IP Reveries: Class 5.1 – Medicine, Secrets and techniques, and Innovation: Brooding Over The Fundamentals

WHO is the authority?

Prof Antilegend’s courses are again! After just a few classes on conceptual and theoretical concepts round IP, this set of classes will now take the category on a special not-so-theoretical matter and deliberates upon IP points that crop up round scientific trial take a look at information, drug innovation, Indian drug regulatory regulation and so forth. If that is your first time coming throughout the IP Reveries sequence, you possibly can see what its about in addition to get hyperlinks to our earlier courses within the introductory put up right here. IP Reveries is co-authored by Lokesh and myself in equal measure.

Medicine, Secrets and techniques, and Innovation – Brooding Over The Fundamentals

Nya: Prof., good morning. I’ve some questions, doubts, and requests right now. (hurriedly) It’s essential to have heard concerning the loss of life of 66 youngsters from diethylene glycol (“DEG”) poisoning in The Gambia and the World Well being Organisation declaring 4 Indian cough syrups as containing unacceptable quantities of DEG contaminants. and ethylene glycol as contaminants. Whereas studying, I discovered that it had additionally occurred in India 5 occasions prior to now from the identical substance. In reality, DEG poisoning is a widely known contaminant and has brought on deaths since 1937. Why is it even available in the market? 

Akira: I learn this too.. Earlier, I recollect studying {that a} bunch of medicine had been first banned for not having any profit, after which some had been unbanned. I don’t perceive this entire factor round medicines (annoyed). And extra just lately, one thing a few freebies scandal relating to one other painkiller. Prof., we should always focus on these items right now … about patents, medicine, and well being care, please!

Prof. Antilegend: Certainly, IP has a number of very important interfaces with the well being enviornment, and fact be advised, there are numerous bitter capsules to be swallowed when you begin wanting extra carefully.  You’ll have a extra detailed examination of pharmaceutical patents later in your course nevertheless it might not be a foul thought to at the very least begin opening this pandora’s field – particularly on the non-patent-related elements! Whereas there’s a lot to chew – we are going to solely contact upon the areas and fundamentals insofar as they work together with “IP”, and also you’ll should go to your well being legislation class for the remaining! 

Mindy: That is fascinating … I believed patenting (or maybe trademarkmurmuring) is all we have to find out about medicine within the IP context. 

Prof. Antilegend: It’s essentially the most mentioned – however there may be one other important space! And that entails commerce secrets and techniques and scientific trial information. However to speak about that, we first want to know a bit concerning the regulatory system. And this introductory bit could assist you determine how one can go about answering the questions you opened the category with! 

Slato: Regulatory system … as in one thing for checking the standard of the patents granted on medicine? However that’s what they’re already given after novelty, non-obviousness and so forth. (Confused face)

Prof. Antilegend: No, that’s completely different. Patents don’t decide if a drug is protected and efficacious for folks. (1) Patenting an invention utilized in a drug, and (2) getting regulatory approval to promote a drug available in the market. These are two utterly separate ideas! To get patent safety, an invention (which is often part of the drug) must fulfill the authorized standards of novelty, inventiveness, and utility. However to ensure a drug is match to be bought to folks as drugs – it must be accepted by a rustic’s drug regulators who (are purported to) look into the protection and efficacy of the drug! Illustratively, there are particular bars on patenting of conventional data medicine, admixtures of identified medicine, or new types of identified substances – all of which we’ll want to debate in future courses for nuances. Nevertheless, there is no such thing as a such bar on the promoting of those as pharmaceutical merchandise as long as they’re accepted by the drug regulatory authority.

Nya: So … Can anyone go to a drug regulator and get it registered by submitting some varieties and paying charges?

Prof. Antilegend: Not likely, there’s a little bit of a course of. The Central Medicine Normal Management Organisation (“CDSCO”) is the drug regulator in India to whom producers submit information from their scientific trials in the event that they need to promote new medicine in India. This information is named ‘take a look at information’. (interrupted

Mindy: Scientific trials? Like attempting medicine on sufferers in clinics and discovering out in the event that they work? That sounds darn harmful.

Prof. Antilegend: Haha, no … no. So (pondering) … possibly let’s begin from the start. Pharmaceutical innovation, or extra particularly, arising with a brand new drug, is commonly a protracted, multitudinous, time taking journey involving substantial prices. Let me attempt to offer you a really approximate thought of this journey – simply keep in mind, all of the numbers are very approximate and may differ from case to case! (emphasising)

Usually, there are 4 levels/phases that may take as much as 10 -15 years to finish – 

(i) the invention part (1-3 years) – the place scientists (often universities and public labs) analysis for the sake of science and undergo hundreds of compounds. Right here, the essential identification of promising leads is finished.

