Health Ministry orders withdrawal of 80 batches of vital life saving drugs

80% antibiotics: Quality failure the reason



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By Suresh Perera


The Health Ministry has ordered the immediate withdrawal of 80 batches of vital life saving drugs, 80% of which are antibiotics and the anti-diabetic Metformin, worth billions of rupees from government hospitals island-wide after the National Drugs Quality Assurances Laboratory (NDQAL) discovered they failed quality standards, and hence were ineffective, senior medical officials said last week.


Amongst the medicines withdrawn is Monotax (Ceftriaxone 1g) injection, which Dr. Kamal Jayasinghe, director, Medical Supplies Division (MSD) says in a circular to all government health institutions, "led to the recent death reported from the Karapitiya Teaching Hospital". The victim was a small girl who had been administered this antibiotic.These drugs had been dispensed through state-run hospitals during the past six to twelve months. With their efficacy coming into question, patients who had used them over this period of time would have been denied the medicinal benefit of the treatment to cure or control ailments they suffer from, the officials asserted.


In October 2012 alone, 30 batches had been withdrawn and over the past year 100 similar quality failures had been reported in drugs procured by the MSD through suppliers, it has now come to light.


"When drugs lose their efficacy it is disastrous as human lives are at stake and it is not known how many patients who had sought treatment in government health facilities had died as a result or suffered severe side effects as no research has been done or any reports collated in this regard", they noted.


The MSD director in his circulars pertaining to the respective drugs has asked hospitals to "withhold the products/batch from use immediately".


Dr. Jayasinghe has directed that "institutions under line ministry, special campaign, armed forces and police should also inform the withheld quantity directly to chairman SPC/SPC with copy to D/MSD".


It is the responsibility of the respective heads of government health institutions to ensure that all relevant officers are informed of the quantity withheld from use, he said.


An impression is created in circulars that the "cost would be recovered from suppliers", but has this ever happened to give credence to such assurances?, the officials queried. "This is just eyewash – the tax payer has to ultimately shoulder the burden".


In an incredibly shocking development, this is the first time in the history of the Health Ministry that such a large number of drugs had been withdrawn from dispensation due to the NDQAL "report on failing sample", which means failure of a quality test on the drugs, the officials pointed out.


The withdrawal of these drugs from use comes amidst allegations of widespread corruption and malpractices in the awarding of tenders for the procurement of drugs by the Health Ministry.


A senior government medical practitioner, who spoke on condition of anonymity, said yesterday that his blood sugar level had zoomed despite taking the stipulated dose of Metformin tablets (BP 500mg) from the hospital he worked for.


"I have been taking an ineffective drug for months and it is no surprise now that the truth is known that the medicine has had no effect to control my diabetes", he said. "How many people would have had to pay the price for no fault of theirs".


With two million diabetic patients in Sri Lanka, one shudders to think of the human disaster caused by the inefficacy of the commonly used Metformin, he noted. "A runaway blood sugar level can cause irreparable damage to one’s vital organs".


Medical administrators have also voiced concern over the rampant corruption plaguing procurements with blatant political interference marginalizing reputed suppliers known to purchase drugs from credible manufacturers.


This is no longer a mafia but a kind of terrorism which kills innocent people, the officials claimed. "Compromising quality, some people are busy making big bucks at the cost of the poor who seek treatment in government health facilities".


It was widely reported some time ago how a political lackey had threatened former Director-General of Health, Dr. Ajith Mendis over a tender procurement.


Unlike in developed countries, there is still no culture in Sri Lanka to sue medical companies which play with human lives, he said. "This is unfortunate".


Samples of all registered drugs procured are tested by the NDQAL, but it is no secret that the stocks imported by some suppliers do not match the high quality of the samples they submit for testing, medical officials pointed out. "What is more shocking is how the poor quality goes undetected despite samples of imported consignments drawn at random being tested".


All this points to a system failure and the procurement process has largely collapsed, they noted. "Immediate corrective measures are required to save lives of patients".


The whole issue stems from attempts to "procure from the lowest bidder". This translates into compromising quality to keep the bids low and also meet other demands from health officials overseeing procurements, they asserted.


Repeated attempts to contact Health Secretary, Dr. Nihal Jayathilake were futile. His mobile phone went unanswered and so did a SMS sent to him. However, a senior official conceded that with the situation getting out of hand, those at the helm opted to duck questions from journalists which could embarrass the politically powerful.


With a Rs. 64 billion budget, in 2011 the Health Ministry allocated a staggering Rs. 22 billion for the procurement of drugs, most of which are sourced from manufacturers in India.


 
 
 
 
 
 
 
 
 
 
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