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Healthy Skepticism Library item: 20161

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.


Publication type: news

Dabade G
When drug regulators play with people’s lives
The Deccan Herald 2012 May 22

Full text:

There is evidence to conclude that there is a collusive nexus between drugs manufacturers and medical experts.
Safety of drugs is of paramount importance, but the same is compromised by many selfish drug manufacturers, who in their mad pursuit of wealth, build a nexus with drug regulatory authorities and doctors.

Medicines play an important role especially when we are sick. Their safety and appropriate use is of critical importance for saving lives as otherwise these very powerful tools can become detrimental. There are four major players in this entire gamut: the drug manufacturers, who are mostly profit oriented, there are drug regulators, who are supposed to protect public interest, there are doctors, who do not always act in the interest of their patients, and there are the consumers – who have absolutely no say at all in anything.

Just imagine what would happen if the first three gang up. It would totally jeopardise and put at risk the lives of millions of people. This is exactly what is happening in India, so says a report titled “The Functioning of the Central Drugs Standard Control Organisation” (CDSCO), which was laid in Parliament on May 8, 2012. The report reveals threadbare how “the drug regulatory system in the country (India) suffers from several deficiencies and shortcomings, some systemic and several manmade.” In its very opening pages it makes a scathing attack, stating that “The Committee is of the firm opinion that most of the ills besetting the system of drugs regulation in India are mainly due to the skewed priorities and perceptions of CDSCO.” Taking strong exception to this continued neglect of the hapless patients, the committee recommends that the Mission Statement of CDSCO be formulated forthwith to convey in very unambiguous terms that the organisation is solely meant for public health.”

Creating doubt

The callousness of the CDSCO can be very well gauged when the committee members randomly selected 42 drugs for scrutiny. The CDSCO could not provide any documents on three drugs (pefloxacin, lomefloxacin and sparfloxacin) on the grounds that files were non-traceable. All these drugs had been approved on different dates and different years creating doubt if disappearance was accidental. Strangely, all these cases also happen to be controversial drugs; one was never marketed in the US, Canada, Britain, Australia and other countries with well-developed regulatory systems while the other two were discontinued later on. In India, all the three drugs are still being sold. Given this state of affairs it is not possible to monitor if drug manufacturers are abiding by the conditions of approval viz. indications, dosage, precautions etc.

Even if a drug has been approved in developed countries like the USA or Europe, it is mandatory as per Indian drug laws that the drug be scrutinised by conducting proper clinical trials for safety as the ethnicity of the population can vary. Several hundreds of drugs have been cleared without proper clinical trials. On an average, CDSCO is approving one drug every month without trials.

There is sufficient evidence on record to conclude that there is a collusive nexus between drug manufacturers, some functionaries of CDSCO and some medical experts. Look at this example: Letters of opinion recommending approval of dapoxetine were received from two medical experts residing at Mumbai and one at Kolkata by the office of DCGI exactly on the same day, April 6, 2010 and were diarised under consecutive references 3667, 3668 and 3669. The enquiring committee has collected several such instances and thus is compelled to raise a very uncomfortable question to drug regulatory authorities “Is it unreasonable on the part of the committee to come to the conclusion that all these letters were collected by the interested party from New Delhi, Mumbai and Kolkata and delivered to the office of Drug Controller of India (DCGI) on the same day?”

Such scathing reports attacking the drug authority is not new. In fact earlier Hathi Committee (1974), Lentin Commission Report (1984), and Mashelkar report (2003) have made excellent reporting and recommendations. Every such report raises the pitch only to wean away over a period of time. What is really needed is sustained and ongoing effort on the part of consumer groups.

One is reminded of the great work of Dr Olle Hansson, a Swedish paediatric-neurologist who was a powerful campaigner against unethical promotion and marketing of drugs. In many ways, he represented the conscience of the medical profession. His influence was felt not only in Sweden and Japan, which have thousands of SMON victims, but also in Europe and developing countries. Olle Hansson will be remembered by all who campaign for rational use of drugs. He died of cancer on May 23, 1985, at the age of 49; he remains a continuing source of inspiration for public interest workers everywhere. Let Olle Hansson inspire all consumer groups!


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