“Maintain and sharpen your intellectual honesty so that you’re always realistic. See things as they are, not way you want them to be.”

The above profound statement is what the Management Guru Ram Charan made in his book titled, ‘Execution: The Discipline of Getting Things Done’ co-authored by Larry Bossidy.

Placing the content of this book against current series of events plaguing the Indian pharmaceutical industry, a pertinent question floats at the top of mind. Are these books meant to hone the corporate leadership practices at all level or for preserving in the bookshelves, just as another collector’s item?

This is probably a good question to deliberate upon. Otherwise, why do we keep on encountering barrage of newspaper reports on rampant fraudulent practices within the pharmaceutical industry, especially related to quality of drugs and pricing?

Today’s flavor of ongoing practices:

Just to give a flavor of ongoing practices, following are what appeared in today’s newspaper headlines, besides umpteen numbers of instances reported in the past:

  • USFDA says team threatened during Wockhardt inspection”
  • Or “FDA caution on Wockhardt US unit”
  • Or even “GSK Consumer fined for overcharging” Crocin Advance tablets

All these similar and unabating instances of “short changing” the systems by the business leadership, vindicate the point that much sought after management Pandits’ precious wisdom to corporate honchos seems to be falling in deaf ears, as a sizable section of the Indian pharmaceutical industry apparently sacrificing the “Intellectual Honesty” in the alter of greed and quick profit making.

“Medicine is for people, not for the profits” – George Merck:

To exemplify “Intellectual Honesty” in the above book, Ram Charan and Larry Bossidy deliberated on ‘The 10 Greatest CEOs Ever’. One of these 10 greatest CEO is George Merck of the global pharmaceutical giant Merck & Co, who articulated his vision for his Company way back in 1952 as follows:

“Medicine is for people, not for the profits.” 

George Merck believed that the purpose of a corporation is to do something useful, and to do it well, which also ensures decent profits.

Some say, those were the good old days of ethics and values. Things do not seem to be quite the same in today’s India, for various reasons. ‘Walking the Talk’ clutching the ethics and values close to one’s heart, is glaringly missing in a large section of pharma leadership of date.

Currently, all indications confirm that the market would keep growing at a decent pace, despite all odds, as we move on. To achieve sustainable success in the rapidly changing business environment, especially in the healthcare space, globally accepted quality standards of products and services, delivered in a credible and equitable way with built in scalability, would matter the most

Does India believe in two different drug manufacturing quality standards?

Not withstanding the possible opportunities galore, as stated above, the spate of ‘Warning Letters’ from the US-FDA have brought to the fore existence of two different quality standards for drug manufacturing in India:

  • High quality plants dedicated to serving the largest market of the world – the United States and following the US-FDA regulations.
  • Other plants, with much less regulations, to cater to the needs of the Indian population and other developing non-regulated markets.

In a situation like this, especially when many Indian manufacturers are repeatedly failing to meet the American quality standards, the following questions come up:

  • Is the US-FDA manufacturing requirement too troublesome, if not oppressive?
  • If not, do the Indian and other patients too deserve to have drugs conforming to the same quality standards?

Answers to these questions are absolutely vital to convince ourselves, why should Indian patients have access to drugs of lower quality standards than Americans, with consequential increase in their health risks?

Different strokes for different folks:

To immediately alleviate the business risk of Indian exporters through resumption of business with those banned drugs in the United States, the only immediate solution is to ensure strict conformance to US-FDA regulations by enhancing organizational ethics and value systems to the desired level of acceptance of the US regulator, as most of these were identified as fraudulent practices and alleged ‘threats’, as reported above.

However, for getting answer to the question of dual drug manufacturing quality standards in India, Indian Ministry of Health has already made the public understanding on the subject even more complicated.

This is due to conflicting acts of two responsible officials in the Ministry of Health of India on the same issue, as follows:

  • On February 10, 2014, Dr. Keshav Desiraju, the then Secretary of Health signed a “Statement of Intent” with Dr. Margaret A. Hamburg, Commissioner of US-FDA to encourage collaboration between American and Indian regulators to effectively address this issue.
  • The very next day, on February 11, 2014, the Drug Controller General of India, while addressing the media expressed his great apprehension against over regulation of the US regulator.

It is, therefore, amazing to note the above different strokes for different folks by the same ministry and on the same very sensitive subject, creating a snowballing effect of confusion within the stakeholders.

