It has been the dream of Indian Pharma to establish itself in the United
States. In many cases, this craving is even for the ‘halo effect’ the
US FDA approval may have. While these augur well, it is essential to
understand the manner in which Indian Pharma is perceived in developed
countries, especially the US.
US pharma market
"Growth
in US sales of pharmaceuticals bounced back last year as rebates and
low-cost generic drugs drove an increase in the number of prescriptions
filled, according to data tracking firm IMS Health. US drug sales
"climbed 5.1 per cent to $300.3 billion in 2009 after two prior years of
slower growth".
Pharma faces a number of key challenges to
growth including the impending 2011 patent cliff which is set to erode
$78 billion in global branded sales from drugs facing patent expiry over
the 2010 - 2014 period (in addition to $32 billion from continued
erosion of already expired brands). Price cuts, reimbursement
restrictions and growing regulatory pressure are further set to limit
sales growth going forward. Source: Pharmaceutical Key Trends 2010 -
FierceBiotech.
To maintain profitability in the current
environment, pharma companies have implemented a number of cost-cutting
measures (in addition to strategic repositioning and diversification
strategies) to boost profitability going forward. One of them is
‘outsourcing’ in order to move lower their cost base. The following
facts prove this strategy (source: ABC news):
? 44,200 U.S.
manufacturing facilities have closed down since 2001 across all
industries. Despite being the ‘most TV viewing’ in the world, not a
single TV is assembled in USA.
? US Pharma reduced more than quarter million jobs in the past three years.
? Maximum ANDA filings from Indian companies in the recent years.
Opportunities
The
usage and consequent increase in sales accompanied by closing of more
and more manufacturing facilities/downsizing by pharma majors, cost
reduction measures forced by large chunks of drugs coming out of patent
and thereby erosion of margins has made pharma industry pursue
outsourcing.
When one thinks of outsourcing drugs, especially
the finished dosage forms at reduced costs, India definitely comes to
their minds. A parallel consideration that surfaces is the notion of
‘data Integrity’. Unfortunately, the positives Indian pharma deserves
such as- excellent plants, outstanding chemists, second largest pool of
scientists, flexibility and fast reaction time, etc do not readily come
to the American sourcing manager’s mind when he/she thinks of
outsourcing from India. These thoughts are overshadowed by the opinion
of ‘low cost’ and ‘potential Data Integrity’ problems.
Perception
According
to New York times, "India's drug industry -- on track to grow about 13
per cent this year, to just over $24 billion -- was once notorious for
making cheap knockoffs of western medicines," but is "now starting to
take on a more mainstream role." Still, the expansion "has been shadowed
by quality problems" and "dozens of intellectual property suits are
still being fought" even though the country "toughened its patent laws
in 2005". Thus, "some drug executives in the United States say that
their Indian peers may be too optimistic about their industry's
prospects." Notably, the FDA, "in response to India's growing influence,
has opened two offices in" the "country -- in Delhi in early 2009 and
another in Mumbai in June of last year. In a recently held FDA sponsored
seminar conducted at Athens, Speakers presented the following about
Indian Pharma:
Focus on inspections in India
? Application integrity (records, manufacturing systems, laboratory test results)
? Manufacturing process robustness and validation
? Impurities in API and inactive ingredients
? Stability studies and investigations of Out Of Specification incidents
? Ensure that supply chains are secure
Challenges of data integrity
? Committing to unrealistic specifications
? Lack of manufacturing capacity
? Unhealthy market competition
? Poor record keeping practices
? Deliberate manipulation of documents and data
Committing to unrealistic specifications
? Applications/DMFs with unrealistic commitments
?
In the old paradigm ,firms obliged regulators by agreeing to their
demands to continually tighten specifications based on meagre data
submitted from limited manufacturing experience
? Such unrealistic commitments could also be due to unhealthy competition in the industry
? And a limited knowledge of US regulations and FDA’s expectations
Inadequate development work
? Reaction parameters often too wide and not supported by development work
? Either extreme of an executed range of parameters is often selected as optimal condition
? Gaps in knowledge management in progressing from one stage to another
? Lack of formalized structure for process development
Inadequate batch records
? Wide process parameters are given to the operator without proper guidance
? Important process details are not stated in the BPRs but left in related SOPs
?
Results from confirmatory in-process QC tests upon which process
decisions are based are not shown in BPRs or not readily accessible
Supply chain
?
Price pressures may prompt a few firms to substitute inexpensive
excipients, raw/starting materials, intermediates and APIs from
unapproved or unqualified sources
? FDA has a draft guidance about supply chain management
? The agency is willing to work with any companies or individuals with credible information to mitigate this risk
The discussions hinged on the following recommendations for Indian Pharma
? Data Integrity practices
? Investigations
? Reporting incidents/deviations
? Proper OOS investigations
? GLP
? Vendor qualification procedures
? Annual vendor performance evaluation and re-qualification
? Vendor disqualification criteria
? Employee training
There
could be many people in India who oppose this perception. If this has
hit you, welcome to the club! It is this original feeling of defiance
and despair that sparked this write up and created a mission. I would
have been amongst the first to argue against this perception. However
after experiencing the working in the US Pharma, the intensity of the
argument could reduce. Working in the US Pharma has brought about
changes in the perception.
Again, we can go on arguing, but it
is smarter to work towards the requirements. Believe me, there is a
stark difference in certain aspects. This does not mean that there is
something wrong with Indian Pharma, however some perceptions of issues
are definitely different. This could be due to various factors like
socio economic situation, the environment, the patent environment in the
past, the local statutes etc, It is the subtle changes in this
perception which could make the difference and be perceived wrongly.
Overall,
India is emerging to be a power to be reckoned with and it is predicted
that it would be the super power in 50’s from the economic point of
view. It is every Indian pharmacist’s dream to see that India takes
giant strides in the pharmaceutical field also similar to the leadership
role already established by the IT industry.
However the
perceptions of Indian Pharma at present do not point towards this dream
in the near future. This is despite the strong resilience, versatility,
skill, technology and potential the Indian pharma companies have
including the significant development during the last four decades. The
expectations in the developed countries are very high. It must also be
realized that, these high expectations cannot be achieved along with
‘low cost’. Some Indian pharma companies have definitely made a mark in
the US market, at the same point, many are struggling. This is the
reason for the present perception.
It is imperative that we need
to Understand the perceptions, Identify the differences, Analyse the
reasons for the differences and then chart out Strategy to overcome the
present perceptions and then build on the good foundation. This boils
down to USA and I. This is self explanatory.
This is not beyond
the architects of future India; however such achievement requires
determination, will power and hard work. Half hearted attempts and
juggling between the restrictions imposed by price control and speed on
one hand and aiming for high regulatory compliance on the other is not
achievable.
We need to find the ‘sweet spot’ of quality and appropriate cost.
Being
a patriot and a pharmacist who desires that India is one amongst the
elite nations for pharmaceuticals, I am confident that these dreams can
be achieved.
ARE WE WILLING, IF YES LET US DECIDE TO GET STARTED
ON THIS MISSION by grooming of the new generation to shape the future
of Indian Pharma.
(Author has decades of experience in India and is presently working in USA)