Aims at pro­vid­ing a longer term sta­ble pol­icy en­vi­ron­ment

To over­come the chal­lenges like De­clin­ing CAGR; Non-ad­her­ence to qual­ity stan­dards and norms; Grow­ing com­pe­ti­tion from other coun­tries; De­pen­dence on im­ports for the key start­ing ma­te­ri­als as also of the APIs; Lack of R&D and dis­cov­ery of new mol­e­cules, a

BioSpectrum (India) - - BIO CONTENT - Narayan Kulka­rni Narayan.kulka­rni@mmac­

With the aim to boost do­mes­tic man­u­fac­tur­ing of drugs, levy cap on trade mar­gins, crack­down on un­fair mar­ket­ing prac­tices and limit 'loan li­cens­ing' by pharma com­pa­nies, the Depart­ment of Phar­ma­ceu­ti­cals (DoP), Min­istry of Chem­i­cals and Fer­til­iz­ers, govern­ment of In­dia has come up with a 18 page Draft Phar­ma­ceu­ti­cal Pol­icy, 2017 on Au­gust 17.

The new Draft Phar­ma­ceu­ti­cal Pol­icy, 2017 ad­dresses a range of is­sues in­clud­ing indige­nous pro­duc­tion of ac­tive phar­ma­ceu­ti­cal in­gre­di­ent (API), qual­ity con­trol and reg­u­la­tory ap­proval, man­u­fac­tur­ing ar­range­ments, for­eign di­rect in­vest­ment, in­no­va­tion and R&D and in­tel­lec­tual prop­erty. A ma­jor por­tion of the draft is de­voted to pric­ing and makes var­i­ous rec­om­men­da­tions for the re-struc­tur­ing of the Na­tional Phar­ma­ceu­ti­cals Pric­ing Author­ity (NPPA) and changes to the Drug Price Con­trol Or­ders (DPCO) says All In­dia Drug Ac­tion Net­work (AIDAN), an in­de­pen­dent net­work of sev­eral non-govern­ment or­ga­ni­za­tions work­ing to in­crease ac­cess and im­prove the ra­tio­nal use of es­sen­tial medicines.

Wel­com­ing the ef­forts of Depart­ment of Phar­ma­ceu­ti­cals, In­dian Phar­ma­ceu­ti­cal Al­liance (IPA) com­pli­ments sec­re­tary, DoP for ini­ti­at­ing work on a com­pre­hen­sive Phar­ma­ceu­ti­cal Pol­icy. Re­act­ing to the draft pol­icy DG Shah, Sec­re­tary Gen­eral, IPA said “We wel­come the ef­forts of DoP to in­cor­po­rate in one doc­u­ment var­i­ous el­e­ments from the 1978 Pol­icy as mod­i­fied in 1986 and 1994 and fo­cus on some new is­sues.”

Com­ment­ing on the draft pol­icy re­lated to man­u­fac­tur­ing and qual­ity, IPA noted that the draft makes sev­eral ob­ser­va­tions about the cur­rent state of qual­ity and the Good Man­u­fac­tur­ing Prac­tices (GMP). These ob­ser­va­tions need to be mod­er­ated as, if read out of con­text, they could dam­age the na­tional in­dus­try's rep­u­ta­tion in the world as provider of qual­ity medicines at af­ford­able prices. These ob­ser­va­tions can also com­pro­mise the coun­try's as­pi­ra­tions to be rec­og­nized as Strin­gent Reg­u­la­tory Author­ity (SRA) by the World Health Or­gan­i­sa­tion (WHO). These ob­ser­va­tions also cast a shadow on some ex­cel­lent work done in a short time by the drug reg­u­la­tory author­ity and the health min­istry to strengthen the reg­u­la­tory func­tion and its work­ing.

