LOCOST’s Statement in Response to Certain Allegations Made by Dinesh Thakur on Twitter

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chinusrinivasan.x

2 May 2023, 10:06:4202/05/2023
to mfccircle, JSA Discuss, Jsa-ncc, aidanindia, LOCOST - 2

May 2, 2023

 

Dear friends,

 

LOCOST’s Statement in Response to Certain Allegations Made by Dinesh Thakur on Twitter

 

In his Tweets dated March 29, 2023, @d_s_thakur, the co-author of the book, The Truth Pill (2022), made some intemperate accusations against LOCOST and against the All-India Drug Action Network (AIDAN), of which LOCOST is a part. These accusations are also a kind of ‘response’ from him to the critical review,   'Half Truth Pill', by Dr Anant Phadke (who is a trustee of LOCOST and part of AIDAN) in the Economic and Political Weekly (EPW) of March 25, 2023. 

 

We are not active on Twitter and are inclined not to get into Twitter exchanges. Hence this statement. 

 

This communication is to briefly share with friends and concerned people, LOCOST’s response to these misleading accusations. 

 

The response is divided into two parts: 1) About LOCOST and 2) About the Enalapril Incident.

 

Available through hyperlinks specified, are Annexures 1 and 2, which are our email exchanges with Dinesh Thakur, et al., on the issue of enalapril maleate; and about issues in their book, The Truth Pill. 

 

Please circulate this to all concerned. If you have questions or need clarifications, please write to S.Srinivasan (‘Chinu’) at chinusri...@gmail.com with a copy to anant....@gmail.com and lowco...@gmail.com.

 

With kind regards,

Sincerely,

Sd/- S.Srinivasan, Mng Trustee, LOCOST

Attached:  LOCOST Stt May 2, 2023  Annexure 1 

Annexure 2

LOCOST Annexure 1.pdf
LOCOST Annexure 2.pdf
May 2, 2023 Stt from LOCOST on DT tweets of 29th March 2023 (1).pdf

chinusrinivasan.x

2 May 2023, 10:26:4802/05/2023
to Vandana Prasad, mfccircle, JSA Discuss, Jsa-ncc, aidanindia, LOCOST - 2
Thank you Vandana. 

Chinu

On Tue, 2 May 2023, 10:24 Vandana Prasad, <chau...@yahoo.com> wrote:
thanks for this information - factual and well put together. receiving fairly unfair potshots is all part of the game i suppose, but phrases like 'in bed with pharma industry' are so outre that one can hardly even begin to respond...
all the best 
Vandana

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sarojinipr

2 May 2023, 12:08:5102/05/2023
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Dear Chinu
Thank you very much for sharing these documents with full information and clarification. 
Regards
Sarojini

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chinusrinivasan.x

2 May 2023, 16:34:0002/05/2023
to Amitava Guha, jsa...@googlegroups.com, Vandana Prasad, mfccircle, JSA Discuss, aidanindia, LOCOST - 2
Thank you Amitava and Vandana and others.

Best,

Chinu

On Tue, May 2, 2023 at 4:16 PM Amitava Guha <amit...@gmail.com> wrote:
Dear Chinu'
I have read about the saga of Mr. Dinesh Thakur in the book 'Bottle of Lies'.
The book gave some exposure of drug regulatory system of US FDA and CDSCO of our country. Both are infested with bureaucracy and maintain many lapses. But the book expressed that medicines produced by Indian manufacturers are mostly untrustable or have questionable quality. I have not read 'Bottle of Lies' but believe that the same confluence would be observed in this book.
His bitter experience with Ranbaxy has branded adversely on the role of Ranbaxy in IPR activity. I know that Mr. Tahkur has began his work in Ranbaxy after Bhai Mohan Sing had left.  I attended several meetings of the National Working Group on Patient Law in the board room of Ranbaxy.  Bhai Mohan Singh's approach against foreign multinationals was explicitly clear that foreign drug companies are doing much objectionable work. We have an unusual combination in fighting for Indian Patent law. Indian big companies, trade unions, scholars from all over the world and many health activists like AIDAN joined together. Such a cluster was not found in any country. I agree with Chinu that even today, taking the exceptions of TRIPS agreement Indin Patent Act even after amendment is a significant Act which no other country had dared. These facts are not known to Mr. Thakur.
The other area Mr. Thakur would have paid attention isto the ugly role of Indian Drug regulators in continuously allowing a host of irrational combinations some of which are injurious to health.
In soliderity to LOCOST.
 
Amitava Guha
1B, New DDA Janata Flats,
Mayur Vihar, Phase-1
New Delhi-110 091
Mobile No. 9013379037


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chinusrinivasan.x

2 May 2023, 16:35:4302/05/2023
to Amitava Guha, jsa...@googlegroups.com, Vandana Prasad, mfccircle, JSA Discuss, aidanindia, LOCOST - 2
And Sarojini an Siddharth I shld add

Chinu

abhayshukla1

2 May 2023, 17:31:4802/05/2023
to chinusrinivasan.x, mfccircle, JSA Discuss, Jsa-ncc, LOCOST - 2
Dear Chinu,

Thanks for these detailed clarifications. Some of us are coming to know about these allegations against AIDAN and LOCOST only recently, after publication of 'The Truth Pill' and responses to the book, especially Anant's well written review, and related exchanges.

As you have mentioned, the allegation that 'public health activists in AIDAN are in bed with pharmaceutical industry' is unjustified and at variance with the consistent work done by all of you over the last few decades on so many aspects of pharma policy, from a people oriented perspective.
LOCOST's exemplary work on producing good quality generics at affordable prices is of course well known and appreciated by all of us.

Hope that such critical public exchanges are replaced by substantive dialogue among civil society activists on areas of common concern, as far as possible.

With regards,
Abhay


narendra531

2 May 2023, 18:36:0702/05/2023
to abhayshukla1, chinusrinivasan.x, mfccircle, JSA Discuss, Jsa-ncc, LOCOST - 2
Dear Chinu:

I have not read the entire statement painstakingly drafted by LOCOST/AIDAN as I am already aware of the issue. If you recall I wrote against the writers of the book The Truth Pill with regard to the manner its being advertised by the writers. But contrary to what I wrote someone saw a lot of merit. I think AIDAN/LOCOST should write to Newlaundry (Abhinandan Sikri) who is continuously promoting the book.

Best regards.

Narendra .  



“Go to the people. Live with them. Learn from them. Love them. Start
with what they know. Build with what they have. when the work is 

done, the task accomplished, the people will say 'We have done this ourselves.”



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amar.jesani

2 May 2023, 18:58:3702/05/2023
to chinusrinivasan.x, mfccircle, JSA Discuss, Jsa-ncc, aidanindia, LOCOST - 2
Thanks for sharing the Locost statement and annexures. i also read the AIDAN statement. These public statements were overdue.
Dinesh Thakur's tweets were in bad taste and offensive. The manner in which he has covered the activism around the pharmaceutical and rational therapeutics by activists in India in last 40 years in his book showed how ill-informed he is about the social movements in India. It has not done good for the efforts for the reforms in drugs regulations - of course, provided he is serious about the pro-people reforms in the drugs regulations.
I must commend LOCOST and AIDAN for being so decent, simple and straight forward in the way they have drafted the statements and the provision of additional information that speaks for itself.
In solidarity.
Amar
________________________________
Amar Jesani
Independent Researcher and Teacher (Bioethics, Public Health).
Editor, Indian Journal of Medical Ethics (https://ijme.in);
Visiting Faculty: *Yenepoya (Deemed-To-Be) University, Mangaluru, India. Web of Science Researcher ID: AAD-2202-2020; ORCID Id: https://orcid.org/0000-0001-8884-9858



On Tue, 2 May 2023 at 10:06, S Srinivasan <chinusri...@gmail.com> wrote:

Akshay S Dinesh

2 May 2023, 19:25:0502/05/2023
to amar.jesani, chinusrinivasan.x, mfccircle, JSA Discuss, Jsa-ncc, aidanindia, LOCOST - 2
There seems to be long standing discontent in Dinesh about Anant: https:// go.gale.com/ps/i.do?p=HRCA&u=googlescholar&id=GALE| A614034766&v=2.1&it=r&sid=sitemap&asid=0c9651c0

(That would at least explain why so much outrage on twitter)

ASD

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deepa.venkatachalam

3 May 2023, 13:15:1103/05/2023
to Akshay S Dinesh, amar.jesani, chinusrinivasan.x, mfccircle, JSA Discuss, Jsa-ncc, aidanindia, LOCOST - 2
Dear Chinu

Thank you for sharing this statement by LOCOST.  It is a clear assertion of facts that refute the misleading accusations made against LOCOST.  I have yet to read the statement by AIDAN. 

In solidarity with LOCOST and AIDAN,  
Deepa




chinusrinivasan.x

3 May 2023, 13:33:4603/05/2023
to deepa.venkatachalam, Akshay S Dinesh, amar.jesani, mfccircle, JSA Discuss, Jsa-ncc, aidanindia, LOCOST - 2
Thank you very much Deepa. Hope you are well.

Chinu

weareraman

3 May 2023, 13:41:5603/05/2023
to jsa...@googlegroups.com, mfccircle, JSA Discuss, aidanindia, LOCOST - 2

Dear Chinu,

 

I went through the well written note and thanks for sharing the same. Lets hope this answers well to those who made the allegations. However, at times we know that such things are done with a purpose and the image of LOCOST and AIDAN and the space these organisations occupy in the public health and pharmaceuticals domain cant even questioned , forget about tarnishing. Said that this note is very well required for those who don’t know the genesis, and the struggle that these two organisations have led and held.

 

In solidarity,

 

Raman

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chinusrinivasan.x

3 May 2023, 15:14:5803/05/2023
to weareraman, Jsa-ncc, mfccircle, JSA Discuss, aidanindia, LOCOST - 2
Thank you Raman. We would have - and still do - welcomed a civil exchange of views. But DT et would have it otherwise. 

Best,

Chinu

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chinusrinivasan.x

3 May 2023, 15:16:4003/05/2023
to Jsa-ncc, deepa.venkatachalam, Akshay S Dinesh, amar.jesani, mfccircle, JSA Discuss, aidanindia, LOCOST - 2
Thank you Dr Ekbal. 

How are you? Hope you are keeping well.

