The paracetamol syrup tragedy
Sunday, 2 August 2009
Avik Sengupta
Twenty-five children recently died after taking paracetamol. Following this tragedy, the government formed a probe committee which examined 300 samples of paracetamol and vitamin syrup produced by 10 pharmaceutical companies. The probe committee has found the presence of poisonous Diethylene Glycol in the paracetamol syrup produced by one of those companies.
The paracetamol syrup tragedy has brought to the fore the issue of how well equipped the Drug Administration is to deal with spurious and substandard medicines which pose a grave threat to public health. The ground reality is that the Drug Administration has to rely on only two drug testing laboratories to make sure that poor quality drugs do not enter the market. But the deaths of the babies have proved once again that the two laboratories fall far short of the requirement of what has to be done to stop marketing of drugs containing toxic substances.
The malpractice of unethical drug promotion and the marketing of substandard and non-essential drugs were very common in the country before 1982. Instead of producing essential drugs, most drug manufacturers manufactured non-essentials drugs such as vitamins, tonics, enzymes, gripe waters and cough mixtures. Of the 300 pharmaceutical companies in Bangladesh, only 20 to 25 top ones produce drugs of standard quality. Many small companies market substandard drugs in the country. Fake or substandard medicines, including lifesaving ones, with an estimated worth of US$ 150 million per year, are flooding the domestic market.
Good manufacturing practice (GMP) is a major criterion to maintain standard quality in drugs, and one of the principal objectives of the National Drug Policy is to ensure standard manufacturing practices by the drug manufacturers. But there are some 265 pharmaceutical companies in Bangladesh that do not allegedly follow or comply with GMP. It is widely alleged that adulteration flourishes in the country because of poor government vigilance and supervision over drug manufacturers and sellers. Unfortunately, a section of corrupt physicians and government officials is involved in these underhand dealings. The government states that it has a limited workforce and facilities to handle difficult situations with the country's fast expanding pharmaceuticals sector. In fact, the regulatory authorities have given scant attention to maintaining quality. Inadequate supply of essential drugs, substandard quality, uncontrolled drug prices and inappropriate uses of drugs are major problems in Bangladesh. The drugs control authorities should be better equipped and more vigilant to handle difficult situations. Health professionals and drug manufacturers should be more committed to achieving the goals of the National Drug Policy.
The Drug Administration is also performing well below the required level as far as supervision of the procurement of raw materials by the drug manufacturers is concerned. It has only 24 supervisors against the sanctioned posts of 45. It shows that the supervision of the procurement process of raw materials has never been treated as a matter of priority. And we have just seen what such lax supervision can lead to.
Children have been murdered through supplying drugs unfit for human consumption. And the saddest part of the story is that similar deaths occurred in the early nineties too, but the Drug Administration has not bothered to do anything to stop the repetition of the tragedy. It is really disturbing to learn that the government-run drug testing laboratory does not have the modern equipment and trained manpower required to handle an issue as sensitive as clearing drugs for use by patients. Now, the question is: if the laboratory does not have the required facilities, how can it justify its existence? Obviously, it is not an area where shoddy or slipshod work should be permitted. And how can the Drug Administration refute the popular notion created by the recent deaths that it has no concern for human lives? True, the manufacturer of the poisonous drug is the real culprit here, but how can the Drug Administration avoid the responsibility of protecting people from the hands of the highly unscrupulous manufacturers? Quality is remembered long after the price is forgotten.
.....................................................
avik.sengupta@mail.mcgill.ca
Twenty-five children recently died after taking paracetamol. Following this tragedy, the government formed a probe committee which examined 300 samples of paracetamol and vitamin syrup produced by 10 pharmaceutical companies. The probe committee has found the presence of poisonous Diethylene Glycol in the paracetamol syrup produced by one of those companies.
The paracetamol syrup tragedy has brought to the fore the issue of how well equipped the Drug Administration is to deal with spurious and substandard medicines which pose a grave threat to public health. The ground reality is that the Drug Administration has to rely on only two drug testing laboratories to make sure that poor quality drugs do not enter the market. But the deaths of the babies have proved once again that the two laboratories fall far short of the requirement of what has to be done to stop marketing of drugs containing toxic substances.
The malpractice of unethical drug promotion and the marketing of substandard and non-essential drugs were very common in the country before 1982. Instead of producing essential drugs, most drug manufacturers manufactured non-essentials drugs such as vitamins, tonics, enzymes, gripe waters and cough mixtures. Of the 300 pharmaceutical companies in Bangladesh, only 20 to 25 top ones produce drugs of standard quality. Many small companies market substandard drugs in the country. Fake or substandard medicines, including lifesaving ones, with an estimated worth of US$ 150 million per year, are flooding the domestic market.
Good manufacturing practice (GMP) is a major criterion to maintain standard quality in drugs, and one of the principal objectives of the National Drug Policy is to ensure standard manufacturing practices by the drug manufacturers. But there are some 265 pharmaceutical companies in Bangladesh that do not allegedly follow or comply with GMP. It is widely alleged that adulteration flourishes in the country because of poor government vigilance and supervision over drug manufacturers and sellers. Unfortunately, a section of corrupt physicians and government officials is involved in these underhand dealings. The government states that it has a limited workforce and facilities to handle difficult situations with the country's fast expanding pharmaceuticals sector. In fact, the regulatory authorities have given scant attention to maintaining quality. Inadequate supply of essential drugs, substandard quality, uncontrolled drug prices and inappropriate uses of drugs are major problems in Bangladesh. The drugs control authorities should be better equipped and more vigilant to handle difficult situations. Health professionals and drug manufacturers should be more committed to achieving the goals of the National Drug Policy.
The Drug Administration is also performing well below the required level as far as supervision of the procurement of raw materials by the drug manufacturers is concerned. It has only 24 supervisors against the sanctioned posts of 45. It shows that the supervision of the procurement process of raw materials has never been treated as a matter of priority. And we have just seen what such lax supervision can lead to.
Children have been murdered through supplying drugs unfit for human consumption. And the saddest part of the story is that similar deaths occurred in the early nineties too, but the Drug Administration has not bothered to do anything to stop the repetition of the tragedy. It is really disturbing to learn that the government-run drug testing laboratory does not have the modern equipment and trained manpower required to handle an issue as sensitive as clearing drugs for use by patients. Now, the question is: if the laboratory does not have the required facilities, how can it justify its existence? Obviously, it is not an area where shoddy or slipshod work should be permitted. And how can the Drug Administration refute the popular notion created by the recent deaths that it has no concern for human lives? True, the manufacturer of the poisonous drug is the real culprit here, but how can the Drug Administration avoid the responsibility of protecting people from the hands of the highly unscrupulous manufacturers? Quality is remembered long after the price is forgotten.
.....................................................
avik.sengupta@mail.mcgill.ca