Tuesday, March 28, 2023
HomeOpinionDCGI’s Covaxin ‘approval’ is political jumla. It reinforces idea of Modi’s Atmanirbhar...

DCGI’s Covaxin ‘approval’ is political jumla. It reinforces idea of Modi’s Atmanirbhar Bharat

The Modi govt must not damage India’s competitive advantage in vaccines & pharmaceuticals through absurd benchmarks that will not be trusted by other countries.

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Other than to the highly credulous, it is pretty obvious that the Drugs Controller General of India’s ‘approval’ for Bharat Biotech’s indigenous vaccine candidate, Covaxin, was announced for extra-scientific reasons. It has neither completed Phase 3 clinical trials, nor has the safety and efficacy data been published. In fact, the drug regulator has not so much approved the vaccine for general public use, but rather granted permission for “restricted use in emergency situation in public interest as an abundant precaution, in clinical trial mode…”.

Again, other than to the highly credulous, it is pretty obvious that such an ‘approval’ was announced alongside that of the Serum Institute’s Covishield for political reasons. The Narendra Modi government did not want to lose the opportunity to score political points: that India has produced an indigenous vaccine under the leadership of Prime Minister Narendra Modi.

In other words, it’s a jumla. And an effective one at that. It reinforces the government’s narrative of Atmanirbhar Bharat. Plus, anyone who questions the decision can be attacked for not being patriotic, nationalistic, or proud-of-our-scientists enough.

Also read: After Congress’ Jairam & Tharoor, now Milind Deora questions ‘speedy’ approval for Covaxin

Politics or science

What is amusing is that just like in the story of the Emperor’s New Clothes, a lot of people — including experts — are going out of their way to justify the decision on scientific or public health grounds. It is one thing for politicians and political commentators to do this, quite another when scientific experts and public officials undermine their personal reputations and institutional credibility by offering implausible technical justifications. It would have been far more honest to admit that there is a strong political imperative to fast-track an indigenous vaccine, and that the regulators have accommodated it while minimising the risks to the public.

At a time when even the Indian republic’s top judiciary is unable to resist the tide, the drug regulators have done well to ring-fence their grant of permission using clever language to restrict the use of the vaccine before the trials are completed and the results are out. It is quite likely that the actual large-scale rollout of Bharat Biotech’s Covaxin will happen after the trials are completed.

The Modi government is likely to have assessed that the political risks of the move are low enough and can be managed. The vaccine is perhaps quite safe and effective. If problems are detected in the ongoing Phase 3 trials, its use in the public vaccination programme can quietly be discontinued. If problems are detected later, the short span of public memory and the government’s dominance over public discourse can be relied upon to shift attention to other matters. To its credit, the government has already put in place a national vaccination plan down to the grassroots, and it will start doing its job in a matter of days now.

If the risks to public health and the political health of the Modi government are somewhat contained, the risks to India’s international credibility as a healthcare and pharmaceutical player are not. Even if Bharat Biotech’s Covaxin is safe and effective, it does not serve the national interest for regulators to claim “110% safety” based on an unpublished internal report submitted by a group of experts whose very names have not been announced. “Trust us, we are experts” or “Have faith in Indian scientists” might work to silence domestic sceptics, but it won’t cut the ice with foreign countries. That the Russian and Chinese vaccines have fewer takers than Western ones is because the latter demonstrate massively higher levels of transparency and scientific probity.

Also read: Why Bharat Biotech’s Covaxin is the object of national pride & scientific scepticism

Time for Indian healthcare to step up

It is certainly a matter of pride that India is one of the world’s leading vaccine and drug manufacturers, and the Narendra Modi government must do everything in its power to promote the indigenous industry. But it should remember that the most basic dharma is “ahimsa”, and in medical practice “primum non nocere”. Both mean the same thing: “do no harm”.

As I wrote last August, amid reports of Indian Council of Medical Research (ICMR) calling for a vaccine to be announced before trials, “The Modi government must not damage India’s competitive advantage in vaccines and pharmaceuticals through absurd benchmarks that will not be trusted by other countries…The greater the official transparency, the greater the credibility of the vaccines and treatments developed in India. Indeed, the credibility of India’s medical and pharmaceutical regulatory authorities is of strategic importance. Beyond protecting Indians, indigenously developed vaccines and treatments have global potential.”

Few in India or abroad doubt the prowess of our scientists or entrepreneurs. When it comes to health, more than any other subject, what people worry most about is the “system”. India’s healthcare and pharmaceutical industry has the potential to realise the numerous opportunities in a post-pandemic, less China-reliant world. To capture these opportunities, it is more important for the healthcare governance system to be — and be seen as — professional, honest, and transparent.