Regards,

Chinu



On Wed, 3 May 2023, 15:11 Dr. B. Ekbal, <ekb...@gmail.com> wrote:
In solidarity with LOCOST and AIDAN. The reply is very well drafted and self explanatory.
Ekbal 

Health For All Now

On 03-May-2023, at 1:33 PM, S Srinivasan <chinusri...@gmail.com> wrote:


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das.seed@gmail.com

3 May 2023, 19:35:5903/05/2023
to narendra531, abhayshukla1, JSA Discuss, Jsa-ncc, LOCOST - 2, chinusrinivasan.x, mfccircle

Dear Narendra,

Newslaundry is a repeat recipient of grants from the Thakur Family Foundation (the US-based foundation started by Dinesh Thakur). You are probably aware that it funds very widely at the moment, both individuals and organisations. The list of awardees is athttps://www.thakur-foundation.org/our-impact.php. So, it's no surprise that Dinesh Thakur gets a platform easily.

Since you mentioned it, this is the link to the recent interview with Abhinandan Sekhri, who is asking questions about topics he doesn't quite understand :)https://www.newslaundry.com/2023/04/18/pharma-woes-dinesh-thakur-and-prashant-reddy-on-indias-regulatory-shortcomings

But more seriously, given the reach of the foundation, there are very few people who can afford to make critical comments or call Thakur et al out for their dishonesty and unethical conduct, because that is what it is.

Prashant Reddy, a close associate of Dinesh, and former board member of Thakur Foundation, has an established track record of attacking civil society activists working on IP issues, which perhaps people are not aware of in general. There is a glimpse of it in the new book where civil society has been criticized amply, including JSA. It speaks of Dinesh Thakur's success that many groups or individuals are receiving funds through his foundation and regardless of the size of the grant it does seem to color their impressions of his work and influence their ability to voice public reservations with his ideas and misrepresentation of the work of other groups.

Best,
Siddhartha

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Siddhartha Das,
International Institute of Information Technology (IIIT), Hyderabad
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leenamenghaney

3 May 2023, 20:27:0103/05/2023
to das.seed@gmail.com, narendra531, abhayshukla1, JSA Discuss, Jsa-ncc, LOCOST - 2, chinusrinivasan.x, mfccircle
Dear all,

While the criticism of different aspects of the movement is not difficult to accept, the toxicity and mansplaining that the partners Dinesh and Prashant display in any engagement with civil society is challenging in a dialogue with them.

Secondly, any response is used for publicity, as we have seen with how they use Twitter. I worry that they will use the exchange with LOCOST to move away from the issues that Anant raised and to undermine the credibility of an important initiative that has played a critical role in public health in India.

Ignoring them may be a better way of responding, and talking to news laundry on quality issues may be a strategy.

Regards, Leena



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anant.phadke

3 May 2023, 21:59:5203/05/2023
to Rema Nagarajan, das.seed@gmail.com, narendra531, abhayshukla1, JSA Discuss, Jsa-ncc, LOCOST - 2, chinusrinivasan.x, mfccircle
Dear all,
 The detailed response to the nasty criticism by Dinesh Thakur on Twitter has been shared with jsa only yesterday night. It is not fair to say that jsa response has been quite inadequate. Many leading activists of JSA have responded on the jsa forum expressing  their full solidarity with locost and AIDAN.
    About activists and journalists temporary supported from Thakur Foundation we need to have just approach about their role alsom I will write my views about it tomorrow.
Anant
   
   

On Wed, 3 May, 2023, 20:11 Rema Nagarajan, <reemanaga...@gmail.com> wrote:
Thanks for this mail Siddartha and the link to the list of awardees. It's quite a revealing list. It looks like many in JSA too have got funding from him and that perhaps explains the muted reaction from JSA to the attack on AIDAN.
Rema
PS: Looks like a huge number of health journalists too have been funded within such a short span of time-July 2019 to Jan 2023

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Akshay S Dinesh

4 May 2023, 01:12:0204/05/2023
to anant.phadke, Rema Nagarajan, das.seed@gmail.com, narendra531, abhayshukla1, JSA Discuss, Jsa-ncc, LOCOST - 2, chinusrinivasan.x, mfccircle
Anant, while you write about that, can you also write a bit about your review of the Truth Pill on the six points you make and whether you stand by all of them as strongly as of today:

===

The first point is that of appreciation of globally acknowledged increase in access to medicine and mention of regulation of political economy. This point does not directly make to your December 2022 email exchange. I think this book has a specific objective and it is arguable whether it has to make a balanced and fair assessment of the broader issues. Not to mention chapter two of the book ends with a paragraph on Indian being "pharmacy of the developing world". So I think this point is weak.

===

The second point is about the definition of generic medicine - whether "no longer under patent protection", or whether "unbranded". I think chapter 6 makes it very clear that they're talking about branded generics no longer under patent because they talk about different brands of generic and also about patent laws in the US and "innovator drug". This point also doesn't make it to the email exchange.
In the same section you add a point about exports to regulated market "The authors overlook the fact that these manufacturers exporting generics to regulated markets are very much part of the Indian generic industry". Chapter 6 talks about data manipulation by clinical research organizations in this exact context. Therefore, I don't understand whether your point has any direct relevance.

===

You repeat that in the third point "Third, though the book, especially Chapter 6, titled “Can ‘Made in India’ Generic Medicine Be Trusted?” answers this question in the negative, it is not clear which generic medicines the book is referring to. Obviously, this answer does not apply to Indian generics exported to developed countries because these importers have strict regulations." - It is not "obvious" here whether the strict regulations are not being circumvented through data fabrication.
But more importantly you make the point that only 3% of samples in National Drug Survey are found NSQ. Interestingly, you make the counter-point just a couple of paragraphs earlier that "The National Drug Survey 2014–16 found, for example, that 56% of the samples of Pfizer Maharashtra were found to be NSQ" which was what I was also going to write after looking at the results section of the survey https://web.archive.org/web/20220713191727/https://main.mohfw.gov.in/sites/default/files/Chapter10SurveyReslutandAnalysis.pdf There are 10 manufacturing units (including Pfizer Maharashtra) for whom >20% samples were NSQ.

As you acknowledge in the email thread it is not easy to decide which should be prioritized whether low cost or 100% good quality "This exorbitant pricing is almost universal compared to a 3% to 5% incidence in India of Not of Standard Quality (NSQ) medicines as found in the National Drug Surveys done during the last 10 years in India. To be sure, it should be close to zero and any unnecessary loss of health or life is bad enough. Hence at one level, there is no point in judging which is worse – health damage due to unaffordable prices of medicines or due to substandard medicines even though incidence of un-affordability of critical medicines due to unreasonably high prices is much higher. But in your wisdom, you seem to give highest importance to the problem of the gross deficiency and bankruptcy of pharma quality regulation in India."

This balance does not make it to your book review either.

===

The fourth point you make is that the book overemphasizes bioequivalence. As acknowledged in the email exchange (and from the 2020 debate over the bottle of lies), this seems to be the core contention. Dinesh does emphasize bioequivalence and stand by it. Your criticism of that is on the point that:
1) they quote Ranjit Roy report selectively - https://web.archive.org/web/20170517061913/http://www.indiaenvironmentportal.org.in/files/file/clinical%20trials1.pdf seems to be a badly OCR'ed copy where I do find the part you quote about bio-waivers. It also includes this other line which I found interesting: "In case some countries insist on BA and BE studies in humans with each generic drug containing the same chemical compound, such countries should be convinced, based on scientific data, of the futility of such a study for every trade name". But, the overall point that was being made in that section of the book titled "The lethargic Indian approach to mandatory in-vivo bioequivalence studies" was that Indian regulations have been not trying to make bioequivalence studies mandatory. Which means, if they did quote Ranjit Roy fully, their point would be further strengthened.
2) you talk about bioequivalence being now mandatory in India for low solubility medicines. Isn't that a vindication then, that bioequivalence was necessary?


===


The fifth point you make is about "the authors rather blindly insist on imprisonment for every manufacturer of an NSQ drug". This doesn't make to the December 2022 mail exchange, but Dinesh in the 29th March tweet thread points out to the stance on severity of punishment as another core difference (along with bioequivalence) between you both. As per April 4th tweet by Dinesh https://twitter.com/d_s_thakur/status/1643076391976550400 ( article at https:// economictimes.indiatimes.com/opinion/et-commentary/dont-dilute-the- drugs-and-cosmetics-act/articleshow/99071088.cms?from=mdr ) they have a public position against further decriminalization when courts are already being lenient (and this they've argued with several examples in the book).

Since I haven't read the whole book slowly, I cannot find where exactly the authors insist on imprisonment for every manufacturer. But you quote them ""It may also be time to rethink the nature of criminal punishments prescribed under the Drugs and Cosmetics Act 1940. ...The choice between a lengthy sentence in prison versus punishing fines should be well-defined in the law so that there is no ambiguity. (p 99)".

I quote that paragraph in full: "It may also be time to rethink the nature of criminal punishments prescribed under the Drugs and Cosmetics Act 1940. There are many in India who believe that the state must refrain from criminal punishments in what are essentially economic activities. However, given the potential of drugs to cause hurt or even death, we believe that criminal punishments must certainly be retained in the law. There is, however, a valid case to argue for greater flexibility for drug inspectors to choose between criminal punishments that involve imprisonment or a system of monetary fines. This would of course need a relook at the paltry fine of ₹20,000 in the current law. Ideally, fines should be linked to the turnover of the company. The choice between a lengthy sentence in prison versus punishing fines should be well-defined in the law so that there is no ambiguity. For example, if a drug drawn from the market is declared NSQ and a subsequent investigation of the manufacturing facility demonstrates a failure to comply with GMPs, a criminal prosecution with jail time should be mandatory. Similarly, if inspections reveal a poor adherence to legally mandated GMPs, a prosecution should be mandated regardless of whether the drugs resulting from such a manufacturing process fails a quality test."

The paragraph right after that also starts thus: "We are apprehensive of default criminal prosecutions for all pharmaceutical manufacturers whose drugs test NSQ because the supply chain in India is the regulatory equivalent of the “wild west”, as we discuss later in this book." Several sentences in this section, including the line between the two sentences you quoted "

To me it sounds like they're asking for a nuanced approach in punishment.

===

The last point you make is that "Lastly, this book is completely silent about the virtual lack of regulation of medicine prices in India". Similar to the first point, and as acknowledged by Dinesh in the email exchange, this book was perhaps not meant for a broad discussion.