Conclusion:

To reap rich harvest out of the emerging gold-plated opportunity, as stated above, not just coming from India, but across the world, Indian pharma does need a strong leadership with unflinching belief in business practices weaved in corporate ethics and values.

Even to come out of the episodes of repeated ‘Warning Letters’ from US-FDA, casting aspersions on the quality of Indian drug manufacturing standards, which are mainly related to alleged fraudulent business practices, strong corporate leadership with high ethics and value standards at all level is of absolute necessity.

Equally important is to follow the visionary statement of the pharma iconoclast George Merck, made way back in 1952 that “Medicine is for people, not for the profits”.

Moving towards this direction, would the newly formed Ministry of Health clarify expeditiously, without any ambiguity and with intellectual honesty that Indian patients are taking as safe and effective medicines as their counterparts, living in any other corner of the developed world, including the United States?

By: Tapan J. Ray

Disclaimer: The views/opinions expressed in this article are entirely my own, written in my individual and personal capacity. I do not represent any other person or organization for this opinion.

Lactose intolerance: lack of labelling and awareness

Wikipedia has a nice article about Lactose Intolerance, including the part titled “Lactase Persistence”, which discusses the fact that amongst all the mammals, it’s very abnormal to actually still be lactose tolerant well past the childhood, where only certain human populations do not lose the ability to produce lactase to digest lactose as they age (in other words, lactose intolerance, on the other hand, is absolutely normal).

http://en.wikipedia.org/wiki/Lactose_intolerance
http://en.wikipedia.org/wiki/Lactose_intolerance#Lactase_persistence
http://en.wikipedia.org/wiki/Lactase_persistence

In light of that, I find it quite distressing that in this day and age, the USFDA labelling requirements seem to have absolutely no mentions or regulations regarding the lactose content of the products. Why are the Fats always itemised, and even Fibre is oftentimes itemised for Soluble and Insoluble, whereas the Sugars are never so itemised?

http://www.fda.gov/forconsumers/consumerupdates/ucm094550.htm

http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/FoodLabelingNutrition/FoodLabelingGuide/default.htm

And many people working in the food industry likewise have little understanding that lactose intolerance is not like an allergy or anything, and that people may merely be interested in ensuring that they’re not up to the consumption of noticeable amounts of lactose, but couldn’t care less about trace or insignificant amounts.

Still, I find it disenchanting that noone seems to be caring, even with all the research, and even with all the regulation opportunities.

For example, if the FDA labelling says that the product contains milk, as part of the Food Allergen Labelling requirements from FALCPA 2004, how is one supposed to know, without delving deep into the ingredients list, whether it has merely milk proteins without any lactose content, or whether noticeable amounts of lactose are still there? And to be fair, would milk proteins have lactose, or would they not? I’m not a biologist, for Christ’s sake, and although LI, as FDA points out, is not “life-threatening” as a milk allergy could be, it’s still a major discomfort (that stomach pain can be very unbearable) that’s very prevalent amongst a very considerable chunk of the population, so it’s striking to see no efforts being made about clear identification of the lactose content.

Even if you’re not the one who’s lactose intolerant, or even if you’ve mastered out all the labelling nuances and sources of lactose in the interest of being a pro at avoiding non-trace amounts of lactose, there’s still a considerable benefit to the appropriate lactose labelling for the population at large. For nothing else, it’ll be one step further into saving you from having to smell someone’s flatulence in a room full of people, many of whom may be clueless about their lactose intolerance or the fact that certain items contain noticeable amounts of lactose.

Stability Data for ANDAs in the USA: a new Q&A Document of the FDA provides further Clarity

Stability Data for ANDAs in the USA: a new Q&A Document of the FDA provides further Clarity
The applicant for an ANDA in the USA has to submit data of several stability tests. The FDA guidance on this topic coming into force last year left open some issues, however, that now are clarified with a questions and answers document published lately.

Read more.

http://www.gmp-compliance.org/enews_435…

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Others say the whole industry is effectively a lost cause. “I threw the word natural out the window a few years ago,” says Dana Price, 38, currently an inventory manager at Oregon Growers, a supplier of jams, fruit butters, honeys, and other niche products. After a decade working with companies like Trader Joe’s and Wild Oats, he says he’s disgusted. He blames the profit motive. “So many of the trusted names in organic have been bought out by bigger non-organic conglomerates,” he says. “The whole-food industry is a serious mess, and the only thing I really trust is the farmer’s market. I don’t even care if what they sell is organic.”
—  Matthew Mientka,”The Unnatural Death of ‘Natural’”, Newsweek 11.22.13

‘Warning Letter’ of May 7, 2014 from the USFDA to Sun Pharmaceuticals – the no.1 pharma major by market capitalization in India has nailed its Karkhadi, Vadodara, Gujarat based plant in India for similar data deletions as found at Ranbaxy.

