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J&K: State of 'Pharmacy & Pharmaceuticals'
By Dr. Javid Iqbal
"
The administration should have moved much beyond what it has done so far. The question remains to be answered-what action, if any has been taken against the distributor. Merely saying that whatever was supplied got distributed is not enough.

The recent controversy about the combination of Amoxicillin and Clavulanate acid tablets that forms the generic drug Augmentin has brought up a whole range of health issues to fore. The state of our pharmacies where drugs are dispensed as well as the pharmaceuticals-the drugs supplied to these pharmacies has come in sharp focus. The scandal about spurious antibiotic being supplied to the Valley hospitals surfaced after State Drug and Food Control Department reported that antibiotic Maximizin-625 (Amoxicillin Trihydrate and Potassium Clavunate) was "not of standard quality." "It had tested negative in the analysis as it contained zero milligrams of Amoxicillin instead of 500 milligrams claimed by the company. It is alleged that a high ranking departmental official has defended the drug supplied by stating that even if the report of compound Augmentin supplied by the brand name Maximizin-625 has had cheaper Amoxicillin missing, nevertheless the expensive element Clavulanate acid being present would keep it potent. Words to that effect if not the exact quote, if true point to a serious deficit in assessing the potency of the drug. Clavulanate acid as the name of the compound suggest has no role except augment the potency of the antibiotic-Amoxicillin. We may not dwell in which element is cheaper and which one is expensive. Clavulanate acid, the augmenter, the enhancer could be well used with any other antibiotic like fourth generation Cephalosporin to produce the same augmenting effect as it does in combination with Amoxicillin. There are serious issues involved. The most immediate concern would be to judicially assess the fault lines in supply of drugs to the state. Two, whether a departmental mechanism exists to establish the potency of drugs supplied by a team of experts beyond any measure of doubt?

The reports of the supply of this drug to J&K public sector health institution reveal one shocking revelation after another. It stands reported that 2 lakh tablets of spurious antibiotic supplied to public sector hospitals. Instead of antibiotic manufactured by Medley Pharmaceutical, the company approved by the government, it stands related that a Jammu-based distributor-- Life Line Pharmaco Surgical supplied spurious tablets purportedly manufactured by Himachal-based Affy Parenterals. In a bizarre tale, Affy has said it didn't manufacture the supply and its brand name has been faked. The drug with brand name of Maximizin-625 (Amoxicillin Trihydrate and Potassium Clavunate) carries the name of manufacturer, which is-- Affy Parenterals. However in an e-mailed response, Affy Parenterals states, "We have never signed any contract or supplied any pharmaceutical product to any government tenders in Jammu and Kashmir". Geeta Jain, General Manager Marketing, Affy Parenterals added, Maximizin 625 is their brand, however, "Seized drug has totally different packing and Affy Parenterals has got nothing to do with it. We manufacture the brand Maximizin 625 with B.no. 1583 and manufacturing date is August 2012 and expiry date is January 2014 in AS 6X1X10 ALU packing whereas the seized drug has the packing of AS 1X5X10 blister which is totally a different packing," she said. Jain said that Maximizin 625 tablet (Amoxicillin and Potassium Clavulanate tablets IP) has been given standard certificate by Quality Control Department". M/s Medley Pharmaceutical, the company approved by the government has reportedly denied having anything to do with the medicine supplied.

It is not surprising that civil society is aghast, it has taken a serious note of issues involved. News reports have alleged that it was the lack of potency of the drug due to basic element being absent that resulted in the death of scores of children in the GB Pant pediatric hospital over the last few years. This is a serious allegation and it is doubtful if a departmental probe ordered by Minister of State for Health, Shabir Ahmed Khan would be enough. It calls for a judicial probe as demanded by civil society and association of doctors. The civil society has gone to the extent of calling it culpable homicide, if proved. Civil society circles wonder whether a suo moto notice of the case by their lordships in the State High Court might be warranted. Whatever the form an enquiry takes, the matter is too serious for handling on the executive turf only. However, the political executive in the state seems to make it an administrative probe in a situation where the judiciary and the legislature need to play their role to the maximum possible extent.

The medical community has expressed concern. Doctors Association Kashmir [DAK] calls it genocide and it has accused former Health Minister, Sham Lal Sharma, of being hand in glove with the accused firm. DAK president Nisar-ul-Hassan said, "Sham Lal Sharma should take responsibility and step down from his portfolio. The owner of the Life Line Pharmaco surgical is a close relative of Sharma. The wrongdoings have happened in his tenure. If FIR is not registered against Sharma, doctors in Kashmir will go on indefinite strike. Every drug in the hospitals should be sent for testing," he demanded. Questions have been raised vis-à-vis the probe panel. DAK has filed a PIL in the State High Court, it reads that officials directly or indirectly related with the scam should not be appointed as members of the probe panel. The PIL was filed by DAK president Dr Nisar-ul-Hassan through his counsel Advocate Fayaz Bhat seeking a thorough and independent probe into the drug scandal. It mentions former Health Minister, Secretary Health, Director Health Services, Controller Drug and Food Organization, CPC officials and others related to the matter. The PIL reads that the "use of spurious drugs proves very harmful and dangerous to human body, and can even cause death of a person". The petitioners have stated that thousands of people have consumed these drugs and it might have proved costly for hundreds of patients.

"The spurious drugs mostly affects the patients already suffering from infections and can make them less resistant to different forms of infection," reads the PIL.

There are various aspects of the problem. Now that the pharmaceutical company-- Affy Parenterals that is supposed to have supplied the drug in question-Maximizin-625 has denied that it ever supplied the drug and the pharmaceutical company originally approved-- Medley Pharmaceutical is out of the picture altogether, what stands to be established is who manufactured the drug. The administration should have moved much beyond what it has done so far. The question remains to be answered-what action, if any has been taken against the distributor. Merely saying that whatever was supplied got distributed is not enough. Next, what is the state apparatus to test what the state gets supplied with? Sources in department of Food and Drug Controller have revealed to a local daily that drug testing laboratory is not equipped with latest machines to test majority of drugs supplied to hospitals across the valley and available in market. It was further revealed that only first and second generation antibiotics can be checked in the laboratory. If true, it is a serious matter as advanced antibiotics mostly in use have thus to be sent to other places. In case of the drug in question-- Maximizin-625, the sources have revealed that the sample was lifted by a drug inspector on February 2, 2013, from Gousia Hospital [in downtown Srinagar] and was immediately sent to drug testing laboratory. However the report came out on April 1. Staff shortages and lack of funds has also been reported in drug testing laboratory. It is sad commentary on the priorities of the state and proof enough, if one is needed that state of health care inspite of the pretensions of official agencies is abysmal.

Only the collective judgment of executive, judiciary and legislative bodies could satisfy the collective conscience of the people of the state. Apart from judicious verdicts, the issue may call for serious legislation to plug loopholes in our health care.

Yaar Zinda, Sohbat Baqi [Reunion is subordinate to survival]

Feedback on: iqbal. javid46@gmail.com


News Updated at : Sunday, April 14, 2013
 
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