===

There's one extra question I have which is regarding Conflict of Interest. IJME links to https://www.icmje.org/recommendations/browse/roles-and-responsibilities/author-responsibilities--conflicts-of-interest.html for guidance on CoI. There are two sections I want to quote:
"Individuals may disagree on whether an author’s relationships or activities represent conflicts. Although the presence of a relationship or activity does not always indicate a problematic influence on a paper’s content, perceptions of conflict may erode trust in science as much as actual conflicts of interest. Ultimately, readers must be able to make their own judgments regarding whether an author’s relationships and activities are pertinent to a paper’s content. These judgments require transparent disclosures. An author’s complete disclosure demonstrates a commitment to transparency and helps to maintain trust in the scientific process."
"Financial relationships (such as employment, consultancies, stock ownership or options, honoraria, patents, and paid expert testimony) are the most easily identifiable, the ones most often judged to represent potential conflicts of interest and thus the most likely to undermine the credibility of the journal, the authors, and of science itself. Other interests may also represent or be perceived as conflicts, such as personal relationships or rivalries, academic competition, and intellectual beliefs."

Being a trustee of LOCOST does make it possible for people to have a "perception of conflict". I would also urge you to think about whether your review might have been conflicted on the following point:
- LOCOST being close to your heart, are you taking an attack on generic medicine industry as an attack on LOCOST too? Are you able to vouch for any other manufacturer other than LOCOST? If you are not, (except for the 3% statistics from national drug survey), what guarantee do you have on the quality of other manufacturers?

Considering that, wouldn't it have been appropriate to include your trustee role in LOCOST in your by-line or as an expression of CoI? (I only have access to the PDF you shared of the article, and am not sure if EPW has a field for CoI online that's not included in the PDF).

===

I believe that you should consider whether there are any elements in this review that could have re-triggered an ongoing debate between you two on the two core issues (of bioequivalence studies and stricter punishments) - and whether you can find a path of reconciliation with Dinesh.

When I search the tweet history of Dinesh, I see that Dinesh and Malini had been regularly mentioning, retweeting, quote-tweeting, etc in agreement - which would suggest that there's at least been a past where Dinesh was in agreement. It could be the Gambia incident that tipped him over.

Or it could of course be multi-national interests.

But I like to believe that these are just unresolved debates that have been exaggerated by the toxic engagement style that's usually practiced in twitter.

ASD


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sandhya199

4 May 2023, 10:30:1604/05/2023
to das.seed@gmail.com, narendra531, abhayshukla1, JSA Discuss, Jsa-ncc, LOCOST - 2, chinusrinivasan.x, mfccircle
Thank you for putting  out this excellent summary of the problem, Siddhartha. 

Sandhya Srinivasan
8 Seadoll 54 Chimbai Rd
Bandra West Mumbai 400 050
INDIA
(91) 98204 10849

sandhya199

4 May 2023, 10:36:0204/05/2023
to Rema Nagarajan, das.seed@gmail.com, narendra531, abhayshukla1, JSA Discuss, Jsa-ncc, LOCOST - 2, chinusrinivasan.x, mfccircle
It's unfortunate that many journalists and media organisations who one would have otherwise respected  seem to  have taken money without checking about their agenda and understanding the issues. Also unfortunate that some have in a clear conflict of interest and violation of media ethics actively promoted them. 


Sandhya Srinivasan
8 Seadoll 54 Chimbai Rd
Bandra West Mumbai 400 050
INDIA
(91) 98204 10849

On Wed, 3 May, 2023, 20:11 Rema Nagarajan, <reemanaga...@gmail.com> wrote:
Thanks for this mail Siddartha and the link to the list of awardees. It's quite a revealing list. It looks like many in JSA too have got funding from him and that perhaps explains the muted reaction from JSA to the attack on AIDAN.
Rema
PS: Looks like a huge number of health journalists too have been funded within such a short span of time-July 2019 to Jan 2023

On Wed, May 3, 2023 at 10:05 AM Siddhartha Das <das....@gmail.com> wrote:

--
Jan Swasthya Abhiyan (JSA) is the Indian Chapter of the People's Health Movement. JSA brings together organisations and individuals in India working to promote health equity across all population groups. Also visit our website: www.phmindia.org
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jagdish.jb

4 May 2023, 10:55:1004/05/2023
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I did not know it is this Thakur Foundation that has funded a documentary on silicosis on Newslaundry

Jagdish

On Thu, 4 May 2023 at 10:50, Rosamma Thomas <rosa...@gmail.com> wrote:
I too have applied for grants with Thakur Foundation and was never successful. I thought some of the work done by grantees was quite good too. And there is such a dearth of funding options for freelancers too. 

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--
Jan Swasthya Abhiyan (JSA) is the Indian Chapter of the People's Health Movement. JSA brings together organisations and individuals in India working to promote health equity across all population groups. Also visit our website: www.phmindia.org
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--
Jagdish Patel
Director
Peoples Training And Research Centre
43,Srinathdham Duplex,
Dinesh Mill -Urmi Rd
VADODARA-390007
Gujarat, INDIA
Ph: +91- 0265- 2965576 (R)
M-94264 86855
Website: www.peoplestraining.org
Twitter:@Jagdish37914614
Skype: j.b.patel

weareraman

4 May 2023, 11:23:1304/05/2023
to jagdish.jb, Rosamma Thomas, sandhya199, Rema Nagarajan, das.seed@gmail.com, narendra531, abhayshukla1, JSA Discuss, Jsa-ncc, LOCOST - 2, chinusrinivasan.x, mfccircle
I know many people who received funding from the Thakur Foundation for different public health and cilvil liberty related research or media work. I have not come across an issue of interference from them on the project work or any other issues. So, I don't think there is a point taking things or thinking in that direction. There can be a person or two who consider the donor a master and you cant help it, but not everyone does that.  As I stated earlier, I see that those who came to know about the issue and who know the work of Locost or AIDAN are taking clear positions and solidarity on the matter. Hence, as I think,  what we need to is to focus on the allegations made by the specific individuals and the response therein (some of us here are active @Twitter can help in communicating those responses effectively there too- as the language is totally different). 

We need to also understand little in depth, I think, about the new era attention building proceeses and the new capital formation around it, which can probably generate ideas and leads towards formulation  of a healthy social media concept and social media ethics- which could be a good outcome from this discourse. 

Best, 

Raman



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anant.phadke

4 May 2023, 13:13:0604/05/2023
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Dear all,
     As I indicated yesterday we need to take a dispassionate, just and balanced view of the Grantees of Dinesh Thakur Foundation. 
      Among the list of grantees of the Thakur Foundation only a small proportion consists of journalists and barring couple exceptions, hardly anything on drug quality regulation in India. So it cannot be said that Thakur Foundation is fueling, funding the spread of his ideas about drug quality regulation. Secondly those who have got funding from Thakur Foundation need not necessarily agree with his views and more than that, they need not help in propagation of these views. However, this Foundation is invitably promoting his image. But if we are able to have some dialogue with some of his  journalists, columnists, followers, it is possible that they would Re examine their views about Thakur's  allegations on this issue of quality of generic medicines in India.  This may not happen and we can't help it anyway.
     There is bound to be great appreciation of Dinesh thakur's role as whistleblower against the frauds by Ranbaxy. At a young age he staked his career and in a way his life by standing against the misdeeds of this pharma giant. Thanks to his determination and some civil society support that he got in the United States he was able to fight against Ranbaxy for years together and finally won the battle. The award he got has been converted into Thakur Foundation Corpus. All this is very very impressive. For an average reader his book is also impressive and the major flows in the book can be detected only by some of us who know the complexities of Pharma quality. Even Karan Thapar got very impressed and therefore carried his long interview on this book.
    Unfortunately in the process of battling against Ranbaxy he fell into bad company of MNC experts and has adopted their false narrative completely and now he is effectively a MNC man. Whether Thakur materially benefits from them, or not I do not know. Brainwashed individual can be stupid enough to keep singing the same song for years even though the point it wants to make is untrue. This is seen from the trajectory of starting from the misdeeds of an Indian pharma company he and all other MNC guys have been painting all Indian generic companies with a black brush. Even though the Indian Pharma quality regulation system is inadequate, incompetent and corrupt, only 3 to 5% of medicines in India have been found to be of 'not standard quality'. If we have a discussion with Krishna, the production manager of locost we will find out why.
      The new thing that I discovered recently that he is nasty. His nastiness came on the surface because it was probably stimulated by my to the point critique of his positions related to quality of generic medicines in India.
Anant

       

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Akshay S Dinesh

4 May 2023, 15:30:2804/05/2023
to anant.phadke, weareraman, jagdish.jb, Rosamma Thomas, sandhya199, Rema Nagarajan, das.seed@gmail.com, narendra531, abhayshukla1, JSA Discuss, Jsa-ncc, LOCOST - 2, chinusrinivasan.x, mfccircle
Anant,
- Can you clarify the source of the 3 to 5% medicines are NSQ? Is it the CDSCO drug alerts? https://cdsco.gov.in/opencms/opencms/en/Notifications/Alerts/
- If so, do you have a documentation on the methodology they follow for sampling? What kind of randomization do they perform?

- Also, can you (or others) tell me what has been done about the 19 (I didn't count two tables in the last email) manufacturing units that have been found to produce >20% NSQ in 2014-16? Have these been okayed to continue producing 1/5 drugs NSQ? (Also, 20% is an arbitrary cut-off I made).

I hope you can respond to only these, if you're tired to respond to the other "to the point" points.

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chinusrinivasan.x

4 May 2023, 18:09:2804/05/2023
to Akshay S Dinesh, anant.phadke, weareraman, jagdish.jb, Rosamma Thomas, sandhya199, Rema Nagarajan, das.seed@gmail.com, narendra531, abhayshukla1, JSA Discuss, Jsa-ncc, LOCOST - 2, mfccircle
Akshay:I am in a bit of hurry. 

For some of the key chapters, see this link https://drive.google.com/drive/folders/1MJrMvBeSnf6kAHTmlzalhEMsoJJ0n0aW?usp=share_link

See Chapter 10, pdf page 30 of 70.  Icould not uploadsome of the initial chapters - which I am sure you can find in the net. 

Chinu

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anant.phadke

4 May 2023, 18:31:4004/05/2023
to Akshay S Dinesh, weareraman, jagdish.jb, Rosamma Thomas, sandhya199, Rema Nagarajan, das.seed@gmail.com, narendra531, abhayshukla1, JSA Discuss, Jsa-ncc, LOCOST - 2, chinusrinivasan.x, mfccircle
Dear Akshay,

    I have given reference in my review- National Drug Survey 2014-2016, page 215.