Such data manipulation reportedly got Ranbaxy into so much trouble that it last year paid U$ 500 million and agreed to plead guilty to 7 felony charges.

The concerned Gujarat based plant of Sun pharma manufacturers the antibiotic cephalosporin.

This development came to the fore just weeks after Sun Pharmaceutical announced a US$ 3.2 billion deal to buy the much troubled, yet the largest generic drug company of India – Ranbaxy.

My earlier apprehensions on this deal:

At that time in my blog post of April 14, 2014, I expressed my apprehensions on this deal on four key areas, with as many words as follows:

1. Sun Pharma too is under USFDA radar:

As we know that along with Ranbaxy, Wockhardt and some others, Sun Pharma also had come under the USFDA radar for non-compliance of the Current Good Manufacturing Practices (cGMPs).

Under the prevailing circumstances, I apprehended, it would indeed be a major challenge for Sun Pharma to place its own house in order first and simultaneously address the similar issues to get USFDA ‘import bans’ lifted from four manufacturing plants of Ranbaxy in India that export formulations and API to the United States.

This could be quite a task indeed for Sun Pharma.

 2. Pending Supreme Court case on Ranbaxy:

Prompted by a series of ‘Import Bans’ from US-FDA on product quality grounds, the Supreme Court of India on March 15, 2014 reportedly issued notices to both the Central Government and Ranbaxy against a Public Interest Litigation (PIL) seeking not just cancellation of the manufacturing licenses of the company, but also a probe by the Central Bureau of Investigation (CBI) on the allegation of supplying adulterated drugs in the country.

Ranbaxy/ Sun pharma would, therefore, require convincing the top court of the country that it manufactures and sells quality medicines for the consumption of patients in India.

 3. CCI scrutiny of the deal:

Out of the Top 10 Therapy Areas, the merged company would hold the highest ranking in 4 segments namely, Cardiac, Neuro/CNS, Pain management and Gynec and no. 2 ranking in two other segments namely, Vitamins and Gastrointestinal.

Noting the above scenario and possibly many others, the Competition Commission of India (CCI), after intense scrutiny, would require taking a call whether this acquisition would adversely affect market competition in any of those areas. If so, CCI would suggest appropriate measures to be completed by the two concerned companies before the deal could take effect.

This would also be a task cut out for the CCI in this area.

 4. SEBI queries:

Securities and Exchange Board of India (SEBI), has already sought information from Sun Pharmaceutical on stock price movement and the deal structure.

According to reports, it is due to “Ranbaxy shares showing good movement on three occasions: first in December, then in January and subsequently in March 2014, just before the deal was announced.” This has already attracted SEBI’s attention and has prompted it to go into the details.

The matter is now subjudice.

The current scenario:

Out of my four identified areas of challenges, Sun Pharma has already started feeling the heat in the following two areas:

1. Quality issues with FDA:

The issue is extremely important, as to turn around Ranbaxy, this has to be addressed to the complete satisfaction of the USFDA. Otherwise, the game is a non-starter.

2. SEBI queries on stock price movement and the deal structure:

In this area, just today the Supreme Court reportedly refused to stay the Andhra Pradesh High Court order that stalled the US$ 4 billion Sun Pharma merger with Ranbaxy. Daiichi Sankyo and Ranbaxy had approached the Supreme Court seeking vacation of the stay of the status quo order by the High Court, which on April 25, 2014 directed the BSE and NSE not to approve the merger while admitting a petition by retail investors alleging insider trading in the US$ 4 billion deal.

The vacation bench comprising of Justices B S Chouhan and A K Sikri also directed the High Court to decide on Sun Pharma’s application seeking vacation of the status quo order within two days and posted the matter for further hearing on May 29. The judges observed that the Andhra High Court has no territorial jurisdiction over the merger process.

The outcome of this case would indeed be interesting and crucial for Sun Pharma.

Conclusion:

Even if one keeps aside the three issues out of above four as the legal ones, the very first challenge related to USFDA on drug quality, would continue to remain as the ‘make or break’ area, for this deal to be commercially successful for Sun Pharma.

