Shortage of inspectors will hit fortunes of India's pharma companies, says Assocham sectoral study
India has a meagre 1,500 well equipped
inspectors for more than 10,000 factories engaged in pharmaceutical products leading
to country's products facing regulatory hurdles in the overseas markets like
the US which follow stringent protocols for the manufacturing processes, a
sectoral study done by ASSOCHAM and research firm RNCOS has pointed.
It
said Indian pharmaceutical sector which made rapid strides in the global
markets, is now faced with several regulatory hurdles, especially in the US and
EU, according to a study on 'Focus on Quality
Management in Pharmaceutical Manufacturing,' jointly conducted
by ASSOCHAM and RNCOS.
"While at times, the US Food and Drug
Administration (FDA) gets into minute details which have more to do with
cumbersome procedure rather than quality, we need to get our own house in order
by way of continuous skilling of
regulators at national and state levels in sync with the best global practices.
However much we may wish otherwise, pharma sector is and will always remain one
of the most regulated sectors all across the world for the sake of public
health," ASSOCHAM secretary general D S Rawat said releasing the study.
The mismatch between domestic regulatory
mechanism and the international regime is resulting in recall and rejection of
drugs made by even some of the well known companies, leading to unrest and frustration.
In the long run, the pharmaceutical exports during the fiscal year 2013-14
reported US$ 14.8 billion of drug exports would take a setback.
According to the study, India ranks 4th in
pharmaceutical production in the world with a production output of about US$ 31
billion in 2014. The country has a 1.4% share by value and 10% by volume in the
global pharma industry. India is one of the leaders in pharmaceutical exports.
The domestic pharma market was valued at US$
15.4 Billion in 2014, and is expected to expand at a CAGR of 13.3% to US$ 32.7
Billion by 2020. Driven by favourable demographics including growing aging
population, increasing lifestyle diseases, steep growth in disposable incomes
and increasing penetration of Indian drug players in the global market, India
is likely to be among the top three pharmaceutical markets by incremental
growth and sixth largest market globally in absolute size, noted study.
The pharmaceutical manufacturing is managed by multiple regulatory
authorities, which include the central regulatory agency, the office of Drugs
Controller General of India under Central Drugs Standard Control Organization
with zonal offices and the State FDAs. This makes the process of obtaining
license, for pharmaceutical product manufacturing complex.
There are numerous patent offices in metro
cities all over India. Each of these offices follows non-uniform patent
practices. Thus, these varied practices and poor centralized controls affect
the quality of the pharmaceutical products. The pharmaceutical industry in
India has a concurrent regulatory practice, which is sometimes poorly manned
and poorly headed by less knowledgeable pharmacists who are not properly
trained.
Lower awareness among such personnel
regarding the quality norms leads to non-uniform implementation of regulatory
standards. Small and Medium size manufacturers in the Indian pharmaceutical
industry do not have the funds and the capacity to carry out the quality checks
The government provides subsidies to only those pharmaceutical companies, which
are present in special economic zones. Manufacturers which are not present in
these zones are not able to avail these benefits, which they can use for the
implementation of quality standards in their manufacturing sites.
With the absence of global harmonization of
quality systems makes it all the more challenging for India that exports to US,
Europe, Australia, Japan, to comply with a plethora of regulatory guidelines
across the globe, Rawat.
Comments
Post a Comment