There maybe examples of gross and repeat violations of Pharma quality parameters. But on an average the proportion of not standard quality medicines have not been high and has been decreasing over a period of time if we see the data of earlier national surveys. At the same time the last survey shoes a higher proportion compared to the last but one survey!

We are certainly not happy with the situation of Pharma quality regulation in India. But we are certainly against the particular twist that Thakur has given to this problem.


Anant

chinusrinivasan.x

4 May 2023, 20:40:4704/05/2023
to Jsa-ncc, Akshay S Dinesh, weareraman, jagdish.jb, Rosamma Thomas, sandhya199, Rema Nagarajan, das.seed@gmail.com, narendra531, abhayshukla1, JSA Discuss, LOCOST - 2, mfccircle
I think Anant it is probably Annexure 3.

Chinu

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mohanrao2008

4 May 2023, 21:03:1604/05/2023
to chinusrinivasan.x, Jsa-ncc, Akshay S Dinesh, weareraman, jagdish.jb, Rosamma Thomas, sandhya199, Rema Nagarajan, das.seed@gmail.com, narendra531, abhayshukla1, JSA Discuss, LOCOST - 2, mfccircle
Dear All,

I have been a recipient of funding from the Thakur Family Foundation, on two projects. One was a book project with Prof.Balveer Arora on Public Health and Federalism ( which is on-going in that the mss is not with the publishers), and the other was a project on what impedes states from having a public health cadre. ( An essay based on this was published in EPW). Almost all our friends in MFC and JSA have been part of these two projects.

The Foundation made no demands other than financial accountability.

I have not seen their website and do not know what their "agenda" is.  I am sorry about that.

But let one who has not had foreign funding cast the first moral stone. I can say that excellent health journalists have been enabled by the TFF.

We need to discuss this, not paint black and white pictures based on an idiotic tweet of Mr.Dinesh Thakur. He should of  course delete that offensive tweet.

I am glad I am not on twitter.

But if you think I can be influenced by my funding, clearly you  do not  know me. I scrutinise where I  get my funding from, as much as the funders probably do.
 
Best,

Mohan









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Akshay S Dinesh

5 May 2023, 01:35:1405/05/2023
to anant.phadke, weareraman, jagdish.jb, Rosamma Thomas, sandhya199, Rema Nagarajan, das.seed@gmail.com, narendra531, abhayshukla1, JSA Discuss, Jsa-ncc, LOCOST - 2, chinusrinivasan.x, mfccircle
Srinivasan,
It is the same 19 manufacturing units with >20% NSQ in exhibit 10.20, 10.21, 10.40, 10.41 that I'm asking about (from the PDF you shared). 

Anant,
What exactly is the twist that Dinesh is bringing? 

Can you explain how Digital Vision pharmaceuticals from Himachal Pradesh which was found 4/8 samples NSQ in this report in 2014-16 ( https://web.archive.org/web/20210708143659/https://main.mohfw.gov.in/sites/default/files/Annexure5DrugsSurvey.pdf ) land up in this news article from 2020 https://thewire.in/health/digital-vision-cough-syrup about death of children in Jammu?

Why does Skymap Pharmaceuticals Uttarakhand (14% NSQ in 2014-16 report) continue to produce NSQ samples as per drug alerts by CDSCO?
Why does Ridley Life Sciences Delhi (21% NSQ in 2014-16 report) continue to produce NSQ samples as per drug alerts by CDSCO?
Neon Laboratories Maharashtra?
Preet Remedies Himachal Pradesh?
Shiva Biogenetic Himachal Pradesh?
Zee Laboratories Himachal Pradesh?
Mercury Laboratories Gujarat?

Can you explain why Maiden pharma whose drugs caused the deaths in Gambia does not appear in the list of all samples tested in the 2014-16 report Annexure 5 ( https://web.archive.org/web/20210708143659/https://main.mohfw.gov.in/sites/default/files/Annexure5DrugsSurvey.pdf ) although it was established in 1990?

The 2014-16 survey's methodology includes only 177 molecules to be picked up from retail outlets https://web.archive.org/web/20210708143659/https://main.mohfw.gov.in/sites/default/files/Annexure5DrugsSurvey.pdf  Of these 47 they didn't/couldn't find samples either. So among 130 pure molecules that are sold within India there is an average of 3% NSQ in a random sample. Can you explain how you extrapolate that to drugs that India exports to Africa, etc? Can you explain how you extrapolate that to drugs (and manufacturers) that are not included in that list?


> His nastiness came on the surface because it was probably stimulated by my to the point critique of his positions related to quality of generic medicines in India.

Your self-congratulatory note in here misses the point that your critique has methodological weaknesses and therefore sufficient cause to irk people who do not engage in friend circle groupthink.

ASD


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chinusrinivasan.x

5 May 2023, 06:33:1005/05/2023
to Akshay S Dinesh, anant.phadke, weareraman, jagdish.jb, Rosamma Thomas, sandhya199, Rema Nagarajan, das.seed@gmail.com, narendra531, abhayshukla1, JSA Discuss, Jsa-ncc, LOCOST - 2, mfccircle
Akshay: shdn't you be also asking why so many don't make the NSQ list?  And why has Pfizer made the list -  more than 50% NSQ - and there is a deathly silence?

And it may be relevant to look at what type of NSQ label frequents what drugs.

Chinu

anuragb17

5 May 2023, 07:49:0605/05/2023
to chinusrinivasan.x, Akshay S Dinesh, anant.phadke, weareraman, jagdish.jb, Rosamma Thomas, sandhya199, Rema Nagarajan, das.seed@gmail.com, narendra531, abhayshukla1, JSA Discuss, Jsa-ncc, LOCOST - 2, mfccircle
Akshay,
I ran the pharmacy at JSS for 10 years which made it possible for us to provide healthcare at a very low cost to hundreds of thousands of poor people. Most of the drugs were sourced from LOCOST and we used the same drugs for our own and our children's illnesses. 
We published a booklet on drug pricing in India in 2003 in the context of our PIL in the Supreme Court. ( attached). We made a presentation to the 7th Standing Parliamentary Committee which extensively quoted this document in their report. (attached)
The silence of these public health activists on the issue of prices and its anarchy is stunning, or the issue of irrational FDCs for that matter. Both of these were raised consistently by AIDAN. At one time the Pfizer brand of Amlodipine was 95 rupees a tablet, then it came down to about rupees 6 a tablet. The LOCOST tablet was 50 paise. What should one assume about its quality? Earlier it was 200 times better, then 10 times better ? Ranbaxy was the leader in Ciprofloxacin and was openly flouting the DPCO by selling it at 9 rupees a tablet against the DPCO price of 6 rupees. Did these activists protest when combinations of Nimesulide + Paracetamol were churning out money for their companies ( Nimrest by Ranbaxy for example)  and endangering the lives of Indian children? Nimesulide was not approved in any developed countries markets and there was no agency that would allow a combination of two potentially hepatotoxic drugs. Did they raise the issue ?Or was their conscience pricked when till the year 2000, the most popular hematinics were irrational preparations of iron in homeopathic doses mixed with hemoglobin from slaughterhouse blood and being prescribed by Sanskari doctors to our vegetarian population? Ranbaxy has been selling a preparation called Revital which is a mixture of vitamins and Ginseng ( alleged aphrodisiac ?) marketed aggressively with Salman Khan/Akshay  as its brand ambassador. Did they protest against the irrationality and hazard of the consumption of this medicine. For example Ginseng can raise BP ( even more when used with caffeine) can interact with drugs for diabetes, anticoagulants. Do these top selling OTCs mention these? Can these activists explain why Indians need FDCs as 45% of the market when the US and UK can do with much less, why unbranded generics make up 87% of the US market and less than 5% in India ?
Dr. Rajendra Tandon, legendary clinician and HOD of Cardiology at AIIMS ( may his soul RIP)  once remarked when asked for a definition of a good person after we had finished rounds. "A good person is one who tolerates other good persons." I will not expand on this as it is the sad story of activism in India, the present nasty episode included. 
I did not know that I was in bed with the pharmaceutical industry when I was part of the PIL in the SC that led to the National List of Essential Medicines and a DPCO based on it; when I  made a presentation against it and the Chemists Association before the Standing Parliamentary Committee in 2004, or the Pronab Sen Committee, or the Sandhu Committee or the Supreme Court-appointed Committee for irrational FDCs. I am thankful that none of us were thrown out of a moving train as happened to some activists in Bangladesh arguing for regulation of the pharmaceutical industry. I am thankful to these evangelists for letting me know where I was "lying" for all these years. 
Anurag 
 


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Impoverishing-the-poor-Pharmaceuticals-and-drug-pricing-in-India (1).pdf
seventh report of standingcommittee.pdf

Akshay S Dinesh

5 May 2023, 08:02:0105/05/2023
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Anant covered it in the revie:

> The book does not present any data to indicate that, in India, the brands of MNCs and big pharma are always of standard quality. The National Drug Survey 2014–16 found, for example, that 56% of the samples of Pfizer Maharashtra were found to be NSQ.1 Many MNCs get their branded medicines made in micro, small and medium enterprises (MSMEs) and merely market them, thanks to their deep pockets.

It is another example of the review not being able to work through the contradiction that "not happy with the situation of Pharma quality regulation in India" and "only 3-5%" don't go together. 

You either say that "there are quality issues that we need to work on, that it is not just generics but across the board, and that there are some generics which are high quality, and that we need to balance this quality issue with price issue", or you attempt to confuse the audience by talking about 6 different things. The review is mostly attempting to do the second thing. Dinesh is obviously having enough time to read and understand what the logical argument the review is making (and isn't).

Pfizer does seem to be having problems with Thane Unit - and there are news reports too https://www.thehindubusinessline.com/companies/The-tale-of-Pfizer%E2%80%99s-Thane-plant/article20834632.ece

image.png


> And it may be relevant to look at what type of NSQ label frequents what drugs.

It is indeed. I have no qualification to do that. I'm piggy-backing on the analysis that Anant is already performing and only asking questions based on that. To figure out what type of NSQ is relevant, etc will take me more learning.

