|Year : 2019 | Volume
| Issue : 4 | Page : 101-103
Essential medicines for noncommunicable diseases: “Quality variable”
Department of Pharmacology, Post Graduate Institute of Medical Education and Research, Chandigarh, India
|Date of Submission||24-Dec-2019|
|Date of Acceptance||24-Dec-2019|
|Date of Web Publication||31-Dec-2019|
Dr. Samir Malhotra
Department of Pharmacology, Post Graduate Institute of Medical Education and Research, Chandigarh
Source of Support: None, Conflict of Interest: None
|How to cite this article:|
Malhotra S. Essential medicines for noncommunicable diseases: “Quality variable”. Int J Non-Commun Dis 2019;4:101-3
“Again and again we hear about firms who did the math and concluded that harming their customers was cost-effective up to a carefully calculated point.”
Years ago, Prof. Dixit (name changed) from our institute was admitted in the Coronary Care Units (CCU) with massive myocardial infarction leading to cardiogenic shock. The treating cardiologist Prof. Gill (name changed) gave me a call to ask for help – in spite of the best possible care, the patient was not responding. It would have been stupid of me to question the line of management being followed – Prof. Gill is a thoroughly competent professional; he understood perfectly well the reasons and factors involved in nonresponse. Specifically, his concern was whether the norepinephrine they were infusing was of good quality because even at the highest doses; there was no BP response.
Prof. Dixit had been the cardiologist's teacher, and mine too, and I still remember his concerned, almost panicky voice. “Do something,” he pleaded. There is no way to conduct the necessary tests to examine the quality of a medication immediately. However, there was a way out of this distressing situation.
During those years, animal experimentation was a common part of the training of our residents, and almost every day, some residents would be conducting some experiments. I collected the norepinephrine vials from the CCU and gave it to a few animals and checked the pressor response. This provided a vital bit of information to the cardiologist.
Prof. Dixit survived, thanks to the care provided by the team of intensivists, and is still doing well.
At the time of prescribing, and when monitoring the response to therapy, the physician has several factors to take into account – they are well known and can be disease related (severity) or patient related (concomitant illness, age, sex, and weight) or drug related (safety, efficacy, and cost). One factor that she presupposes is that the medicine the patient will take satisfies the regulatory requirement of being of standard quality, assuming that it was manufactured according to established protocols.
She may or may not be aware that the manufacturer involved in the process of preparing, marketing, and selling of medicines is primarily profit driven. Unless, profit is not only achieved but also maximized; some other company may outcompete him, perhaps even putting him out of market. In such a situation, some manufacturers start cutting corners, leading to marketing of medicines of inferior quality, with its accompanying consequences.
Five years remain to achieve the call given in 2010 by the United Nations and the WHO for 25% reduction in mortality from noncommunicable diseases (NCDs)., The challenges  to achieve this, deficiencies in health-care provider expertise, particularly in developing nations at primary and secondary level, inadequate access to essential medicines, and cost, among others, are well understood.
The challenge of quality of drugs, called “Global Pandemic of Falsified Medicines,” is an important cause of mortality, prolonging/increasing severity of illness, occurring not only due to the obvious reason of compromised quality but also because the treating physician has the false sense of security.
In India, the terms used by the regulatory agency are: Not-of-Standard-Quality; Spurious; Adulterated; and Misbranded. Several studies, including by us, to test the quality of medicines show sample failure rates of <1%–41%; these studies have included drugs for NCDs as well as communicable diseases.,,,, This wide range is attributable to various definitions used and cities and areas from where samples are obtained; for instance, even within a city, 30% of samples obtained from some pharmacies failed whereas in others none failed.
In India, the regulatory agency, Central Drugs Standard Control Organization (CDSCO), has provided their past 8-month data of “Not of Standard Quality” drugs.
During this period, 8143 samples were tested in five labs, of which 230 (2.8%) failed on one or more quality control tests. Most failures were from Chandigarh lab and the least from Chennai lab [Figure 1].
|Figure 1: Month-wise failures seen in the five drug testing laboratories in India|
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About 13% of failures belonged to what can be categorized as lifesaving medicines.
Antimicrobials accounted for the largest proportion of failures, followed by analgesics, vitamins, antiallergics, cardiovascular/renal, Gastrointestinal tract (GIT) and endocrinology drugs [Figure 2].
|Figure 2: Drug category-wise sample failures in the five testing laboratories in India|
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Oral drugs were the largest category (>60%), followed by injectables (>10%) and creams and eye drops (8%). The reasons for failure are shown in [Figure 3], with assay failure being the most common category.
|Figure 3: Reasons for failure of samples over a 7-month period (from data provided by the Central Drugs Standard Control Organization)|
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Nearly one-fourth of the samples failed for two or more reasons. No medicines were found to be spurious or adulterated. These data make us point out several issues.
Public disclosure by the CDSCO about sample failures must be appreciated. This permits various stakeholders to perform analyses and discuss ways of dealing with this issue. The failure rate of <3%, which as compared to the earlier data, is quite encouraging although the presence of a significant proportion of lifesaving drugs among the failures should be a serious concern. Another reason for alarm is the failure of nearly a quarter of samples due to two or more reasons – this points to systematic failures in case of some manufacturers.
More information from areas within a city from where samples were collected would be interesting as wide variations have been observed earlier. It will not be wrong to assume that failure rates will be higher in pharmacies located in poorer socioeconomic areas, which, added to the disease burden and high cost of treatment among these populations, is troubling.
Finally, the fact that in a country known as the “Pharmacy of the world,” having 3000 pharmaceutical companies and >10,000 manufacturers, only 8000 samples could be tested over 8 months. This points to the need of urgent capacity-building and setting up more labs, failing which substandard medicines will continue to be marketed, which not only has grave consequences for patients. It also dents country's reputation of being an important provider of quality medicines at low costs all over the world. Of course, it adds an unnecessary variable for a physician to consider when her patient does respond despite adequate management.
The reasons for failures are multiple. About one-third of countries have little or no regulations; even when regulations exist, they may not be enforced; the profit-cum-cost-cutting motive, deficiency of trained workforce, and poor quality equipment are some of the other causes.
It is not an easy task to improve the scene, at least in India – the diversity, the width and length of manufacturers' spread, the multitude of pharma company manufacturers, and contract manufacturers – make implementation of regulations difficult, but must be done.
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[Figure 1], [Figure 2], [Figure 3]