Form 20 F Drug License: Fill & Download for Free

Eligibility Criteria to open Pradhan Mantri Bhartiya Janaushadhi Kendra NGO, Charitable Institutions/Hospitals, Reputed professional bodies/organizations, Private Hospitals, Trusts, Societies, Self Help Groups etc are eligible to open new Pradhan Mantri Bhartiya Janaushadhi Kendra IV. Margins and Incentives a. Operating agency will be provided 20% margin on MRP (Excluding taxes) of each drug. b. BPPI will provide one-time financial assistance upto Rs. 2.50 lakh as per details given below where space is provided free by State Govt in Government Hospital premises i. Rs. 1 lakh reimbursement of furniture and fixtures. ii. Rs. 1 lakh by way of free medicines in the beginning. iii. Rs 0.50 lakh as reimbursement for computer, internet, printer, etc c. In all other cases where space is NOT provided free by State Govt in Government Hospital premises: JAS that are linked with BPPI headquarters through internet (using BPPI provided software) will get incentive upto 2.5 lakhs. This will be given @ 15% of monthly sales subject to a ceiling of Rs 10,000/ per month upto total limit of 2.5 lakhs. In NE states, and naxal affected areas, tribal areas, the rate of incentive will be 15% and subject to monthly ceiling of Rs. 15,000. upto total limit of 2.5 lakhs d. The Applicants belonging to weaker sections like SC/ST/Differently-abled may be provided medicines worth Rs. 50,000/- in advance within the incentive of Rs. 2.5 lakhs which will be provided in the form of 15% of monthly sales subject to a ceiling of Rs. 10,000/- per month up to a total limit of Rs. 2.5 lakh.Important Operating Terms and Conditions conditions for operating PMBJK are given below: a) Applicant will enter into agreement before commencing operations of “Pradhan Mantri Bhartiya Janaushadhi Kendra”. All operations of Jan Aushadhi Store will be conducted as per agreement terms and conditions. b) It shall be the responsibility of the applicant to obtain drug license in the name of “Pradhan Mantri Bhartiya Janaushadhi Kendra” and other permissions to run a drug store. Compliance to all statutory requirements for storage of drugs shall be ensured by the applicant. c) Applicant will use the premises solely for the purpose for which it has been allotted and for no other purpose and shall not part with the premises, sub-let the premises to anyone directly or indirectly. d) All billings should be done using software provided by BPPI. No medicine can be sold in PMBJK without using the software provided by BPPI. e) PMBJK operators will be allowed to sell allied medical products, commonly sold in chemist shops. NGO’s/Charitable institutions/Reputed professional bodies/organizations will be allowed to sell generic medicines which are not included in the list of medicines supplied by BPPI with prior information and approval of BPPI f) BPPI’s Distributor will take back Expiry/Breakage to the maximum extent or upto 2% of the total purchase value by PMBJK. g) Credit period of 30 days will give from date of receipt of medicines by JAS but postdated cheque will be required to given by JAS in advance against goods supplied.

Stock market fluctuations are too unreliable of an approach to assess an entire industrial sector. Wild speculations apart, something tangible needs to underpin any boom. While Indian Pharma doesn't have upcoming blockbusters, several trends augur its healthy growth.Indian Pharma: Essentially High Volume-Low Value Global Supplier Of GenericsThe world's 3rd largest pharmaceutical industry by volume (10% of global production) but only 14th by value (1.5% of global value) suggests Indian Pharma is a high-volume, low-value proposition (1).A highly fragmented industry with ~10000 manufacturers, though only ~250 are large-scale, generics dominate Indian Pharma (2), contributing no less than 40% of the US generic drug import for example.US FDA drug approvals reveal Indian Pharma doesn't have a strong presence in the US new drug market. Of the 96 new drugs it approved in 2013, only 2 were from Indian companies, Lupin's Suprax (active ingredient Cefuroxime) and Alembic's extended release form of anti-depressant desvenlafaxine (3). Thus, a boom can't be justified on hopes of extremely big paydays down the road from expensive new blockbusters selling on drug markets like the USA or the EU. That's simply not Indian Pharma's track record nor is such a US-like process even likely in India, where the government deliberately intervenes with powerful instruments like price controls and compulsory licenses. Through the