About six years ago, or if you prefer, four years before the pandemic besieged the world, the world made a promise to itself. Well, the world actually made seventeen promises to itself, but we are focusing today on only one of them.
The sustainable development goals came into force on 1-1-2016. And one of these goals states as clearly as is possible the need to have universal healthcare for all. As if to drive the message home, the United Nations General Assembly High Level Meeting reaffirmed this goal in 2019.[1] But if one-sixth of humanity were to not meet this goal, it is difficult to envision how the world as a whole might succeed.
When it comes to universal healthcare for all, India needs to get a move on, not just for itself but for the rest of the world as well. Universal healthcare for all cannot be achieved without India, the pharmacy of the world.
We have the necessary ingredients, on the face of it. When it comes to pharmaceutical production by volume, India is the third largest producer in the world. When it comes to generic medications, there is nobody better than us. Fully 20% of the worldwide supply by volume is from India, and we meet about 60% of the global vaccination demand.[2] We can go on: one in every three generic pills consumed in the United States is manufactured by India, and in the UK, that number is one in four – but in the UK’s case, it is for all medicines, not just generic. India’s role in making generic drugs available for dealing with AIDS in Africa is one of the more unheralded stories of our time.[3]
How might we leverage these advantages to rise even higher, and move closer towards achieving the ambitious, but attainable goal of healthcare for all. In our view, this boils down to processes, products and people. Let us deal with each of these in turn.
Over time, our drug regulator has gained global credibility, and is today at maturity level 3. In English, this means that we have “stable, well-functioning and integrated regulatory systems”. Which sounds like, and is in fact, a good thing. But a better thing would be to reach level 4, which would indicate regulatory systems operating at an advanced level of performance and continuous improvement.[4] We assure you, this is all too attainable.
But this attainment will come only if we improve our processes, and by a lot! Arbitrary drug approval processes[5], for granting emergency use authorisation (EUA) for drugs such as Itolizumab, Remdesivir and Favipiravir and treatment like plasma therapy is indicative of a slapdash approach towards processes, at best. In the case of EUA, this is doubly problematic. Firstly because the Drugs Act does not even include a provision for granting EUA. And secondly, because the aftermath of the pandemic has revealed to us that these drugs are all but useless for COVID-19 and have resulted in pushing so many to poverty. This just shows how “immature” our drug regulatory processes are.
Remember also the many “herbal” and “homeopathic” remedies that were actively promoted by the Government. These have caused untold harm by reinforcing absurd beliefs of immunity in these concoctions peddled by the unscrupulous, but have also served to undermine the credibility of the drug regulator.
It gets worse. It would seem that the United States Food and Drug Administration (US FDA) has audited and inspected more Indian pharma manufacturers[6], and has enforced more regulatory actions than has the Indian drug regulator.[7] Further proof can be gleaned from the fact that only 100 drug units out of 8500 are WHO-GMP compliant, and only 300 drug units are US FDA compliant.[8] Spurious drugs and the lack of recall on the basis of the lack of quality are further indications that our processes simply are not good enough[9]. If we were to apply WHO-compliant good manufacturing practice (GMP) norms in this country, a large number of the 4200 MSME drug units would likely face severe challenges – and that is likely an understatement.[10]
Let us turn our attention to products next. We have and there really is no other way to put this shot ourselves in the foot by imposing many non-tariff and regulatory barriers to generic medicines. This is true of the Global South at large, but that is surely cold comfort, if that. Contrast this with Europe, where generics gain access to wider markets immediately upon patent expiry. We would strongly recommend a system of “passporting” Indian drugs, especially to the Global South, so that approval for a particular drug in one country will mean approval in all countries where we have standing agreements.
In our opinion, India has missed many golden opportunities to integrate with and help nations of the Global South. This could, and should have been done in the case of both the green and the white revolutions.These were missed opportunities and that has diluted India’s global influence over the decades. Now that there exists an opportunity to be a leader when it comes to providing universal healthcare, we think it imperative that India steps up to the mark, and shows the way to other nations. The world needs India because there is currently no alternative for low cost high quality medicines[11]. This was the sweet spot for India during the IT revolution of the 1990s.
Finally, as regards products, our wishlist may well sound long, but each of the items on it are eminently attainable. We need a dramatic increase in the number of Jan Aushadhi stores[12], INN[13] prescriptions (as opposed to brand name prescriptions), fixed trade margins to prevent rampant profiteering, government interventions on the supply side (most notably in the case of centralised procurement) and finally, a dramatic rationalisation of the many healthcare schemes that are offered by the Government across multiple levels.
Or, to put it more succinctly, what we need is universal healthcare, rather than universal health insurance where it is the insurers who profit off patients. We have seen the irreversible damage private health insurance has done to healthcare in the United States and we have also seen the benefits of universal free healthcare in Europe.
Our final point is about the most important grouping of them all: People. Our treatment of frontline healthcare workers has been nothing short of shameful during the pandemic, and we argue that we haven’t exactly covered ourselves in glory in this regard even before 2020. No healthcare system can function well without well trained, well respected and well compensated healthcare workers, and we don’t think we do a good enough job in any of these cases. Whether it be overworked doctors on strike during the pandemic, understaffed medical establishments, [14] or the shoddy treatment meted out to Anganwadi workers, or hundreds of other examples – we need to do better as a nation.
Universal healthcare for all is an aspirational yet attainable goal. But for us to get there, we need to dramatically improve our processes and our products. But above all, we need to do better by the people who work in this sector. As the meme goes, the best time to get started was yesterday. The next best time? Right now.
† Murali Neelakantan is the principal lawyer at amicus. He was formerly global general counsel at Cipla and global general counsel and executive director at Glenmark
†† Ashish Kulkarni teaches courses in economics and statistics at the Gokhale Institute of Politics and Economics, Pune, and blogs at econforeverybody.com
[3] See HERE https://www.ipa-india.org/wp-content/uploads/2020/10/indian-pharmaceutical-industry-way-forward.pdf.
[4]See https://www.who.int/initiatives/who-listed-authority-reg-authorities/maturity-level.
[5]See, Fifty-Ninth Report on the Functioning of the Central Drugs Standard Control Organisation (CDSCO) available HERE .
[6]Center for Drug Evaluation and Research Office of Pharmaceutical Quality Report on the State of Pharmaceutical Quality: Fiscal Year 2019 HERE .
[9] See, Katherine Eban, Bottle of Lies: The Inside Story of the Generic Drug Boom (2019) for a deep investigative report on India’s many problems with the pharma industry.
I had no clue about how hard it is for drug organizations to follow administrative necessities. An extensive perspective on this viewpoint is given by your blog.