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On the Danger of Substandard and Fake Medicine
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PyongSu is strongly committed to make safe and high quality medicine available to the medical profession of the DPR of Korea, either by producing it itself according to highest international industry standards or by importing it from sources that are committed to original quality pharmaceuticals. By doing so PyongSu actively contributes to minimize the risk of health hazards stemming from substandard and fake pharmaceuticals.
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The organisation at the forefront in the fight against fake medicine is the World Health Organisation (WHO) which warns about the danger of substandard or fake medicine in its Fact Sheet No. 275:
Consequences of substandard and counterfeit medicines
At best, the regular use of substandard or counterfeit medicines leads to therapeutic failure or drug resistance; in many cases it can lead to death.
During the meningitis epidemic in Niger in 1995, over 50 000 people were inoculated with fake vaccines, received as a gift from a country which thought they were safe. The exercise resulted in 2,500 deaths.
The consumption of paracetamol cough syrup prepared with diethylene glycol (a toxic chemical used in antifreeze) led to 89 deaths in Haiti in 1995 and 30 infant deaths in India in 1998.
Of the one million deaths that occur from malaria annually, as many as 200,000 would be avoidable if the medicines available were effective, of good quality and used correctly.
A study conducted in South-East Asia in 2001 revealed that 38% of 104 antimalarial drugs on sale in pharmacies did not contain any active ingredients and had resulted in a number of preventable deaths.
In 1999, at least 30 people died in Cambodia after taking counterfeit antimalarials prepared with sulphadoxine-pyrimethamine (an older, less effective antimalarial) which were sold as Artusenate.
(Out of many publications on the danger of Counterfeit Medicine we selected just the following two in order to help raise awareness of this threat.)
China Gets Tough on Counterfeit Medicine Makers
When Chi Suzhen, a 44-year-old cosmetics saleswoman, bought over-the-counter cold medicine for her 12-year-old daughter in September, she thought nothing of the safety of the drugs, which are commonly used by Chinese to treat mild illnesses.
Less than three days later, her daughter died from what doctors told her was a deadly dose of counterfeit medicine. Although the family made numerous attempts to find out how the poorly manufactured drugs had made it onto the store shelves, government officials were unable to provide answers.
"I thought these drugs were safe," she said. "No one told me, not even the doctors, to be concerned about fake medicines in the marketplace. There is no way to describe how sorrowful I feel having lost my only daughter." The Chi family, who plans to sue the pharmacy that sold them the bogus medicine, is not alone in their grief. According to the Shanghai Drug Administration, drug poisonings killed an estimated 200,000 Chinese and hospitalized2.5 million in 1999.
Officials blame counterfeit over-the-counter and prescription drugs -- many of which they say contain raw, unprocessed ingredients -- for the majority of the deaths. Faced with increasing pressure, both at home and from abroad, to combat abuses in the country's $40 billion pharmaceutical market, China has been getting tough on the manufacturers of counterfeit medicines. In the past year, the central government has closed down at least 113 pharmaceutical factories and nearly 15,000 illegal drug distributors.
Zheng Xiaoyu, director of the State Drug Administration, said reforms currently being carried out in the health care sector would require hospitals and clinics to purchase medicine through a competitive bidding process, which is aimed at reducing kickbacks in the prescription drug industry.
"A complete and strict supervision system will help the pharmaceutical distribution sector move along a sound track, guarantee people's health and provide a good investment environment for drug manufacturers," he said. "But there is still much work to be done."
In Shanghai, home to a large majority of the country's drug manufacturing plants, city officials have come under increasing pressure to crackdown on counterfeiters. In a highly symbolic move last week, officials destroyed 70,000 cases of counterfeit drugs, valued at RMB 2 million (U.S. $2240,000), and announced the creation of a special task force.
"Those bogus medicines, produced and sold by illegal factories and marketing offices, not only pose harm to public health, but also affect the dynamic development of the city's pharmaceutical industry," Zhou Yupeng, Shanghai's vice mayor, said as a steam roller plowed over a pile of bogus medicine.
This year alone, the city's drug administration has prosecuted 28 cases that violated the medicine regulation. One prosecution involved 120 cases of pirated Tibet Rhodiola -- an herbal medicine containing a powerful bioflavanoid -- made by Huaxi Pharmaceutical (Group) Co., Ltd. another concerned 2,185 cases of pirated Amoxycillin of the United Laboratories Ltd.
As China completes final negotiations on its membership the World Trade Organization, one of the chief issues still to be resolved is the country's plan to protect intellectual property rights, and many global pharmaceutical giants are calling on the government to get tougher on counterfeiting.
"The ingredients in those fake medicines aren't the same as those in legitimate drugs. The fakes are very dangerous and pose a threat to public health," said Paul Li, managing director of Merck Sharp & Dohme (China) Ltd., "We hope government will crack down on those bogus drugs as well as the smuggling, but so far their efforts have not been successful."
Copyright 2000 by United Press International.
Sales of fake medicines continue unabatedly: WHO
MANILA, Oct. 5, 2005 Kyodo
Sales of counterfeit medicines remain unabated despite continuing crackdowns on manufacturers and distributors of these potentially hazardous substances, a World Health Organization official said Wednesday.
''Counterfeit medicines have become a public health danger because of dramatic increase in the production, distribution and sales in recent years in many countries,'' Budiono Santoso, the WHO's regional advisor on pharmaceuticals, told a press conference.
Although the annual trade in counterfeit medicine is roughly estimated at $35 billion, Santoso said, ''There is no system that can quantify exactly.''
He stressed the need to intensify efforts to combat the illicit trade, which he called ''a never-ending battle.''
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'The profits are enormous and the chances of prosecution are low,'' he said. ''Counterfeit products move across national boundaries very fast.''
The WHO estimates that more than 10 percent of the medicine in the global market is counterfeit, having either no active ingredient, a wrong active ingredient, or the correct ingredient in an insufficient quantity.
Santoso said use of counterfeit or substandard medicine leads to therapeutic failure or drug resistance, or even death. ''These medicines are silent killers,'' he said.
The poor, who cannot afford to buy genuine drugs from legitimate outlets, are the usual victims, he said. Drugs that are commonly faked include anti-malarial drugs, antibiotics, vitamins and painkillers.
Last May, WHO unveiled a web-based communication network called Rapid Alert System intended to alert member countries and the public about cases of counterfeit and substandard medicine.
Through RAS, people who believe they have come across counterfeit drugs can report what they have discovered to a team of specialists, who will assess the report, attempt to confirm it and then possibly issue a worldwide alert, while incorporating the confirmed information into a WHO database.
Copyright 2005 by Kyodo News International, Inc.
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