latter mechanism, if the Indian government deems an originating firm’s listing price unaffordable, it can force them to license their technology to a generic competitor, an extremely strong countervailing force that, though seldom used, hangs like a Damocles sword over the pricing decisions originator firms make when trying to sell their products in India (2, 4), a situation utterly unlike the rampant drug price gouging that's today the norm in the US. This is why drugs in India are among the cheapest in the world (2). Also why Indian Pharma depends on drug volume not price for its profits.Indian Pharma: Nearing An Inevitable Fork In The Road, Will It Be Super Generics or Biosimilars NextOn the plus side, Indian pharma has built up an enviable infrastructure, with the largest number of US FDA compliant API (Active Pharmaceutical Ingredient) manufacturing plants outside the US (>262), ~1400 WHO GMP-approved plants and 252 European Directorate of Quality Medicines (EDQM) approved plants (1). This capacity has made Indian Pharma a global leader in generics, supplying anti-HIV drugs widely across Africa, Asia, Latin America for example.Long specializing in generics, Indian pharma faces a major fork in the road in terms of how to expand and diversify in an extremely rapidly changing global pharma landscape. In the ongoing Patent cliff, i.e., patent expiration of blockbuster drugs coming off of patent since 2011 continuing through to 2019, bulk of the patent loss on traditional pharmaceutical drugs has already occurred. Far fewer are expected after 2017. Thus the generics market can only remain a high volume-low value proposition for Indian Pharma.To gain value, Indian Pharma has to climb the value chain. Developing new drugs all by itself is an extremely costly proposition with very high regulatory burden. New drug development never having been its expertise, options that best leverage Indian Pharma's existing expertise and capability are super generics and biosimilars.Super Generics represent an incremental innovation to Indian pharma's already well-established generics capability. Though they entail greater regulatory burden, Indian Pharma's making steady inroads into this space (see below from 3, 5).As generics are to patented drugs so Biosimilar are to biologics (6). Indian Pharma is a relative newcomer in the biologics and biosimilars arena. Making biosimilars, while much more arduous and expensive compared to generics (see below from 7), may yield greater long-term payoff in terms of expanding technological capability which could serve as a launching pad for in-house new drug development down the road.The ongoing Patent cliff on biologicals (3, see below from 7) is thus a net opportunity for Indian Pharma to enter the biosimilars sector.Biocon was one of the early entrants, getting approval for its biosimilar CANMab, a remake of Roche's Trastuzumab (Herceptin), a breast cancer drug (8).Indian Pharma: Steadily Increasing Global Reach Through Mergers, Acquisitions & Joint VenturesJoint ventures offer a ready-made platform for global pharma to leverage R&D capabilities of well-established Indian entities as Contract research organization (CRO), which helps to considerably reduce cost of new drug development.In the long-term, expansion of Indian CROs can also help Indian Pharma gain the technological, managerial and regulatory know-how necessary for new drug development, something they currently lack.Indian Pharma's also been steadily increasing its presence in other countries through acquisitions. A 2016 study reported that 67 Indian companies valued at >US $6 billion made 191 acquisitions across 33 countries from 2000 to 2012 (see tables below from 9, 10).Indian Pharma: Serious Teething Problems With Clinical TrialsVast genetic diversity, large 'treatment-naive' population, ~30% urban dwellers with >67 million living in India's 6 largest cities alone plus cost of conducting a clinical trial in India is < 50% of that in the US, all these factors make India an attractive destination for conducting clinical trials. However recent speed-bumps in the form of serious lack of oversight in clinical trial recruitment and informed consent processes (11, 12, 13) have chilled Indian clinical trial activity. A lessons learned mind-set on the part of global pharma and its local regulators and clinical trial partners would help resume trial activity.Indian Pharma: Dwindling Opportunities For Contract Research For API (Active Pharmaceutical Ingredient) Manufacturing For Europe & USAAlong with China, India leads in API