Are you taking drugs made by Ranbaxy?

I had heard rumblings about some US regulatory bodies taking action on Ranbaxy. At first, I was not interested in the details – it sounded too much like American protectionism. But this article on Firstpost was an eye-opener.

However, after five years of legal battle, now Ranbaxy has pleaded guilty of the same wrong doings that it was exonerated of. The company has admitted to selling adulterated drugs from the two plants and submitting false statements to the FDA.

Take a minute. Step back from the screen. This is not financial fraud. Not an industrial espionage or a patent litigation case. We are talking about medicine. Make no mistake – flooding markets with cheap generics is good.  But what sort of sick psychopath floods the market with adulterated, untested drugs? It is right out of a Bond film.

I followed a link and came upon one of the worse indictments possible for a pharmaceutical company. Do yourself a favour and read the report. Some highlights of report are listed below. Text in italics is quoted directly from the article.

  • Standard operating procedures for clinical studies and drug testing, manufacturing and storage facilities were violated – sometimes, the company would create its own SOPs to prove compliance on paper.
  • senior managers of the company, heads of research and development, people responsible for formulation … clinical people – all were “in” on this game.
  • Drug tests were carried out with actual brand-name drugs substituted in place of the generics meant to be tested.
  • Drug degradation (“expiry date”) was almost always under-reported. This means medicines would expire sooner than mentioned on the label.
  • crucial testing data for many of the company’s drugs did not actually exist and submissions to regulators had been forged.
  • “There was a total lack of understanding,” Dr. Kathy Spreen (former executive director of clinical medicine and pharmacovigilance, Ranbaxy U.S.) says, “of what it meant to be ethical and what it meant to actually protect the patient.”
  • Six other pharma veterans who worked for Ranbaxy in the U.S. as recently as 2010 tell Fortune they found themselves in a corporate culture like nothing they’d ever experienced. Executives approached the regulatory system as an obstacle to be gamed. They bragged about who had most artfully deceived regulators.
  • In Europe, for example, the company used ingredients from unapproved sources, invented shelf-life data, tested different formulations of the drug than the ones it sold, and made undocumented changes to the manufacturing process.
  • In entire markets—including Brazil, Kenya, Ethiopia, Uganda, Egypt, Myanmar, Thailand, Vietnam, Peru and the Dominican Republic—the company had simply not tested the drugs and had invented all the data.
  • The company had a “reputation for threatening people, bullying people,” Dinesh Thakur (former global head of psychiatry for clinical research and development, Ranbaxy) recalls.
  • Ranbaxy used its international staff as drug mules to bring brand-name drugs to India – violating import-export laws of multiple nations.
  • “Every single inspector that went to India said they would never take a Ranbaxy drug,” says David Nelson (former senior investigator, House Energy and Commerce Committee), “like eight out of eight.”
  • One by one, each of the former Ranbaxy executives Fortune interviewed had determined, while still at the company, to stop taking Ranbaxy drugs.
  • Ranbaxy has been recalling its blockbuster drugs at an alarming rate in the US.

Dinesh Thakur – the whistle-blower.

The question remains – why are Indian regulators moving so slowly? Why is Indian media – print, TV, Internet – silent? Ranbaxy should be splashed on the front page of every newspaper and news portal. The intent here should not be to protect Ranbaxy but the Indian generic drugs industry and patients – both Indian and international – who depend on generics for their medical needs. Only by taking Ranbaxy to task and verifying that its systems and processes are in order can confidence be restored.

I don’t know about you, but from now on, I will be assiduously avoiding the Ranbaxy brand. The pity is I can do so only if there is an alternative that I know about.

What about the millions who do not have the means to search for and procure alternatives?

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Grid-lock on the JVLR

I shot out of the office a little later than usual today, but still anticipating relaxed rush hour traffic on way home. Instead, I was brought to a screeching halt on the flyover bypassing SEEPZ.

Extent of grid-locked traffic at 6PM

Extent of grid-locked traffic at 6PM

From the SEEPZ flyover, I could see a river of vehicles going towards WEH jammed on the JVLR. This continued till the Sham Nagar junction 2.3 Km ahead. The reason was a chicane set up by police just ahead of Sham Nagar junction. There was a bus blocking a lane and a couple of cars and bikes, probably intercepted by traffic police. May be some incident occurred because the police were more alert than for a routine traffic check-point.

Somebody could have thought of diverting traffic. Exiting JVLR, I could have taken the Aarey Colony road via MIDC and Marol Maroshi Road. Or even earlier – I could have turned right at L&T itself.

Whatever. I spent some quality time sweating in the sun next to cantankerous AC buses.

The slippery slope of censorship

(This post was first published on Feb 17, 2013. There is an update added on Feb 18, 2013.)

I have no stake in the MBA business beyond ensuring that the MBA I work for knows that MBAs don’t make the world go around. The recent upsurge of protests against IIPM blocking 73 URLs has me concerned and I must join the protest.

