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Inspection of firms ordered to curb ‘diversion’ of drug substances
MANILA — Philippine Drug Enforcement Agency (PDEA) Director General Aaron N. Aquino has ordered an intensified conduct of compliance inspections to prevent the use of legitimate substances for illicit purposes, particularly in the manufacture of dangerous drugs.
Aquino said 5,427 registered pharmaceutical and chemical entities handling controlled precursors and essential chemicals (CPECs) and other similar substances would be targeted for compliance inspections.
PDEA, through its Compliance Service, exercises regulatory functions including processing and issuance of licenses and permits to pharmaceutical and chemical establishments engaged in the importation, distribution, manufacture, prescription, dispensing and selling of such items.
“This is to determine the compliance of our regulated parties such as corporations, institutions, individuals and other legal entities with the terms and conditions of any license or permit granted pursuant to Republic Act 9165, otherwise known as the Comprehensive Dangerous Drugs Act of 2002, and other implementing rules and regulations enforced by the Agency,” Aquino said in a statement.
Aquino said the inspections conducted by all Regulatory Compliance Officers (RCOs) must comply with the agency’s Quality Management System.
For Regional Compliance Units, each RCO is required to conduct at least four monthly inspections.
The PDEA chief said to balance enforcement on chemical diversion control, regulatory information advocacies are also being undertaken by PDEA-Compliance Service/units through meetings and conduct of seminar-workshops to stakeholders in collaboration with the Chemical and Pharmaceutical Industry Organization of the Philippines Inc.
The agency also maintains harmonious coordination and collaboration with other government regulatory agencies and international counterparts.