manufacture (see below from 14).In their efforts to reduce manufacturing costs in Europe and USA, in recent years their Big Pharma increasingly off-loaded API manufacturing to cheaper sites located in places like India. This meant increased scrutiny from foreign regulatory authorities like the US FDA. Indian Pharma leads the pack in number of US FDA warning letters (15). While these setbacks can be and indeed are being interpreted several ways, a pragmatic interpretation would be to see them as a steep but necessary learning curve for Indian Pharma to effectively compete in supplying essential drugs to the US and the EU. Indian Pharma got here by becoming an expert mass manufacturer of API. However, shoring up manufacturing to meet their more stringent regulatory standards is beneficial in the long-term as it improves Indian Pharma's QA/QC, data integrity and compliance standards. High profile warning letters are also beneficial in highlighting a glaring shortcoming in the Indian Pharma regulatory landscape, namely long-standing, tremendous shortage of well-trained and qualified drug inspectors (16, 17), something the Drug Controller General of India, G.N. Singh himself conceded in Jan 2014 is a situation that desperately needs improving (18).'You cannot equate the Indian regulator with the US one. We are still evolving and it will take us at least 10 years to reach that level. We do not have resources and infrastructure equivalent to those of US FDA. We have a total staff of 650, compared with US FDA's 13,000. Look at the size of our manufacturing industry. The Indian industry is currently supplying generics to over 214 countries.Also, as a national regulator, the steps that we are taking are voluntary. Manufacturing compliance and quality assurance is a state subject.'To add to Indian Pharma's woes,On 16th July, 2015, the European Commission directed all its member states to suspend national marketing authorization of 700 generic drugs tested and approved by GVK Biosciences (19).An early 2016 decision by the US government's made it mandatory for APIs to be manufactured locally for government procurement. According to Live Mint (20), currently ~88% (9 out of 10) of prescriptions dispensed in the US are for generics. India and China are the largest API suppliers to the US. Of the US $2 to 3 billion worth of API that India exports to the US, ~40% is for government purchase so this decision will definitely hit Indian Pharma exports and companies with holdings or subsidiaries in the US.Thus, Indian Pharma outlook looks bright if it leverages its proven generics expertise into expanding into super generics and biosimilars. Becoming a preferred destination as a clinical trials site and an essential cog in the drug supply chain to the US and the EU, however, need more work in improving its compliance and manufacturing to match their more rigorous standards.Bibliography1. Pharma Industry Promotion | Department of Pharmaceuticals2. http://www.pacificbridgemedical.com/wp-content/uploads/2015/04/India-Pharmaceutical-Regulatory-Report-2013.pdf3. Suri, F. K., and A. Banerji. "Super Generics—First Step of Indian Pharmaceutical Industry in the Innovative Space in US Market." Journal of Health Management (2016): 0972063415625566.4. Duggan, Mark, Craig Garthwaite, and Aparajita Goyal. "The market impacts of pharmaceutical product patents in developing countries: Evidence from India." The American Economic Review 106.1 (2016): 99-135. https://openknowledge.worldbank.org/bitstream/handle/10986/23939/aer.20141301.pdf?sequence=1&isAllowed=y5. Stegemann, Sven, et al. "Improved therapeutic entities derived from known generics as an unexplored source of innovative drug products." European Journal of Pharmaceutical Sciences 44.4 (2011): 447-454. https://www.researchgate.net/profile/Willibald_Stumptner/publication/51690038_Improved_therapeutic_entities_derived_from_known_generics_as_an_unexplored_source_of_innovative_drug_products/links/02e7e52a88a1e8e039000000.pdf6. http://www2.deloitte.com/content/dam/Deloitte/us/Documents/life-sciences-health-care/us-lshc-biosimilars-whitepaper-final.pdf7. Daubenfeld, Thorsten, et al. "Practitioner’s Section." Journal of Business Chemistry 13.1 (2016): 33. http://www.businesschemistry.org/downloads/issues/Issue02-2016.pdf#page=378. The Hindu, Jan 18, 2014. Biocon launches cheaper breast cancer drug9. Trehan, A., Gaikwad, A. Indian Pharma Industry: Trends, Predictions and Challenges. Asia-Pacific Biotech News, 2014: 18: 27-44. Asia Pacific Biotech News - PR NEWSWIRE10. Jayanthi, Bhargavi, S. N. V. Sivakumar, and