Anurag, (I quickly read your mail)
You are making the same review as Anant. Pricing is important. But should it come at the cost of quality is a question that you and I shouldn't answer on our own. Even assuming that we answer that it can come at a cost of quality, we should be writing book reviews based on logic and/or moral arguments. I repeat that in the attempt to make the point that pricing is important, this debate descended into "whataboutery" in the book review by Anant and it is shameful to then do character assassination of Dinesh to establish that this was started by Dinesh.

"A good person is one who tolerates other good persons."

Quoting Anant from the thread about the review:

>  The Truth Pill has indulged into unfair criticism of JSA activists and specifically of Chinu and myself as LOCOST/AIDAN. I have deliberately not touched upon this point in the review. In this review I have shown that the authors have a defective, superficial  understanding regarding the issue of quality of medicines and regarding the appropriate legal framework for pharma quality regulation; regarding Indian generic pharma industry. Secondly they have reduced the issue of pharma regulation to only pharma quality regulation and have neglected other aspects of pharma regulation and even omitted price-regulation and all this serves the interests of theMNCs, big pharma.

Is Dinesh declared to be a bad person and therefore we do not have to tolerate Dinesh? Anant has admitted that the issue was criticism of JSA, Chinu, etc, but the writing was used to show authors have defective understanding. When the issue is different, and the writing is different, what does it convey?

ASD

Akshay S Dinesh

5 May 2023, 09:32:1605/05/2023
to anuragb17, chinusrinivasan.x, anant.phadke, weareraman, jagdish.jb, Rosamma Thomas, sandhya199, Rema Nagarajan, das.seed@gmail.com, narendra531, abhayshukla1, JSA Discuss, Jsa-ncc, LOCOST - 2, mfccircle
Anurag,
I read your email slowly now. There is no question of the quality of LOCOST drugs.

Do you order for JSS or for your children drugs from:
Skymap Pharmaceuticals Uttarakhand?
Ridley Life Sciences Delhi?
Neon Laboratories Maharashtra?
Preet Remedies Himachal Pradesh?
Shiva Biogenetic Himachal Pradesh?
Zee Laboratories Himachal Pradesh?
Mercury Laboratories Gujarat?


If you don't, how do you talk about their quality?

Omesh Bharti

5 May 2023, 11:03:0805/05/2023
to chinusrinivasan.x, anuragb17, Akshay S Dinesh, anant.phadke, weareraman, jagdish.jb, Rosamma Thomas, sandhya199, Rema Nagarajan, das.seed@gmail.com, narendra531, abhayshukla1, JSA Discuss, Jsa-ncc, LOCOST - 2, mfccircle
Dear friends, 
                       Pharma lobby is very strong 💪 I can see how they are trying to scuttle the price of rabies prophylaxis that was made a hundred times cheaper by my research by one way or the other. How they scuttle DPCO orders by combining price controlled drugs with other drugs as irrational combinations. How they donot produce Drugs made cheaper by DPCO order.
See the drug prices now in the market,  some of them are hundred times more now than 10 years back.
Very sad situation and no body to help the poor consumers!

Regards, 

Dr. Omesh Kumar Bharti
(Padma Shri Awardee)
M.B.B.S.,D.H.M.,M.A.E.(ICMR),
Principal -cum-State Epidemiologist, 
State Institute of  Health and Family Welfare,  Department of Health & Family Welfare,
Government of Himachal Pradesh,
Parimahal. Kasumpti Shimla- India-171009, 

TEDx Talk;




narendra531

5 May 2023, 12:03:4505/05/2023
to Omesh Bharti, chinusrinivasan.x, anuragb17, Akshay S Dinesh, anant.phadke, weareraman, jagdish.jb, Rosamma Thomas, sandhya199, Rema Nagarajan, das.seed@gmail.com, abhayshukla1, JSA Discuss, Jsa-ncc, LOCOST - 2, mfccircle
Dear All:

Let me add my bit in the debate here. Attached is a fact sheet we first brought out on medicines pricing in 2009-11 when campaigning for free medicines to all which resulted into the launch of the Free Medicine Scheme of Rajasthan in 2011. The fact sheet addresses the issue of pricing with facts. A pamphlet in Hindi is also attached which we brought out later to educate people why they should use medicines supplied free by the government rather than buying or even getting free from the market. Using medicines supplied from the government outlets not only saves money but also health. 

Narendra.   


“Go to the people. Live with them. Learn from them. Love them. Start
with what they know. Build with what they have. when the work is 

done, the task accomplished, the people will say 'We have done this ourselves.”


Medicine pricing.pdf
Why Govt Medicines are Good.pdf

anant.phadke

5 May 2023, 15:47:0305/05/2023
to Akshay S Dinesh, chinusrinivasan.x, weareraman, jagdish.jb, Rosamma Thomas, sandhya199, Rema Nagarajan, das.seed@gmail.com, narendra531, abhayshukla1, JSA Discuss, Jsa-ncc, LOCOST - 2, mfccircle
Dear Akshay,

    I really appreciate your penchant for quickly accessing information sources on the internet and the sharpness in your thinking. I wish that people from my generation had these faculties as much as you guys have.

     As regards the question that you have asked I think you would have got the answer if you had read my review a little more carefully. Your query is as follows -

   "You either say that "there are quality issues that we need to work on, that it is not just generics but across the board, and that there are some generics which are high quality, and that we need to balance this quality issue with price issue", or you attempt to confuse the audience by talking about 6 different things. The review is mostly attempting to do the second thing. -------------."

     Within the word limit of 2000 words, in my review, I have clearly put forth in different words that the drug quality regulation system in India is bad and needs overhaul. About the quality of medicine produced in india i have made no positive claim except the fact that the proportion of nsq medicines in india has been around 3 to 5 percent. I have said the following-  "about medicines marketed in India, though the book presents convincing evidence that the pharmaceutical drug quality regulation in India is ‘broken’, grossly insufficient, under functioning, etc., where is the evidence that the large proportion of medicines in the Indian market are sub-standard, that in general, medicines in the Indian retail market cannot be trusted for their quality?".

      Secondly if you read my review a little more carefully you will also discover that my main emphasis in the review has been to question the fundamentally flawed use by Dinesh Thakur of the concept of generic medicine and the role of bioavailability as a parameter of quality of medicine. I have done this in a somewhat detailed manner by raising six issues in 6 different paragraphs. Compared to this, to quote your allegation " to confuse the audience by talking about 6 different things" I have devoted only one sentence!".

     You of course have every right to assess my review the way you like. But I may not find time and energy to respond to all your questions, especially when I have already expressed my views on it in my review or in my earlier correspondence with dinesh thakur.

With best wishes,

Anant



 


image.png

prab...@yahoo.com

5 May 2023, 15:48:5805/05/2023
to MFC
Simple enough.
Dinesh Thakur is happy to criticize LOCOST and AIDAN
But takes badly to a critique of his book

Many MFC ites criticized MSF on Plumpy Nut
Many have disagreed at some point with Jagannath, Dr Nadkarni, SOCHARA or Akshay
Yet we agree that Leena, Jagannath, Akshay, or Dr Nadkarni may also make reasonable disagreements with me or any of us. Attacking the motives of the critic appears "under the belt"

Prabir

On Friday, 5 May, 2023 at 02:43:36 pm IST, Rema Nagarajan <reemanaga...@gmail.com> wrote:


If taking funding or expectation of future funding makes people wary of criticising the foundation or the founder that's problematic. Just wondering aloud if Dinesh repeatedly attacking AIDAN and LOCOST and claiming that AIDAN is in bed with the pharma industry might have elicited a stronger response from many if it wasn't for funding taken and expectation of funding in the future.
AIDAN's work predates the arrival of Dinesh on the scene. Dinesh's focus is on drug regulation and quality to the exclusion of all other issues. Perhaps we need someone to do that to get the govt to do something on the issue. But he can do that without having to bad mouth the work being done by others on various other aspects. Or is it because he needs to displace/discredit AIDAN so that the various bodies he is setting up and funding, like CASEM (Citizens for Affordable Safe & Effective Medicines), become the only legit ones on any issue to do with drugs?
Just because he is doing some good work or funding good work doesn't mean one has to drop all scepticism regarding the foundation or the founder.
Bullying on social media or buying silence/support through funding should not work or be acceptable.


anuragb17

5 May 2023, 15:57:1305/05/2023
to Akshay S Dinesh, chinusrinivasan.x, anant.phadke, weareraman, jagdish.jb, Rosamma Thomas, sandhya199, Rema Nagarajan, das.seed@gmail.com, narendra531, abhayshukla1, JSA Discuss, Jsa-ncc, LOCOST - 2, mfccircle
No Akshay I did not trust these companies to supply drugs. I would have known and been responsible for their quality if I was the drug inspector of these states or the DCGI of India. I had a limited mandate then, to cater to patients under my care and it became possible to lower the cost of treatment to 60 rupees a month when they were not taking medicines as they cost more than 10 times the amount and were not available in the government facilities. Later I got involved in a PIL to take this matter up at other levels. The drug regulatory system in India is weak as well as corrupt, and patients are paying heavily for its sins of omission and commission. We lost 34 children in Gurgaon to PEG poisoning in 1997 and it is a matter of shame that we are now exporting these kinds of deadly syrups. 

The dichotomies of access and quality are false as both are required whether the issue is of healthcare, medicines, or even food.

Certain segments of the Indian industry like CIPLA made it possible for India and the world to access anti-HIV medicines of good quality at affordable prices, while the MNCs raised issues of patents as well as quality of these drugs. There were some hard-won battles fought on patents and prices of medicines in India. But the MNCs have been trying to perpetuate an iniquitous system by a variety of means that we need to be wary of. That doesn't mean that we don't clean up our own act by stricter drug regulation. But it needs more people to engage with these issues. 
Within the health movement, there have been people working on issues of policy, patents, pricing, government procurement, and rational use of drugs, or irrational drugs, and groups like AIDAN did not or do not have the resources to engage with the entire spectrum of issues. If someone with expertise and influence is highlighting issues of drug quality, then he/she is a welcome ally. But if the atmosphere is vitiated by ill-conceived remarks on social media questioning the integrity of individuals, that is hardly advancing any cause.
There my case rests. 

Anurag  


dpadma2017

6 May 2023, 10:48:3006/05/2023
to chinusrinivasan.x, mfccircle, JSA Discuss, Jsa-ncc, aidanindia, LOCOST - 2
Dear Chinu

Thank you for sharing this. You have set standards yet again and this time on  how to respond to nastiness. What a cool statement. 