When USFDA reportedly nailed Sun Pharma’s Karkhadi , Vadodara, Gujarat based plant for similar data deletions as found at Ranbaxy, it may give a feeling that the acquirer Sun Pharma possibly is also sailing in the same boat as the acquiree Ranbaxy.

If this apprehension makes any sense, the moot question that comes up:

“Can one blind man show the right direction to another blind man sailing in the same boat in the midst of a storm?”

Let us wait for the eternal time to tell us the answer.

By: Tapan J. Ray

Disclaimer: The views/opinions expressed in this article are entirely my own, written in my individual and personal capacity. I do not represent any other person or organization for this opinion

New Post has been published on The Rakyat Post

New Post has been published on http://www.therakyatpost.com/business/2014/01/25/shares-of-indias-ranbaxy-slide-19-on-new-us-fda-ban/

Shares of India’s Ranbaxy slide 19% after new U.S. FDA ban

Ranbaxy-manufactured drugs at an Indian chemist shop in New Delhi. Shares in Ranbaxy Laboratories, dropped 17% on Friday after the US Food and Drug Administration suspended imports from a fourth manufacturing facility of the firm. —AFP pic[/caption]

MUMBAI

Shares in one of India’s biggest drug makers, Ranbaxy Laboratories, slid 19% on Friday after the US Food and Drug Administration suspended imports from a fourth manufacturing plant of the firm.

The FDA said on Thursday it found significant violations from expected “good manufacturing practice” standards at Ranbaxy’s Toansa factory in the northern state of Punjab.

“Appropriate management action will be taken after completion of the internal investigation,” Ranbaxy said on Friday in response to the FDA statement.

The New Delhi-based drug manufacturer’s stock finished the day at 335.65 rupees, down 81.50 rupees or 19% on the Bombay Stock Exchange.

The Toansa plant makes so-called APIs — active pharmaceutical ingredients — for the company’s drugs which include treatments for ailments including heart and nervous system disorders.

Toansa now joins the firm’s Mohali plant and two other facilities which have been banned by the FDA, further excluding the company from one of its biggest markets.

Alleged violations at Toansa included staff re-testing raw materials and drugs “after those items failed analytical testing and specifications in order to produce acceptable findings,” according to the FDA regulator.

The plant now cannot supply drugs for the United States until the FDA regulator re-inspects the facilities and is satisfied that failings have been corrected.

Prospects are “bleak for the company near- to mid-term”, brokerage house Prabhudas Lilladher said in a research note, according to Indian financial website Moneycontrol.com.

Japanese drugmaker Daiichi bought Ranbaxy in 2008 believing its dominance in cheap generic medicines and developing markets would help the firm grow.

But the Indian company has been a weight on Daiichi’s books ever since due to its regulatory problems.

Shares have fallen 27% in the last 12 months. Daiichi paid 737 rupees per share in 2008, more than double their current level.

The US market traditionally makes up some 40% of Ranbaxy’s sales.

Petition for Finalizing Gluten-Free Labeling

Have you signed this petition yet? The FDA promised us a year ago that they’d finalize the standards this year. Time is running out. Make consuming gluten-free products safe for those with celiac disease and gluten intolerance. Sign the petition to the Obama Administration at https://petitions.whitehouse.gov/petition/finalize-standards-gluten-free-labeling/SsmdZh3C?utm_source=wh.gov&utm_medium=shorturl&utm_campaign=shorturl

Many parents in the U.S. and North America are unknowingly feeding their infants and small children Gerber Baby Foods which contain genetically modified corn and soy, both of which contain Bt toxins, a registered pesticide with the USFDA.

If it was sold at Home Depot instead of your grocery store, it would require a label from the EPA that stated, “Pesticide” with a registration number. While Bt proteins can kill insects when they bite into the corn, the toxin is also absorbed into the entire plant – roots, stems, leaves, and fruit. If only parents knew, surely they wouldn’t ask their five month old to suck down a bottle of Bt poison.

Nestlé has received thousands of letters from concerned parents requesting that they remove GMOs from their baby formulas, but the company refuses. So, its time to stick it to Nestlé where it hurts and trigger another boycott. People are turning to other brands left and right when they find out what the company is really up to.

http://naturalsociety.com/nestlegerber-wont-listen-boycott-company-puts-gmo-bt-toxins-baby-food/

anonymous said:

Hi! I was interested for getting colored contacts online for a cosplay, and I'm kind of hesitant, would you mind giving some tips/ advice?