The author is the director, Takshashila Institution. Views are personal.

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  1. As much as you say that Covaxine is a jumla we can say that you are jumla. And as much as you can say that people can attack you for ‘not being patriotic, nationalistic, or proud-of-our-scientists enough’, we know that all that you are doing is writing on the same vein against Modi. And you are not alone. There are plenty on the pay rolls of commies, jhadis and khalistanis who are getting exposed by the day, whether at JNU, Shaheen bagh or Delhi’s borders.

  2. Instead of so many contortions, the regulators should have been directed to be pro active. Approval for Phase 1 & 2 trials was given in end June ’20. Phase 3 trials could have been started by beginning of October if the regulators had carried out weekly review. The number of centres should have been 50 and all centres given clear instructions in advance. Perhaps proper preliminary data could be available by Feb ’21 and based on solid data, EUA could have been given without any controversy. It is purely a failure of the Establishment, who initially wanted a vaccine to be ready by Aug 15 2020 (biggest jumla)

  3. By criticising Bharat Biotech vaccine and damaging jio towers ( who are competing with Chinese G5 ) congress and leftist elements are batting for China/CCP. These are difficult times all countries are taking calculated fast track approval path, so we must trust our scientists n refrain from putting Indian priducts on mat.

  4. The writer’s cribbing is mainly about the political mileage gain by the government by granting restricted permission to Covaxin. When he himself says it is a ring fenced permission, I am unable to understand what is his objection. Evidently the writer is not a scientist. But he ventures to opinion that the vaccine is “perhaps safe”. How does he sit in judgment over the scientists who have supported the permission granted to Covaxin? The article is full of ambivalence. This is bound to happen when someone writes on a technical matter with a political agenda.

  5. What about Sputnik 5 of russia did u criticize it, what about chinese vaccines which are already being used…for last 6-8 months,and at the same time third phase trial is conducted, u all are blinded by hatered for India’s PM, that u all don’t think anything except criticising him, let me clarify i am not a supporter, as u may justify ur idiotic sense by saying he is a supporter, nop i am commoner who is following the prints articles from few days… Totally Ediot.. whoever wrote this article..

    • Why was Sputnik V asked to run Phase 2 & 3 trials before it would be accepted? Why not the same yard stick for Covaxin?

  6. What about Sputnik 5 of russia did u criticize it, what about chinese vaccines which are already being used…for last 6-8 months,and at the same time third phase trial is conducted, u all are blinded by hatered for India’s PM, that u all don’t think anything except criticising him, let me clarify i am not a supporter, as u may justify ur idiotic sense by saying he is a supporter, nop i am commoner who is following the prints articles from few days… Totally Ediot.. whoever wrote this article..

  7. If there are any problems with the vaccine Modi will be the biggest looser and mind you he is no Raga to do that.

  8. Modi should not have linked it with Atmanirbhar. By doing so he divided the SII and Bharat Biotech camps.

    These companies existed before 2014 and would have produced the vaccine even if Modi or BJP were not in power. So how is it connected to Atmanirbhar? We were already self-reliant in vaccines before 2014!

    So Modiji is the one who first tried to score political brownie points. I doubt the Opposition would have reacted if it were not for Modi’s nationalist style of messaging. It is not anti-Covaxin that is driving coverage of this in the media but the fact that Opposition sees Modiji as an opportunist trying to steal the credit.

  9. I am in CT Industry from last 16 years and there have been several instances where drugs were approved when Phase III trials were still ongoing. You are a journalist so stick to your Job. Don’t try to be a Researcher. If you go in depth of CTs then majority of CT violations happens in Western world. Data from India is respected by Health Authorities of all other Countries. I as a researcher have no doubt on Bharat Biotech vaccine and approval from DCGI’s SEC.

    • Drugs are given to a small set of people, wgo are suffering from the particular disease. Vaccines are given to a very large population who may have existing diseases or medical conditions. You are just unable to differentiate between the 2. Even for drugs against Covid, phase 1, 2 & 3 trials have been held and so far no drug has been approved. That is the reason existing drugs are being tried for Covid as approval for new drugs will take unduly long.

