The Real Lie in " Bottle of Lies"
In the review of the book “ Bottle of lies” published in the NY Times Eban quotes "Inspector after inspector saying that they themselves fill only the most essential prescriptions — and will pay anything to avoid taking a drug made overseas. They’ve seen how those drugs are produced, and they live in fear of them”.
This set me thinking if what these inspectors say is indeed true then it should be reflected in the Inspection reports issued by the FDA to companies in India. The FDA conducts inspections of regulated facilities to determine a firm's compliance with applicable laws regulations and cGMP’s. If these reports are then compared to companies in the USA, it should reveal a huge difference if the Quality of the Drugs made in India is really as BAD as described by Eban in the book. SEE THE COMPARISON AND JUDGE FOR YOURSELF. THE DIFFERENCE IS MARGINAL AND DOES NOT REFLECT WHAT EBAN ACCUSES INDIAN PHARMA INDUSTRY OFF. The Real Lie in " Bottle of Lies".
Inspection Classification Database classifies the inspection by each project area with one of three classifications. The three classifications displayed are:
No Action Indicated (NAI) which means no objectionable conditions or practices were found during the inspection (or the objectionable conditions found do not justify further regulatory action),
Voluntary Action Indicated (VAI) which means objectionable conditions or practices were found but the agency is not prepared to take or recommend any administrative or regulatory action, or
Official Action Indicated (OAI), which means regulatory and/or administrative actions, will be recommended.
I give below comparison of inspection report classification issued by FDA – CDER under Drug Quality Assurance from the database for the years 2015, 2016, 2017, 2018 and 2019 for Indian and US companies.
NO OF REPORTS ISSUED FOR ABOVE CLASSIFICATION TO INDIAN & US COMPANIES.
The values given below in the graph are in percent of the total inspection reports for that particular year.
The following graph gives number of inspections, which were classified as “ Official Action Indicated “ as a percentage of the total inspections for CDER- DRUG QA for India and the USA between the years 2015 to 2019.
For India the OAI was between 7 to 16 % of total inspections. For the US it was between 2 to 10 %. A marginal difference. If what Eban say si her book is true that the entire Generic Industry in India is Fraud as opposed to the Industry in US , then there should have been a significant difference in above values.
Following graph gives number of inspections, which were classified as “Voluntary Action Indicated“ as a percentage of the total inspections for CDER- DRUG QA for India and the USA between 2015 to 2019.
For India VAI was between 50 to 68 % where as for US it was between 45 to 48 % . Similar to the OAI figures the difference here to is not significant.
Following graph gives number of inspections, which were classified as “No Action Indicated“ as a percentage of the total inspections for CDER- DRUG QA for India and the USA between 2015 to 2019.
For India NAI was between 22 to 39 % where as for the US it was 42 to 53 %.
Judge for yourself the Quality of Drugs of Indian & US Companies. The facts figures given above expose the LIE in " Bottle of Lie".
Senior specialist - Quality Technical Operations, Pfizer.
5 年Are US Companies performing good than Indian companies??
Director Consulting Operations at CONVAL group
5 年Katherine's book tells the public the truth, the facts, pretty or not, and let the publishing of those facts make a difference in how patients look at generics, the insiders within the industry and drug regulators - at themselves, and what they stand for...
DIRECTOR GOEL AND GOEL ASSOCIATES
5 年Nobody is trying to jusitfy anything . The fact remains that the mortality rate in India has gone down and the same generic companies exporting to USA? are manufacturing for the 1.3 billion population. If the Bottle really contained poison than according to the author of the book, India's population should have decimated by now. FDA is the watch dog for the American Drug Industry. If they are not doing the job, let POTUS look into it.?
CEO/Founder of Redica Systems; Independent board director
5 年Hi Uday,? While I appreciate your attempt to bring data to bear on this topic, unfortunately, the inspection and enforcement data you are using is highly suspect.??Basing an argument on the FDA’s data is a type of “argument from authority” fallacy, which reminds me of how people defended Lance Armstrong because he never failed a doping test.? FDA inspections can be ineffective and misleading Katherine Eban?outlines these reasons very clearly in her book 1) the FDA is not designed to combat systematic institutional fraud, like the case of Rambaxy 2) FDA inspectors have vastly different skillsets (i.e. the FDA has too few inspectors with the skillset and hutzpah of Peter Baker) and 3) the FDA is crippled by political pressure to keep cheap drugs on the market, so it defangs its observations (which causes them to downgrade very serious inspections to VAI when they should be OAI). All of that said, I agree that there are many high quality Indian and Chinese suppliers on the market. The onus is on those suppliers to level the playing field in their home markets by increasing the transparency of quality. Only then can we have a real conversation about who is truly good and who is committing fraud, because the FDA probably isn't going to get it done.
Vice President & Head of MSAT|ASAT| Biologics|DS & DP|Biocon Biologics Limited | PDA India Chapter Board Member (Member at Large)
5 年Hi! Uday, Let us forget for a moment the book itself! Even if your assessment is technically correct, it appears as if you are trying to justify one wrong by comparing with another wrong! Generic companies, irrespective of the country they are in, have a moral obligation to contribute towards public health and what many of the companies have done is compromised on quality or rigged the prices to make money out of people ill-health! How many Indian generic companies have volunteerily recalled substandard drugs from domestic market? While the same companies have recalled drugs from US or EU? Why is this so? Compassionate capitalism being exhibited for US and EU markets? While it is acceptable to market anything in India? Ranbaxy episode is indeed a debacle and a major dent on the image of the Indian pharmaceutical industry! For the systematic scientific fraud which was committed over the years and more importantly, playing with patients lives across the world, the fine they paid was very less! And that too only for the US government. What compensation have they given to patients in India and other countries? They have actually escaped punishment which is unfortunate!