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Indian pharma companies versus the US FDA and Indian regulators: the story in a nutshell.In the proverbial blink of an eye, soaring US drug costs have driven the shift from branded to generic, from drugs made in the US to those made elsewhere. As much as ~80% of active pharmaceutical ingredients (APIs) and as much as ~40% of finished drug products in the US now come from China or India (1). Not because this is necessarily better for the health of US patients but because generics are much cheaper. The statistics reveal how drug pricing pressure plays out in the US market.Even though generics comprised only ~22% of US drug spending in 2019, they made up ~95% of prescribed medications, which amounted to ~$2 trillion dollars in savings over the past 10 years (1).As production shifted overseas, US regulatory oversight initially didn't keep pace even as local oversight remained lax to non-existent. The FDA didn't initially uncover evidence of outright fraud at overseas drug manufacturing facilities proactively but rather unusually courageous and persistent whistleblowers such as Dinesh Thakur brought it to their attention.In any case, Indian (and Chinese) generics makers have also quickly adjusted to more stringent standards and inspections from the FDA since regulatory laxity at home has allowed them to evolve ways to manufacture drugs that vary in quality depending on the country that buys their drugs, “dual-track”, “multi-tier” or “row A/row B production (2). Who pays the price in terms of lives lost? Why, poorer countries of course, India itself among them, countries that don't insist on safety and quality, countries that gratefully buy whatever drugs come their way, the cheaper the better. In fact, people across Africa have actually died as a result (2).Whistleblowers notwithstanding, such persistent demand for cheaper drugs gives global generic drugmakers powerful leverage to continue as is and they're learning that all too well. After all, what are the alternatives?Bring back US-based drug production? Prices would go up even more when they're already unacceptably high.Stop buying generic drugs made elsewhere and let US patients die? Out of the question.Classic Catch-22. What needs to happen to change this terrible and untenable status quo?The US Congress needs to step up and do its job.Force the FDA to better enforce its regulatory mandate. Not just warning letters and import bans but they also need to start pursuing cases in US courts of law to hold errant companies and their senior executives criminally liable for fraudulent actions. Also make surprise inspections standard in overseas facilities the way they are in the US.Enact laws that set drug price controls.Overseas drug regulators need to start enforcing. That requires dramatic changes on their part as well as broader changes within their civil society,A cultural sea change; Indian drugmakers should fear Indian regulators rather than see them as partners.A mammoth increase in the Indian drug inspection workforce with intensive and thorough training commensurate to their onerous drug enforcement authority (below from 3 and 4).What if Indian investigative journalism also came into its own and began to regularly expose wrongdoing within Indian pharma? Doing so would enable the creation of a virtuous cycle whereby the Indian public would also demand better quality drugs and pressure their government and drugmakers to implement necessary changes.Obviously, all this is a very tall order indeed and, at least at present, seems quite unlikely to come to pass. This is why where Indian pharma companies are concerned, neither the US FDA nor Indian regulators emerge covered in glory.What investigative journalists and whistleblowers have uncovered about Indian generic drugs manufacturing.The stink from regulatory oversight failures became so bad in recent years, the investigative journalist, Katherine Eban - Wikipedia wrote a 2019 New York Times bestseller about it (2). A wild, hair-raising ride into the extremely lucrative but corrupt belly of global generic drug manufacture. For me, the highlights of Eban's recent interview (February 18, 2020) to The Wire's Siddharth Varadarajan - Wikipedia were (my transcript from 5),“Fraud is endemic in the generic drug industry. What if anything is the incentive for quality?...The Indian market has a significant amount of substandard drugs. There is also no question that US patients have gotten substandard generics...The US companies fear the FDA, they fear their regulators and they are subject to surprise inspection. If you are going to be subjected to a surprise inspection and you are fearful of your regulator, you would be more inclined to follow the rules whereas you know all of my reporting here [in India] suggests that companies don't fear the regulator, they see them more as the partner, which I think is very problematic from a public health point of view...The book is highly critical of the US FDA. I mean the 8 years they spent investigating Ranbaxy all the while approving Ranbaxy's drugs, giving them the green light for the biggest generic drug launch in US history, generic Lipitor. Why? …I think the global regulatory system is broken...Ranbaxy...The fraud...is documented in US FDA inspection reports...No individual was ever prosecuted...The company pled guilty to 7 felonies...No criminal prosecution of individual executives and without that, it's very hard to really hold people accountable and to send a message through the industry that this behavior is not accepted...The US FDA...are committed to not creating a public panic, to telling everybody that it's fine and they barely even stop doing that when people are literally falling over dead. I mean with the tainted heparin...they almost never tell people to stop taking their medicine...Dual track production which is that the generic companies make one level of quality for their export markets, to Europe and the US, and they make another level of quality for the rest of the world market, so that would be India, Africa, and unfortunately, they are making just the worst of the worst drugs...