Arunima Haldar. "Cross-border Acquisitions and Host Country Determinants: Evidence from Indian Pharmaceutical Companies." Global Business Review 17.3 (2016): 684-69.11. Tirumalai Kamala's answer to Should we have an international forum to resolve clinical trial mishaps?12. Tirumalai Kamala's answer to Is it true that Bill Gates faced trial in India for illegally testing tribal children with vaccines?13. Tirumalai Kamala's answer to Do western drug companies test more dangerous drugs on the poor in India, and should they be held accountable?14. CHEManager Europe, April 2012. Will API Manufacturing Move out of India and China? http://thomsonreuters.com/content/dam/openweb/documents/pdf/pharma-life-sciences/misc/12-pharma-cmi0412.pdf15. Business Standard, Aneesh Phadnis, May 5, 2016. Indian drug units violate most US pharma regulators' rules16. Kadam, Abhay B., et al. "Correcting India’s chronic shortage of drug inspectors to ensure the production and distribution of safe, high-quality medicines." (2016). http://www.allysonpollock.com/wp-content/uploads/2016/04/IJHPM_2016_Kadam_CorrectingIndiasDrugInspectorsShortage.pdf17. A report on fixing India's broken drug regulatory framework. Dinesh S. Thakur, Prashant Reddy T. June 4, 2016. http://spicyip.com/wp-content/uploads/2016/06/Report_India-Drug-Regulatory-Framework_June-2016.pdf18. Business Standard, Sushmi Dey, Jan 30, 2014. If I follow US standards, I will have to shut almost all drug facilities: G N Singh19. European Medicines Agency - Human medicines - GVK Biosciences20. Live Mint, Reghu Balakrishnan, Shine Jacob, Feb 6, 2016. No major impact on API import ban in USThanks for the R2A, Kritika Gupta.

The example of nitroglycerin made by a few of the other answers, prompted me to dig around a bit. I found an article from 1975 that describes a stability study of the drug that illustrates exactly some of the major issues around drug stability and why e.g. Dr. User-10185532933882708813 conveys a dangerously simple explanation of drug stability as "grossly overlabeled", or "a conspiracy between the FDA and its partners in capitalism". Further, shout out to Jill E Griffin for calling out the real reason behind expiration dates.image: nitroglycerin, from Wikipedia.First: in the US, stability studies are governed by USP 35:1150 (excerpt, explanation of terms) which describes, at length, the various tests and calculations involved in drug stability and related drug tests including content uniformity and dissolution. To a doctor, "is it ok to use" is a yes-no question that they face every day, and the expected answer is either yes, or no. The reason why we have a set of standards for drug stability is because "yes" must be backed by science, but "no" must be backed by economics; at the drug manufacturer, the pharmacy desk, and the insurer billing.The question of testing these days seems to be driven more by CSI-style "science" which imagines there's a little machine that you put the drug into, it says "doot" and gives you a yes no answer. But, a close reading of DP Page et al, J Pharm Sci. 1975 Jan; 64(1):140-7 will convince you that you know jack about drug stability. Let me walk you through it.image taken from DP Page et al, J Pharm Sci. 1975 Jan; 64(1):140-7excerpt from Batman (1989): "He's been using Brand X"Pretend you are buying nitroglycerin to stock in your pharmacy. You have your choice of brand A through F. (But not Brand X!) Based upon the results of figure 1 above, what conclusions might you draw? For example, you might (rightly) assume that A is a terrible choice.excerpt taken from DP Page et al, J Pharm Sci. 1975 Jan; 64(1):140-7The details of manufacture are shown above in the excerpt from the paper show the otherwise unremarkable differences between the tablets, yet even by visual inspection of the graph, you can see there are some marked differences in the tablets. Now, the process of quality control on a drug is never easy, and the nature of tablets makes these problems even more complicated. First, we are talking about minute quantities (mfg. E: 1/150 grain). In order to perform a purity analysis at that time, you had to do TLC, an intensive process involving 8 inch square glass plates soaked in a tank containing benzene, ethyl acetate, and acetic acid at the bottom, observed until the solvent had wicked up the plate (a process which could take 20 minutes or more) and then carefully compared (visually!) against standard solutions. For the stability measurements, the drug was only measured for "nitrate" content using the