Emergency Medicine (lack of) the great equalizer

I have not really read much about the effectiveness of emergency medicine in India. One of the great equalizers in India is that if you happen to be in a car crash on one of its bucolic highways the chances of you surviving it is pretty much providential be you the a rich man or a poor man. All the money in the world will not help you at that instant when you really need professional medical help. There were over 98,000 road accident deaths in the year 2005 in India. You can find more sobering details about killer Indian roads (for once I agree which such crass hyperbole)

What really prompted me to touch of this issue are two simultaneous publication that show the problem and also offer a solution. That should get health policy wonks thinking about this issue. The first is this sad story that I read.

For 45 minutes, a biker and a pedestrian lay injured and bleeding on the highway near Mulund; traffic cops tried to flag down vehicles but nobody stopped to take them to hospital. Source

And then there was this story in the recent issue of the TIME magazine.

On São Paulo's chaotic streets, ambulances often can't get through the traffic to an accident scene. Hence the motorbike medic.

And these medicos are firefighters who take 240 hours of first-aid education and two week course on motorcycles skills and maintenance. Not to be snarky but can you imagine what an MBBS kid from Pune would be like? A god/goddess amongst these Sao Paolo firefighting medicos? Why Pune, coz everyone is born riding a two wheeler in that city.

But that comment should get you thinking about the possibilities of such a service in major metros in India. After all if we can have putatively deadly motorcycle riding commandos to stop crime in Mumbai, imagine what REAL service can be provided by similarly trained medicos on motorbikes in the same city.

At the risk of sounding like an insta-punditz, I think its quite feasible. There is no dearth for MBBS docs and there is no dearth of motorcycles in India and especially in Mumbai. Rather than trying to train firefighters who are way to busy rescuing folks from crashed buildings it is better to use someone who is professionally trained in the fundamentals of medicine to take over the task of emergency medicine.

The idea is the get "just the bare amount" of care to those who really need it the most in the time that its needed the most. Its really not that costly to implement something like this. Sure the insta-critics will wonder if such a project is sustainable, I think it is, there are more people dying or getting hurt on Indian roads (specially Metro roads) than there are D-company men running around. Heck even a D-company man who gets hurt in an "encounter" needs to be sewed up (or so I would naively assume)

If you ask me the pandu in the Mumbai story did more than what was expected of him. This is a direct quote from the Sao Paolo story...think about it

......(the) firefighters have become the go-to guys when accidents occur, perhaps because the country's health service is in disarray and the police are among the nation's least esteemed public servants.

Revamped Drug Distribution: About time.

Ok so its been a while since I posted on rxmalice, part of the problem is was that I didnt know how to get folks to read it. Its one thing to write a blog its another to get folks to read it. I got some great advice from a more experienced blogger and based on his rx imma gonna keep this short and sweet.

Retail pharmacies to get distribution prescription

The government is planning to tighten the norms for transporting, storing and selling medicines in the country even as big corporate houses are opening retail pharmacy chains and the existing ones get corporatised........ The proposed good distribution practices would make it mandatory for every retail pharmacy to issue computerised receipts, employ a full-time pharmacist who could guide the consumer to cheaper alternatives in case the prescribed drug is not available and to display the price list properly........ The changes could very well push up the cost of compliance for standalone pharmacies that do not have the economies of scale to lower costs and invest in good practices. In fact, some pharmaceutical companies that opened their own retail pharmacies earlier had to close them down as the corporate tag forced them to adopt high standards that turned out to be too costly.......

Now for those of you who consider CVS/Rite Aid/Eckerd to be the norm this might be quite surprising but least ye forget, not too long ago there were a LOT of community pharmacies all over America and the CVS wallahs just muscled in ably aided by economies of scales provided by managed care and pharmacy benefits management (PBM) and now with CVS taking over CareMark (PBM) they have now achieved whats euphemistically called as Intergrated Pharmaceutical Services. That was bound to happen: the retails were being whipped by PBM's mail order arms (psst the retail chains also have their own mail-order pharmacies but they just couldn't compete) and the PBM's would rather have their own retail ends for their members than pay someone else to fulfill their rx.

I have always felt that India's retail pharmacies (a.k.a Chemist, Druggist and the best one of them all Pharmaceutists (there is one in tony Kemps Corner, Mumbai)) are nothing more than mom and pop shops that have not remotely trained or qualified to dispense rx. Its a well known that you DONT NEED a prescription for ALMOST ANY DRUG (expect the ones that kill quickly or are narcotics). This has lead to MANY folks who are remotely educated to self diagnose and self prescribe and consume rx based on what they feel, read or have seen. This is unthinkable in any mature healthcare system.

But then in ALL mature healthcare systems (developed countries) you CANNOT afford to buy any lifesaving rx with the change thats in your middle class wallet. In India you can and RVPji is trying his best to keep it that way.

One of the biggest criticism leveled against Indian Pharma has been that its not produced any original compounds even though I argue that its a sophisticated industry. This is absolutely true and its totally unnecessary. The reason it was unnecessary is as long as they could legally copy and innovate on any compound that was available in patent filings and literature they would save the $800 odd million that it costs to develop a similar drug. Why spend $800 million when you can produce the same molecule for pennies and make it available for a couple of rupees? They do innovate where it counts, given the hyper-competitive market they are in, they found that where they really need to differentiate their product is in novel drug delivery systems (NDDS) and hence they produced extended release version of most compounds.

While India has a greater proportion of infectious disease most of the compounds available in the world pharma market to fight such diseases are also available in India. So why reinvent the wheel?

