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Expiry of innovative biopharmaceuticals is a major driver of Indian biosimilar industry : Dr. Bhaswat Sundar Chakroborty (Interview)


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What is your opinion about pharmacy education in India?
In general, the theoretical part of pharmacy education in India is very good. That is the undergraduate and graduate program contents and learning objectives are comparable with world standards. However, the practical part –the laboratories, term papers, projects etc. varies so much from institution to institution that graduates from some institutions have a poor idea of this practical aspects. Some institutes like NIPER are definitely very balanced in offering both theoretical and practical aspects, but they cater to only graduate students. There is plenty of room for improvement on the undergraduate students’ needs.  There is another difference from world standard though. That is the difference in clinical orientation of pharmacy curriculum. In India especially the undergraduate programs are heavily inclined towards industrial orientation and in the west for e.g. in USA and Canada, the current programs are patient-centric and often clinically and community oriented. Overall, I must say that Indian pharmacy curriculum as given by the top 100 schools of pharmacy are functional and meeting the current needs of Indian employers.   

Do you feel that presently educational institutes are able to cater the need of Industry?
As I stated in the answer of your previous question, yes, by and large educational institutes are being able to develop and supply the entry level candidates for various disciplines. However, the success is coming only with some additional modules of training from the industry once they enter. There is still some gap towards between the education and the industry needs which is being addressed by the policy makers, teachers and industry leaders. In India, community and hospital pharmacy needs are badly underplayed for one reason or the other. Thus, numbers of modules in undergraduate curriculum for these sectors are yet to develop to their full potential. These sectors are also part of real life pharmacy industry. In fact, the community and hospital pharmacy constitute the major part of pharmacy industry in the developed economies in the west. If you talk about pharmaceutical manufacturing and R&D of generic medicinal products, yes, Indian educational institutes are successful to a great extent. 

What is scope of clinical research in India? Do you feel any substantial changes are required for effective regulations of Clinical research in India? Few suggestive opinions.
India can potentially carry out up to 20% of global clinical trials. But the reality is only less than 1.5% of global trials are currently being conducted in India despite a rich and diverse patient population and qualified investigators in the country. One of the major reasons for this underperformance is the slow rates of allowing the conduct of even low to medium risk clinical trials, let alone the high risks one. This slow-down of regulatory approvals has hurt us in two ways. First, the outsourced clinical trials from abroad have stopped coming into India and second, big Indian companies which need to do trials with very demanding timelines are looking elsewhere to carry out their projects.

Price control norms are definitely another factor but overall regulatory indecisions to allow trial conducts is probably the major factor. There is no denial that the slowdown was a result of the Supreme Court’s directives (to correct the uncalled for deaths and SAEs in clinical trials) and assessment of trial risks in India by international authorities. Somewhere the regulatory authority in India became too strict and too hesitant to grant trial licences and product approvals in general. This has hurt the Indian clinical trial and CRO industry very badly for the last 3-4 years.  The Subject Expert Committees, The Technical Committee and Apex Committee constituted by the Union Health Ministry have started according approvals to global clinical trials and other proposals. One noteworthy development is the appreciable growth of pharmacovigilance (PV) sector mediated through PV program of India in collaboration with global ADR monitoring Centre (WHO UMC) Sweden.

My suggestions for remedy of the regulatory hurdle would be twofold. First of all we need to understand that there are many trials which are of low risk for e.g. bioequivalence trials and limited clinical trials for high therapeutic index drugs.  As an ex-regulator from a developed country, I can assure you that such trial licences need not wait for several months. They can even be granted by the local FDA or only an Ethics Committee positive review would be good enough. As regards to higher risk trial and special product categories, a properly trained review team with a world class review system can bring back a healthy speed to regulatory approvals. Secondly, DPCO and other price control policies should not discourage the investors to invest in the first place. Every country has some kind of policy regarding pharmaceuticals pricing but they do not drive down the prices which can de-incentivize the investors and researchers. Pharma companies should be allowed to make legitimate profits so that it can be ploughed back in R & D. At present leading Indian companies invest from 4 to 8 percent of their turnover in R & D and this is required to be increased in view of the forthcoming challenges & opportunities.

