Mar­gin on Im­ported Knee Im­plant for Re­vi­sion Surgery is 4.5x Cost: NPPA

Price of im­ported de­vice is ₹ 91,967 to .₹ 1.99L, but re­vi­sion pro­ce­dure can cost a pa­tient up to .₹ 9L, it says

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New Delhi: The av­er­age trade mar­gin on an im­ported knee im­plant used in pa­tients with a failed pre­vi­ous pro­ce­dure is more than four-and-a-half times its cost, data re­leased on Wed­nes­day by In­dia’s drug pric­ing watch­dog showed. Ac­cord­ing to the in­for­ma­tion, an im­ported de­vice used in such re­vi­sion surg­eries can cost a pa­tient as much as ₹ 9 lakh.

Global knee im­plant mak­ers said this data may be in­ac­cu­rate. The new in­for­ma­tion comes a few days af­ter Na­tional Phar­ma­ceu­ti­cal Pric­ing Author­ity (NPPA) data showed the av­er­age trade mar­gin on total knee im­plants at more than 300%, or four times the ac­tual cost. The mar­gin on im­ported im­plants used in re­vi­sion surg­eries, ac­cord­ing to the lat­est data, is 369%. The av­er­age mar­gin for im­porters of total knee sys­tems used in re­vi­sion pro­ce­dures was 56%, while for dis­trib­u­tors and hos­pi­tals, it was 200%, ac­cord­ing to the data.

The cost on the joint com­po­nents of a total knee sys­tem used in a re­vi­sion pro­ce­dure ranges be­tween ₹ 4.35

lakh and ₹ 9 lakh. The im­port price can be ₹ 91,967 to ₹ 1.99 lakh, it said.

Dis­trib­u­tors and hos­pi­tals on av­er­age mark up the prices of com­po­nents like the femoral, tib­ial plate, insert and patella by 89-139%, the data showed.

“We have just seen the of­fice mem­o­ran­dum re­lat­ing to re­vi­sion knee im­plant sys­tem, which has been is­sued by NPPA to­day. As an ini­tial re­ac­tion: this demon­strates a lack of un­der­stand­ing of the re­vi­sion knee sys­tem and the data seems in­ac­cu­rate,” said the Med­i­cal Tech­nol­ogy As­so­ci­a­tion of In­dia (MTaI), a lobby group for mul- NPPA says re­vi­sion im­plants can cost as much as

Im­plants used in a re­vi­sion knee surgery are com­pletely dif­fer­ent in de­sign and the in­stru­ment set used by sur­geons in this type of pro­ce­dure is also dif­fer­ent and more ex­pen­sive than those used in pri­mary knee im­plant pro­ce­dures, ac­cord­ing to an in­dus­try ex­ec­u­tive, who spoke on con­di­tion of anonymity.

Around three crore pa­tients in In­dia are es­ti­mated to be suf­fer­ing from os­teoarthri­tis cur­rently, and only around 1.2 lakh go in for knee im­plants, the ex­ec­u­tive said. NPPA chair­man Bhu­pen­dra Singh could not be reached for com­ment. It is not con­firmed whether NPPA has re­leased its lat­est data be­cause it in­tends to cap the prices of knee im­plants and re­vi­sion knee im­plants. The reg­u­la­tor had ear­lier this year asked com­pa­nies to sub­mit trade data on 19 classes of med­i­cal de­vices, in­clud­ing knee and hip im­plants, catheters, heart valves and eye lenses used in cataract surg­eries.

At the same time, the health min­istry is con­sid­er­ing a pro­posal by the Cen­tral Drugs Stan­dard Con­trol Or­gan­i­sa­tion to set up a com­mit­tee to de­cide whether heart valves, in­traoc­u­lar lenses and or­thopaedic im­plants be brought un­der the Na­tional List of Essen­tial Medicines — a move that would al­low the De­part­ment of Phar­ma­ceu­ti­cals to no­tify them for price con­trol.

9 lakh

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