Ram Vilas Paswan (RVP ji) and Drug Pricing

Introduction

Ram Vilas Paswan (RVP ji) is the current Minister of Chemicals and Fertilizers (C&F). And since small molecules are chemicals (don't ask...more on this quixotic issue later...hey this is my first post, I got a lot to say) RVP ji's ministry has been traditionally in charge of setting policies for the chemical (including pharma) industry and especially for pharma: monitoring and controlling drug prices via the National Pharmaceutical Pricing Authority (NPPA).

Now before you roll your eyes and wonder where the ministry of health is, there is one and its under Dr. Anbumani Ramadoss (AbR ji) and is officially titled the Ministry of Health and Family Welfare (HFW). The way it works (loosely) is that HFW has the Indian Food and Drug Administration under it (it sets and tries to implement the National health Policy but in the drug pricing context lets stick with what directly impact the topic), its called the Central Drugs and Standards Organization (CDSO) and each state had something else called as the State FDA, which is in charge of controlling ONLY the manufacturing, safety and sales of drugs (in their state) that are approved for mfg/sale by the CDSO.

HFW also maintains the National Essential Drug list (EDL) which consist of 354 drugs and the C&F's NPPA controls the prices of these essential medications.

Latest Tamasha

"In a move certain to draw sharp reactions from pharmaceutical companies, chemicals and fertilizers minister Ram Vilas Paswan has proposed to control the prices of 354 essential medicines by taking into account their cost of production. The final drug pricing formula is part of a Cabinet note moved on Friday, sources told ET. The new drugs are in addition to the list of drugs currently price-controlled. As of now, one-fourth of the Rs 23,000-crore domestic pharma market is controlled.

The ministry has not accepted the industry’s offer to voluntarily lower the current prices of essential drugs by 5% to 10% as an alternative, sources told ET. Mr Paswan decided to go for cost-based pricing after the industry could not measure up to its commitments to lower prices of chemist-promoted drugs."

Source

This issues cannot be tackled with off the cuff comments and needs to be examine systematically before the reader can form an opinion (I know mine keeps evolving as I document it for this blog). Since most people don't really understand all aspects of this issue I have decided to list a few aspects that will help you understand the background of this issue and state of the Indian pharma industry.



History

In the 70's Indira Gandhi government decided to implement the concept of process patents, this meant that unlike the gold standard of product patents, India would allow anyone to manufacture any active pharmaceutical ingredient (API) which were usually small molecules as long as the manufacturer showed that their process of manufacture of this API was different from the originators process. This led to a prolific proliferation of literally thousands of API at 1/100th their international prices in the Indian market.

Reverse Engineering ???

Very often you will find the term reverse engineering associated with Indian pharmaceutical Industry. Everyone from NYT to peer reviewed pharmaceutical journals are guilty of using this term with the Indian Pharma industry. I take severe exception to this statement coz technically it is incorrect on several levels.

1) The process of synthesis of EVERY small molecule is available in peer-reviewed literature and patent filings with regulatory body in significant detail (this is where Article 39.3 of TRIPS-Data Protection comes into play in the new&improved 20 year patents...but more on that later). If you are in a country that enforces product patents you are NOT allowed to manufacture and sell such molecules as your own. But you are very much allowed to benchmark your product in development against an existing product. So if you did manufacture and sell such a product it would be illegal. This does NOT apply to India, coz we have process patents.

2) By implying that Indians are reverse engineering small molecules would give the impression that a bunch of sweaty sambar/avial eating Indians are toiling away in sweat shop conditions trying to physically hammer together a molecule without knowing what they are doing. Sort of like the folks in China who can stitch up a Coach Large Flap SOHO bag and make it look exactly like the original. Errr....don't ask me how I know about Coach Bags...more on that later. Anyway, the last I checked Coach does not publish their material and manufacturing standards in open source publications but you will easily find the same for most small molecules.

3) The sambar/avial eating chemist is ably assisted by an army of pharmacologist, industrial pharmacists, pharmaceutical scientist (dosage form folks) and many many other highly educated individuals trained to somewhat similar standards as their western counterparts and hence do know a LOT MORE about the small molecules they are trying to synthesize than the folks trying to illegally replicate Coach Large Flap SOHO bag (remember knockoffs are illegal in China too).

Most NYT types dont really know or care for the nuances and hence terms like knockoffs or reverse engineered are generously slathered onto the Indian Pharma effort. I am not saying that Indians are holier than thou and DON'T reverse engineer. They do and most of it is in areas of defense technology/spares where getting spares for 60's era Mig-21 or 80's era Mig-29 are either controlled by the Russian Mafia or simply non-existent. And they do a darn good job with it. (note: you are again not likely to find standards and methods of manufacture of titanium valves and plates used in Soviet era fighters in any open source publications...see the difference)

More on the concept of reverse engineering and patents here.

78 Ciprofloxacin manufacturers !!!

Thank to Indian Ingenuity (much more appropriate term than reverse engineering) there was no such thing as a branded drug in India. Several people made Sildenafil Citrate (Viagra) and in 2001 US Anthrax Scare we learned that there were 78 manufacturers of Ciprofloxacin India (including a controlled release version which speaks to Indian Pharma's deep understanding of the science of medicine and dosage form design...so much for reverse engineering). While the drug was under product patent (expired in 2003) and only Bayer could legally sell the drug in the US for $4.67 per 500 mg pill (with a best price for Federal Govt. of $1.83) you could get the same drug for $0.03 from Ranbaxy India.

While what RVP ji is doing does not impact US Cipro Market it does give you an insight on how competitive the market for Ciprofloxacin is in India and how if the Anthrax scare ever came true, folks like Ranbaxy and others could effortlessly supply millions of Cipro tablets in weeks. But now with price control all 78 manufactures will have to take a cut in their profits and that WILL impact how many manufacturers remain.

Ok....I am hungry now...and I am NOT done yet...will wait to see how many folks actually read this blog (appreciate it or find faults with it) and then post more on this issue.