How Indian regulatory agency is differing from Canadian system?
The Canadian system of therapeutic products regulation is significantly different from the current Indian system. The main differences are in three areas: a) the proportion of new chemical or biological entities reviewed; b) performance standards of review times taken for allowing a clinical or bioequivalence trial or approving a marketing authorization; and c) the written review system of first review, second review and final reviews for marketing authorizations (NDA, ANDA, DMF etc.).
In the first category, needless to say that Canada receives way more applications for approval of new chemical or biological entities as prescription drugs. Thus, the involvement of the Canadian authorities in discovery, development and approval of innovations is much higher than their Indian counterparts. Indian authorities still deal with more than 95% generic products, risks of which have already been estimated elsewhere, especially in developed economies. The second aspect of review timelines differ significantly between these two countries. As I answered to your previous question, trials like bioequivalence (BE) studies of wide therapeutic index drugs need not even be cleared by CDSCO as the risk is very low and no developed countries requires this. In India, NOC for a BE studies may take from 6-8 months! Finally, a review system of any drug application system in Canada is a written, transparent, scientific document where the entire basis of approval has been documented point by point with data summary and justifications. This is yet to happen in India.

Do you feel personally Indian Pharmaceutical Industries will able to lead in world in area of NCE research?
India surely has the potential. The reason I say so is that the performance and brilliance of ideas of Indian scientists abroad are well demonstrated and established. So, given the right resources and regulatory environment why shouldn’t they be able to create the same magic in India?  However, the time has not come yet. The main reason may be the huge cause of drug discovery of NCE discovery and development. Indian companies are yet not that rich to bear these expenses from end to end – from discovery to approval. 

What are key new development of Cadila Pharmaceuticals in coming years?
Cadila Pharmaceuticals have already put their footmarks in discovering and developing Mycidac-C (s novel anti-cancer) and Polycap (a novel multidrug therapy for prevention of cardiovascular disorders) along with a few others significant innovations. Currently, Cadila is also collaborating with several overseas partners in the area of cancer, anti-biotic resistance and vaccines to name a few. These are both knowledge and cost intensive projects which are going well and the results will be announced publicly in due course in the coming years.

Your view on potential trends of development for Indian Companies.
I strongly recommend that Indian companies not be content with championing the generic market alone.  India is uniquely positioned among the BRICS countries in that along with pharmaceutical R&D capability, it has awesome IT industry. Even devices can be discovered and developed here in a very cost effective way.  With the tightening of IPR and exclusivity laws, India is being forced to look deeper into R&D. Then why not look very hard into the innovation space for small molecules and biologicals? If we still think we have to go the generic way, then the first market entry in the developed markets would be the desirable path.  But let us realize that barring some notable exceptions, the generic product will not bring a billion dollar sales (blockbusters).  

What are key attributes as per your opinions is very necessary for career path for new students or freshers?
Pharmaceutical R&D scientists in India are mostly concentrated in private sector pharma business companies and some academic institutions. Majority of freshers get a job orientation following their graduation from academia and only after joining their employment. However, they can work hard and learn well to earn their undergraduate and post graduate degrees.  They can increase the value of their skills so it can benefit them and their employers by further education and training in laboratories with intellectually stimulating environments. Then they can develop an interest in technology management as well as newconcepts such as disruptive technology and open innovation.  You see, the main challenge is to be a part of large multidisciplinary drug discovery & development teams. A suitable mentor can hold the hands of a fresh graduate during these bewildering times. The freshers need both curricular qualifications as well as interpersonal and team playing skills.

How do you feel future of Indian Pharmaceutical sector for coming 10 years?
India is already the third major Pharmaceuticals player in the world after US and China. However, India is still lagging behind in earning the value (14th in global position) which is commensurate with this productivity. So, the Indian pharmaceutical sector is trying hard to increase their value not only as an export player but also in the domestic market. Then comes the recently acquired R&D abilities in NCEs and Biologics. India is showing all the signs of progress in the right direction. The next 10 years probably usher the most golden times in expanding Indian pharmaceutical business.  

How do you feel Biosimilars development for Indian pharmaceutical industries? Any specific strategy to be planned.
Pharmaceutical and health biotechnology are one of India’s fastest growing sectors. Biopharmaceuticals account for 64% of the Indian biotech industry which is valued at more than four billion US dollar.  This sector (consisting of biosimilars, vaccines, therapeutics, diagnostics, regenerative medicines and medical technology) is growing at about 20-25% rate per annum.
The upcoming expiry of dozens of innovative biopharmaceuticals is a major driver of Indian biosimilar industry. Many companies are planning to diversify into biosimilars and get into joint ventures for mfg etc. Indian biotech should offer all areas of strength especially in collaborative efforts as it is already matured in the areas of discovery, research and development, support activities, marketing, and lobbying are other opportunities. Thus Indian biosimilars as well as the larger biotech industry can enjoy a huge humanitarian value as well as a huge financial return of investment.

- Dr. Bhaswat Sundar Chakroborty