IPA pointed that the draft re­it­er­ates some pro­pos­als from the old doc­u­ments. Many of them have not been im­ple­mented for more than two decades. It would

Un­less all con­cerned are con­vinced of its long term ben­e­fit to the con­sumer and are agree­able to pa­tients pay­ing more to­day for bet­ter to­mor­row, this could re­main just a thought. It also ob­served that the out­comes of these pol­icy ini­tia­tives will be nei­ther in the in­ter­est of the pa­tients nor in the in­ter­est of the in­dus­try as the in­dus­try has been fac­ing many other chal­lenges.

- DG Shah, Sec­re­tary Gen­eral, In­dian Phar­ma­ceu­ti­cal Al­liance (IPA)

be use­ful to ex­am­ine and eval­u­ate their util­ity and rel­e­vance to the out­comes. The draft also pro­poses some new ini­tia­tives. It is per­ti­nent to have a nar­ra­tive on the ob­jec­tives of these new ini­tia­tives. They need to be ex­am­ined with ap­pro­pri­ate data to as­sess their im­pact on the out­comes. In the cur­rent con­text of im­prov­ing in­dus­try's com­pet­i­tive­ness and cre­at­ing em­ploy­ment, it is all the more crit­i­cal that these ini­tia­tives are also eval­u­ated for their im­pact on these two pa­ram­e­ters.

The draft rec­om­mends cer­tain ac­tions aimed at im­prov­ing the qual­ity and the GMP. These in­clude manda­tory bioavail­abil­ity (BA) and bio-equiv­a­lence (BE) stud­ies by all man­u­fac­tur­ers and sug­gest self­cer­ti­fi­ca­tion as so­lu­tion for large num­ber of prod­ucts cur­rently mar­keted with­out BA/BE stud­ies. It also rec­om­mends an­nual in­spec­tion of man­u­fac­tur­ing fa­cil­i­ties with op­tion for self-cer­ti­fi­ca­tion. These so­lu­tions grossly un­der­mine the im­por­tance of the qual­ity.

En­sur­ing “world class qual­ity of drugs” re­quire more qual­ity pa­ram­e­ters than mere bio equiv­a­lence with the in­no­va­tor prod­uct. The world class qual­ity also needs the sta­bil­ity data, in-vitro dis­so­lu­tion, im­pu­rity pro­file and GMP com­pli­ance. These be­ing tech­ni­cal mat­ters, they are best left to the drug reg­u­la­tory author­ity and the ap­pro­pri­ate tech­ni­cal com­mit­tees and bod­ies.

Mak­ing point on price and avail­abil­ity of the drugs, IPA noted that the draft makes sug­ges­tions that al­ters the ba­sic tenets and the struc­ture of the Na­tional Phar­ma­ceu­ti­cal Pric­ing Pol­icy (NPPP), 2012 and mod­i­fies the Drugs (Prices Con­trol) Order (DPCO), 2013. It would be es­sen­tial that the draft pro­vides the ra­tio­nale and ob­jec­tive of these changes. The changes in­clude: con­fer­ring ab­so­lute pow­ers to the Depart­ment of Phar­ma­ceu­ti­cals for vet­ting Na­tional List of Es­sen­tial Medicines (NLEM) and de­cid­ing the drugs that should be ex­cluded from price con­trol; bring­ing all strengths and dosages of spec­i­fied drugs un­der price con­trol; do­ing away with the "Re­tail Price" and hav­ing only the "Ceil­ing Price" for non-sched­uled prod­ucts, thereby ex­pand­ing the span of con­trol; con­sid­er­ing man­u­fac­tur­ers' one­time bonus and pro­mo­tional of­fers to trade in price fix­a­tion; fix­ing mar­gin for the whole­salers; etc.

The draft also pro­poses to strengthen the NPPA by in­duc­tion of rep­re­sen­ta­tives of civil so­ci­ety, doc­tors, phar­ma­cists, in­dus­try and the govern­ment in the ad­vi­sory board. In ad­di­tion, it seeks to con­vert the NPPA into a multi-mem­ber body, which has to work by con­sen­sus. IPA ap­pre­hends that both these measures will lead to fur­ther de­lays and com­pli­cate the func­tion­ing of the NPPA, in­stead of sim­pli­fy­ing its work­ing.

