Pharmaceutical industry
The govt has declared pharmaceutical industry as the thrust sector. That's good news, no doubt. The country has a commendable track record and has achieved almost self sufficiency in pharmaceuticals production. Currently, at 700 million dollar, this industry has attracted huge public and media attention. Over the years, the sector has attracted overseas buyers, mostly in unregulated markets, and it has earned good reputation as a quality drug manufacturer. I am talking about top manufacturers. It is indeed encouraging when we hear about its tremendous export potential in the dailies, talk shows. With recent certifications of top 3-4 pharma facilities by major drug regulatory agencies like UKMHRA, TGA etc, the sector has reached new heights. I am not contradicting the popular notion but would like to draw your attention to some of the ground realities. The country certainly has huge potential in the pharmaceutical sector. But what have we done to realize that potential? Since the DOHA declaration, six years have elapsed. How far have we progressed in terms of infrastructure development or competitiveness? Nothing mentionable. After many years of tiring efforts by the pharma industry association, the govt. has just allocated land for the proposed central API (active pharma ingredient) facility. Isn't it quite a big lapse when the time factor is critical? Again, the industry is yet to have any bioequivalence testing facility which is mandatory for product registration in developed markets, and there is mounting pressure from even semi regulated markets for such compliance. Unless you prove that your medicine is equivalent to the originator brand in terms of safety and efficacy, by conducting bioequivalence testing in human subjects, you cannot make any foray into the regulated markets like US, EU, Australia etc. The cost of doing such test is exceedingly high in developed countries ranging from Tk 70-90 lakh per study; in India it costs around Tk 40 lakh. A central bioequivalence facility in the country can largely benefit the industry by saving foreign currency, at the same time this will significantly improve the quality of our medicines. I know the govt and the industry are currently working on this. Again the same question arises- why is the delay in taking action? Couldn't this be done much earlier? By the time the central API and bioequivalence facilities are ready, there is no clear timeline though, 2016 is knocking at the door -- the waiver period will expire without any real benefit to the industry. Having so many advantages, as many experts say, how is the industry equipped to realize them is a million dollar question. When we have generic drug producers like India and China, we will have to make double the efforts required to enter any export destination. Is India sleeping? India has over 100 US FDA-approved pharma plants, the highest number outside the US; and they are increasingly focused on R&D.
This is pharma industry and India is far ahead of us in terms of know how or scale of operation to be competitive in export markets. Not only manufacturers from Israel, India or China, the ever increasing number of generic players are fiercely competing in the 75 billion dollar generic drug markets. As of now, there is little infrastructure in BD to support this industry to compete even in African countries where Indian companies have already set up plants taking advantage of LDC status of those countries -- particularly for HIV drugs. Here we don't understand the issues of TRIPS well as to what we are allowed to export and how to take maximum benefit before the deadline expires. Nobody could clearly explain where we are now and what would be our competitive advantages in the export market. Say, for example, we can produce any new patented drug without the permission of the patent holder. Fine.. but where will we get the raw material or API for this formulation? India or China are no longer allowed to manufacture the new drugs, and we are mostly dependent on them for our APIs. The only possible way is to produce those APIs in our own country with our own skills. Do we have that? Although we are producing some of the old and conventional APIs like amoxicillin, cipro, ranitidine, paracetamol etc on a commercial scale, we are far from synthesizing the new and patented drugs. So, the question is capability as well as availability.
To build up the capabilities we must start from the university which is the skill development workshop, we must improve our education system with practically-oriented advanced courses having adequate laboratory facilities. There should be more industry-university alliance and collaborative research between universities at home and abroad to promote research activities.
If we cannot have the degree of competence developed back in the university level, we cannot compete in any way- in the long run. This is largely a knowledge based industry- unlike many other industries such as RMG the cheap labour or conventional wisdom is not enough.
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