(ii) the pre-clinical phase (1-2 years) – from these hundreds of compounds, just a few hundred compounds that present some promise for treating a specific illness, are recognized. These are checked on animals and solely after approval go to the following stage for human trials;

(iii) the scientific trial part (6-7 years) – A extra detailed choice course of is finished on beforehand verified compounds to isolate the few most promising ones. (emphasising) This stage verifies how properly a brand new drug compound works in folks in three levels, every performed on an ascending variety of volunteers.

(a.) Stage I assessments fundamental pharmacology i.e. whether it is protected to take. That is often completed on a small quantity (between 20 and 80) of wholesome human volunteers,
(b.) Stage II entails a bigger quantity (between 100 and 300) of affected person populations and focuses on whether or not the drug improves the situation of these with a sure illness and potential unwanted side effects,
c.) Stage III entails extra folks (between 1,000 and three,000), to firmly affirm each security and efficacy in deeper element.

Lastly, after the scientific trials are cleared comes the approval stage:

(iv) Regulatory Approval – regulatory approval is sought. Does it present the advantages it claims to? What sort of unwanted side effects can it trigger? And questions alongside these strains.  If profitable, the drug is launched available in the market!


Pocrati: Oh … 4 levels of drug improvement together with 3 phases of scientific trials, that’s rather a lot! Hmm. And I suppose pharmaceutical firms are those that do all of this? 

Prof. Antilegend: Hah, good query! Whereas it adjustments from drug to drug, it may be mentioned that they will are available in anyplace across the preclinical stage after the general public labs have completed a few of the fundamental groundwork, proper up until the scientific trial stage. They usually zero in on what they contemplate essentially the most promising from their lens, after which they purchase these compounds from public labs, and/or proceed to speculate/fund the remaining a part of the drug’s journey. 

Akira: Hmm, such a protracted course of. And what’s the associated fee they actually incur 1 – 2 – 3 million … how a lot?

Prof. Antilegend: One other superb query – with out an excellent reply, for the reason that estimates differ greater than Feus’ moods! The actual quantity just isn’t identified however the estimates vary from as little as $314 million all the best way as much as $5 billion! DiMassi et al’s 2016 research is essentially the most cited research which supplies an quantity of $2.8 billion. On the opposite excessive, is Donald Gentle & Rebecca Warburton’s research which locations it nearer to 300 or 400 million. And there are a variety of different research that take a look at completely different present research after which come to their very own numbers, comparable to Wouters et al which estimated it at $ 1.1 billion! And every of those numbers retains getting completely different criticisms from completely different corners. We received’t go into the accuracy of those numbers however for the needs of this class, it’s simply related to know that a big portion of the whole estimates (whoever is making them), are sometimes attributed to scientific trials. In scientific trials alone, the prices of phases 1, 2, and three in the US are estimated to be within the vary of $ 1.4 – 6.6, $ 7.0 -19.6, and $ 11.5-52.9 million respectively.

Slato: Oh gosh … that’s loadsamoney! Then, glad to know we’re placing a lot cash into one thing so vital to us – well being is wealth in spite of everything! Hmm. However does all this wealth translate to well being?

Sugastine: Appears there could also be a intermediary between the 2! I examine tuberculosis (TB) final yr… Have you learnt this TB has killed over 4 lakhs folks in India in 2020 alone? That is round 34% of the whole toll of 1.5 million deaths attributable to TB worldwide. It could be comprehensible if TB had been a brand new illness like Covid 19, however TB is tons of of years previous, is it not? Are we actually positive this spending of cash is going on the fitting method? (emphasising)

Prof. Antilegend: To place it mildly – no, we’re in no way positive. There’s a number of juicy stuff in there, that we should always undoubtedly speak extra about. However for now, let’s preserve our cogitation on regulation. What occurred in The Gambia just lately, and related situations that occurred prior to now counsel some critical issues with India’s drug regulation system. Given the title of the “Pharmacy of the World”, India’s drug issues are further important as a result of not solely do they make Indians endure, however so many exterior folks additionally endure as a result of many international locations on this planet purchase medicine from India. The current Gambia mishap amply clarifies this.

Slato: Please elaborate?

Prof. Antilegend: Earlier than any nation permits any drugs to be bought, they’re first chargeable for making certain that the drugs is the truth is drugs, and never snake oil passing as drugs. That is the place their regulatory system is available in. And … you understand what. That is the place I’ll pause right now’s class. It’s already previous the hour, so why don’t you all learn up a bit on the regulatory system and let’s reconvene with solutions as a substitute of questions within the subsequent class! 

For a little bit of context for our subsequent courses, you could begin with Prashant Reddy’s The Information Exclusivity Debate in India: Time for a Rethink?  and Shree Agnihotri & Sumathi Chandrashekaran’s Drug Regulation in India: The Working And Efficiency Of CDSCO and SDR to get a way of India’s drug (mal?)regulation system.

Pocrati: Certain Prof, thanks. See you within the subsequent class.

(steps of the scholars leaving the category)

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