standard method at the time, which non-specifically created a colored solution from the otherwise "invisible" trinitrocellulose. (see figure 4, below)image taken from DP Page et al, J Pharm Sci. 1975 Jan; 64(1):140-7You might be quick to discredit such stone-age analytical techniques, but for many biopharmeceuticals, a nearly identical analytical technique like 260/280 protein is the most common way one quantitates the amount of drug (protein) in a sample even today, correcting for any DNA contamination, since both DNA and protein absorb at similar wavelengths. Even HPLC, which separates molecules (sometimes) from the contaminants, are still only "estimated" in concentration since small changes in the protein structure can result in differing absorbances. It is actually no more sophisticated than the test above, and just as prone to error. While methods like LC/MS/MS can isolate the molecule and fragment it into pieces to check for identical chemical structure, the cost of a single analysis (in manpower and computation/reagents, not even factoring capital equipment costs in the millions) could easily exceed the cost of a year's supply of the drug, or more, and in reality provide no more exacting an analysis when averaged over hundreds of samples....back to nitroglycerin. The data in figure 1 is re-imaged as a percentage degradation, and we see a very different picture, one that begins to explain what is going on.image taken from DP Page et al, J Pharm Sci. 1975 Jan; 64(1):140-7Now you can see that both A and D are subject to similar levels of degradation, about 12% over the course of the year in total nitrate measured. If you look at the excerpt, both of these are packed in cotton, and it is discovered by the authors that over time, nitrate is both exchanged between nitroglycerine and cotton cellulose forming nitrocellulose and transforming the drug from trinitroglycerine (presumably the active ingredient, called API) to one or more degradation products (including di- and mono- nitrated glycerin and other byproducts) as well as transferred to the cotton. Note: analysis on nitrate alone underestimates the degree of decomposition since nitrate is still present in many of the degradation products.The important point I want to observe here is that the packaging material matters! Simply changing from cotton to rayon packing apparently reduces the amount of nitrate lost over time. In fact, packaging of pharmaceuticals is strictly regulated, and any time you change the packing between capsules, tablets, liquid, or injectable forms, you can dramatically change the profile of the drug. Moreover, since tablets can be subject to a range of conflicting pH values as they travel through the body, the ability of the tablet to properly degrade and release the drug can vary widely from one patient to the next, and simple mistakes like taking a pill with an antacid tablet, or orange juice, or milk, or soda, or bourbon, rather than water can transform how the drug is delivered.It's not uncommon to see herbal companies selling empty gelcaps which are then filled by the consumer, but now that you know that some compounds can evaporate or transform being next to cellulose (or glycerin, or gelatin...) and remembering that many herbs lose their "smell" or "taste" sitting on the shelf while the container or other materials packed together pick up hints of that "smell", should leave you much more skeptical not only of the label claims on pharmaceuticals, but herbal supplements and vitamins as well. Luckily, for drugs you have the Pure Food and Drug act of 1906 to prosecute bad actors, while no such regulation exists (and has been actively stopped by the efforts of senators like Orrin Hatch) for so-called "nutraceuticals".Finally, to directly contradict the example of "magnesium sulfate" presented by Steve Harris' answer, let's talk about the stability of a salt. Epsom salts, like you might put in your bath, typically are sold with no expiration date, can be mined, and when used in a non-medical application like bath salts, a salt is a salt is a salt and whether or not your epsom salt contains 100% pure magnesium sulfate, or only 99%, probably doesn't concern you. Since it readily absorbs water, weighing "dry" magnesium sulfate is an exercise in futility, as water content of the 100% "pure" magnesium sulfate can mean the "magnesium sulfate" part measured against a freshly dried and weighed standard might read anywhere between 80% and 120% (!) depending on the humidity in the lab, temperature, skill of the chemist, etc. etc.A funny