(Siddharth Varadarajan: different standards for different markets?)...that is absolutely problematic. I mean, you know, as one executive described it to me, that's almost like a cancer that spreads throughout your organization, if you begin to assume that it's okay to make a substandard drug for one set of humans and a different quality for another set of humans...From what I can observe it's only economic harm to the companies in India that will essentially lead the government to become better regulators. I don't see evidence right now that the Indian regulators feel compelled to act and similarly in the US, the dynamic is there that only the US Congress is going to be able to compel the FDA to change how it regulates. You know regulatory bodies are very sleepy animals and they have to be frightened into working properly. ”Consistent bad press of this nature (6) as well as whistleblower reports over the past few years helped stoke public pressure and finally forced the FDA to step up its vigilance and enforcement practices with respect to the quality of generic drugs being sold in the US. Result is many more FDA warning letters and import alerts to overseas generics drugmakers. Some of the unacceptable issues that forced the FDA to bar some Indian drug makers from shipping drugs to the US included (from 7 drawing on data in 8).“(1) alteration/manipulation of product and air quality data;(2) failure to review consumer complaints and hiding incident reports off site;(3) back dating quality testing;(4) altering/forging clinical trial data;(5) alteration of training records for quality assurance personnel or functions;(6) using data recording methods where data were preliminarily written down but could be overwritten, with the original data lost;(7) presence of unauthorized quality assurance stamps; and(8) performing multiple retesting of deviant samples and only recording the one that passed.”Also (from 7 drawing on data in 9, 10, 11),“(1) shredded documents late at night before an FDA inspection,(2) allowed unsanitary manufacturing conditions, or(3) allowed “uncontrolled use of ‘trial’ injections during chromatographic testing” to achieve passing tests for drug batches or other reporting irregularities.”Nothing new under the sun. Much of this sounds like Theranos redux except that was about regulatory oversight failure over blood tests by a US start-up while this is about Indian generic drug makers. Note also that some of these egregious manufacturing failures were reported to have taken place not just in plants in India but also in the US (10).A long view of where things are at would suggest that we are in the middle of a tumultuous and momentous transition phase as global drug manufacturing shifts from US and Europe to China, India and elsewhere. That necessitates a steep learning curve for all involved. With human life at stake, manufacturing drugs has nothing in common with making cheap, throwaway widgets and gadgets. That the learning is thorough and beneficial for public health depends more on the actions of lawmakers and regulators and less on drugmakers. The Hindi proverb, “jiski lathi uski bhains” (who holds the stick, owns the buffalo) comes to mind. As long as drugmakers wield the stick, i.e., they get away with a mere slap on the wrist, outcomes will continue to be in favor of company profits over product quality.Bibliography1. 2019 Generic Drug and Biosimilars Access & Savings in the U.S. Report2. Amazon.com: Bottle of Lies: The Inside Story of the Generic Drug Boom (9780062338785): Katherine Eban: Books3. If I follow US standards, I will have to shut almost all drug facilities: G N Singh4. Kadam, Abhay B., et al. "Correcting India’s chronic shortage of drug inspectors to ensure the production and distribution of safe, high-quality medicines." International journal of health policy and management 5.9 (2016): 535. Correcting India’s Chronic Shortage of Drug Inspectors to Ensure the Production and Distribution of Safe, High-Quality Medicines5. Watch | Katherine Eban Interview: How Drug Makers Are Compromising the Lives of People6. Eban, Katherine. "Dirty medicine." Fortune Magazine (2013). https://rauhpsychiatry.com/wp-content/uploads/2017/04/Dirty-medicine-Fortune-Features-copy-4.pdf7. White, C. Michael. "Generic Drugs Not as Safe as FDA Wants You to Believe." (2019): 1060028019881692. Generic Drugs Not as Safe as FDA Wants You to Believe - C. Michael White, 20208. FDA Form 483s From India: A Deep Dive Into the Problems9. Hetero Labs plant hit with Form 483 for suspicious shredding of documents10. http://10.https://www.fiercepharma.com/manufacturing/wockhardt-u-s-plant-nailed-by-fda-a-warning-letter11. US FDA flags issues at Sun Pharma’s Halol plantThanks for the R2A, Kritika Gupta.

