Especially Biopharma

1. Vol. 3, Issue 10 | magazine.pharmatutor.org
PharmaTutor
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
Expert Talk:
Expiry of innovative
biopharmaceuticals
is a major driver of
Indian biosimilar
industry
Dr. Bhaswat Sundar
Chakroborty,
Senior VP & Chair Scientific core
committee
Research & Development,
Cadila Pharmaceuticals Ltd,
Ahmedabad, Gujarat, India
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2. Vol. 3, Issue 10 | magazine.pharmatutor.org
PharmaTutor
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.
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3. Vol. 3, Issue 10 | magazine.pharmatutor.org
PharmaTutor
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 new concepts 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.
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