Warm regards 
Padma 

On Tue, 2 May, 2023, 10:06 am S Srinivasan, <chinusri...@gmail.com> wrote:

May 2, 2023

 

Dear friends,

 

LOCOST’s Statement in Response to Certain Allegations Made by Dinesh Thakur on Twitter

 

In his Tweets dated March 29, 2023, @d_s_thakur, the co-author of the book, The Truth Pill (2022), made some intemperate accusations against LOCOST and against the All-India Drug Action Network (AIDAN), of which LOCOST is a part. These accusations are also a kind of ‘response’ from him to the critical review,   'Half Truth Pill', by Dr Anant Phadke (who is a trustee of LOCOST and part of AIDAN) in the Economic and Political Weekly (EPW) of March 25, 2023. 

 

We are not active on Twitter and are inclined not to get into Twitter exchanges. Hence this statement. 

 

This communication is to briefly share with friends and concerned people, LOCOST’s response to these misleading accusations. 

 

The response is divided into two parts: 1) About LOCOST and 2) About the Enalapril Incident.

 

Available through hyperlinks specified, are Annexures 1 and 2, which are our email exchanges with Dinesh Thakur, et al., on the issue of enalapril maleate; and about issues in their book, The Truth Pill. 

 

Please circulate this to all concerned. If you have questions or need clarifications, please write to S.Srinivasan (‘Chinu’) at chinusri...@gmail.com with a copy to anant....@gmail.com and lowco...@gmail.com.

 

With kind regards,

Sincerely,

Sd/- S.Srinivasan, Mng Trustee, LOCOST

Attached:  LOCOST Stt May 2, 2023  Annexure 1 

Annexure 2

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sandhya199

7 May 2023, 15:50:3207/05/2023
to chinusrinivasan.x, mfccircle, JSA Discuss, Jsa-ncc, aidanindia, LOCOST - 2
1.  I greatly appreciate Locost's and AIDAN's statements and also find much of the discussion very informative. However, a couple of the sharp comments on this thread made me hesitate to write in.  We are all more likely to learn something from a civil discussion. .   

2.  While funding is not something that can  be discussed in a couple of email conversations, I think some things are are pretty straightforward. First, one should have an idea about any agenda the funder might have. Some senior journalists who have received funding from TFF have no idea of what the man stands for.  They only needed to glance at his twitter profile and his pinned tweet on "why doctors in India do not prescribe generic drugs"   ( https://twitter.com/d_s_thakur ) with a link to a cringeworthy "documentary".   Second, one should be concerned about conflicts of interest when taking funds.  TFF grantees have moderated Thakur-Reddy book readings; some have attended these readings giving their book more credibility; some have organised webinars where Thakur, the organiser and another (journalist) awardee together lobby for their version of drug regulation, and some have given him an unrestricted platform in the media to speak about their book and their campaign.  None of these respectable grantees asked Thakur or Reddy a single difficult question.  Talk about groupthink.  

3.  I have many rather basic, possibly poorly articulated questions on this subject.  Are the current standards sufficient to ensure quality medicines? If not, what elements are missing? Are they missing because they are too expensive or for some other reason? Is there a dispute about when BA/BE trials are essential?  How should one decide on adding new tests to the production process for safety? For example, are tests for nitrosamine needed to reduce contamination by a potential carcinogen? If they are, would it increase the manufacturing costs so as to put ethical small manufacturers out of business? If so, is there a way around this problem? Are individual generic drug manufacturers expected to come up with their own reverse engineered "recipes" for each drug? If so, why? Why is there not one single recipe that is approved to be followed by everyone? Is there a link between the demand for good standards and the resistance to permitting the manufacture of generic drugs? Actually, why are manufacturers expected to come up with their own recipes for off-patent drugs?  Wouldn't making the original recipe available for everyone post-patent expiry completely bypass the need for BA/BE trials?   Is the current system for checking for NSQ and substandard sufficient or is it up to ethical manufacturers to put their own systems in place? Do we really have a good idea of the extent of NSQ/substandard drugs being consumed today in India?     And so on and so forth.  

While many of the exchanges on this thread give a good overall picture of the issue, I believe that it would also be useful to discuss questions such as the ones I've asked above (or suggest reading materials).     

Sandhya 

Sandhya

Sandhya Srinivasan
8 Seadoll, 54 Chimbai Road
Bandra (W), Mumbai 400 050
INDIA
Cell: (91) 98204 10849

chinusrinivasan.x

9 May 2023, 10:14:3709/05/2023
to sandhya199, mfccircle, JSA Discuss, Jsa-ncc, aidanindia, LOCOST - 2
Sandhya: Recipe is a simpler word than Master Formula Card. Tnx. 

I saw the cringeworthy 'documentary' from Amsterdam. 

Your questions are relevant. 

I really can't understand why commercial grade or even pharma grade Propylene Glycol is not tested by the mfrs  before formulation as the long term damage to the company as well as to all stake holders is so terrible.

Re BA BE, it was/is  recommended only for low solubility drugs. Apart from that each drug has its quirks.

Best, and hope to hear from others on Sandhya's comments as to how take fwd the discussion on drug quality issues. Can it be, inter alia, one of the mfc seminars online?


Chinu

amar.jesani

9 May 2023, 12:40:2009/05/2023
to chinusrinivasan.x, sandhya199, mfccircle, JSA Discuss, Jsa-ncc, aidanindia, LOCOST - 2
Thanks for a very informative discussion on the subject.
I do not know much about how the quality assurance is done and about the regulations on manufacturing in the pharma industry. But I do share the impression that while we have campaigned a lot on the issues of rational aspects and pricing of drugs, we have not done enough on the quality issue. Therefore, I think I will learn a lot if an online webinar on that aspect is organised by the MFC or JSA or AIDAN.
amar
________________________________
Amar Jesani
Independent Researcher and Teacher (Bioethics, Public Health).
Editor, Indian Journal of Medical Ethics (https://ijme.in);
Visiting Faculty: *Yenepoya (Deemed-To-Be) University, Mangaluru, India. Web of Science Researcher ID: AAD-2202-2020; ORCID Id: https://orcid.org/0000-0001-8884-9858



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dhrvmankad

9 May 2023, 14:57:5609/05/2023
to amar.jesani, chinusrinivasan.x, sandhya199, mfccircle, JSA Discuss, Jsa-ncc, aidanindia, LOCOST - 2
I agree with you, Amar!

To view this discussion on the web visit https://groups.google.com/d/msgid/mfccircle/CAEUPHhJmpcN7jZj%3Dw_bxq2_tZG9f4kRddD0TWEq3%3D2BgAWji7A%40mail.gmail.com.

drmirashiva1978

9 May 2023, 15:22:2509/05/2023
to amar.jesani, chinusrinivasan.x, sandhya199, mfccircle, JSA Discuss, Jsa-ncc, aidanindia, LOCOST - 2
 Dear Amar , 
Many years ago there were deaths in JJ Hospital in Mumbai . Justice Lentin    was asked to investigate . Absolutely  wonderful  in depth informative , critical  Lentin Commission  Report was brought out . which today remains recommended reading . This Glycerol Tragedy  because of Contamination  ,  of Glycerol with Di Ethyl Glycol had led to several deaths in Ophthalmology and Neurology ward . Mannitol and Glycerol were zeroed in as both were used in both ey and Neurology dept to decrease Intra Ocular Tension in the former and Intracranial  Pressure in the latter . It was Indstrial Glycerol that had been supplied not even  Medical Glycerol . 1 % diethyl Glycol was capable of   hetoxic effect . If I remembercorrectly it was  18 % or more   adulteration  .
 Investigation showed Tender rules were violated . Company providing the drug in Qs had not been in Manufacturing for required number of years , quality Control test was done in a private lab , which had cleared it , there was much much more  to    recognize the gaps  , had they not been there   , basically violations that took place 18 patients died ,  of Kidney failure , Many would have  suffered from kidney damage   having been discharged  . Issue of Follow up , issue of compensation , many issues came up . Justice Lentin 's recommendations were solid .  Very few chose to even read them   & follow them up .
 Dr Wishvas Rane & I stayed for many days in Mumbai  working on  this issue . Since resources were scarce , it was very kind of Dr Anil Pilgaonkar to put up in his home . His Bhabhi ji fed us and we worked diligently . I hope Dr Anil is fine , We owe him so much .  Dr   Arun Bal who wa from ACASH  part of AIDAN   came to Dr Anil 's place to work and contribute 
 During the High Dose Estrogen   Progesterone hearings , It was Llate Lakshmi Menon ;s Mother who  gave us place to stay and food 
  We had a Press Conference in  Press Club related to this . If I am not mistaken  it was Mrinal Gore  we met and who took up the issue in the Assembly .
 Anjum Rajabali and John of CED  photocopied  numerous documents related  to the Glycerol Tragedy  and   the investigation . 
 Rupa Chenoy  in Indian Express   kept all the health & Drug activists involved about the  Glycerol Tragedy . We were grateful to her as sitting in far off places we would have never known  what ws happening in the courts . God bless Rupa wherever she is . Her Contribution we deeply  appreciated and still do . 
 Had Justice Lentin Commission 's recommendations been followed   deaths of children  in Gambia , Uzbekistan , Marshal Isnd and in India due to Contamination with the same Toxic ingredient Di Ethy Glycol  could have been avoided , andprobably many other deaths  and   adverse effects   with other aadulterants .  
 Chinu has   explained that this adulterant   is in Propyl Glycol which is  legally allowed under Indian Pharmacopea . Hence    monitoring of Quality of up stream Manufactures of Propyl Glycol should have taken place and should continue to take place . Imports of Ingredients  API testing leaves much to be desired  . Formulation makers  acquire these ingredients  assuming that due process of GMP  Good Manufacturing Practices has been followed 

  In " Banned  and Bannable Drugs  , Unbiased Drug Information , Essential Drugs & Rational Drug Policy "  5th Edition  brought out in 2004 by VHAI , with Dr Rane and me as Editors ,
 Chapter 16 is on Quality Control  Pg174 
, Ch1 7 is on Lentin Commission Report  pg 179
   Ch 18 Mashelkar Committee Recommendations  :Strengthening Drug Regulation  pg 185 .. 
 Justice Lentin had very kindly  sent a message  for the 4th Edition which we had reprinted  in 5th Edition .. 
 We had met Justice Lentin , wonderful person , one of the things he said when we were trying to invite him to speak at  "  All party Parliamentarians  meet  on Rational Drug Policy ". He said i " Leopards would not change their spota and tigers their stripes " . In other words , ethics and rationality mafe little sense to them . How true his words have been . 

