Em­pow­er­ing pa­tients to self-med­i­cate, but re­spon­si­bly

Mar­keters, phar­ma­cists, con­sumer bodies should take re­spon­si­bil­ity for OTC medicines

The Hindu Business Line - - PULSE - G SATHYA NARAYANAN

Glob­ally, cul­tural trends and so­cial at­ti­tudes are redefin­ing con­sumerism. But, con­sumerism in health calls for an ecosys­tem that em­pow­ers con­sumers to make wise choices. And it’s here that over-the-counter (OTC) medicines es­say a crit­i­cal role in help­ing many self-treat or man­age their own health con­di­tions.

Con­sumers ben­e­fit from wellde­fined OTC reg­u­la­tions that sup­port a favourable en­vi­ron­ment for re­spon­si­ble self-med­i­ca­tion. How­ever, In­dia lacks de­fined OTC reg­u­la­tions thereby com­pro­mis­ing pa­tient safety. With the Ayush­man Bharat roll out, the gov­ern­ment needs to con­sider a well -reg­u­lated OTC frame­work that will help ac­cel­er­ate the process of ex­pand­ing ac­cess to medicines.

In the con­text of In­dia’s health­care in­fras­truc­ture and the es­tab­lished trend of un­der­the-counter sales of pre­scrip­tion medicine, it is im­per­a­tive to en­cour­age re­spon­si­ble self­med­i­ca­tion among In­dian pa­tients as a means to im­prove over­all health out­comes. In fact, just on Fri­day, the Or­gan­i­sa­tion of Phar­ma­ceu­ti­cal Pro­duc­ers of In­dia (OPPI), rep­re­sent­ing the re­search-based phar­ma­ceu­ti­cal com­pa­nies, re­leased a study on “Shap­ing In­dia’s OTC Pol­icy 2018.”

The study high­lights the need to cre­ate an ideal reg­u­la­tory frame­work for OTC medicines, which in­cludes cre­at­ing a ro­bust list of OTC medicines with reg­u­la­tions, which are dis­tinct from the cur­rent laws gov­ern­ing pre­scrip­tion medicine. En­sur­ing large-scale avail­abil­ity of qual­ity OTC medicines through dis­tri­bu­tion chan­nels beyond con­ven­tional phar­ma­cies is also nec­es­sary.

Other high­lights from the study in­clude — ed­u­cat­ing con­sumers and phar­ma­cists on the ju­di­cious use of OTC medicine through clear and re­spon­si­ble mes­sag­ing; cre­at­ing a sys­tem of checks and bal­ances re­lated to the safety, ef­fi­cacy, pro­mo­tion, and con­sump­tion of OTC medicines, such that their ben­e­fits are max­imised and risks mit­i­gated; cre­at­ing a pric­ing par­a­digm that en­cour­ages in­vest­ment in the pro­duc­tion and re­spon­si­ble pro­mo­tion of OTC drugs that pro­vides wider con­sumer choice and cre­at­ing a reg­u­la­tory path­way for pre­scrip­tion or Rx-to-OTC switches based on es­tab­lished safety and ef­fi­cacy pro­file.

The study pro­poses the need for a leg­is­la­tion that would serve as the prin­ci­pal law reg­u­lat­ing im­port, man­u­fac­ture, pro­mo­tion, dis­tri­bu­tion and sale of OTC drugs. Hence, the sug­ges­tion is to in­clude a sep­a­rate Rule and a sep­a­rate Sched­ule on OTC (pro­posed nomen­cla­ture Sched­ule “O”) in the Drugs and Cos­met­ics Act, 1940 and Drugs and Cos­met­ics Rules, 1945.

The pro­posed OTC Sched­ule could also in­clude the list of Ac­tive Phar­ma­ceu­ti­cal in­gre­di­ents (API) that can be used in OTC drug prod­ucts.

Most of these APIs are in­cluded in the In­dian Phar­ma­copoeia and in the Na­tional For­mu­lary of In­dia and the ones which are not in­cluded are pro­posed for in­clu­sion.

Fur­ther, the study stresses on the need for es­sen­tial pa­ram­e­ters such as qual­ity, safety and ef­fi­cacy stan­dards to re­main the same as for “pre­scrip­tion” drugs. Reg­u­la­tions re­lated to man­u­fac­ture, sta­bil­ity/shelf life stud­ies, qual­ity con­trol, qual­ity as­sur­ance, fa­cil­ity in­spec­tion and ap­proval, clin­i­cal tri­als, post-mar­ket­ing safety mon­i­tor­ing, risk man­age­ment, stor­age and dis­tri­bu­tion, im­port, etc, should ap­ply equally to OTC drug prod­ucts too.

The roles and re­spon­si­bil­i­ties of OTC mar­keters, phar­ma­cists and con­sumer bodies who have a col­lec­tive re­spon­si­bil­ity to­wards driv­ing the ju­di­cious use of OTC medicines should also be well de­fined.

The over­ar­ch­ing vi­sion of Ayush­man Bharat in de­liv­er­ing good health be­gins with greater pa­tient em­pow­er­ment and self­care. This study is the first step in that jour­ney.

The au­thor is Chair­man-OPPI OTC Task­force and Man­ag­ing Di­rec­tor, South Asia, Nes­tle Skin Health In­dia Pvt Ltd

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