  10. For your reading pleasure below from US FDA. The Biontech vaccine has been approved only for EUA not for the general public. Stop writing about stuff you do not have expertise in.
    “Most drugs undergoing Phase III clinical trials can be marketed under FDA norms with proper recommendations and guidelines through a New Drug Application (NDA) containing all manufacturing, preclinical, and clinical data. In case of any adverse effects being reported anywhere, the drugs need to be recalled immediately from the market. While most pharmaceutical companies refrain from this practice, it is not abnormal to see many drugs undergoing Phase III clinical trials in the market”

  11. It is unfortunate that instead of encouraging local talent, the author is criticising it without any examples.

  12. Extending the logic further of Mr.Sachine Patel, when ever any Arm or ammunition is procured or developed in India It should be tried on chest of PM and Defense Minister of India, Further down the line Generals ,and armed force officers should offer themselves as Test – kit.

    • Foolish analogy.

      But since you brought in Modi here –

      Science does not work on faith and trust in someone. Science is all about questioning, proving or disproving hypotheses. The moment a culture tries to douse the fire of questions, it indicates that culture is not interested in exploration of truth but want to say “believe us and trust us we know what is good for you”.

  13. Government of India should pass a law that henceforth , permission for induction of all medicines , pharmaceutical preparations shall have to be taken from the office of the President of Congress party . In case the President or its nominated dignitary is not available in India , a group of leftists journalists will be second authority vested with the powers to grant permission in such matters , because as per logic of some worthies belonging to leftist ideology, India has become a country — devoid of Scientific manpower and scientific temper since 2014 . The example of The Prime Minister National Relief Fund is there , where Congress President was/is made ex-officio – Member of PMNRF , as it was thought in 1947-48 that Congress President is more rational authority than incumbent PM and his team, and hope such arrangement still persists. . As we have been living and breathing in such environment even Britishers left us in 1947, It has been fully ingrained in our national conscious . So why degrade ourselves by having independent pool of scientists, technologists , Doctors, research scholars , when we need approval from West for every thing done by our national talent . Until we get approval , every research & development done in India , it is JUMLA , as this honorable writer thinks and write,

  14. In case BB’s vaccine fails in phase 3, it will hit them very hard. Their reputation will be ruined. I am sure they must be aware of this. In that context, BB is entitled to be confident given that the whole company is at risk and they are ready to take that risk. Even SII indicated that BB’s vaccine is safe. Question is about efficacy, which will be proven anyways. U cant hide it for long. So, BB getting an approval should not cause so much alarm.They say that 20000 people are going through the phase 3, which is a very good number. Lets give them credit for coming up with the vaccine.
    It will be good if the article talks about phase3 trial data from covidshield ( Serum institute vaccine). How many people were in Phase3 and their demography details ( age, ethnicity, etc etc)

  15. Kudos to the writer for pointing out how Modi jeapordises India’s credibility in Pharmaceuticals by eliminating requirement of completion of trials before releasing a vaccine to promote ‘Make in India’.
    Kindly ignore the brain dead bakhts in the comment section screaming Anti nationals. People, news channels, politicians, farmers, students, businessmen and women like you are The ‘VALKYRIES’ that our nation needs to prevent the fascist govt led by JHUTLER from turning this country into ‘Animal Farm’.

  16. Just another hit job in efforts to copycat western commentators.
    Actually even nyt article was very informative and political.
    You are making jumla by writting on it.
    Why the humanities background talk crap about science they dont understand. Give it up.
    Like tharoor who is only oxford dictionary specialist and has no other credentials.
    Bharat biotech is better candidate. Just wait for few months.
    You have no skill except english language.
    We want skill india. Get a real job.

  17. You are a cad. We are well aware of all the facts of about covaxin and understand the reasons for why it was put on the same pedastal as covishield. The reasons are noble and are in India’s national interest. The politics of the decision is in the interest of the nation. Covaxin will not be rolled out until the phase 3 trials are completed and the results are satisfactory. Cowards like are only interested in pulling down your own country. You sir, are a disgrace.

    • Vaccine nationalism is a stronger instinct than unbiased science.

      Testing with Animal models cannot translate to human models.

      We all wish the best for Bharat Biotech as it is indigenous. Of course we should be proud of this company if the vaccine is successful. Even if it is finally shown not as efficacious as other vaccines we should appreciate our scientists for trying. But we should trust actual clinical data to review the approval decision not Twitter or youtube messaging.

  18. Bharat Biotechs Covaxin should be taken by our PM , politicians of the BJP first to prove its mettle , and boost confidently Atmanirbhar bharat

    • The nationalists should wait to take Bharat Biotech as it is wholly indigenous research compared to the Oxford vaccine. It looks like this vaccine will not be publicly available until all the clinical trial data is made available for scientific review.

      But our health workers can’t wait, better to start them on the Oxford vaccine right away. Don’t experiment on health workers please with hastily approved vaccines. The pandemic is slowly withering away under present circumstances anyways.

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