thing happens to magnesium sulfate when you dissolve it in water. Magnesium ions are freely released into solution, where they can exchange sulfate for hydroxide and form the relatively insoluble magnesium hydroxide (also known as milk of magnesia), particularly at alkaline pH. If dissolved in pH 7.4 saline solution for injection, the stability of the salt as its sulfate is put into question, as the colloidal precipitate magnesium hydroxide will begin to form a hazy white color under the right conditions.A haze in solution could mean any number of problems with a drug, including microbacterial contamination (Ringer's Lactate, a common IV solution, is particularly dangerous in this regard since a number of microbes can survive and even thrive in this solution). Package inserts might explicitly say, "if you see a haze or precipitate, throw it away", and one of the "failure criteria" for stability testing might be so called "visual inspection"- clear, colorless solution being the only "pass" criteria.If magnesium sulfate is put dry in a sealed container, it will likely be stable infinitely. However, once you introduce liquid water, even sterile water for injection (WFI), there is a nonzero probability of introducing microbes to an environment where they may be able to take traces of nutrients from the solution to begin growing. Indeed, even in the most sterile environments, contamination is a fact of life: it is vastly more likely in one of those biohazard "moon-suits" for you to contaminate the experiment than it is for the experiment to contaminate you; you are a walking coughing spewing biohazard to most biomedical research, and much of gowning and safety procedure is not to make things safe for the person wearing the suit, it's to keep the fragile experiments free and safe from the contaminants you might introduce. Imagine what "influenza tests" might show if your doctor, the nurse or one of a handful of lab techs happen to have the flu, too.So, is that haze in your magnesium sulfate ignorable, or critical? Is it microbial, or mineral, or milk of magnesia contamination, and do any of those influence product quality or safety? On average, under harsh conditions as might be experienced during transport or if carelessly left on a shelf in hot sunlight, the drug manufacturer performs a series of tests, and say, in a certain percentage, "haze" is observed at 12 months. So, the manufacturer might say, "12 months" is the shelf life, while under more ideal conditions it might last indefinitely. The USP guidelines help to set a bar such that specific testing can be reproducibly performed such that the "opinion" of the manufacturer is relied upon as little as possible.When a drug company applies for a new drug license, they are required to provide evidence and criteria for stability. These criteria are not set in stone by regulation, since each new drug might have more or less restrictions, but there are recommended guidelines that can speed approval. It is the job of the company to say what the rules are- yes, the drug companies set their own rules- that they agree to follow during the sale of the drug. Even for generics, the manufacturer can't just scoop up some salt spilled on the dinner table and call it sodium chloride for injection- the generic manufacturer applies for a license, too. These rules are subject to inspection, but unless it is particularly risky, a manufacturer might never see an FDA inspector to check to see if the manufacturer is following the rules that it agreed to and dictated at the license grant. It is when a product complaint is launched that inspectors are likely to show up. This is why e.g. Theranos' CLIA License is such a bad occurrence: before this, their CLIA License was actually just a "waiver" based upon the fact that they self-certified they aren't really doing things "differently" than standard methods available, which directly contradicts claims that they had "new patentable technology" and was something I noted years ago before the subsequent scandal broke. You set your own rules, and if you don't follow them, it doesn't matter whether your drug or machine is actually safe or not. You will be shut down. Doctors or activists or lobbyists who argue that the "big bad FDA" is coming to shut them down with all their "big government rules" are flat out lying to you. In fact, you are required to continue as you began, or submit an updated application. If the drug seems to be subject to arbitrary rules, whether or not those rules are in the drug manufacturer's best interest, those