Minister's "Ease of Doing Business", the association requested the PM to have a regular dialogue between all regulatory authorities and OIMA as a major stakeholder for smooth implementation of rules and regulations for orthopaedic implants as a medical device. tors and hospitals, unlike other 22 nos. of medical devices.

"We feel that Indian brands do not have to be dependent immediately on the international market for raw material, tests, etc. We need to develop such facilities in India itself to stop the outflow of our foreign exchange reserves and avoid the shortage of such implants during unusual and adverse conditions of even trade war or war with such countries." the letter added