After melamine-laced milk and lead-contaminated toys that left consumers paranoid last year, another health danger is coming—in the form of drugs that either do not help people get well or are toxic.
In 2008, the Department of Health (DOH) reported that one in every 10 medicines available in the market is counterfeit.
Republic Act (RA) No. 9502, otherwise known as “Universally Accessible Cheaper and Quality Medicines Act of 2008,” and RA No. 8203 or the “Special Law on Counterfeit Drugs,” classify drugs as chemical compounds or biological substances intended for use in treatment, prevention or diagnosis of diseases in man or animals.
RA 8203, meanwhile, defines counterfeit drugs as any product with the wrong or no active ingredients, which result in the reduction of the drug’s safety, efficacy, quality, strength, or purity.
According to Nemia Getes, officer-in-charge of the Regulation Division 1 of the Bureau of Food and Drugs (BFAD), counterfeit drugs, which can either be “fake” or “unregistered,” are illegal and hazardous.
“Unregistered drugs are products without the trademark, identification mark, or name which is registered for use in this country. These are unlawful, imported drug products,” she told the Varsitarian. “Fake drugs contain no amount, or have a different active ingredient, or possess less than 80 percent of what the drug claims as part of its ingredients.”
These products are deliberately mislabeled with respect to the name and source, with fake packaging. They can claim to be either branded or generic products, Getes added.
Dr. Benjamin Co, executive director of the UST Center for Drug Research, Evaluation and Studies (Cedres), said expensive medicines are commonly faked.
“A cheap drug is rarely faked because everybody can afford it. So, most of the over-the-counter drugs are not faked. Expensive medications which cost 3,000 pesos to 4,000 pesos per vial are the usual drugs replicated and sold as fake,” Co said.
UST Cedres conducts drug researches, such as bioavailability, which determine whether chemicals are absorbed by the human body; and bioequivalence, the process of comparing the effects of drugs. It also conducts clinical research and monograph testing for the academe, pharmaceutical industry, and private and public agencies to ensure the safety and effectiveness of drugs.
Fake drugs kill
Co, former member of the National Adverse Drug Reaction Advisory Committee, said the proliferation of fake and unregistered drugs is a serious problem, and the lack of access to medicines as well as poverty are partly to blame.
“What they (manufacturers of fake drugs) do is put in a placebo, some powder, and an unknown formulation to copy expensive drugs. And sometimes they include medications which are illegally brought in from other countries,” Co told the Varsitarian.
Drug counterfeiting thrives in places where people cannot afford the high cost of medicines, Co added.
“We have had several patients, especially in the (UST Hospital’s) charity division who bought (fake) medicines outside,” Co said. “Fake drugs are usually available in Quiapo or Divisoria,” he added.
According to Dr. Manuel Jacinto, chief of the Medical and Dental Division of the Bureau of Customs, counterfeit drugs either have too little or too much of the active ingredient, and could lead to adverse effects to the skin, heart, kidney, and blood pressure.
Aside from “hypersensitivity reactions,” there are some cases where brain function is affected, depending on the active ingredient present in a drug.
“Most counterfeit drugs do not inhibit any effect to the body,” Jacinto said. “However, there are some that might be a risk to the health as they contain harmful ingredients.”
Co agreed.
“Fake drugs kill. But drugs that do not heal patients can also kill. In the case of unregistered drugs, these are not safe. But if something happens to you or develop a reaction, you cannot sue the company.”
Getes identified Manila, Cebu, provinces in Region III like Aurora, Bataan, Bulacan, Nueva Ecija, Pampanga, Tarlac, and Zambales, as well as Batangas, Cavite, Laguna, Rizal, Quezon in Region IV-A as hotspots for the sale and distribution of counterfeit drugs. International sources of counterfeit drugs are China, India, and Pakistan.
Often faked are costly medicines like Lasix, a drug for cardiovascular diseases; Plendil, which dilutes blood vessels; Meronem, an antibiotic; and Sensorcaine, a local anesthetic.
Combating counterfeit
BFAD’s strategies in fighting the proliferation of counterfeit drugs include licensing and inspection of establishments—pharmacies, groceries, sari sari stores, supermarkets, and malls—monitoring of products, advocacy drives, and partnership with local government units and law enforcers.
“We have intensified our surveillance of counterfeit drugs, especially at the height of the melamine issue, by doing regional audit inspections, search and seizure operations with law enforcers, and close collaboration with the Bureau of Customs,” Getes said.
Imported medicines are scrutinized in particular because many drug labels, particularly those that come from China and India, are not written in English.
Memorandum No. 02-2006, a checklist for the registration of human drugs of the Products Services Division of BFAD, states that imported products must contain an original certificate with a summary of product information, translated in English.
“We asked the Customs to report to us any product not labeled in English, because the risk of these drugs is higher since we cannot understand what the label says about its ingredients and medical purpose,” Getes said.
Last year, BFAD launched a TV and print campaign, “Pekeng Gamot…Malaking Salot!” which warned the public about the dangers of counterfeit drugs.
“It is the only way that we can warn the public of the threats of fake drugs to health. Despite the BFAD’s lack of manpower, we are trying our best,” Getes said.
For his part, Angelito Agulto, officer in charge of the Intellectual Property Unit (IPU) of the Bureau of Customs, said that fighting counterfeit drugs requires close coordination with the BFAD.
“If we find an importer’s papers dubious, we immediately inform BFAD to determine if their products are fake. Once they verify that their products are counterfeit, that is the time that we take the legal procedures,” he said.
However, out of the 16 large ports in the country, only two ports are actively monitored.
“We have only two out of 16 ports where our people are active: the Manila South Harbor and the Manila International Container Port, because these ports pose a higher risk,” Agulto said. “Smugglers rarely use the other ports because containers that come in are fewer and are well inspected. Containers in the major ports come in bulk.”
Recent data from the IPU show cases of counterfeit drugs worth millions of pesos, confiscated in the last three years.
In 2006, a person was caught aboard a plane in possession of three kilograms of counterfeit drugs worth almost half a million pesos.
The incident was declared a violation of RA 8203 and RA 8293, or the Intellectual Properties Code of the Philippines.
In 2007, passengers bound in a Manila to Bangkok flight were intercepted by the IPU in separate buy-bust operations. They found bottles of erectile dysfunction drugs such as sildenafil citrate (viagra) and tadalafil (cialis). The estimated value of the goods was 2.2 million pesos.
In the same year, almost 14 million pesos worth of drugs was seized by the IPU from 13 separate ships.
Co expects a flood of more fake drugs with the implementation of RA 9502.
“We have come into an era allowing for cheaper medicines. But the question is, are all these cheaper medicines of equal quality? Are they of equal value or bioequivalent with branded medicines?” he said.
As of June 2008, the Bureau of Customs and BFAD have confiscated 684 cases of counterfeit drugs; 342 of them fake, 144 substandard, and 198 unregistered.
“We always have to remember that drugs are double-bladed swords. While they can save, they can also kill. So, we just want the middle part, that is, the part that will alleviate people’s health problems and save lives,” Co said.