rules are set because they combine what the drug company (generic or branded) has determined, through scientific method, to be a set of rules that combine patient safety and good practice with routine testing requirements that are not too expensive and don't make the drug unaffordable. Is it too much to ask companies to follow their own rules?Yet there is always pressure to cut both cost and price to their economic ideals, and any CEO who sets out to "disrupt" should be eyed with suspicion. Does the CEO have experience or history with the technology so that they can feel confident they can choose a cheaper tech over a more expensive one and get the same results? Even the doctor, who might "claim to know" the vial is safe and might be right, has a conflict of interest because when they throw it away, it costs money out of their profit and lifestyle to replace it. Again, I'm not arguing that any patients are harmed- simply that there is a chain of license rules dictated on the package insert tracing all the way back to when the drug was first licensed (if not grandfathered) that every intermediate and including manufacturer and patient agree to when they open a box of pills. These licenses are unlike those "software license" checkboxes that "no-one" reads- any time anyone suggests breaking drug licenses, they are in effect breaking that 1906 law, put in place to balance the need to end quackery but also promote and encourage positive, cost effective innovation by letting manufacturers decide what science they use to prove their point. That is what the FDA enforces, and why opinions such as voiced by User-10185532933882708813 are so dangerous.That is why, TL;DR: prescription medications have an expiration date for a good reason. It's also why Joker's Smylex vs "Brand X" from the video excerpt above is such an apt analogy: it's not always as simple as any one chemical that makes or breaks things, it can be incompatible combinations, like nitroglycerin and cotton packing.One final point on the nitroglycerin paper. The graphs, with their circa 1975 level technology, are notably missing error bars, but the authors do perform a significant amount of statistical calculation that isn't swallowed up by dumbed-down error bars. In fact, the USP has fairly clear guidelines, which as a pharma manufacturer you can agree to follow (and will be enforced by law) or waive by special pleading. To demonstrate to you the challenges, I need to show you three more tables from the paper.In table 2, we see a good statistical summary of the raw data, showing averages, population size, and coefficient of variation. We've already established that A is an outright failure, and maybe also D, but look at the range of results for F! You might, on any dose, get 25% more or less of the active ingredient (and in fact, this would fail content uniformity USP testing even though on average, it appears to get dose right.) We can see some of the problem- out of a bottle filled with 1000 0.6mg tablets, 7-8mg of drug is transferred to the cotton, or 12-15 pills worth. Manufacturer A, who also packs in cotton, doesn't seem to have the same kind of problem, though definitely also has a quality problem.In fact, it is not just packing material that matters- the excipients (non-drug ingredients in a drug formulation) matter too, as well as how it is packed and stored.And one last dig at the latest craze in quackery- p-hacking. In Table 5, the ANOVA shows that the difference in A is significant, but the variation in F is not significant. This might lead a p-hacker to declare that F is "perfectly stable", when it is clear that individual samples vary so much to begin with that changes over time fail to be significant. The temptations to skimp on the testing abound, but the USP provides a good and fair set of guidelines that simply can be followed and defended if you choose to do so.image of Elizabeth Parrish from Singularity blogAs an aside, the most recent claim by BioViva's CEO to have "cured aging"- I'm not exaggerating, see the article- is the end result of this kind of missing-forest-for-the-trees kind of nonsense that should never be uttered publicly by a scientist. That's not a "no true scotsman" fallacy: there's a tremendous amount of uncertainty behind measurement of length of telomeres, which she completely ignores, and by her own admission the first set of tests showed "abnormally short", hence old for her age, results that were seemingly reversed after therapy, an extraordinary claim that requires extraordinary levels of scrutiny and