Vet­eri­nary drug han­dover to new reg­u­la­tor de­layed

Business World - - The Economy - Revin Mikhael D. Ochave

THE Bureau of An­i­mal In­dus­try (BAI) has been given a six-month tran­si­tory pe­riod to trans­fer reg­u­la­tory du­ties over vet­eri­nary drugs to the Food and Drug Ad­min­is­tra­tion (FDA).

In a joint ad­min­is­tra­tive or­der, the De­part­ment of Agri­cul­ture (DA) and the De­part­ment of Health (DoH) re-adopted Joint DoH and DA Ad­min­is­tra­tive Or­der No. 2013-0026 for six months, in or­der to fa­cil­i­tate the li­cens­ing and reg­is­tra­tion of vet­eri­nary drugs.

Un­der the part­ner­ship, BAI reg­u­lates vet­eri­nary drugs and bi­o­log­i­cal prod­ucts such as vac­cines, den­tal sticks, dis­in­fec­tants, and feed sup­ple­ments.

The FDA cov­ers vet­eri­nary drugs in phar­ma­ceu­ti­cal dosages ex­cept feeds, med­i­cated soaps and sham­poo, and med­i­cated col­lars.

The 2013 or­der was orig­i­nally is­sued to avoid over­lap­ping reg­u­la­tory func­tions of the FDA and BAI, which de­rive their author­ity from Re­pub­lic Act (RA) 3720 or the Food, Drugs and De­vices and Cos­met­ics Act as amended by RA 9711 or the Food and Drug Ad­min­is­tra­tion Act.

How­ever, the or­der has ex­pired af­ter a va­lid­ity of five years, ef­fec­tively strip­ping BAI of its reg­u­la­tory author­ity.

Un­der RA 9711, the FDA has the power to ask any de­part­ment or agency for as­sis­tance in im­ple­ment­ing its reg­u­la­tory ca­pac­ity.

Ac­cord­ing to the new joint ad­min­is­tra­tive or­der, the re- adop­tion of the 2013 or­der was in­tended to pro­vide un­in­ter­rupted de­liv­ery of vet­eri­nary drug and nu­tri­tional prod­uct reg­u­la­tory ser­vices dur­ing the pan­demic.

In a mo­bile phone in­ter­view, Philip­pine Vet­eri­nary Drug As­so­ci­a­tion (PVDA) Pres­i­dent Eu­ge­nio P. Mende said the six-month ex­ten­sion given to BAI al­lows the vet­eri­nary medicine in­dus­try to ad­just to the trans­fer of reg­u­la­tory pow­ers to the FDA.

Mr. Mende said the in­dus­try’s rev­enue has taken a hit due to African Swine Fever (ASF) as well as dis­rup­tion caused by the pan­demic.

“Many busi­nesses have closed due to ASF. Ev­ery pig uses nu­tri­tional prod­ucts and vac­cines. Add to that the ef­fects of the COVID-19 pan­demic. The in­dus­try has been badly hit in terms of rev­enue,” Mr. Mende said.

“The changes in the reg­u­la­tion will add an­other chal­lenge in the vet­eri­nary medicine in­dus­try and nu­tri­tional prod­ucts,” he added. —

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