Rx: A Good Doc­tor to Treat the Ail­ing Pharma Sec­tor

An open let­ter to PM Naren­dra Modi for an ef­fec­tive drugs reg­u­la­tor to re­vive the sec­tor

The Economic Times - - The Edit Page - Di­nesh S Thakur

Dear Prime Min­is­ter, ike mil­lions who hope your lead­er­ship can pro­pel our coun­try to­ward pros­per­ity, I too was glued to the tele­vi­sion to hear your vic­tory speech. I was heart­ened to hear your ap­peal to the res­i­dents of Varanasi to col­lec­tively pledge to clean up the streets of the city; to re­store the city to its past glory. That you chose per­sonal hy­giene and pub­lic health as your first ob­jec­tive is com­pelling.

Pub­lic health has never re­ceived the same at­ten­tion as mon­e­tary health in In­dia. For a coun­try of over a bil­lion people, we have his­tor­i­cally done a poor job of pro­vid­ing ef­fec­tive ser­vices in de­liv­ery of health­care. En­sur­ing ef­fec­tive reg­u­la­tion in health­care is as im­por­tant as your call for in­di­vid­ual re­spon­si­bil­ity for per­sonal hy­giene. They are two sides of the same coin of a co­he­sive pub­lic health pol­icy.

LAr­chaic Rules

The laws gov­ern­ing the phar­ma­ceu­ti­cal in­dus­try in In­dia are colo­nial. The Drugs and Cos­met­ics Act (1940) and the Rules (1945) are still ap­pli­ca­ble to­day. Later amend­ments — the most re­cent was in 2005 — have weak­ened the law and pa­tient safety, than bring it up to global stan­dards.

There are also ma­jor, in­ten­tional gaps. The Cen­tral Drugs Stan­dard Con­trol Or­gan­i­sa­tion (CDSCO) reg­u­lates “new drugs”, but the le­gal def­i­ni­tion of “new drugs” ex­cludes new generic medicines (Rules, s. 122E). CDSCO has ju­ris­dic­tion over “new drugs” for just four years from their ap­proval; who, if any­one, reg­u­lates them af­ter four years is not re­ally clear. Medicines that are not “new drugs”, such as new generic ver­sions of old drugs, are never un­der CDSCO ju­ris­dic­tion; they are reg­u­lated by in­di­vid­ual states. These in­di­vid­ual states have con­sti­tu­tional ju­ris­dic­tion to li­cense man­u­fac­tur­ing fa­cil­i­ties, mon­i­tor prod­ucts and pros­e­cute vi­o­la­tions.

Im­ports and safety of drugs for do­mes­tic con­sump­tion is the remit of the CDSCO. But its role over drug ex­ports is that of a Potemkin reg­u­la­tor: it signs off on ex­port li­cences, while al­low­ing drug firms to self-as­sess their com­pli­ance. CDSCO claims these medicines meet the World Health Or­ga­ni­za­tion (WHO) stan­dards for Good Man­u­fac­tur­ing Prac­tices (GMPs), but it does not re­ally know, and has no ap­par­ent le­gal ba­sis for this re­spon­si­bil­ity.

Faulty Im­ple­men­ta­tion

CDSCO, lo­cated within the min­istry of health and fam­ily wel­fare, pre­scribes stan­dards for en­sur­ing safety, ef­fi­cacy and qual­ity of drugs; it reg­u­lates mar­ket au­tho­ri­sa­tion of new drugs and clin­i­cal stud­ies, su­per­vises drug im­ports and ap­proves li­cences to man­u­fac­ture new drugs. The min­istry of com­merce and in­dus­try pro­motes the In­dian phar­ma­ceu­ti­cal in­dus­try, but it doesn’t have any knowl­edge of the qual­ity of prod­ucts it pro­motes. The Na­tional Phar­ma­ceu­ti­cal Pric­ing Author­ity (NPPA), un­der the depart­ment of chem­i­cals and petro­chem­i­cals, es­tab­lishes prices of drugs and en­forces avail­abil­ity of medicines in the coun­try. It is hardly a sur­prise that the in­dus­try has dif­fi­culty in deal­ing with such a dis­jointed, bu­reau­cratic sys­tem.

The Im­pact

Lack of a co­or­di­nated reg­u­la­tory frame­work has a di­rect bear­ing on lim­it­ing the growth of this in­dus­try. De­lays in se­cur­ing reg­u­la­tory ap­provals to con­duct clin­i­cal stud­ies in the coun­try is forc­ing the in­dus­try to spend a lot more money to con­duct these stud­ies over­seas. A knee­jerk re­ac­tion against en­force­ment of global man­u­fac­tur­ing stan­dards to en­sure prod­uct qual­ity is erod­ing the cred­i­bil­ity of the in­dus­try. A schiz­o­phrenic pol­icy that gov­erns lo­cal pric­ing and global in­vest­ments pro­vides no as­sur­ance to the in­dus­try of sta­ble and sus­tain­able poli­cies leading to muted growth.