evidence.So, I'm making a public call to the two Elizabeths: for Parrish to repent her evil ways, and not to fall into the same trap that Holmes has fallen into and may never recover from. I hope they network and learn from each other. I want to be careful, though: there's a pervasive sexism, lookism, lurking both in criticizing these women and lauding their accomplishments, particularly coming from a man, so I want to call it out in advance in case I have become subject to a subtle and unwanted bias in my analysis of these women.Furthermore, there's a pervasive ageism and denial of the cost issues behind increasing technological solutions to the "aging" "crisis". High cost therapies to reverse the costs and damage associated with aging that have never actually demonstrated an impact on life length or quality-of-life measures become (even if real) a kind of snake oil, too, and contribute to increasing the kind of wealth inequality criticized in the theme of the movie Elysium (2013) (so much so that I am shocked that a company took that name and sells snake-oil creams and lotions into an already stuffed anti-aging market) that preys upon the fears of aging women (and men, too!) and a very lookist culture that prematurely declares forty-year old women to be toeing a Goldilocks-like line of "cougar" if too sexy, and "mannish" if not sexy enough.Parrish and Holmes seem to be driven by their fears and phobias (though, not unique in combining wealth with aging anxiety), and I would find (all) their respective positions more credible if they shone more light on how these social pressures both help and harm their cases significantly.The pharmaceutical business is guilty of many wrongs as well, but let's not confuse correlation with causation. I have made, perhaps, a controversial correlation between the efforts of Holmes and Parrish (and Kurzweil) on one hand, and sexism and the youth-industrial complex on the other, but there is, in my opinion, fire behind this smoke, and by highlighting what "real data" looks like, I'm trying to set a bar, create a standard, by which we can separate rumor and hope from success.There is also the temptation to correlate the dirty dealings of Martin Shkreli and the business end of pharma with the science behind expiration dates on things that "don't seem" to change in effect (affect?) on the lives of patients. Likewise, there is a significant portion of the pharmaceutical industry who play on the fears generated by the youth-industrial complex that demands we increase our consumption of statins despite having little age- and comorbid- adjusted benefit, for example, that puts negligible economic harm on wealthier recipients but becomes a cudgel for classist notions of poor health among those in poverty by suggesting if they divert a significant portion of their incomes from food and shelter related expenses to healthcare costs they will see longer lifespans and healthier outcomes, a claim which is prima facie absurd.That said, there is considerable evidence, hard data, behind the guidelines of the USP. Furthermore, the way the rules are written allow both good actor and bad-faith actor to self-enforce based upon rules of evidence they themselves have set- and if you "disrupt" those rules, you better have lots of data, public data, to back why you decide to break your own rules. But the bad-faith dealings of a few are not justification to doubt the overall veracity of expiration dates as striking a balance between the proof needs of science and the economic needs of corporations. In a world where the ideal is the enemy of the good, but where the needs of the many sometimes outweigh the needs of the few, questions often have fraught, complicated answers. Careful application of science is the best way to cut through opinion to fact: and the science of drug stability is reasonably settled (if fairly recent) science.That said, there is definitely a need for better tools to improve performance and assist in managing the costs of drug testing, especially stability, so that good data is not missed because too much time is spent on collecting data of marginal quality or impact. If anything, I see this as the reason I was put on this earth: to make this better for everyone, not just the rich or nerd-obsessed. Having the opportunity to explain at length why quality is so important and how cost-effective quality can make a huge impact on outcomes, is a tremendous personal opportunity, and I deeply thank the community of Quora, and readers willing to go through such a long read, for such a question.