The IPA rec­og­nizes the need to make medicines af­ford­able and sup­ports this ini­tia­tive. How­ever, the in­dus­try alone can­not take this bur­den. The over em­pha­sis on af­ford­abil­ity is a mat­ter of con­cern as it could dis­turb the del­i­cate bal­ance be­tween the price and avail­abil­ity. Also, sev­eral measures pro­posed in the draft to im­prove qual­ity and GMP will have ma­jor im­pact on the cost of pro­duc­tion. The pres­sures to re­duce the prices and im­prove the qual­ity at the same time will only squeeze the man­u­fac­tur­ers' mar­gin, im­pact­ing the avail­abil­ity of medicines.

Talk­ing about the in­no­va­tion and in­di­g­e­niza­tion, DG Shah pointed out that the draft dis­plays in­ad­e­quate ap­pre­ci­a­tion of the in­dus­try's ef­forts to­wards in­no­va­tion and com­plete ig­no­rance of the drug dis­cov­ery process. The in­dus­try's spend on re­search and de­vel­op­ment has in­creased by more than 150% in the ten-year pe­riod from Rs 1,441 crore in 2004 to Rs 3,632 crore in 2014, ac­cord­ing to Cap­i­taline. A few ma­jor com­pa­nies spend about 8% to 12% of their rev­enues in re­search, which is com­pa­ra­ble to the global generic play­ers, in spite of op­er­at­ing in a hos­tile pric­ing en­vi­ron­ment. The no­tion

that "giv­ing brand names to generic drugs ham­pers real in­no­va­tion" is with­out any ba­sis. On the con­trary, learn­ing to build brands is a first step in the process of in­no­va­tion.

In­no­va­tion needs a sup­port­ing pol­icy en­vi­ron­ment, in­clud­ing pro­tect­ing trade­marks and pro­mot­ing brands, whereas the ear­lier poli­cies and the cur­rent draft sug­gest abol­ish­ing brands. Even in the ab­sence of such a pol­icy en­vi­ron­ment, the na­tional in­dus­try has not lost sight of putting In­dia on the global map of in­no­va­tive coun­tries. It should there­fore be rec­og­nized for its ef­forts and risk tak­ing.

The draft needs to rec­og­nize that re­search and de­vel­op­ment re­quire lot more than mere con­ces­sional rate of cus­toms duty. It is a high risk in­vest­ment and needs re­turns com­men­su­rate with the risks.

The IPA com­pli­ments sec­re­tary-Depart­ment of Phar­ma­ceu­ti­cal for the very thought of cre­at­ing de­mand for in­dige­nously pro­duced APIs to re­duce de­pen­dence on im­ports. How­ever, its im­ple­men­ta­tion is a chal­lenge. Un­less all con­cerned are con­vinced of its long term ben­e­fit to the con­sumer and are agree­able to pa­tients pay­ing more to­day for bet­ter to­mor­row, this could re­main just a thought. It also ob­served that the out­comes of these pol­icy ini­tia­tives will be nei­ther in the in­ter­est of the pa­tients nor in the in­ter­est of the in­dus­try as the in­dus­try has been fac­ing many other chal­lenges.

Be­cause of the many chal­lenges, the in­dus­try’s growth has slowed down. The do­mes­tic mar­ket has de­clined to mid-sin­gle digit rate and the ex­ports have re­ported ab­so­lute de­cline. DG Shah sug­gested that the draft should be viewed against this back­ground. Its dis­rup­tive pro­pos­als could fur­ther hurt the sen­ti­ments and desta­bi­lize the in­dus­try. The tim­ing of these dis­rup­tive changes is not op­por­tune. The IPA there­fore re­quests that the draft pol­icy be held in abeyance un­til such time as some sta­bil­ity is re­stored and the in­dus­try is ready to han­dle new dis­rup­tions.

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