Pharma industry cites red tape for over 1,500 of pending registration

THE PHARMACEUTICAL sector called on the government to address the red tape in processing medicine registrations, citing more than 1,500 pending applications at the Food and Drug Administration (FDA) with some filed over seven years ago.

In a House of Representatives panel hearing on Thursday, Philippine Chamber for Pharmaceutical Industries (PCPI) Technical Director Frances Evelyn P. Robles said the total is based on data from among its member companies.

For certificates for product registrations that are low risk to no risk, there  are 479 pending applications since 2013.

For high risk applications, Ms. Robles said 1,025 are pending based on data provided by 30 of its member companies.

In terms of new applications or applications for a license to operate, 50 have been pending since 2018.

The PCPI was among various pharmaceutical stakeholders invited to the House committee on good government’s motu propio inquiry regarding guidelines of the FDA and Department of Health in product registration.

Philippine Pharmaceutical Manufacturers President Higinio Porte, Jr. said the Philippines should adopt drug registration practices from other Asian countries, which enjoy drug self-sufficiency.

“In the Philippines almost all government procurement of medicines are imported. The share of locally-produced pharma medicines is down to 32% from 36%,” he said.

House Deputy Speaker Bernadette Herrera-Dy, who filed the House Resolution on the probe, said red tape is a “grave sin” in a time of pandemic, noting that it discourages local production.

“If we use our local pharma, we will have more supply and it could be cheaper and medicines will be more accessible,” she said in Filipino during the hearing. — Gillian M. Cortez