 Coming to Cough Syrups  you and others may recall that DAFK-AIDAN - NCCDP  PIL in the Supreme Court in  the court of Chief Justice of India late Justice  J.S Verma  One of the cough Syrup Category which  we wanted to see thrown out of the market was   FDCs of Cough Expectorant and Cough  Suppressant . 
 Just a few years after long pursual of irrational Potentially hazardous FDCs,  Kakote Committee Report Recommendations  DCGI banned Codeine containing Cough Syrups . 
Within a day US MNC  Pfizer filed  for a Stay order in Delhi High Court  against the ban as it would have affected the sales of their  high selling Cough syrup "Phensedyl " 
 Next Day Abbottt   did he same    to continue sales of their  Cough Syrup   Corex . 
  Many other  Pharma Cos in fact hundreds filed  for stay orders against the ban oftheir Irrational FDCs

 In  Locost 's "A Lay person's Guide to Medicines , : What is in them and what is behind them " Revisedenlarged Edition of 2006.  Recommended Reading 
Pg 186  Ch 4 is on Marketing of Drugs  
Pharma Scenario in India 
  Marketing of top 300 drugs their analysis ,
Marketing of Drugs and Abondoning  of Quality  and Ethics 
Manipulating Quality. Prevalence of Spurious Drugs . 
 I forget the Year  but there  were deaths in Safdarjung Hospital due to Contaminated IV Fluids . A very detailed Investigation was done . A report by Rajeev P.I .who was  part of the Media team with Dr Unnikrishnan and Satya Sivraman in PHA 1 in Savar was brought out . Late Mr HD Shourie of Common Cause was deeply involved with us  .  Incidentally Rajeev who worked with me  his major report was  not allowed to be brought out only recommendation  to prevent such     tragedies to be  preventd n the future  . 
  For those involved with the issue of Rational Drug Policy , issue of Quality , was   one of the  issue .  Flooding of the marked with Irrational , Non Essential Potentially hazardous drugs was  linked with it . Doing Quality control of irrational FDCs was difficult , and in fact not required . 
 Therefore issue of Rational Selection of Drugs that should be in the market was tied to it . 
 Mashelkar Report on Strengthening Regulatory System   was  important Report . Since Drug Control came under Health Ministry   Meagure Health Budget ,  Shortage of Drug Testing Labs , for biologicals as well as chemicals , trained Drug Inspectors (with integrity ) Issueing Of Manufacturing License , Registeing of manufacturers    , . 
Uniform Code for Pharmaceutical Marketing Practices  all are intrinsically linked and you know this well having been part of the health movement fore decades . 
 Issue of Quality  requires intervention at many levels   . 
  There were cases in Rajasthan ,  I remember imported HIV testing kits which were no good gave false positives and negatives , also something related to TB  also related to Covid . 
 Do you recollect over 1 Lakh False Tests reported during Kumbh  Mla   during Covid time  , Where  same name  was repeated several time  .. Those who had got the contract was not from  there . The    complaint was given by the CMO .
 I hope some enthusiastic  person    tries to dig it all up while documents are still around , unless they have already disappeared . The  Contracted company  owners were absconding  . 
 How much of all this false unethical  exercise led to further spread and deaths  one can only  imagine . 
 Keep well Amar . Please do  convey our warm regards to Dr Anil Pilgaonkar , Dr Aerun Bal and if you can trace Rupa Chenoy . 
 Warm regards 
 Mira 
 
  PS Happy  Anniversary  to Sahaj , Renu and Chinu  for all that you have been contributing as Sahaj and as Locost . 
    
  
 

To view this discussion on the web visit https://groups.google.com/d/msgid/mfccircle/CAEUPHhJmpcN7jZj%3Dw_bxq2_tZG9f4kRddD0TWEq3%3D2BgAWji7A%40mail.gmail.com.

anant.phadke

9 May 2023, 22:21:3709/05/2023
to sandhya199, chinusrinivasan.x, mfccircle, JSA Discuss, Jsa-ncc, aidanindia, LOCOST - 2
Dear all,
   Yes, it is a good idea to organise an online session. In the meanwhile, let me briefly answer some of the questions Sandhya has raised. My answer is based on discussions within LOCOST and my discussions with Krishna, the  highly committed, competent, sincere production manager of LOCOST. Chinu may correct me or add if necessary -
         Are the current standards sufficient to ensure quality medicines? If not, what elements are missing? Are they missing because they are too expensive or for some other reason?
   In India Schedule M  lays down manufacturing standards. They are adequate to ensure the quality of medicines. WHO's standards called Good Manufacturing Practices (GMP) are not mandatory in India and this has not adversely affected the quality of formulations manufactured in India. WHO's GMP are close to the standards in developed countries' whose per capita income is from 10 to 30 times that in India. The problem is - the State FDA's are grossly understaffed; like many other such govt  agencies, their functioning is below par and they are to a large extent corrupt. Despite this, as per the National Drug Survey only 3 to 5% of the medicines are substandard. This is because many production chemists do their job with due diligence. This is many times sufficient given the fact that preparing good quality  formulations from the medicines bought  from the bulk drug producers can be done without much difficulty. Krishna has learnt on his own to produce more than 50 formulations.
    
   Is there a dispute about when BA/BE trials are essential? 
     No, there is no dispute among regulatory authorities that only medicines with low solubility should undergo BE test. 

    How should one decide on adding new tests to the production process for safety? 
    It's a complicated exercise which we can not get into here. As I said earlier, what Schedule M lays down is adequate. 

    For example, are tests for nitrosamine needed to reduce contamination by a potential carcinogen? 
     No not needed. 
     
     If they are, would it increase the manufacturing costs so as to put ethical small manufacturers out of business? If so, is there a way around this problem? 
     They are not needed. 
     
      Are individual generic drug manufacturers expected to come up with their own reverse engineered "recipes" for each drug? If so, why?
     Reverse engineering etc is required by bulk drug manufacturers to reinvent the wheel of how to manufacture a generic drug from the basic stage. Here we are only talking about the formulations industry where medicine powder bought in kilos, tonnes from the bulk market is to be converted into tablets, capsules, syrup etc etc. 
     
      Why is there not one single recipe that is approved to be followed by everyone?
      Ideally at expiry of the patent period of any medicine, the innovator company should put in Public Domain all the details of the process (it's recipe) it has been following all these years; so that the generic formulators don't have to re-invent the wheel. 
    
     Is there a link between the demand for good standards and the resistance to permitting the manufacture of generic drugs? 
     Yes, Thakur, Reddy, Eban illustrate this. 
     
      Actually, why are manufacturers expected to come up with their own recipes for off-patent drugs?  Wouldn't making the original recipe available for everyone post-patent expiry completely bypass the need for BA/BE trials?
      Yes,  This is exactly the pointI have been making ! The current practice needs to be abandoned. 

       Is the current system for checking for NSQ and substandard sufficient or is it up to ethical manufacturers to put their own systems in place? 
       Every manufacturer is supposed to test the quality of his/her medicine by doing in-house tests on every batch of medicines which the company produces. 
        
      Do we really have a good idea of the extent of NSQ/substandard drugs being consumed today in India? 
    As per the National Drug Survey only 3 to 5% of the medicines are substandard.

SY
Anant 
          

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With Regards,
Sincerely Yours,
 
Anant
 
Anant and Sandhya Phadke,
8, Ameya Ashish Society, Kokan Express Hotel Lane,
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Please note our new landline number - 020 29529556
Mobile number - 9423531478, 9356155836

dhrvmankad

10 May 2023, 07:58:5810/05/2023
to anant.phadke, sandhya199, chinusrinivasan.x, mfccircle, JSA Discuss, Jsa-ncc, aidanindia, LOCOST - 2
Thanks Anant, for a comprehensive response to Sandhya's questions! Enlightens us a great deal. Just a few corollary sub questions:

1. You say that  tests for nitrosamine (NDMA) needed to reduce contamination by a potential carcinogen are not needed. Does it mean that it isn't mandatory as per Schedule M, or it is not essential to check the quality of medicines so commonly used like sartans, metformin etc.

 2. I would also modify the pertinent question from Sandhya:
    
If they are included in Schedule M, would it increase the manufacturing costs so as to put ethical small manufacturers out of business? If so, is there a way around this problem? 
     
This is important because main cause of banning Ranitidine in India (and elsewhere, too) because of NDMA contamination risk, even though it was actually low. 

I found the attached document quite interesting in context of this issue.

Sincerely,

Dhruv

--
Jan Swasthya Abhiyan (JSA) is the Indian Chapter of the People's Health Movement. JSA brings together organisations and individuals in India working to promote health equity across all population groups. Also visit our website: www.phmindia.org
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presentation2020-17.pdf

dhrvmankad

10 May 2023, 08:04:4010/05/2023
to anant.phadke, sandhya199, chinusrinivasan.x, mfccircle, JSA Discuss, LOCOST - 2

r.sr...@gmail.com

10 May 2023, 09:22:1010/05/2023
to mfccircle
I think the question of quality of generics is completely intertwined with the question of perception of quality of generics.  So as much as discussing the quality of generics which may be the problem, it is also necessary to discuss the question of how generics' quality is perceived by the people.

This is not a superficial problem.  Most often, people buy from trustworthy sellers, even if the cost is a bit higher.  I however am lucky that I have a low cost supplier (LOCOST) which I deem eminently trustworthy, because of its profile in my thinking and imagination.  So what is the way to bring trustworthiness into the representation of generics?  Off the top of my head, in a first and imperfect ideas kind of way:

a) How should generics be publicized?

b) What should generic manufacturers be asked to do to ensure that they are seen as aligned to good manufacturing practices?  What are these practices?

This would imply working with generics manufacturers to adopt a publicly available code of responsibility and practice.  Such moves have occurred in other fields too.

It would also imply a pro-active activism and aggressive criticism of failure of specific generic manufacturers to make the grade.

All this should parallel the criticism and analysis of exorbitant costs in branded patent drugs from multinationals.  A two pronged simultaneous activism:  To draw a parallel, if the cost of drugs is the universal -- applicable at the level of population, the quality of drugs is the particular -- applicable at the level of the individual patients and their concerns.

If there is a reliable mode of developing a profile of generics in the country, it would ensure adherence by the best generic manufacturers to this profile, which would include issues as a publicly audited quality control system; self-control on what drugs they may undertake and what they may not, based on their own financial vulnerability and risk of relatively poor quality to the patients to whom they are prescribed.

