Veterinary drug handover to new regulator delayed

veterinary drug handover to new regulator delayed - Veterinary drug handover to new regulator delayed

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. — Revin Mikhael D. Ochave

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