How Many Kisses?How many kisses must you give when meeting a friend in:ProvenceParisMontpellierAnswers:[1]22 or 53French kissing etiquette is so complicated, there is a website dedicated solely to that information.For a foreigner it is complicated, but for the French, it is second nature.The video below is short (~ 4min.) and entertaining. Martin Silvertant and I had a good laugh watching it while I wrote this answer.So what does all this kissing have to do with Aspie–Aspie versus Aspie–neurptypical relationships? Well, just like I would not know what is expected of me in France and vice versa, we see the same empathy challenges in NT–ASDs relationships.Aspies/ level 1 autistics do have a much better chance of getting along with other Aspies.The reason for this is something that Damian E.M. Milton discussed in his work on the double empathy problem.Although autistic brains are neurologically very dissimilar from each other (read the post below), in terms of proclivities, communication, expression of empathy, and more, there is actually a greater amount of understanding between/among autistic people.Autistic brain differences pt. 1 – Connectivity | Embrace ASDNeurotypicals also have that greater in-group understanding. But when it comes to showing empathy for other groups, challenges may arise.The problem goes both ways; we have challenges understanding neurotypicals, and they have challenges understanding us. So while it seems to neurotypicals as if autistic people have less empathy, this is not due to an inherent lesser ability to empathize, but because we as a minority find ourselves in a society that is very dissimilar from us, and so there tends to be mutual misunderstanding and situational lack of empathy. Although to be fair, autistic people are encouraged to study and understand neurotypical behavior to a degree that just doesn’t happen the other way around; because whereas autistic people live in a predominantly neurotypical society, neurotypicals do not find themselves to be in an autistic society, nor do they necessarily have to interact with autistic people to the same degree we have to interact with them.Unfortunately, researchers like Maxine Aston have basically thrown autistics under the bus. And Tony Attwood (one of the biggest names in autism writing and advocacy) has supported her views.Aston wrote a book called ‘Asperger’s in Love’ (which was actually the first book I read on Asperger’s). I was really irritated when I read it. The research was heavily biased towards neurotypicals. Basically, the message was, “Poor poor neurotypicals if they have to deal with autistics”.Maxine also coined the term Cassandra Syndrome,[2] also know as ‘Affect Deprivation Disorder’ (AfDD). She compares this to Seasonal Affective Disorder, while:AfDD is about emotional deprivation caused by living in an intimate relationship where the one partner is affected by [Autism]I cannot express deeply enough how much I loathe this one-sided research. To make it worse, neurotypical researchers like Bron Wilson, Dr Lisa Abel & Dr Vicki Bitsika, are now following her lead.In order to do what is known as qualitative research, one needs to be able to “speak the language” of your subjects to a certain extent. Some of the researchers (I have spoken directly to them), are motivated to do the research due to feeling that they got PTSD from being in a relationship with an autistic.I feel that coming into research with a bias creates a problem with the research from the beginning, and at the very least a disclaimer should be given by the author.Thanks to Maxine, ugly, ugly websites such as The Neurotypical Site have been created. They share information as:Cassandras have been stomped upon emotionally [by autistic partners] for years, they have been wrung out to dry--alone, for years, they have prayed and pleaded for guidance for years, to no avail.Uninformed NT carers of those with AS are/were sucked into a caring-giving role by the AS person, to be used as a 'prompt director:' an AS ignorant replacement for their primary caregiver; their mother.Many AS spouses, when they learn that their NT spouses are gaining knowledge and understanding of AS, they make a unconscious (?) effort to locate another AS ignorant person, usually via the internet, someone with whom they can have another 'relationship'Books like: Cassandra Phenomenon: The Dangers of Marrying a Partner with OCPD, Asperger's Syndrome, Autism Spectrum Disorder, Schizoid Personality Disorder, and Narcissistic Disorder.Oh and there is even a special day June 8 for the people who are in relationships with us. World Victims of Autistics/Cassandra’s Day. Wow, just wow!One of the big problems with research is that we do not answer questions the same way neurotypicals do. So when neurotypicals interview us using the same questions, they will not really get to know what we think.Surveys have been done, but I see only one side, the neurotypical side. For example here a survey looks at neurotypical and how they feel about being with us. Keep in mind that the sample is biased, as it is only neurotypicals with Cassandra syndrome that took part.