Illicit Pharmaceuticals: Killing us softly?
The rampant use of unauthorised, banned and outdated medication in our country is paving the way for more vicious diseases rather than administering a reliable cure
In the second week of September, the central government went ahead with banning 328 fixed dose combination (FDC) drugs. The decision was implemented after the apex court's nod.
The five-year-long process was not as easy as it appeared. It included investigations, recommendations, notices, a long drawn legal battle and finally the implementation. Even now, the ambiguities remain and the consumer is still unaware whether the medicine he is gobbling is actually benefiting him. The decision has come at a time when grave allegations are being levied against a multinational company for selling discarded medical equipment that may have affected lakhs of patients. These incidents have triggered a sense of fear and scepticism among many who have no choice but to trust doctors, chemists and medicines.
New India is marching forward. Yet, in reality we are also becoming unhealthy. India today leads in life-threatening diseases like diabetes and cardiovascular ailments. In its advanced stages, these diseases are irreversible and increase the dependence on medication by manifold.
According to medical experts, the average cost of medicines for an unhealthy person can range from Rs 2,000 to Rs 10,000 just in the beginning stages of a disease Sordid tales of people not being able to pay their medical bills have often come to the forefront. Director Kalpana Lajmi, credited for directing movies like Rudaali and Daman, died at the age of 61. During her last stages, she had to pay two lakhs a week for her dialysis, for which she received help from her well-wishers and friends.
No wonder then that such a heavy dependence is causing the drugs market to burgeon. The pharmacy market today is pegged at a valuation of one lakh crore which is only expected to grow with time. Our nation today is a leader in pharmaceuticals – not only in domestic consumption but also for exports.
To ensure that drugs are available reasonably, the government has been taking several initiatives to cap prices. In this regard, the government body, National Pharmaceutical Pricing Authority (NPPA), has capped the prices of generic drugs.
Either to gain more profits or recover their huge costs, it is believed that most pharmaceutical firms combined two or more salts to create FDC drugs. This was then sold on the pretext of being innovative and, therefore, more effective.
It was observed by the government in its parliamentary reports that there may be a possibility that most drugs may not have been beneficial or efficacious. The central government appointed Professor Kogate, who in his multiple reports found that most drugs are non-efficacious and advocated for stopping the production of drugs. The government followed the course from thereon and backed the recommendations.
Complexities and legalities have resulted in the process being dragged for more than two years. Including a wide range of drugs, the FDCs which have been banned have a valuation of Rs 4,000 crore. Moreover, there is a consideration of banning more drugs that have been formed by mixing two or more salts.
In the meantime, certain flaws have also emerged in drug manufacturing. It is worth noting that it is the state that provides the permission to manufacture and distribute drugs. A large number of drugs are manufactured and then marketed from the states of Himachal Pradesh and Sikkim. There have also been allegations that due processes are not being carried in passing these drugs, which are then sold to consumers.
With fears rising around the diseases incurred as side-effects of these drugs, voices are now being raised for the need to establish a tougher regulator for the Indian pharmaceuticals market, even though the task is difficult. However, there is no evidence that the use of such medicines has resulted in harming a patient directly.
Most pharmaceutical firms are not only billion-dollar firms but have been in the market for more than a hundred years. Huge investments and required expertise have limited the entry of new players in the pharmaceutical market – thereby eliminating the smaller producers. "In our country, we just have 515 medicines which are sold under 3,000 different names. These medicines are banned across the world and their production and sale are considered a crime. These medicines are dangerous and can cause fatal diseases like paralysis, cancer, blindness and many others," says Dr Usha Manjunath, Director IIHMR (Institute of Health Management and Research), Bangalore.
"One of the banned drugs, Oxytocin, acts as a life-saving drug for women who bleed during childbirth or undergo an abortion. There are alternatives like Misoprostol, but the government has restricted its use in private clinics, as they are worried about the misuse of Misoprostol in sex-selective abortions. However, it is still used by many illegal abortion centres. Despite the awareness about the ill-effects of these drugs, its usage has not reduced," she further adds.
If usage of wrong medicines is a worry, then another source of concern is the over-reliance of consumers on drugs for treating even minor diseases. This has given rise to the use of painkillers and antibiotics. Against a global antibiotic increase of 65 per cent, India reported a 103 per cent rise, according to a study at Princeton University published in March this year.
In a report on the misuse of antibiotics, it has been alleged that the US Food and Drug Administration (FDA) has strengthened warnings for the fluoroquinolone class of antibiotics. This comes in the wake of findings indicating that the particular category of antibiotics can cause mental health problems and serious blood sugar disturbances, including hypoglycemic coma to people with diabetes.
India is the world's largest consumer of antibiotics, with its use more than doubling between 2000 and 2015. Speaking about the issue, Dr KK Aggarwal, says "Antibiotics are only effective against bacterial infections. Several studies have corroborated the adverse impact of antibiotic overuse on health. Misuse and overuse of antibiotics have made once easily treatable bacterial infections harder and often impossible to cure because bacteria evolve rapidly to evade antibiotics, leading to drug resistance. This phenomenon is on the rise not only because of their inappropriate use in human medicine but also due to practices in the agricultural industry."
"There is no denying that regulation in terms of medicines we consume is poor. Forget unhealthy and uneducated people, even healthy and educated people are buying the drugs. From solving your sex problems to curing your obesity or even increasing your height, various drugs today are sold openly and, in turn, compromise with the health of the consumers who want to be healthy and look good," asserts Dr Narender Kumar
"There are various reasons that can be cited in regard to the flow of spurious and inefficacious drugs in our markets. We must ensure that there are well-trained and qualified doctors who ensure that consumers do not purchase these medicines. For better doctors, we require more medical schools, both of which we are lacking today," he further adds.
For a country of over billion citizens, we still have only ten lakh qualified doctors – with a major concentration in the urban areas. The shortage of doctors today has given way to quacks and fake clinics. In Gurugram district, there are over 200 functional fake clinics.
The banning of over 300 FDC drugs may just be the tip of an iceberg. Challenges and difficulties in the health sector remain and cannot be overlooked. The problem can neither be classified as white or black; there are various shades of grey in dealing with the issue. The unaffordable health care system, expensive and now untrustworthy medicines and lack of basic medical knowledge among the masses have created a situation where we may be killing ourselves softly without even realising it.
Yet, amid this scepticism, the fact remains intact that Indian medicines are exported globally and our doctors are deemed to be among the world's best.