https://m.facebook.com/story.php?story_fbid=10226028910334476&id=1387786704&sfnsn=scwshmo
S Sen: Covaxin is indigenously developed. The GoI has partnered with the Bharat Biotech.
The Union Government must let/persuade all the capable manufacturing units to go for producing this vaccine - at low price, on an urgent basis, by sharing the production process in order to massively hike the volume of vaccine production.
Here, no IPR of any foreign body is involved. There's no viable excuse to keep from doing it.
At least, for a while, let the Loot Maar Raj retreat.
Experts feel that the Centre’s stand against compulsory licensing – which the Supreme Court had floated as a tool it could use as part of its pandemic response – is not only contradictory to its position at international forums, it could end up jeopardising India’s efforts to ensure vaccine equity at the global level.
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In simple terms, when a government invokes a compulsory license, it grants permission to a person to make or sell an invention or product without seeking permission from the patent holder. The question of compulsory licensing in India involves two important provisions under the Patents Act, 1970.
First is Section 92. Under this provision, the government can declare compulsory licensing for any patented invention in times of national or extreme emergency. Once a declaration is made, the controller general of patents can grant licenses to any applicant. The patent holder will be paid a royalty fixed by the controller general.
Section 100 of the Act, on the other hand, allows the Centre or others to use the invention for the purposes of the government, if deemed necessary. This would allow Indian companies to begin manufacturing while the royalty is negotiated. If the negotiations fail, it falls upon the High Court with the jurisdiction to fix a reasonable royalty.>>
AA : But the article itself quotes the govt's affidavit that 1 private and 3 public sector manufaturing facilities are to be got ready with enhanced capacities for production of vaccines. That would be Covaxin. Earlier in the month, it was reported in Mumbai that Haffkin Pharmaceuticals in the city would be producing Covaxin, but it would take them 6 months to start manufacturing. Quality of production is a concern with patent being thrown open. Process of production in Bharat Biotech was called into question by a country which was buying Covaxin. As for unilateral compulsory licencing by India, it would affect its negotiations with imports.
SS: I. It is the regulatory authority in Brazil which was dissatisfied with the production process in the Bharat Biotech plant.
That by itself is not too enlightening.
It may even mean (deemed) inadequacy of the system of documentation of the various stages of production.
II. There appears to be a (long) list of unused PSE plants.
Only the one in Maharashtra is going to be pressed into service.
There'd, similarly, be many in the private sector as well.
III. As regards quality, there must not be any laxity.
Any (allopathic) licensed drug manufacturing unit must be having its internal quality control and monitoring system.
On top of that, these are subject to overseeing by the central regulatory authority (CDSCO).
The original patent holder, by virtue of that mere fact, doesn't ipso facto guarantee quality.
The rejection of Covaxin by Brazil is an illustrative case.
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Why is India calling for a global vaccine patent waiver, but against discussing one at home? https://scroll.in/article/994672/why-is-india-calling-for-a-global-vaccine-patent-waiver-but-against-discussing-one-at-home?fbclid=IwAR0fc6T2ckUsL2tJDYZS4xuHk3X0voqFefwUb6hKXFYrXEEtATogwltzuno At the global stage, India is one of the co-sponsors – with South Africa – of a World Trade Organisation agreement demanding a waiver on intellectual property rights for vaccines for the duration of the pandemic. India’s proposal has recently gained steam, after US President Joe Biden announced his support, with hopes that this might make it easier for many more countries to get access to Covid-19 vaccines.
At home, however, the Indian government is not only taking a different stance, it has even asked the Supreme Court to not even discuss or mention the use of the state’s power to override intellectual property rights for essential drugs or vaccines, claiming these could have “serious, severe and unintended adverse consequences in the countries efforts being made on global platform.”
sAre the new gap between vaccines a result of science or lack of vaccines?
https://www.youtube.com/watch?v=P-hqodcwlHc India today video on 14th May. Morning Newswrap| Covid Infection Is Slowing Down In India; Decoding Gap Between Covid Jabs
Are governments adjusting the gap between doses? https://indianexpress.com/article/explained/covid-19-india-second-wave-vaccine-shortage-gap-between-vaccine-jabs-7269540/
Lots of governments have been doing so. For instance, Canada has done this for all of their vaccines. In fact, they’ve decided to go with a four-month interval. I think many countries have decided that there is enough evidence to show that, for the AstraZeneca vaccine (Covishield in India), increasing the gap between doses definitely gives better value. If you look at the effectiveness data in the single-dose studies from the UK, you can see quite clearly that one dose is working very well and that it’s perfectly fine to lose the second dose for at least 12 weeks.
Can waiting longer for the second dose of Covishield increase the risk of infection?
As far as the argument that increasing the dosing interval for Covishield could lead to breakthrough infections is concerned, there is no data so far that proves you will get a greater number of breakthrough infections that result in disease comparing 4-, 8- or 12-week intervals. Data from the first three months of vaccinations in the UK is all based on a single dose — what we’re seeing there is good protection with the first dose.