Fix­ing In­dia’s Drug Qual­ity Prob­lem

The Economic Times - - The Edit Page -

Of­fi­cial es­ti­mates say 4.5% of the drugs sold in In­dia are sub­stan­dard, oth­ers say three times as much. Sub­stan­dard medicines can de­lay re­cov­ery, lead to drug re­sis­tance or even kill. In In­dia, 58.2% of the to­tal health ex­pen­di­ture is borne out-of­pocket, of which 70-77% is on medicines that might or might not work. Blame de­fi­cient reg­u­la­tion of man­u­fac­tur­ing, sale and dis­tri­bu­tion of drugs. Reg­u­la­tors num­ber 36. Suc­ces­sive govern­ments have failed to bring co­her­ence through cen­tral­i­sa­tion, even though suc­ces­sive com­mit­tees right from 1954 have rec­om­mended it. The ab­sence of a le­gal frame­work is com­pounded by in­ad­e­quate hu­man re­sources, both in num­bers and qual­ity, paucity of ac­cu­rate in­for­ma­tion and un­even, un­co­or­di­nated en­force­ment by cen­tral and state reg­u­la­tors. Even the man­ner in which qual­ity is as­sessed is a prob­lem. En­force­ment of qual­ity takes place at the mar­ket place, when the reg­u­la­tors test drugs that are al­ready avail­able. This is not the global prac­tice where the qual­ity con­trol in­ter­ven­tion is at the process level. In 2012, a par­lia­men­tary com­mit­tee went so far as to say that the reg­u­la­tor, the Cen­tral Drugs Stan­dard Con­trol Or­gan­i­sa­tion, has given pri­macy to the prop­a­ga­tion and fa­cil­i­ta­tion of the drugs in­dus­try, while fail­ing to en­sure the in­ter­est of the big­gest stake­holder, the consumer. The pub­lic health cri­sis at home apart, this has had a neg­a­tive im­pact on In­dia’s drug ex­ports as well. In­dia is the largest sup­plier of generic drugs, ac­count­ing for 20% of the global mar­ket. The good news is that fix­ing the qual­ity prob­lem is not an im­pos­si­ble task. The pre­scrip­tions are there, gath­er­ing dust — it re­quires build­ing a cen­tralised and ef­fec­tive reg­u­la­tory mech­a­nism, with the right kind of sup­port. Per­haps the real chal­lenge is to find the po­lit­i­cal will to take ac­tion.

Newspapers in English

Newspapers from India

© PressReader. All rights reserved.