Seal­ing the FDC Drugs Fate

BioSpectrum (India) - - BIO EDIT - Milind Kokje Chief Editor milind.kokje@mmac­tiv.com

This is one in­evitable news which ob­vi­ously the In­dian phar­ma­ceu­ti­cal in­dus­try would not like to hear as it would bring a big blow to the in­dus­try. Over 6000 medicine brands of dif­fer­ent pharma com­pa­nies and nearly Rs 2500 crore to Rs 3,000 crore mar­ket is at the stake for just one or­der from the health min­istry that is ex­pected any time.

The decks for the health min­istry or­der to ban the Fixed Dose Com­bi­na­tion (FDCs) Drugs are cleared now with a sub-com­mit­tee of the min­istry’s Drug Tech­ni­cal Ad­vi­sory Board rec­om­mend­ing such a ban. The sub-com­mit­tee headed by Dr Nil­ima Kshir­sagar, chair in Clin­i­cal Phar­ma­col­ogy at In­dian Coun­cil of Med­i­cal Re­search, has rec­om­mended to ban 343 of the 349 “ir­ra­tional” FDCs that are po­ten­tially harm­ful to pa­tients. It has been stated that FDCs should be banned as their safety was not es­tab­lished by the re­spec­tive drug pro­duc­ers. The re­main­ing six drugs, the sub­com­mit­tee has rec­om­mended, should be re­stricted and reg­u­lated.

This is­sue had been pend­ing since over the last two years when the gov­ern­ment banned these drugs first fol­low­ing a dec­la­ra­tion made by a com­mit­tee headed by Prof C K Kokate, vice chan­cel­lor of KLE Univer­sity, Be­la­gavi. Kokate com­mit­tee was con­sti­tuted fol­low­ing concerns of ex­perts about the safety of FDCs which had been flood­ing the mar­ket. They posed more dan­ger since pa­tients were self­med­i­cat­ing many of those drugs.

How­ever the en­tire mat­ter took a le­gal turn when the in­dus­try chal­lenged the gov­ern­ment ban or­der in dif­fer­ent high courts. Delhi Court quashed the or­der on the grounds that be­fore is­su­ing the ban or­der the gov­ern­ment did not con­sult the statu­tory bod­ies es­tab­lished un­der the Drugs & Cos­met­ics Act 1940. The health min­istry chal­lenged the Delhi High Court or­der in the apex court. Dr Kshir­sagar com­mit­tee was ap­pointed fol­low­ing the Supreme Court or­der ask­ing the min­istry to re-ex­am­ine the is­sue through an­other ex­pert com­mit­tee.

The re­cently sub­mit­ted re­port of the Kshir­sagar com­mit­tee has now come as a bomb­shell for the in­dus­try as it re­con­firmed the ban with se­ri­ous ob­ser­va­tions against FDCs. The com­mit­tee said the FDCs ex­pose pa­tients to overuse risks and could re­sult into ad­verse ef­fects on hu­man or­gans. It has also pointed out that most of the FDCs pro­duc­ing com­pa­nies chal­leng­ing the ban failed to gen­er­ate safety and ef­fi­cacy data. Now that two sub­se­quent ex­pert sub com­mit­tees have given the sim­i­lar rec­om­men­da­tion the in­dus­try may not have any other choice but to ac­cept it.

The pharma ex­perts are rais­ing more fun­da­men­tal and valid points in this is­sue. They have pointed out that the FDCs have flour­ished in In­dia as com­pa­nies used them to es­cape gov­ern­ment price con­trol. Drug price con­trol or­ders capped the prices of drugs hav­ing only one ac­tive phar­ma­ceu­ti­cal in­gre­di­ent (API). Com­pa­nies com­bined dif­fer­ent drugs into one FDC, thus mak­ing a new prod­uct, by­pass­ing the price con­trol. Mix­ing of drugs into one does not nec­es­sar­ily en­hances ef­fi­cacy of the new FDC, but the mix­ing of two APIs could lead to a pos­si­ble toxic com­bi­na­tion af­fect­ing the hu­man body. Hence it is es­sen­tial to test the new FDCs pro­duced by com­bin­ing two or more drugs.

Thus, the more se­ri­ous is­sue ac­cord­ing to the ex­perts is how these drugs got ap­proved in the first place with­out clin­i­cal tri­als. It ap­pears that the cen­tral gov­ern­ment reg­u­la­tor is blam­ing the state reg­u­la­tors for giv­ing ap­provals over­step­ping their ju­ris­dic­tion as only the cen­tral gov­ern­ment reg­u­la­tor can ap­prove a new drug. If this is the re­al­ity, as claimed by some me­dia then it is a very se­ri­ous is­sue which needs a thor­ough in­ves­ti­ga­tion.

It is im­por­tant that be­sides pun­ish­ing the pharma pro­duc­ers by ban­ning their FDCs, the gov­ern­ments should also en­quire into its in­ter­nal sys­tems and take action against the in­sid­ers if they too are vi­o­lat­ing any rules. The in­ter­nal sys­tems need to be free of sys­temic er­rors and peo­ple by­pass­ing the rules to pre­vent re­cur­rences of such in­ci­dences hav­ing po­ten­tial to harm the pa­tients.

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