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.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.
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
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.