First, this is censorship. This feels wrong. A private entity files a defamation case and gets a judgment to block resources on the Internet. This tramples upon the author’s right to freedom of expression. This destroys others’ right to obtain knowledge. How can the courts decide that I should not read or write a critical article about IIPM?

Second, the tactics used in these cases are not ethical.  IIPM is headquartered in New Delhi and has branches in Mumbai, Gurgaon, Noida, Bangalore, Chennai, Ahmedabad, Kolkata, Chandigarh, Hyderabad, Pune, Lucknow, Indore, Bhubaneshwar, Bhopal, Jaipur, Dehradun, and Cochin (as of Feb 17, 2013). Where was this case filed? In Gwalior, by a channel partner. An earlier case was filed in Silchar of all places, by a recruitment agent. None of the cases are filed by IIPM directly. A personal blogger or a small on-line media organisation simply does not have the resources to put their lives on hold and run to these courts to protect their articles; indeed, their constitutional rights. This results in an uncontested case and an automatic win for IIPM. They don’t have to bother with defending against the criticism leveled in the article.

By the way, an educational institution having tens of branches, channel partners, recruitment agents and running full page ads – reminds me of coaching classes for IIT-JEE, CAT and 12th HSC.

Lastly, the list of URLs contain resources put on-line by the University Grants Commission. I am amazed at the audacity of IIPM agents. Howsoever indirectly, UGC is sponsored by all of us who pay our taxes. It is a government organisation working under the Ministry of Human Resources. We are entitled to get access to all notices, regulations and guidelines that the UGC put on its website. What law gives IIPM the right to even request a block on any document put forward by the UGC? A private for-profit organisation has effectively hampered the working of a government organization and put the educational careers of millions of students at stake.

It is time the government and judiciary take a closer look at the IT Act and its application; and if they have more time, may be try fixing the education system too.

Update @ February 18 – Reading this article on The Hindu’s website, it appears that the content owners were not contacted at all. Imagine that. Anybody can file a defamation case in some corner of this huge country and get away with blocking content on the Internet. Quote by Atul Chitnis in the article:

IIPM was not just using a distant court to gag specific websites but was also trying to scare other commentators into silence.

One last thing – they approached Google to remove the URLs from their search results, but Google did not act – because it obviously (and correctly) interpreted the request as an attempt at perverted censorship.

Redmine with Passenger on Nginx

Thanks to the guys at Dotdeb, we can now run Redmine using Phusion Passenger. My earlier requirements were still in force – software to be installed from a repository, upgradeable using apt-get and no compiling on the server.

To use Passenger with Nginx, the official Phusion docs recommend compiling Nginx from source. Fortunately, Nginx PPA provides this version of Nginx – nginx-passenger. I got around to checking Dotdeb; and they provided one for Debian 6 too! The installation is simple.

sudo apt-get install nginx-passenger ruby-passenger

You will need to tune it for your server, but many  guides are available on the Internet.

##
# /etc/nginx/nginx.conf
# nginx-passenger config
##
# Uncomment it if you installed nginx-passenger
##

passenger_root           /usr/lib/phusion-passenger;
passenger_ruby           /usr/bin/ruby;
passenger_max_pool_size  2;
passenger_pool_idle_time 120;
passenger_pre_start      http://redmine.example.com/;
## site config using passenger
server {
    listen 80;
    server_name redmine.example.com;
    root /usr/share/redmine/public;
    passenger_enabled on;
}

Biker meets road

It took three years for me to fall off my motorcycle. I don’t want to know what that says about my riding style!

I tripped the bike when moving over from the shoulder to the main road. The paver blocks on the road shoulder are often not level with the concrete main road surface. I was thinking of “office” stuff, it was way past my usual commute time and it was dark. I misjudged the level between paver blocks and concrete and my bike tipped to the right. The momentum threw me forward so I cleared the bike.

Thanks to the driver of the car I was overtaking! He braked well and saved me some serious grief.

My bike got away easily – scratches on the exhaust, kick-start, leg guard and headlamp cowl. The sticker work on the cowl took some scarring – I think it had an intense chat with the concrete’s edge. My body took some hits – sore knee, elbow and neck on the right side and sore palms and wrists on both sides.

People standing nearby, waiting for their own purposes, helped me up quickly and moved me to the footpath. Some kind Samaritan recovered my left RVM which had rocketed off on to the road. Someone else recovered my bike. And yeah, my heart was racing, adrenaline was pumping and all that shit happened, I guess. My first thought was “Damn, how will I get my bike home?”

I took a few minutes to calm down. People asked me to test my joints – no fractures. Nothing leaking from my bike. After 5 minutes, I shook hands and thanked the ones I could recollect helping me and took off again.

And here the scary part began. My thenar muscles hurt like hell. In fact, a week later, they still hurt. I almost couldn’t hold the handlebar. And operating the horn or dipper was out 😦 … And I was so eager trying to figure out how I tripped over the road shoulder that I almost rolled myself off-road once.

Once home, I blew a thousand bucks on prescribed painkillers.

Oh well, shit happens.