Lo­cally man­u­fac­tured de­vice must be of good qual­ity: Doc


Now only those who have se­cured medals in the Olympics, the CWG and the the Na­tional Games will be el­i­gi­ble for the 0.5 per cent sports quota seats in med­i­cal seats.

Trade mar­gins for med­i­cal devices have be­come a bone of con­tention be­tween the gov­ern­ment and man­u­fac­tur­ers and im­porters of the devices, as the price cap­ping strat­egy that the gov­ern­ment wants to in­tro­duce will not work for all devices and can af­fect the qual­ity of care in hos­pi­tals.

The re­cent move by the gov­ern­ment for Trade Mar­gin Ra­tio­nal­i­sa­tion will re­duce costs and make the devices af­ford­able, but there are fears that this will com­pro­mise the qual­ity of the prod­ucts.

Med­i­cal devices in­clude med­i­cal dis­pos­ables and con­sum­ables; med­i­cal elec­tron­ics, hos­pi­tal equip­ment, sur­gi­cal in­stru­ments, im­plants and di­ag­nos­tic reagents.

At present, only 23 devices are no­ti­fied as drugs and reg­u­lated un­der the Drugs and Cos­met­ics Act. Car­diac stents, con­doms, in­tra uter­ine devices and a range of or­thopaedic knee im­plants are reg­u­lated by the gov­ern­ment in the Na­tional List of Essential Medicines (NLEM). Of these car­diac stents and knee im­plants are sub­ject to price ceil­ings.

Dr K.K. Ag­gar­wal, se­nior mem­ber of the In­dian Med­i­cal As­so­ci­a­tion, says, “We now have two cat­e­gories of drugs — NLEM and non-NLEM.” He be­lieves the trade mar­gins in med­i­cal devices need to be fixed to make health­care more af­ford­able.

At present, the trade mar­gins are fixed by the in­dus­try with­out any reg­u­la­tion. A se­nior drug con­trol of­fi­cer in TS said, “The trade mar­gins are fixed ac­cord­ing to the whims and fan­cies of the man­u­fac­tur­ers. They are dic­tat­ing the price in the mar­ket. But the reg­u­la­tion is aimed at stream­lin­ing the sec­tor and also en­sur­ing that do­mes­tic man­u­fac­tur­ers get a bet­ter chance. Qual­ity checks have to be car­ried out by the gov­ern­ment from time to time to en­sure that there are no lapses. Also, those who are il­le­gally op­er­at­ing have to be booked and brought into the le­gal net.

All man­u­fac­tur­ers come un­der the As­so­ci­a­tion of In­dian Med­i­cal De­vice In­dus­try (AIMED) and their de­mand is that do­mes­tic man­u­fac­tur­ers must be given tax ben­e­fits and a level play­ing field so that they can com­pete with the im­porters. Most med­i­cal devices in In­dia are im­ported. There is qual­ity as­sur­ance in im­ported prod­ucts and they are largely used by pri­vate hos­pi­tals.

A se­nior doc­tor pointed out that the do­mes­ti­cally man­u­fac­tured de­vice must be of good qual­ity.

“It’s just like generic drugs. Main­tain the qual­ity and there will be tak­ers. The trade mar­gin must not be detri­men­tal for the im­porter other­wise In­dia will be­come a dump­ing ground for lowqual­ity prod­ucts which will have a re­verse ef­fect on health­care.”

Ra­jiv Nath, fo­rum co­or­di­na­tor of AIMED, said, “The price of the im­ported prod­uct in­volves cost, in­sur­ance and freight which must be con­sid­ered. With do­mes­tic man­u­fac­tur­ers, the ex fac­tory price must be taken into ac­count. These two as­pects must be con­sid­ered by the gov­ern­ment be­fore fix­ing the trade mar­gins.”

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