Srivats

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Flat 101, Block C, Saincher Palace Apartments
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There is only one solution if old age is not to be an absurd parody of our former life, and that is to go on pursuing ends that give our existence a meaning – devotion to individuals, to groups or to causes, social, political, intellectual or creative work … in old age we should wish still to have passions strong enough to prevent us turning in on ourselves. One’s life has value so long as one attributes value to the life of others, by means of love, friendship, indignation, compassion. - Simone de Beauvoir 

sandhya199

10 May 2023, 17:02:5410/05/2023
to anant.phadke, chinusrinivasan.x, mfccircle, JSA Discuss, Jsa-ncc, aidanindia, LOCOST - 2

Dear Anant,

 

Thank you for your answers to my questions. Clearly people like me will benefit from a thorough education on this topic, because I have more questions. 


For example, it would be useful to understand why Schedule M is sufficient for India. If only countries with much higher per capita income follow WHO’s GMP, does that mean we are following lower standards because it’s cheaper? About BA/BE, nitrosamine testing, or anything else, I’d want to know more about the logic behind these different standards, and their evolution.

 

I would also seek an in-depth understanding of the National Drug Survey’s findings, going beyond the 3-5% NSQ soundbyte.  Did it give an accurate representation of medicine quality for all medicines and all over the country? And would the findings from the 2016 survey (I don’t see a later survey) be equally applicable in 2023? What other information do we have on the quality of medicines in the market?

 

I am confident that the production chemists at Locost do their jobs with due diligence but clearly we cannot rely solely on the due diligence of other medicine makers. 

 

And finally, the link between the call for higher standards and the resistance to generics needs to be demonstrated.  In any case, there does not seem to be any difference in standards or quality control between generics (branded and unbranded) and “in-patent” drugs in India.

 

I would benefit greatly from a webinar on standards for medicine manufacture, and implementation of these standards  – with time for discussion, as evidently there are many issues that may be obvious, and settled, to those in the field but about which people like me will have questions.


Best,


Sandhya

Sandhya Srinivasan
8 Seadoll, 54 Chimbai Road
Bandra (W), Mumbai 400 050
INDIA
Cell: (91) 98204 10849

anant.phadke

10 May 2023, 17:58:0910/05/2023
to Amitava Guha, sandhya199, chinusrinivasan.x, mfccircle, JSA Discuss, Jsa-ncc, aidanindia, LOCOST - 2
Dear all,
   The questions being raised are logical and pertinent and we need more experts to answer them. I will share what I know about two issues - 
    As I have written earlier, the proportion of NSQ in the National Drug Survey being about  3-5 % is in my opinion too high and should be brought down to almost near zero. I was just pointing out that even if the FDA's pharma quality regulation is very poor, comparatively the proportion of NSQ medicines is not very high because of the reasons I mentioned.
   As regards the fact that since 1918, in different countries some medicines have been found to be contaminated with nitrosamine (NDMA), (which can cause cancer), prevention of this has to be at the level of bulk drug manufacturers, companies who manufacture medicines from basic stage to produce Active Pharmaceutical Ingredients. (API). This is because it is at this stage that nitrosamine (NDMA) contamination occurs or nitrosamine (NDMA) gets produced due to some chemical reactions taking place. Control is to be exercised where manufacture of APIs take place. In India for the last some decades, more than half of APIs are imported (majorly from China) and out of about 9000 pharma manufacturers in India, only a very small proportion of companies manufacture APIs. The rest, the overwhelming majority, are mere formulators like LOCOST who merely buy medicine powder in bulk and convert it into different formulations. In India, the pharma industry and the regulators do not even have adequate, sophisticated equipments to detect and measure nitrosamine (NDMA) contamination. India is yet to develop an upper limit of allowable nitrosamine levels ! It's a long way to go! 
    Given all this, there is no point in expecting the formulation industry to detect and monitor nitrosamine levels of it's formulations. That is why I wrote "Not Necessary" while answering the question about making it mandatory to detect nitrosamine contamination in small pharma manufacturers.
    SY
Anant     
     

       

On Wed, 10 May 2023 at 17:27, Amitava Guha <amit...@gmail.com> wrote:
Dear All,
This 3-5% detection of NSQ by the authority is notional but not an absolute value. In the past, I have worked with Govt. and indicated that the criteria of the selection of medicines are highly inadequate and can not cover the entire therapeutic range used in our country. It may be an indicator.
But the position of Thakur, Eban et al that drugs produced in India are untrustable is objectionable. In our country, quality is self-certified and is considered to be OK until sometimes they are found NSQ in random-selected tests. By and large, companies try to maintain some manufacturing standards otherwise harm to people would have been more and observable.
Quality control starts from the shipments of raw materials, excipients and many other materials required for production, transportation and storing of medicines. With the rickety drug control structure, monitoring of all these even if Schedule M standard is not possible.
Greetings,


Amitava Guha
1B, New DDA Janata Flats,
Mayur Vihar, Phase-1
New Delhi-110 091
Mobile No. 9013379037


--
Jan Swasthya Abhiyan (JSA) is the Indian Chapter of the People's Health Movement. JSA brings together organisations and individuals in India working to promote health equity across all population groups. Also visit our website: www.phmindia.org
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dhrvmankad

10 May 2023, 18:34:3510/05/2023
to anant.phadke, Amitava Guha, sandhya199, chinusrinivasan.x, mfccircle, JSA Discuss, LOCOST - 2
Dear Anant,

Thanks for your response about Nitrosamine 'contamination ' level. It goes along, it looks like similar to FDA's advice about Ranitidine. 

Thanks,

Dhruv

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narendra531

11 May 2023, 14:07:1711/05/2023
to dhrvmankad, anant.phadke, Amitava Guha, sandhya199, chinusrinivasan.x, mfccircle, JSA Discuss, LOCOST - 2
As mentioned by Amitava, the market has to rely on the manufacturer certificate of quality for drugs sold in the market and private hospitals and regulatory authorities test very small numbers of them picked up erratically.  In contrast medicines procured by the government at least in Rajasthan are never released for distribution unless a second quality test is done. For this, all medicines on procurement are stored in a quarantine section and blinded samples from each batch of medicine is sent for quality test to a laboratory chosen randomly from empanelled laboratories spread all across the country. As per protocol, the manufacturer would not get to know which laboratory the sample was sent to. This has led to reduction in supply of NSQ medicines by manufacturers as failed medicines add cost and possibility of being black listed. This is something like the US FDA does here. I believe USFDA has a lab here in India and tests medicines here itself before being exported.     

I am unable to understand the point Anant made about the regulatory authorities not having adequate sophisticated instruments and why should not testing of NDMA be done after setting standards..  


“Go to the people. Live with them. Learn from them. Love them. Start
with what they know. Build with what they have. when the work is 

done, the task accomplished, the people will say 'We have done this ourselves.”


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krantony53

23 May 2023, 14:20:2823/05/2023
to narendra531, dhrvmankad, anant.phadke, Amitava Guha, sandhya199, chinusrinivasan.x, mfccircle, JSA Discuss, LOCOST - 2
Continuing on the quality issue of drugs both generic and branded for domestic use as well as for export, today's PTI New Delhi report is some consolation. 
"Cough syrup exporters will have to undertake testing before outbound shipping from specified government labs from June 1st.
Labs are Indian Pharmacopoeia lab at Chandigarh, Central Drug testing labs at Kolkata, Chennai, Hyderabad, & Mumbai plus NABL accredited labs of State Government. 
My comment is why only for Cough syrups? Why not for all drugs? 
The government is seeking to enhance the Ease of Doing Business (EoDB) by decriminalising various offenses. Under the proposed New Drugs, Medical Devices, and Cosmetics Bill 2022, drug authorities have the discretion to waive trials and prison time for offenders if the accused company pays a fine.

The above Bill is the most unethical Policy decision India has taken without any remorse for innocent children died in Gambia and Uzbekistan. Without the WHO prompting, we should have filed criminal case against the Manufacturers and put them in jail, instead of turning a blind eye to such a crime against humanity. GoI took a position that importing countries should have cross checked the Quality standard of the drug that are being imported. 
Is it Ease of doing Business? Or Ease of killing innocents? This Bill should have been discarded before International Community hear about it. Vis a vis that very scandalizing stand, today's news is one step forward. 
Miles to go before we achieve the goal of universal availability of safe, quality and affordable medicines. 

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malini.aisola

23 May 2023, 16:59:3823/05/2023
to krantony53, narendra531, dhrvmankad, anant.phadke, Amitava Guha, sandhya199, chinusrinivasan.x, mfccircle, JSA Discuss, LOCOST - 2
Dear Antony and all,

Sharing the notification from DGFT that was issued yesterday. To provide more context this follows a proposal sent by DCGI to the MOHFW for approval to mandate testing of all cough syrups being exported in government labs. It recommended that the Certificate of Analysis from one of the approved labs of each batch being exported would have to be presented to be cleared for export. Even while acknowledging that the recent incidents bringing disrepute to India are various syrup-based and pediatric formulations, they have limited the focus to only cough syrups (which is how information about the incidents is popularly being conveyed in the media).  

The Government has now followed through on the DCGI's proposal and included government lab-issued COAs in the required paperwork for clearance of cough syrup export consignments. Certainly this is a move to counter the bad PR the government is getting and provide some reassurance to the international community, or to be viewed as taking some action. It is obviously superficial and doesn't get to the root of weak regulation in the country which also leaves gaps for rogue manufacturers to capitalise on the global market. But it is a strategic and limited political intervention. The sustainable solutions obviously lie in cleaning house on regulation in India. I don't think however that it is realistic, or necessarily justified, to demand India exert itself the same way for every batch that leaves its shores and may be complying to the regulatory requirements of other jurisdictions. 

You are perfectly correct to protest the coverup by the Indian government in the case of the Gambian deaths of children, and defiance with WHO. It wasn't able to take the same approach after the incidents in Uzbekistan which snowballed into a lot of unwanted international attention. 

Malini


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Notification No 06 - English.pdf

malini.aisola

24 May 2023, 18:18:1324/05/2023
to krantony53, narendra531, dhrvmankad, anant.phadke, Amitava Guha, sandhya199, chinusrinivasan.x, mfccircle, JSA Discuss, LOCOST - 2
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Notification No 06 - English.pdf
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