Sure! Alright first off, Geo circle lenses are the only colored contacts that are USFDA approved for being sterile and healthy. Geo has a lot of great contacts if you’re just starting off. They have a lot of colors for cosplay. Pinkyparadise is the website I buy my contacts off of and they include a lot of Geo lenses. I like Pinkyparadise because they have customers review every pair of contacts and post real life photos of them instead of just model photos. 

Contact lenses that aren’t doctor prescribed are always risky, especially if you have astigmatism or eye problems. (I actually have astigmatism but never have any issues with them at all and I don’t buy my contacts with prescription. I’ve never been prescribed contacts by an eye doctor either.) Some of the contacts I bought admittedly did cause irritation but I don’t wear them longer than just for pictures because of that. Geo lenses have never bothered me before. 

So basically when you get contacts, if they irritate your eyes do not try to wear them longer than you think you should. I own around 7 pairs of contacts now and only 2 of them cause me any irritation and it’s pretty slight. The others I hardly feel at all. If you are hesitant then just look around on websites and look at the reviews on contacts. People will tell you the comfort level and etc so you know what to expect when you get them. Hope this helps. 

Good morning! 💕
I have a lens giveaway sponsored by the lovely @uniqso!
So the rules are:
Must be following @uniqso and I.
Repost only three times a day.
Use the tag #pinkmutieuniqsogiveaway and tag @uniqso and I.
There will be 2 winners and each winner will receive ONE pair of Geo lenses of their choice! There is a large selection of Geo lenses on the site. Geo circle lenses are the only brand that is USFDA approved! So if you are new to lenses and are worried about them, Geo is strict on safe lenses. c:
Good luck and I hope everyone has a great day. ❤️ http://ift.tt/1rglDYF

FDA Works to Mitigate the West Africa Ebola Outbreak

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By: Luciana Borio, M.D. The world is witnessing the devastating effects of the Ebola virus outbreak in West Africa, the worst Ebola outbreak in recorded history. To date, more than two thousand people in Guinea, Liberia, Nigeria and Sierra Leone … Continue reading → [ http://blogs.fda.gov/fdavoice/index.php/2014/08/fda-works-to-mitigate-the-west-africa-ebola-outbreak/?source=govdelivery&utm_medium=email&utm_source=govdelivery ]

Nestle/Gerber Won’t Listen: Boycott the Company Who Puts GMO Bt Toxins in Baby Food

Like many food producers supplying some of the most popular foods, some baby food companies, such as Purity Brands, are going GMO-free due to public demand. But other companies stuffed with the hot air of their own inflated CEO’s egos refuse – Nestlé International, the parent company of both Nestlé USA and Gerber baby foods – is adamant about using GMOs in their products. It looks like it’s time for another boycott. Many parents in the U.S. and North America are unknowingly feeding their infants and small children Gerber Baby Foods which contain genetically modified corn and soy, both of which contain Bt toxins, a registered pesticide with the USFDA. If it was sold at Home Depot instead of your grocery store, it would require a label from the EPA that stated, “Pesticide” with a registration number. http://b4in.com/jE2d

Innate Me-Me Gripper 7.5oz Stainless Steel Sippy Cup (Puff Blue) - 2012

Innate Me-Me Gripper 7.5oz Stainless Steel Sippy Cup (Puff Blue) – 2012

A great choice for babies 6+ months. Kids can graduate using the A-B-C modular drinking system as they get older.

Product Features

  • Made With a Premium Korean 304 Stainless Steel That Contains 18% Chromium and 8% Nickel; it Does Not Leach Chemicals, Stain, Corrode, or rust
  • Collar and lid are made from #5 Food Grade Polypropylene
  • Dishwasher Safe
  • Independently tested to USFDA, California Prop.65 and…

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CDRH New Update

CDRHNew

Date: August 22, 2014

The following new items were added to the CDRH web pages on August 21, 2014. Previous CDRH New Items can be found on the CDRHNew Page [ http://service.govdelivery.com/service/edition.html?code=USFDA_30&format=Web&email_type=bulletin ].


* Class I Medical Device Recall: Children’s Medical Ventures, Gel-E Donut and Squishon 2 - Possibility of Mold [ http://www.fda.gov/MedicalDevices/Safety/ListofRecalls/ucm410964.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery ]
* Public Workshop - Revamping Microbiological Test Methods for Contact Lenses, Products and Accessories to Protect Health and Ensure Safety, September 12, 2014 [ http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/ucm409778.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery ]

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