NPPA Flags Mar­gin on Knee Im­plants

The Economic Times - - Front Page -

Av­er­age trade mar­gins on knee sys­tems for im­plants are as high as 300%, Na­tional Phar­ma­ceu­ti­cal Pric­ing Au­thor­ity said on Friday. place on July1— more specif­i­cally, the un­der­ly­ing prin­ci­ple that any ex­emp­tions would weaken the ef­fi­cacy of one of In­dia’s big­gest in­di­rect tax re­forms ever.

Medicines im­ported for per­sonal use that were ear­lier ex­empt from cus­toms duty, coun­ter­vail­ing duty and spe­cial ad­di­tional duty now at­tract GST. The gov­ern­ment is charg­ing12% In­te­grated GST on most En­zyme Re­place­ment Ther­apy (ERT) drugs used to treat seven types of LSDs, which means a steep pay­ment on even free medicines be­cause the sticker price is very high.

More im­por­tantly, nearly 200 out of 600 pa­tients with LSDs had been given drugs for free through char­i­ta­ble ac­cess pro­grammes like the In­dia Char­i­ta­ble Ac­cess Pro­gram (INCAP) by Sanofi Gen­zyme, ac­cord­ing to the Lyso­so­mal Stor­age Dis­or­ders Sup­port So­ci­ety (LSDSS), a group for pa­tients with LSDs.

“My son’s med­i­ca­tion will stop by next week and, if treat­ment isn’t restarted af­ter that, he will have about two years to live,” Man­gath said. He lost his daugh­ter to Pompe in 2010 be­cause she wasn’t di­ag­nosed and treated in time. ERT drugs are used to cor­rect the de­fi­ciency of en­zymes, a par­tic­u­lar kind of protein mol­e­cule in his body. Some pa­tients with LSDs re­quire this type of treat­ment to keep their symp­toms in check.

“There are no ex­emp­tions for drugs un­der the GST regime,” said a fi­nance min­istry of­fi­cial. “GST works on the prin­ci­ple of min­i­mal ex­emp­tions.” The of­fi­cial also pointed out that all life-sav­ing drugs that were ex­empted un­der the pre­vi­ous regime have been put in the low­est rate bracket of 5%. Only those that faced tax in the pre­vi­ous regime have been put in the 12% bracket, he said. While life-sav­ing medicines im­ported for per­sonal use would con­tinue to be ex­empt from ba­sic cus­toms duty, they are not ex­empt from IGST, ac­cord­ing to San­deep Chi­lana, part­ner, Shardul Amarc­hand Man­gal­das. Th­ese medicines would at­tract ei­ther 5% or 12% IGST, he told ET. “My medicine would ac­tu­ally cost me .₹ 2 crore a year if I had to pay for it, but I get it for free through an ac­cess pro­gramme,” said Delhi-based Shashank Tyagi, 27, who has Gaucher’s dis­ease and takes a pill by Gen­zyme ev­ery­day to pre­vent symp­toms such as his spleen bloa- ting up. He may have to pay .₹ 2 lakh a month to get his medicines into the coun­try, he said.


Al­ready, ERT medicines from com­pa­nies such as Sanofi Gen­zyme and Shire have stopped en­ter­ing In­dia since July, ac­cord­ing to Man­jit Singh, pres­i­dent, LSDSS. This is be­cause 5% or 12% IGST would mean pa­tients hav­ing to pay lakhs of ru­pees ev­ery month — money they don’t have, he said. ERT drugs be­come costlier as a pa­tient gets older and heav­ier as the dosage in­creases, said Singh.

“I earn around .₹ 50,000 a month, I have a fam­ily of eight to take care of and a daugh­ter to marry off in Novem­ber,” said Greater Noid­abased Ram Naresh Singh, 49, who was di­ag­nosed in Fe­bru­ary with

Fabry, an LSD that he says makes him feel like his body is on fire.

Singh, who said he hasn’t been able to work for the last four months, was told in June that he was added to the thin list of pa­tients el­i­gi­ble for free drugs from the ac­cess pro­gramme run by Sanofi Gen­zyme. He’s been making the rounds of the All In­dia In­sti­tute of Med­i­cal Sci­ences (AIIMS) in Delhi ever since only to be told the medicines haven’t been im­ported yet be­cause of the tax.

“I may be able to scrape to­gether enough to pay the tax for a month, but how can I do this ev­ery time?” he said. Sanofi Gen­zyme said the tax was a burden for pa­tients.

“With re­gards to IGST, the im­pact is not only on the Com­pas­sion­ate Free Drug Pro­gram but also on other life-sav­ing drugs that are im­ported by pa­tients for their per­sonal use wherein they di­rectly pay the over­seas sup­plier for the drug. Th­ese pa­tients will now have to bear this tax,” a Sanofi Gen­zyme spokesper­son told ET.

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