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the indian economy is largely a service-based one and the past few years has only seen that trend intensify with one big exception pharmaceuticals india has the third largest pharmaceutical industry by volume and the 11th largest by value as of 2020 and it is growing extremely fast india is the world's largest provider of generic drugs the united states relies on india for 40 percent of its generics in 2020 they exported 16 billion more of pharmaceuticals than they imported these exports meet the strict standards and regulations of many countries around the world india's pharmaceutical industry is legit the story of how this industry came about is an interesting one in this video we look at how the indian pharmaceutical industry started out as mere copycats but then evolved throughout the value chain to become a global leader but first let me talk about the asian armature newsletter i know everyone has a newsletter now but there's more content in the newsletters that aren't in the videos and those have been quite well received so i think it's worth your while you can find the link to the newsletter in the video description below i try to put one out every week maybe two all right back to the show our story begins in 1947 with india's independence at this time millions of indians had no access to basic drugs the country's drug industry was almost completely controlled by foreigners eight of the top ten firms were multinationals from the west mostly the uk france and germany and they held a 90 percent market share domestic indian companies spend most of their resources marketing and distributing other people's drugs rather than actually creating their own indians had to import almost every drug they took domestic drug prices were amongst the highest in the world since 99 of those drugs were locked up in patents so only the rich had access to any drugs at all obviously the situation cannot hold and the indian government a few times attempted to deal with this over-reliance on foreign drug imports in 1954 the government established a public sector pharmaceutical firm called hindustan antibiotics limited or how a few years later they founded a second one indian drugs and pharmaceuticals limited this time in cooperation with the soviets then in the 1960s the british pharmaceutical company ici pharmaceuticals developed a high blood pressure medication called propanolol it is a beta blocker that helps with anxiety and also prevents migraines the drug was too expensive to be used in india an indian company called sipla began manufacturing a generic version of the drug for the indian market ici complained to the indian government about this syphilis r d head yusuf hamid justified his actions to india's prime minister at the time indira gandhi gandhi saw the merits of the argument and urged parliament to modify the laws governing drug patents this led to the passing of the patent act of 1970 which sparked the revitalization of the indian pharmaceutical industry the patent act of 1970 had two goals the first was to guarantee low-cost access to drugs the second was to foster the development of an indigenous indian pharmaceutical industry and encourage import substitution india's prior patent laws last updated in 1872 were rooted in british ip law specifically they protected products for instance the aforementioned chemical compound this was the farmer industry's favored ip protection regime the 1970 act replaced this with a new system that protected the process rather than the product in other words if the old laws protected the treasure then the new ones protected only the treasure map that leads to it in addition the act set time limits on those process patents about five to seven years after filing rather than the 15 years afforded by the old law furthermore if the indian patent office determined that the patents were not being used in a socially beneficial way the office had the leeway to force patent holders to license those patents to others at a reasonable rate you can see how this new system opened up massive new opportunities for the indian pharmaceutical industry it was now possible to backwards engineer every popular drug import for the indian market let's stop here for a little bit so that we can briefly review the pharmaceutical production value chain there are four major activities discovery clinical trials production and marketing slash distribution discovery refers to the process of finding new drugs as with everything relating to the human body it is a messy complicated process first scientists generate potential molecules sometimes referred to as leads and then test the efficacy of those leads in petri dishes these are referred to as in vitro tests if the petri dish tests show promise then you move to live animal tests in vivo tests these tests can take years to administer and only a very small percentage of them make it through to the next stage after discovery we have the clinical trial stage clinical trials for humans have considerably tighter standards procedures and oversight thus they are extremely expensive to hold and multinationals choose them carefully even with all their efforts failures happen my favorite failure is that of the super hyped startup stem centrics a cancer drug startup that had been backed by peter thiel's founders fund in 2016 they sold to app va for 5.8 billion dollars with additional cash out options as high as 4 billion more but the company's cancer stem cell drugs failed to distinguish themselves in clinical trials at va had to take a 5 billion write-off stem centrics was closed down and its employees laid off founders fund made a 1.4 billion dollar profit on their investment though so that's