In­dian med­i­cal de­vice Firms be given laster ac­cess to US-FDA: study

Assocham Bulletin - - STUDY -

The ASSOCHAM has sug­gested that the In­dian ~ firms en­gaged in the man­u­fac­ture of med­i­cal de­vices, be en­abled faster ac­cess to the US drug and phar­ma­ceu­ti­cal reg­u­la­tor FDA or FDA equiv­a­lent cer­ti­fi­ca­tions in a cost ef­fec­tive man­ner through a fast track FDA desk in In­dia with the gov­ern­ment, fa­cil­i­tat­ing such a dis­pen­sa­tion, ac­cord­ing to an ASSOCHAM-MRSS In­dia.Com joint study.

The med­i­cal de­vices sec­tor has been wit­ness­ing an in­creased in­ter­est from the MNCs which have stepped up their foot­prints in In­dia, along with lo­cat­ing their key re­search cen­tres in the In­dian cities. The in­flow of for­eign di­rect in­vest­ment (FDI) in med­i­cal de­vices was $90 mil­lion be­tween De­cem­ber 2014 and Au­gust 2015, post the gov­ern­ment per­mit­ting 100 per cent FDI un­der the au­to­matic route, jointly con­ducted by The As­so­ci­ated Cham­bers of Com­merce and In­dus­try of In­dia (ASSOCHAM) and MRSSin­

The global med­i­cal de­vices and tech­nol­ogy mar­ket is ex­pected to grow to $520bil­lion by 2020.The In­dian mar­ket is among the top 20 in the world by mar­ket size, and fourth in Asia af­ter Ja­pan, China and South Korea, the study noted.

Fi­nan­cial mea­sures need to be un­der­taken to in­cen­tivise man­u­fac­tur­ing in this emerg­ing sec­tor and specif­i­cal­lyin cre­at­ing an ecosys­tem in the early stages of the man­u­fac­tur­ing. The scope for ex­pan­sion is huge as In­dia's per capita spend on med­i­cal de­vices is the low­est among the BRIC (Brazil, Rus­sia, In­dia and China) coun­tries, In­dia spends a mea­gre share of $3 less than China ($7), Brazil ($21) and Rus­sia ($42)which is sig­nif­i­cantly be­hind de­vel­oped economies­like the US ($340), noted the study, in­di­cat­ing a huge po­ten­tial in the un­tapped ar­eas.

In­dian med­i­cal de­vice in­dus­try is worth over Rs 60,000 crore even as coun­try's im­port bill for this seg­ment amounts to over Rs 23,000 crore while ex­ports amount to about Rs 7,000crore, it said.

The ASSOC HAM sug­gested that par­ity of duty on raw ma­te­ri­als with fin­ished goods should be main­tained to en­able the in­dus­try move from the in­verted duty struc­ture.

Fo­cus can be given on prod­uct seg­ments rang­ing from low to medium tech­nol­ogy and with a prece­dence of man­u­fac­tur­ing in In­dia in the short term. These in­clude dis­pos­ables. con­sum­ables, cer­tain imag­ing equip­ment, im­plants, stents, some cat­e­gories of lab­o­ra­tory di­ag­nos­tics equip­ment, in­no­va­tive mHealth based so­lu­tions etc. Indige­nous man­u­fac­ture in these items can be pro­vided in­cen­tives.

The Gov­ern­ment plays a crit­i­cal role in de­vel­op­ing the ecosys­tem (sup­pli­ers, buy­ers, distribution etc.) of the med­i­cal de­vices in­dus­try. The Gov­ern­ment is also a large pur­chaser of med­i­cal de­vices with its net­work of med­i­cal col­leges, sec­ondary care hospi­tals and pri­mary health­care through pri­mary health cen­tres and sub cen­tres. Var­i­ous other Gov­ern­ment pro­grams also re­quire con­sump­tion of med­i­cal di­ag­nos­tics and de­vices.

The Gov­ern­ment can play a role in en­abling med­i­cal de­vices man­u­fac­tur­ers with faster ac­cess to FDA or FDA equiv­a­lent cer­ti­fi­ca­tions in a cost ef­fec­tive man­ner. A pos­si­ble op­tion is to set-up a fast track FDA desk in In­dia, with the Gov­ern­ment of In­dia sub­si­diz­ing cer­ti­fi­ca­tion ex­penses.

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