Wednesday 29 April 2015

Who is responsible?

India is a world leader when it comes to manufacturing and sale of fake drugs.  According to the World Health Organization (WHO), one in five drugs made in India is fake.  The American Food and Drug Administration (FDA) held a series of raids in India recovering large quantities of substandard medicines and concluded that the penalties for making and selling such drugs are minimal, the convictions rare, and the profits enormous. We have companies manufacturing antibiotics and rat poison in the same facility, resulting in death of many innocent women. India’s reputed Ranbaxy pleaded guilty to felony charges and paid a $500 million fine last year, the largest ever levied against a generic company. India’s Central Drugs Standard Control Organization, the country’s drug regulator, has a meagre staff of 323 people, about 2% the size of the FDA.
Kashmir has become a notorious hub for spurious drugs in India.  Hundreds of deaths at the paediatric hospital are thought to be due to these drugs, with New York Times calling it a ‘targeting of vulnerable’.  In 2013 fake drug racket was unearthed in Kashmir.  Thousands of fake tablets had been supplied to main hospitals in valley including lifesaving antibiotics. Further, 24 drugs were declared as ‘not of standard quality’ by the Government Analyst of Central Drugs Laboratory, Kolkata. The Health Minister at the time Taj Mohidin blamed his party colleague Sham Lal Sharma for the scam.  The chief minister ordered a probe. Few people were arrested from Jammu. The medicines had been purchased after approval by the purchase committee in the Health Department. Various doctors associations alleged that high-ranking officials from health, drug control and other departments were hand in glove with drug mafia, and demanded a high level independent probe. There was severe outcry from civil society, politicians and separatist leaders.  Even after public interest litigation (PIL), there has been no probe.  One of the whistle blower doctors had to face suspension allegedly for demanding justice and punishment for guilty. The probe died a natural death with Mr Lal Singh becoming the health minister.  
Lal Singh does not seem to have any faith in doctors, which questions his intentions for seeking health ministry. How can a department work when there is no mutual respect or trust?  Doctors are held responsible for all the failures in health sector including the evil of fake drugs.  An order was recently issued that doctors should prescribe by writing only generic names, and were threatened with consequences for acting otherwise. It seems the fake drug mafia have succeeded in their mission to run the racket freely with the support of people in power. I am not here to advocate for doctors and there are many black sheep who engage in unethical practices. But even common sense is put to shame by this simplistic approach of a complex problem. From the manufacturers, distributors, retailers, chemists, approving agencies, drug controller department, purchase committees, health minister, medical representatives (MR), and finally doctors, how was it decided that only the doctors are responsible for this heinous crime? May be you can answer this question?  
In a civilised world it would have been a welcome decision that generic names should be written and MRs kept away from hospitals. But from my experience of working in both the Valley and West, this seems to be the beginning of another disaster.  All doctors write generic names in United Kingdom and MRs are rarely seen.  All the prescriptions are written on prescribed format according to the guidelines by British National Formulary (BNF). All the pharmacies are run by qualified and registered pharmacists. Full details of patient, doctor and medicines prescribed are recorded. There is record of every pill issued and can be audited anytime. All medicines are free for children and elderly and rest have to pay nominal fee. All medicines are free for inpatients. The entry of the drugs into the market is controlled and monitored. There are clear guidelines from the National Institute for Health and Care Excellence (NICE) about every disease and medication to be used. 
Meanwhile in J&K, even the order issued is one liner; no guidelines have been issued either for doctors or chemists. If a patient goes to the chemist with a generic prescription, how do we know what the poor patient is going to get? Under what code of ethics are these chemists working?  Has government released any guidelines for them?  Who would monitor what are they going to sell? Have these shops been told to record all sales, names of patients, drugs and the prescribing doctors?  If there is no audit trail, how are you going to make people accountable? What about drugs which come as combinations?  If we are going to adopt the ways of the West, we cannot just pick one thing from a package, it is doomed to fail. Would drug mafia not corrupt poor sales men to work for them and sell whatever they want?  What would happen when a patient’s condition does not improve, should the doctor send him back to the chemist? Finally if something goes wrong who is responsible, doctor or the medical shop owner?
Still no one has been held responsible for the fake drug scam. How is this generic names saga supposed to sort anything out? Coming out of SMHS hospital gives a feel of fish market, scores of men outside the chemist shops literally pulling the patients into their shops. Can we even call these corner shops as pharmacies? Thousands of such shops have mushroomed all over the state, mostly run by barely qualified people, with no training whatsoever. There may be few dozen genuine medical shops with a qualified pharmacist. I am not sure the state has actual number of medical shops on a register.

When the manufacture, supply and sale of fake drugs continue, how on earth is generic prescription going to make anything right? If the government was really serious, it would not have supplied its own hospitals with fake drugs. All illegal shops would have been shut by now.  It would have made sure that only credible and licenced drug companies are allowed in the state.  Exemplary sentences should have been given to drug racket kingpins so that others learn a lesson. But we all know what happened to that probe! Also, if all the drugs in the market are approved by the drug controller how does it matter which brand is written, unless it is hurting the interests of fake suppliers? The drug controller department seems to exist only on paper. Even if they work 24 hours a day and inspect all the shops, they would not be able to monitor a small block let alone the whole state.
Doctors know by experience that there are substandard drugs sold and that’s why they often ask their patients to bring back the medication to check, making sure it is not substituted by something made in a kitchen around Bishna or Hazratbal.   Some may argue that they do so to promote a particular brand which may be the case sometimes, but in majority of cases doctors want to make sure their patients improve. This is the only way of maintaining some quality control as authorities have failed or even collaborated with fake drug mafia.  The allegations that few doctors get paid or receive gifts cannot be denied but should not be generalised to malign all. Why not take strict action against those doctors who indulge in malpractice? If the patients trust their doctors in diagnosing, prescribing, going under the knife, what happens to the trust here?  Clearly this order is an eye wash to make people believe that government is doing something.
Trust between a doctor and patient plays a huge role in recovery. Lal Singh should have tried to bridge the gap between doctors and patients than playing political gimmicks at the cost of poor lives. The chief minister Mr Mufti Sayeed should take stock of the situation before another disaster comes to haunt us. The department needs to be cleaned of corrupt people, irrespective of their position or designation. Drug control department needs to be strengthened with adequate staff.  Strict laws need to be enforced, including charges of homicide against anyone dealing or supplying fake drugs.

Finally, people need to understand the deceptive tactics of authorities. Why do people have to buy medicine from market if health care is free? Why are thousands of hepatitis C patients still waiting for treatment for the last 2 years? Why do we need so many chemist shops? Blaming doctors or creating a wedge in the doctor-patient relationship is not the solution but an escape route for cheap electoral politics.

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