nice after the clinical trial approval by the relevant regulating authority the drug company has to produce its new drug there are two types of production bulk drug manufacturing where you produce the actual active compounds at an industrial scale and formulation manufacturing where you package those active ingredients into pills tablets capsules liquid injectables and so on bulk drug manufacturing is more technically sophisticated than the formulation but this part of the value chain is in general less valuable than the rest scale and cost control are essential here which make it harder for small companies to compete the final part of the industry is marketing and distribution large pharmaceutical companies employ large sales forces to build relationships with doctors and their patients the goal of course is to sell a lot of prescriptions and earn back a good return on what was spent on the other three stages managers and scientists working in india's public sector laboratories recognized a sudden weakness in the patent law and left to take advantage of it the number of firms in india's pharmaceutical industry more than doubled from 1970 to 1980. at this early stage domestic indian companies did little more than reverse engineer existing drugs they studied the sequential steps towards making the drug and made slight modifications here's what that roughly means let's say we have a drug made up of three ingredients a a combo of b and d and c cooked together at temperature x and pressure y to reverse engineer the molecule a company might take a plus b plus e cooked together at temperature x and pressure y this is a new process except in this case e is actually a combo of c and d same ingredients different steps new patent as a former planning director from that area once said earlier there was no r d has such it was simply reverse engineering whatever the patent said you would reproduce and optimize it this sounds cheap and derivative but it helped domestic companies gain real competency in pharmaceuticals by the end of the 1980s indian pharmaceutical companies could manufacture practically any new molecule without needing any access to the original innovator company's recipes the time gap between the original innovations introduction and the indian generics introduction steadily narrowed over the years and this demonstrated domestic firms steadily improving reverse engineering capabilities for instance ibuprofen ibuprofen hit the world market in 1967. india's first generic came six years later in 1973. in 1986 bayer introduced the antibiotic ciprofloxacin to the world market i remember cipro because back in 2001 tens of thousands of people took it for no reason other than because they were worried about anthrax reminds me of the horse drug fiasco anyway indian domestic firms had a generic version of ciprofloxacin in just three years cutting the time lag in half for some other molecules the gap was even shorter by 2006 indian companies supplied a 95 of the country's drugs the import substitution had been a success however as with any policy the 1970 patent change had its drawbacks for one thing the indian pharmaceutical industry it created was high in volume but low in value a drug firm has low barriers to entry with little capital needed to start one by 1990 there were around 16 000 pharmaceutical companies in the industry the companies that survived focused on making as many molecules as they could as cheaply as possible this resulted in extremely low margins and vast over capacity because the only way to make a profit would be to produce at massive scale the industry got extremely fragmented with up to 100 brands for a single molecule the industry had grown to have too many small players and too little profit for all of them without resources incentive or protections for it the domestic indian pharmaceutical industry did not invest meaningful amounts of r d and did not produce many new drugs some companies turned to the export market by the 1990s some 40 percent of indian drug production was for export this might seem like a success but again most of these were of low value indian companies were locked out of more valuable markets in 1992 india signed the agreement on trade related aspects of intellectual property rights or trips this would be a major milestone in the history of the indian pharmaceutical industry and a good one when it comes to fostering indigenous innovation it required the indian government to amend its prior patent policies to more conform to international trade standards the government will now among other things recognize product patents and grant exclusive marketing rights to new products signing this agreement had been extremely controversial the domestic industry split into two camps one favoring more stringent i.p protections and the other opposing it the opposition camp made some compelling points for instance the lack of knowledge transfers and that strong i.p rights had not done good for the indian people in the past in the end though the first group won out encouraged by a stay in the regulations the international trade community gave india until 2005 to first prepare its drug industry the government thus started gradually implementing the necessary changes for instance the exclusive marketing rights amendment to the 1970 patent law enacted in 1999. from 1992 to 2005 the industry underwent a monumental shift leaving behind what had made it so successful for decades towards a new more profitable model the indian industry adapted to these encroaching changes in different ways a few firms decided to invest in r d climb the value chain and enter the drug discovery business for instance ranbaxy drl and walkhart their announcements garnered a lot of