“He lies to cover his mistakes and denies everything I say”“No matter how good your intentions are over time in a relationship they will wear you down until there is nothing left, they will win you over in the beginning and by the time you wake up to them and how they’re destroying you, you’re an empty shell and the damage is done.”“I used to, but now I know not to be dragged into his nonsense since I’ve woken up to his lies and deception.”In addition, researchers did a study which showed that 30% of serial killers and mass murders were likely to have autism[3] . We know from proper research that is not true, but the media keep portraying it that way.Some female NT partners experience a decline in mental and physical health, wellbeing and quality of life, which they attribute to the symptom expression of their partner’s AS. Feelings of loneliness, confusion, frustration, isolation and, at times, of ‘going insane’ are reported, as are disorders of mood (e.g., depression and anxiety), problems with sexual intimacy and sexual activity, and other medical complaints.[4]Until society does a better job of understanding us…Until researchers and psychologists like Tony Attwood stop calling us names like ‘Domestic Terrorists’ (in his Keynote speech 2019 Autism Summit)…Until researchers with autism interview people with autism…And until neurotypicals understand that it is a double empathy problem, meaning that neurotypicals will understand neurotypicals more easily and austics will understand autistic more easily….Until then autistics have a much better chance of getting along with each other.On a personal note, I get along very well with many other Aspie’s. It is just easier. We speak the same language, have the same expectations. My partnership with Martin Silvertant is happy, and has been for 2.5 years. It has been much easier to be together than it ever was with a neurotypical partner.How to Love Well: How to Love WellFor more information on autism, visit EmbraceASD.comJoin our community on Facebook here: Embrace ASD GroupFootnotes[1] The Fine Art of Greeting A French Person With A Kiss: To Faire La Bise[2] Cassandra Affective Deprivation Disorder[3] https://www.theneurotypical.com/articles/docs/neurodevt%20and%20psychosocial%20risk%20factors.pdf[4] Research

PIB 5TH FEBRUARYContents:New major Port at Vadhavan in MaharashtraSoil Health Card SchemePromoting quality standardsVizag-Chennai Industrial corridorIntellectual property rights in defenceSocial and Infrastructure Development Fund (SIDF)National Cybercrime reporting portalNew pension schemes for unorganized sectorNEW MAJOR PORT AT VADHAVAN IN MAHARASHTRAVadhavan port will be developed on “land lord model”A Special Purpose Vehicle (SPV) will be formed with Jawaharlal Nehru Port Trust (JNPT) as the lead partner with equity participation equal to or more than 50% to implement the project.The SPV will develop the port infrastructure including reclamation, construction of breakwater, besides establishing connectivity to the hinterlandMaharashtra has India’s largest container port at JNPT which caters to the hinterland of Maharashtra, North Karnataka, Telangana and secondary hinterland of Gujarat, Madhya Pradesh, Rajasthan, NCR, Punjab and Uttar Pradesh.What is land lord port model ?In the landlord port model, infrastructure is leased to private operating companies or to industries such as refineries, tank terminals, and chemical plantsSOIL HEALTH CARD SCHEMEIn the second phase of the scheme 11.69 crore Soil Health Cards have been distributed to farmers in the last two years.A study conducted by the National Productivity Council (NPC) says the application of Soil Health Card recommendations has led to a decline of 8-10% in use of chemical fertilizers and also raised productivity by 5-6%.In the current financial year a pilot project “Development of Model Villages” is being implemented under which the sampling and testing of cultivable soil is being encouraged in partnership with