The in­dus­try’s ex­ports, driven pri­mar­ily by the ad­van­tage of lower cost of man­u­fac­tur­ing and skills in process and medic­i­nal chem­istry, have been tainted by a few who took ad­van­tage of the frag­mented reg­u­la­tory struc­ture to put prof­its be­fore the hopes of the sick and poor. As a re­sult, those very prod­ucts that are en­joined from ex­port to mar­kets where reg­u­la­tory mech­a­nism is ef­fec­tive make their way into the do­mes­tic mar­ket and are con­sumed by In­dia’s poor.

The Way For­ward

Your party’s man­i­festo recog­nises this sit­u­a­tion. It pledges to re­or­gan­ise the min­istry of health and fam­ily wel­fare for ef­fec­tive de­liv­ery of health­care ser­vices. With a mas­sive man­date for change and bet­ter gov­er­nance, there is no bet­ter time than now to make this hap­pen.

In 2003, the Mashelkar Com­mit- tee Re­port rec­om­mended es­tab­lish­ment of a Na­tional Drug Author­ity to re­struc­ture this dis­jointed reg­u­la­tory frame­work. Un­for­tu­nately, many of the rec­om­men­da­tions made by this com­mit­tee were never been se­ri­ously con­sid­ered and even fewer adopted. Clearly, in­di­vid­ual states have vested in­ter­ests in the cur­rent struc­ture. As a for­mer chief min­is­ter, no one is bet­ter po­si­tioned than you to un­der­stand Cen­tre-state dy­nam­ics. We need an in­no­va­tive mech­a­nism to re­solve this im­passe.

There have been some at­tempts to rem­edy this sit­u­a­tion in the re­cent past. In­creas­ing the budget for the CDSCO from a mea­gre .` 24 crore an­nu­ally to around .` 3,000 crore over five years is a good start. But we need struc­tural re­forms. The role of the Drug Con­troller Gen­eral of In­dia (DCGI) needs to be el­e­vated to an in­de­pen­dent ex­ec­u­tive level. It doesn’t have any statu­tory power over state reg­u­la­tory ma­chin­ery now. It re­ports to a joint sec­re­tary in the min­istry of health, three lev­els re­moved from the de­ci­sion mak­ers.

It is in­struc­tive to com­pare the reg­u­la­tors for phar­ma­ceu­ti­cal and telecom­mu­ni­ca­tions, two in­dus­tries that are sim­i­lar in size. The Tele­com Reg­u­la­tory Author­ity of In­dia (Trai) has been in­stru­men­tal in en­sur­ing ac­cess to low-cost, good qual­ity com­mu­ni­ca­tion ser­vices reach­ing even the most re­mote parts of our coun­try. Sadly, the phar­ma­ceu­ti­cal in­dus­try doesn’t have a reg­u­la­tor of Trai’s stature, and it shows.

The in­dus­try earns more sell­ing its prod­ucts over­seas than it does in lo­cally. One com­plaint I hear most from our global cus­tomers is the lack of com­pe­tence and cred­i­bil­ity of the In­dian reg­u­la­tor. As some­one who has re­cently led a pro­gres­sive and mes­sage-ori­ented cam­paign, you must recog­nise that cred­i­bil­ity of the lead­er­ship is in­stru­men­tal in re­al­is­ing the im­pact of the mes­sage. Our reg­u­la­tor needs to speak ef­fec­tively for pub­lic health in In­dia and for the poli­cies of your govern­ment in a cred­i­ble man­ner to the global com­mu­nity. We need some­one who is not just tech­ni­cally qual­i­fied — a med­i­cal doc­tor, some­one who has worked in the in­dus­try to bring new drugs to the mar­ket, some­one who un­der­stands the ex­pec­ta­tions and has worked with global reg­u­la­tors, some­one who was re­spon­si­ble for in­no­va­tion — but some­one with unim­peach­able in­tegrity.

The man­date you re­ceived was in re­sponse to your vi­sion of good gov­er­nance and a re­spon­sive ad­min­is­tra­tion. Help us cre­ate an en­vi­ron­ment where the global phar­ma­ceu­ti­cal in­dus­try en­gages more pro­duc­tively in In­dia rather than ship­ping its re­search and de­vel­op­ment and man­u­fac­tur­ing fa­cil­i­ties to China. Re­store the cred­i­bil­ity of this in­dus­try al­low­ing it to ful­fil the prom­ise of thou­sands of well-pay­ing jobs to the young people here. Make pub­lic health a pri­or­ity for your ad­min­is­tra­tion; and help re­alise the hopes and dreams of a clean and healthy In­dia.

ANIMISHA

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