attention with some promise from 1956 to 1987 the indian pharmaceutical industry discovered and developed just 13 new drug compounds from 1991 to 2005 that number was seven prior to 1992 the industry grew its r d spent by just 4.9 percent annually after 1992 that accelerated to 6.6 percent a number of indian firms started putting molecules into the drug discovery pipeline pharmaceutical drug patents in india by indian institutions grew from just nine from the 1990 to 1994 period to 48 in the 1995-1998 period that number further expanded to 227 in the years after from 1999 to 2002. the government encourages r d spend with a number of schemes in 1995 they founded various government bodies to coordinate the academic and commercial areas they also created a pharmaceutical r d support fund that disbursed money but going the drug discovery path though hyped was rare most indian pharmaceutical firms correctly considered it out of their grasp especially before 2005. drug discovery is an expensive and time-consuming process multinationals in the west have been doing it for decades and it still is hard for them it would be unrealistic to expect many indian companies most of them small or medium sized to match up to this right away few can afford it even by 2005 smaller firms spent one percent or less of their revenue on r d so many of them have looked to other ways to strengthen or diversify their revenues some companies started r d into drug adjacent fields like drug delivery less technical than drug discovery but still very difficult others expanded and strengthened other parts of the value chain for instance marketing and production other companies struck strategic collaboration deals with multinationals for instance zeitus cadilla did such deals with companies in france cuba switzerland and the united states throughout the 1990s into today biocon a biopharmaceutical company based in bangalore did the same deals have been signed with big companies like novartis their joint venture with the cuban center of molecular immunology helped them gain the competency and knowledge to develop the first new monoclonal antibody treatment by an indian pharmaceutical yet others decided that they needed to scale up to match the size of the western multinationals this means mergers and acquisitions with other companies operating in other parts of the value chain different paths towards the same goal surviving a new more challenging business environment india's pharmaceutical companies have long signaled a shift towards the export market but trips really helped push that along once the industry met its ip regulation responsibilities the global market opened up to them today india's generics industry is very internationally competitive helped along by its lower costs as well as the expertise honed from competing in the brutal domestic market a favorable generic drug regulatory environment helped too with the u.s passing the hatch waxman act in 1984 which allowed the fda to more easily approve generic drugs dr reddy's laboratories grew the export ratio of their overall revenue from 53 in the 2000-2005 time frame to 74 in the 2012 2017 time frame markson's pharma went from 21.2 percent back in the 2000 2005 period to 97.5 in the 2012-2017 period the whole industry grew its export intensity an average rate of about 13 percent in the years after the 2005 implementation of trips it is nearly eight times the size since then with sales to north america africa and asia alike one concerning issue to be had with this export success is the indian pharmaceutical industry's concurrent dependence on china for its active ingredients these are the most important raw materials for the making of the finished drug for instance tylenol's active ingredient is acetaminophen india relies on china for 70 percent of its active pharmaceutical ingredients imports of chinese active pharmaceutical ingredients antibiotics in particular have tripled since 2005. india used to make these domestically but lost the market in the 1990s with the chinese entered with products 40 percent cheaper than what indians can make even today with chinese labor costs higher than what they were back then the price gap remains about 20 percent in 2020 this industrial weakness became especially pronounced when china locked down chinese vendors ran out of stock to send to india and restricted the export of certain ingredients for making virus medicines furthermore geopolitical tensions between china and india are a real thing so the indian industry should work in tandem with the government to close these shortcomings with new import substitution policies for these active ingredients india's pharmaceutical success has not gone unnoticed other countries saw how the indian patent act of 1970 helped lower drug costs and break the hold the multinationals had on the domestic market so ironically about the same time the indians were moving away from process-based patents other countries started moving towards them the indian pharmaceutical industry would not be where it is today without the removal and re-application of these ip rights it is a perfect example of market driven reform sparked by a change in the environment i also admire that they made these changes based on the notion of what was right for them at the time rather than sticking to an ideology that wasn't working for them as deng xiaoping popularized they crossed the river by touching the stones while there remain a few concerns going forward india's pharmaceutical industry has a huge role to play in helping to address the world's health issues in the future all right everyone that's it for tonight thanks for watching subscribe to the channel sign up for the newsletter and i'll see you guys next time