Why most branded generic drugs don’t carry any stigma of quality, even when these are manufactured by small companies? The corollary to it is, why non-branded generics always carry a general stigma of inferior quality, even when produced by large Indian pharma companies?
While pondering over the answers to these questions, several other related facts also float at the top of mind, simultaneously, such as:
1. Just as many non-branded generics don’t go through the regular drug quality scrutiny of the regulators, branded generics are no different in this regard.
2. A large number of both branded and non-branded generics gets manufacturing approval by various State Drug Authorities.
3. The process of regulatory approval is exactly the same for both branded and non-branded generics. Even for branded generics regulatory approvals come only in the generic names and not with the brand names.
4. One can find hundreds of varieties of both branded and non-branded generics of the same molecules or of similar fixed dose combinations in the market.
5. Reports of substandard drugs of both non-branded and branded generics are also not significantly different.
6. Legal measures of reasonably stringent punishment in the country are no different between branded and non-branded generics.
This list is not exhaustive. Nevertheless, in this scenario, it is intriguing to fathom the reason of so much of contempt for non-branded generics within the industry, supported by a section of the media. This disgust gets invariably well-displayed as and when any serious discussion revolves around non-branded cheaper generic drug prescriptions in India.
Is it just a perception or based on solid facts?
This is a million-dollar question, but the optics is interesting. This also gets reflected in the recent media report on February 26, 2018. It writes, ‘The central government’s National Health Protection Scheme (NHPS) is going to put all of its focus on quality generic medicines, and not just the branded generic medicines, said Union Chemical and Fertilizer Minister Ananth Kumar while addressing a closed-door session with chief executives (CEOs) of pharmaceutical companies in Bengaluru on February 15.”
Curiously, in his statement the Minister also used the term ‘Quality’ only against non-branded generics and not against branded generics. Does it mean anything? If it does, is that just a perception or based on solid facts?
In this article, I shall try to assess why is this generally negative perception against cheaper non-branded generics gaining strength among many of us?
A general impression:
An often-repeated fascinating argument is, branding of a generic drug is important as it will ensure high product quality. This reasoning persists, regardless of the fact that the Drug Controller General of India (DCGI) often makes public announcements to the contrary, as happened even recently.
Risks of NSQ drugs don’t lie solely on non-branded generics:
According to the ‘National Drug Survey, 2014-16’, conducted in association with the National Institute of Biologicals, out of the 47,012 samples tested from the country, 13 samples (0.0245 percent) were ‘Spurious’ and 1,850 samples (3.16 percent) were found ‘Not of Standard Quality (NSQ)’.
The data on 1,850 NSQ samples showed that these were from 569 manufacturing units. Of these, 10 percent of manufacturing units were responsible for about 50 percent of NSQ samples. Further, one third of total NSQ samples were from 22 manufacturing units.
Further, quoting the survey carried out through the National Institute of Biologicals, a September 04, 2017 media report also articulated: ‘During its recent survey, the drug regulator found well-known drug manufacturers failing quality tests. In the survey, samples tested from top drug companies were found not to be of standard quality.’
The names of some of these large drug manufacturers in India, including the multinationals, along with their smaller counterparts, appeared in the Public Notice of July 21, 2017 of the Central Drugs Standard Control Organization (CDSCO) of India. Thus, the risks of NSQ medicines can’t possibly be attributed solely to the small time non-branded generic drug manufacturers. This public notice is expected to draw attention of many stakeholders.
More facts:
On April 22, 2017, the Central Drugs Standard Control Organization (CDSCO) reported that popular branded drugs like D-Cold Total, Cetrizine, Combiflam, Panza-40 tablets, Ibuprofen, and antibiotics with ciprofloxacin, ofloxacin, Amoxycillin, Ciprofloxacin have tested sub-standard. Before this, media reports of July 8, 2016 highlighted, “The DCGI has again found Sanofi’s popular painkiller drug, Combiflam, of sub-standard quality, in its latest test last month. It had found the same defect in the medicine in February and April, too.’
Conclusion:
Considering these facts, it is difficult to comprehend why branded generic drugs, irrespective of who manufacturers, will be of high quality perceptually – always. Conversely, non-branded generic drugs, even when manufactured by a reputed manufacturer, say for example – Cipla, are perceptually no good for patients, in terms of quality standard.
Nevertheless, the hard facts indicate, quality is a general issue both for branded and non-branded generic drugs in India, and not particularly for the later one.
This brings me back to where I started from: Do Branded Generics Promise High Quality for Patients? To find the right answer to this question, one should look at the scientific data on the same – sans any perception. Otherwise, it becomes ‘your view’ versus ‘my view’ sort of a mindless, though a highly passionate debate.
I shall refrain from being judgmental in this area. The readers may wish to ponder over it, seriously, and arrive at a well-considered inference on the very basis of this discourse – from the patients’ perspective.
By: Tapan J. Ray
Disclaimer: The views/opinions expressed in this article are entirely my own, written in my individual and personal capacity. I do not represent any other person or organization for this opinion.