the farmers.Under the project a Model Village has been selected for aggregation of soil samples and analysis of each agricultural holding.The scheme provides for the analysis of soil composition by the State Governments once in every two years so that remedial steps can be taken to improve soil nutrients. Farmers can track their soil samples and also obtain their Soil Health Card reportPROMOTING QUALITY STANDARDSThe Quality Council of India (QCI) works for promotion of Quality Standards across various economic and social sectors such as manufacturing, education, health and environment.Was established As a National body for Accreditation on recommendation of Expert Mission of EU after consultation in Inter-Ministerial Task Force, Committee of Secretaries and Group of Ministers through a Cabinet decision in 1996Formed on the PPP model·i) Associated Chambers of Commerce and Industry of India (ASSOCHAM)·(ii) Confederation of Indian Industry (CII)·(iii) Federation of Indian Chambers of Commerce and Industry (FICCI).The QCI is the umbrella organisation of five boards:·NABL – National Accreditation Board for Testing and Calibration Laboratories;·NABH- National Accreditation Board for Hospitals & Healthcare;·NABET- National Accreditation Board for Education and Training;·NABCB- National Accreditation Board for Certification Bodies; and·NBQP- National Board for Quality Promotion.YOUNG SCIENTIST LABORATORIESDefence Research and Development Organisation (DRDO) has identified five niche technology areas and established the following Young Scientist Laboratories (YSLs) in year 2019:Artificial Intelligence (DYSL-AI), BengaluruQuantum Technologies (DYSL-QT), MumbaiCognitive Technologies (DYSL-CT), ChennaiAsymmetric Technologies (DYSL-AT), KolkataSmart Materials (DYSL-SM), HyderabadVIZAG-CHENNAI INDUSTRIAL CORRIDORAsian Development Bank (ADB) had prepared Conceptual Development Plan (CDP) for Vizag-Chennai Industrial CorridorThe loan has been agreed between State Government and Asian Development Bank (ADB).ADB has approved USD 631 million (in loans and grants) for VCIC,More about ADBIt is a regional development bankEstablished on 19 December 1966Headquartered — Manila, PhilippinesOfficial United Nations ObserverThe bank admits the members of the United Nations Economic and Social Commission for Asia and the Pacific (UNESCAP, formerly the Economic Commission for Asia and the Far East or ECAFE) and non-regional developed countries comprising 68 member states.Voting rights:It is modeled closely on the World Bank, and has a similar weighted voting system where votes are distributed in proportion with members’ capital subscriptions.INTELLECTUAL PROPERTY RIGHTS IN DEFENCEIn 2018, Ministry of Defence, Department of Defence Production has launched a programme ‘Mission Raksha Gyan Shakti (MRGS)’ to promote self-reliance and have an enabling framework for creation of Intellectual Property (IP) and management of Intellectual Property Rights (IPRs) in Indian Defence sector.SOCIAL AND INFRASTRUCTURE DEVELOPMENT FUND (SIDF)The Social and Infrastructure Development Fund (SIDF) has been created with a sum of Rs.586.20 crore in the Public Account for North Eastern Region (NER), especially for Arunachal Pradesh and other border areas facing special problems that cannot be tackled through normal schemesNATIONAL CYBERCRIME REPORTING PORTALMinistry of Home Affairs (MHA) operationalised National Cybercrime Reporting Portal on 30th August, 2019 and the complaints reported are dealt by the Law Enforcement Agencies (LEAs) of the concerned State/UT as per provisions of the law.33,152 cybercrime incidents have been reported till 30.01.2020 on the portal, wherein 790 FIRs have been registered by the concerned LEAs.‘Indian Cyber Crime Coordination Centre (I4C)’ to combat cybercrime in the country, in a coordinated and effective manner.NEW PENSION SCHEMES FOR UNORGANISED SECTORGovernment of India has introduced two voluntary and contributory Pension SchemesPradhan Mantri Shram Yogi Maan-dhan Yojana, (PM-SYM), a pension scheme for the Unorganized WorkersNational Pension Scheme for the Traders and Self Employed PersonsThe schemes envisage for providing minimum assured monthly pension of Rs. 3000/- after attaining the age of 60 years.If the subscriber dies, the spouse of the beneficiary shall be entitled to receive 50% of the pension as family pension.Family pension is applicable only to spouse.The monthly contribution ranges from Rs.55-Rs.200/- depending upon the entry age of the beneficiary.Source: Legacy IAs Academy, Jayanagar, Bangalore.