In emphasizing a balanced national drug control program as a priority, the Dangerous Drugs Board sets the regulatory control requirements for Lianhua Qingwen capsules recently approved by the Food and Drug Administration.
Having ephedra as one of the medicine’s components, the FDA has referred the concern to the DDB upon receipt of the application for product registration. In May, the DDB approved a resolution indicating no objection to the registration provided that should it be approved, proper licenses and other regulatory requirements must be secured and complied with by the importer.
Noting FDA’s release of the Certificate of Product Registration for Lianhua Qingwen as a traditional herbal product that may help address fever, muscle soreness, stuffy and runny nose, which are symptoms associated with COVID-19, the DDB believes that access to this medication must not be hampered while preventing diversion and unsafe use and abuse.
The DDB, on Monday, issued another resolution prescribing the regulatory control requirements for the importation, sale, distribution and prescription of Lianhua Qingwen capsules. The regulatory mechanism aims to safeguard the public health interest even during the pandemic.
Importers or distributors of the capsules must secure a S-5-I license or the license to import drug preparations containing controlled chemicals from the Philippine Drug Enforcement Agency. Every batch of importation must also be accompanied by an Import Permit.
As a preparation containing a controlled substance, Lianhua Qingwen capsules can only be prescribed by a physician with a PDEA S-2 license. Given the low or negligible risk of abuse and possible diversion noting the insignificant content of ephedra in the medicine preparation, ordinary prescription in triplicate copies may be used and not anymore the Special Prescription Form for Dangerous Drugs (SPFDD) or the Yellow Prescription.
The DDB also noted that after the laboratory analysis done by the FDA, the medical preparation was found to contain only 9.14 milligrams of ephedra extract and not the previously cited 85 milligrams based on the product indication. Nevertheless, enforcement agencies led by PDEA are ready to monitor every level of distribution of the product and prevent its diversion.
The DDB also warns the public that online sale and distribution of Lianhua Qingwen capsules is prohibited and those engaging in this activity may be charged and apprehended depending on the severity of the violation committed under the Philippine Pharmacy Act or RA 10918.