When journalists swallow spin on substandard drugs

The quality of locally distributed drugs has for long been a touchy issue in India because of pseudo-nationalism by a strong domestic lobby and a regulatory bureaucracy that sees conspiracy behind every allegation that highlights flaws in the Indian system of regulating life saving medicines. Ever so often, their efforts are supported directly or indirectly by “optimistic” journalists doing their part for the cause. A recent report in the Hindustan Times on the recently published report on substandard and falsified medical products by the World Health Organisation (WHO) is a prime example of trying to spin a story in India’s favour even when there is nothing to back up the claim.

This report in the HT was titled “Drugs in Indian markets safer than those in the US, Europe: WHO’s monitoring agency”. The opening paragraphs of the report state, “At a time when quality of Indian medicines is being questioned, a WHO agency has found that only 2% of the medical products in Southeast Asia, including India, were substandard or spurious against a global figure of 10.5%. Effectively, it means medicines and medical products available in India are safer than what is available in American and European markets.” This self-congratulatory report gives the impression that India is regulating its medicines better than developed countries in the Americas or Europe.

The reporter is correct in stating that the WHO figure for South East Asia (which includes India per WHO classification) is only 2 per cent but she completely omits to mention the report’s own limitations. This particular report was based on the instances of substandard and falsified drugs submitted to the “Global Surveillance and Monitoring System” (GSMS) which depends on self-reporting by national regulators. Not all regulators report all instances and the WHO report makes this very clear. It also explains that developed countries report higher percentages because they have better surveillance systems. A few important limitations of the report from the WHO report are reproduced below:

“The first question most people ask about substandard and falsified medical products is: how many of them are there? It is a question that cannot be answered using information from WHO’s GSMS alone. This is because the system receives reports mainly from focal points in NMRAs who have been trained to identify and report incidents.”

“Many assume that high-income countries with strong regulatory systems can effectively exclude substandard and falsified medical products from their markets, but, as the map in Fig. 3 shows, that is not necessarily the case. Well-regulated countries usually have the resources and the networks to survey, investigate and respond internally, so unless there is a clear cross-border threat, they may be less likely than under-resourced countries to report the discovery of substandard or falsified medicines to WHO. And yet despite this, WHO’s database contains reports from several countries in western Europe and North America as well as other high-income settings.”

“Can it be concluded that the countries not shaded in Fig. 3 do not face any problem with the quality of the medical products in their markets? Absolutely not. Reports of substandard and falsified medical products depend on their presence in a market. But the number of reports is also determined by who is looking out for those products, whether they know how to report them, and whether those reports are actually sent to the WHO GSMS. Since 2012, WHO staff have been training regulators, appointed by NMRAs as focal points for substandard and falsified medical products, in the use of the WHO surveillance system.”

All of the above limitations mentioned in the WHO report quite clearly explain the reasons why South-East Asia may be reporting a much lower percentage of substandard or falsified drugs when compared to more developed markets in the West. In fact, in a recent interview, the newly-appointed WHO Deputy Director General, Dr. Sowmya Swaminathan, who currently heads the Indian Council of Medical Research, lamented this exact issue when it comes to reporting cases of diagnosis of Tuberculosis in India.

But perhaps more important is the reporter’s failure to mention India’s own drug quality survey report commissioned by the Central Drug Standards Control Organization (CDSCO) which reported that 10 per cent of the drugs in the public health system were found to be sub-standard. That figure broadly co-relates to the broad estimate of the WHO that 10 per cent of drugs in the global supply chain are either substandard or falsified. There have been reports by the Comptroller & Auditor General (CAG) where the percentage of substandard drugs with the Armed Forces Medical Services Depot (AFMSD) has been pegged at 32 per cent for locally procured drugs!

An unfortunate side-effect of this kind of selective reporting is that it gives well-meaning self-proclaimed experts to pontificate and advance the industry’s agenda that there is nothing to worry about the quality of drug supply in India. There were many such proclamations on social media using this cherry-picked data about how good India’s drug supply is. Here is an example:

Journalists need to be more careful when putting out reports that lend to a false sense of complacency on an issue such as drug quality, which is incredibly important from the perspective of public health.

Dinesh Thakur is public health activist and chairman of Medassure Global Compliance Corporation; Prashant Reddy T is assistant professor at NALSAR University of Law.