Laced with Poison
In the 1980s to early 1990s thousands of infants died of renal failure after being given contaminated paracetamol syrup. The cause was detected in November 1992. At Dhaka Shishu Hospital 339 babies died from 1990 to 1992 taking diethylene glycol-laced paracetamol syrup. At that time the government stopped production of the five accused pharmaceutical companies. However, lack of monitoring of the government agency Drug Administration resulted in history repeating itself last month. This time taking the same toxic tainted paracetamol syrup, produced by Rid Pharmaceutical Company of Brahmanbaria BSCIC area, 25 children between one and five died. Briefing the probe report after suspecting foul play, Health Minister Professor AFM Ruhal Haque on July 28 told the press that tests have confirmed the presence of the toxic chemical, diethylene glycol Rid paracetamol syrup.
Diethylene glycol solvent, usually used in plastic, rubber, textile and leather dying industries, was used in the preparation of the paracetamol syrup as a cheap but deadly substitute for propylene glycol, the authorised solvent for any syrup forms. The company had no license to manufacture paracetamol syrup, rather had permission to prepare paracetamol suspension. However, the product was described as a suspension on the package, but it contained syrup. The health minister at the press conference informed that of the 28 domestic companies that are manufacturing paraetamol, only five companies have clearance to manufacture syrup. Drug Administration stopped marketing of all products of Rid Pharmaceuticals and recommended exemplary punishment for the culprits who had caused so many deaths of children.
"At least this time the government has taken some immediate steps that has decreased the possibility of more causalites", says Professor M Hanif of the department of Pediatric Nephrology of Dhaka Shishu Hospital, who again discovered the existence of the toxic chemical in paracetamol. He adds: "After being doubtful I voluntarily tested the paracetamol syrup that I received from a patient's parent at a private laboratory and found the presence of 'diethylene glycol."
"I suspected the presence of diethylene glycol since it was a common form of adulteration in 1980s. Those days we used to face very unusual renal failure in the children, but it took almost a decade to identify the cause. But this time we have addressed the problem immediately and sent a report on it to the Directorate General of Health Services that later directed the hospital authorities to carry out further investigation. It was a sensible decision by the government that they acted so promptly."
On the reason behind such adulteration Professor Hanif says that since the diethylene is less expensive and can be bought only at Tk 200 per litre, the unscrupulous businessmen use it instead of authorised solvent 'propylene glycon' at Tk 1,100 per litre.
"Usually financially sick medicine producers do such adulteration to exist in the market competing with well reputed companies", observes Professor M Hanif. Like many other pharmaceutical experts he blames the failure of the Drug Administration as a regulatory authority for the repetition of this tragedy.
On the other hand, the government agency responsible for giving license and monitoring the standard of medicine in the country has repeatedly given the excuse of lack of manpower behind its inefficiency. Drug Administration director Brigadier General Ismail Hossain, however, told the press about its quick actions against the accused company. The director also suggested the government amend the existing laws to take stern action against the unscrupulous individuals involved in the tampering.
In fact, the incident has raised several questions regarding the monitoring system of the medicine manufacturing companies in the country as well as the ongoing practice of adulteration, fraud and violation of the existing rules by many medicine manufacturers.
Professor Faroque of the department of pharmaceutical technology, Dhaka University is actually very critical about the performance of the Drug Administration. Referring to the recent paracetamol fiasco, he says, "I admit that due to lack of facilities the drug administration may not identify immediately the adulteration of the solvent, but is it possible that the drug superintendents did not know that a company authorised to manufacture paracetamol suspension is producing syrup? I can't believe it, as it does not need any laboratory test."
In fact, the government agency has completely failed to ensure good manufacturing practice (GMP), a WHO set standard guideline, says Faroque, "Only the well reputed companies follow the guideline considering their image."
"When the drug administration cannot properly monitor because of lack of manpower why does the government agency give permission to so many companies to produce medicine?" asks Professor ABM Faroque, also the president of Bangladesh Pharmaceutical Society, "Over 850 companies are producing allopathic, homeopathic, unani and ayurvedic medicines in the country. Is it possible to monitor efficiently so many companies? As far as I know there 242 companies that are manufacturing allopathic medicine in the country, however, the Health Minister briefed the press that of the 164 companies are in production of the existing 222 companies. Let's forget the debate on the number. But is it logical that 164 produces medicines of which 57 companies manufacture paracetamol? Is there sufficient market for 350 Unani companies, when only six companies are producing medicine in Hungary, which is one of the largest pharmaceuticals exporting countries in the world?"
Then why does a pharmaceutical company like Rid Pharma get permission, when the government's policy is to give new permission only for big budget companies? The concerned sources identify some hidden causes. "The more number of pharmaceutical companies create 'opportunity' for the officials at Drugs Administration. The increase of manpower will never improve the scenario unless the whole system is changed", says Professor Faroque.
Professor Faoroque gives an alarming picture of the pharmaceuticals industry in the country, which is causing several problems. According to him, "Only a few pharmaceuticals companies maintain standard quality in the country. The rest of the companies have very low productions, most of these brands have limited market in the capital whereas there are many companies that do not have any production at all. Then how do these companies survive?"
"Importing elements for pharmaceuticals manufacturing, many of the small companies sell these elements in the black market, where there is every possibility for adulteration," continues Professor Faroque, "We have heard about duplication and adulteration by some small companies of some popular brands, which is really alarming. If we know the facts. It's difficult for me to believe that the officials of Drugs Administration and police do not know."
According to Professor ABM Faroque, there is no alternative to a total reform of the existing Drugs Administration. Following many developed countries he advises forming a separate organisation like Food and Drug Administration (FDA) in the US. "In many ways public health in Bangladesh is in threat due to adulteration of valuable medicines and daily food. BSTI and Drugs Administration are not in a position to meet the challenge. For the proper monitoring the government should immediately form an autonomous body like FDA including the experts", he suggests.
Professor ABM Faroque (left) and Professor M Hanif
It's a positive sign that the parliamentary standing committee on health formed a separate four-member parliamentary committee to look into the manufacturing processes of pharmaceutical companies across the country, however, Professor Faroque believes after the proper monitoring of the existing technical facilities of these pharmaceuticals companies and their products, the government should take drastic action against the substandard companies.
Hundreds of these substandard and financially sick companies usually market their products in the rural areas and give attractive commission to the retailers. "The brands of the financially challenged companies are not usually available in Dhaka. Their target market is rural areas and district towns. Even the pracetamol case also proves that people suffer mostly in the rural areas for the medicine adulteration. They do it just to keep the production cost cheaper to give more commission to the retailers who peruse the consumers to by substandard medicine", Professor Faroque says.
"For its own interest Bangladesh Association for Pharmaceuticals Industries (BAPI) should pursue the government to quit so many substandard and financially sick companies those are basically manufacturing adulterate and duplicate medicine, which is a great threat for public health. Considering the fate of the employees working in these companies, the government should help these companies to switch to other products rather manufacturing medicine. But no company should be allowed to operate without proper technical facilities."
In fact, adulteration and unauthorised duplication of valuable medicine is not an isolated incident in Bangladesh. Many countries in the world have overcome the crisis taking proper steps. Consulting the stakeholders the government should immediately to ensure marketing of only standard pharmaceutical products for the welfare of the public health and take drastic action against the culprits.
(R) thedailystar.net 2009