CEBU, Philippines – The Food and Drug Administration has issued a notice of violation against 112 establishments in Central Visayas that either sell “substandard and unregistered” medicines or operate without an FDA permit.
Majority of the notified violators are from Cebu province.
Sarah Oriol, FDA Food and Drugs Section head, said that of the 800 drugstores and cosmetics shops they assessed from January to August this year, 112 violated food and drugs standard rules and regulations.
She said the month of May got the highest recorded cases at 40 followed by the months of August with 22, June (18), July (13), April (9), March (7) and June (3)
This year, FDA targets to evaluate at least 1,000 establishments.
Oriol said some of the shops were ordered padlocked following a concrete and clear discovery of violations against Republic Act No. 6675 (An Act to Promote, Require and Ensure the Production of an Adequate Supply, Distribution, Use and Acceptance of Drugs and Medicines Identified by their Generic Names) and RA 9502 (the Universally Accessible Cheaper and Quality Medicines Act of 2008).
She said others, including sari-sari store owners, were issued cease-and-desist orders after health officials discovered that the stores sold “substandard” medicines that contain less than the standard amount of the active ingredient they were supposed to contain.
The order was issued within three weeks after the inspection conducted by FDA and health officials.
Oriol said the most common violations were the selling of products not registered by FDA, selling without permits and seals, and drugstores or retail outlets without pharmacists. She said every pharmacy has to have a licensed pharmacist who is present at all times to directly and personally supervise the sale of medicines.
In relation to this, Department of Health-7 Director Jaime Bernadas called on pharmacy owners to buy only generic medicines from legitimate manufacturers and distributors to ensure the safety of consumers.
He warned them against buying generic medicines from sari-sari stores and ambulant vendors with questionable credentials.
He said the public and pharmacy owners must be vigilant in buying medicine especially against those sold cheap and the imported ones that are not FDA-registered.
He advised the public to check medicine labels and bottles for the Certification of Good Manufacturing Practice and Certificate of Product Registration to avoid the risk of buying counterfeit and poor quality medicines.
“At our end, we have to ensure that the medicines we are buying are of quality and safe and from reputable manufacturers,” he said.
“Substandard medicines are not safe and it will make you even more sick,” he added.
The presence of counterfeit and unregistered drugs and drugstores, he said, is a “serious” concern that needs constant monitoring and more teeth to existing laws.
He stressed this as the country celebrates September as Generics Awareness Month, which is aimed at promoting generic drugs.
Meanwhile, Dr. Nelson Elle, chief of DOH’s Local Health Support Division, said Central Visayas has shown improvement in terms of implementing the Generics Act of 1988.
He said doctors have now become compliant in terms of writing the generic name of the prescribed medicine and not just the brand name so as to give the patients the option to either buy generic or branded medicines, and consumers are already aware of their right to ask for cheaper medicines.
“The public should know and really insist of their right to purchase cheaper medicines but are effective and safe,” he said.
Bernadas said government doctors are mandated to prescribe generic medicines, while private physicians are disallowed to dispense branded medicines in their clinics.
Section 6 paragraph “a” of RA 6675 states that “all government health agencies and their personnel as well as other government agencies shall use generic terminology or generic names in all transactions related to purchasing, prescribing, dispensing and administering of drugs and medicines."
The same law penalizes physicians who do not write the generic name of the prescribed medicine.
First offenders would be reprimanded by health authorities and the violation will be recorded with the Professional Regulations Commission.
A P2,000 to P5,000 penalty is imposed on second offender while third offense means a P5,000 to P10,000 fine as well as suspension of the license to practice the profession for 30 days. –/RHM (FREEMAN)