|
Experts see need for India to align with global good practices to reinvogorate capability in pharma manufacture
|
|
Nandita Vijay, Bengaluru
May 27 , 2019
|
|
|
India needs to align with global good practices to reinvogorate its
capability in pharmaceutical manufacture. The regulatory authority in
the country came up with several new regulations enabling the industry
to be able to produce the required high quality drugs for exports.
Pharma companies too are increasingly looking to align with the best
practices in the world. Moreover, Indian drug manufacturers have
motivated countries in emerging markets of Asia, Africa and Latin
America to build capability and capacity, stated experts.
At the
day-long event organised by Pharmexcil to deliberate and discuss on the
'Recent advancements in the regulatory landscape of the emerging
markets', Raghuveer Kini, executive director, Pharmexcil said that the
Indian pharma garnered revenues to the tune of US$ 19.3 billion from
exports in the year 2018-19. The Pharmexcil has been providing the much
needed support along with the Union government’s slew of financial
assistance for companies to initiate their export forays. With the
barcodes made mandatory, medicines manufactured in India for the world
will now have a mark of quality and affordability in the stringent
global market.
India needs to have a standard for approval for
exports across emerging markets. The Indian Pharmacopeia should be an
accepted benchmark for drug clearances across the emerging markets. This
will do away from the separate set of data to be submitted for domestic
and international markets that is currently in practice, said Sunil
Attavar, president, Karnataka Drugs and the Pharmaceutical Manufacturers
Association.
According to Amaresh Tumbagi, Karnataka drugs
controller, e-governance is the only way forward to speed up approval
process for drugs and registration in other countries.
Arun
Mishra, executive vice president, regulatory affairs, Indian Sub
Continent, GSK, in his presentation on ‘Living Quality- Measuring Pulse:
Focus on Behaviour and Culture' pointed out that India has made a mark
in the global markets and there are many countries looking at making it
big. For example last month, Bangladesh’s pre- accession of application
was received by the PIC/S Committee. Similarly, China which dominates in
API manufacture has already made considerable in-roads into
formulations development. Now India needs to be mindful of the fact
there is competition brewing for it.
Our industry has inspired
many countries in Asia, Africa and Latin America to get into this
business by building both capability and capacity. In terms of the
former, our scientific strength, skills sets and technical expertise is
not seen anywhere in the world. Similarly in terms of production plants,
India is home to the large base of globally approved units. Now taking a
cue from Indian talent in pharma, many countries are changing their
curriculum. So we should be heedful that our academic programmes are
globally relevant.
Stating that there was a paradigm shift in
healthcare on understanding the disease and prescribing targeted
therapy, Mishra said that India too need to realise that there is
decentralisation of information and decision making is changing. Even in
drug manufacturing, quality and increasing number of regulations coming
in called for Indian pharma to continuously ensure enhancing its
standards, transparency and accountability.
In the wake of the
recent advancements on the regulatory landscape of the emerging markets,
the experts noted that Indian pharma needs to be cognisant about the
different regional drug guidelines implementation processes across
various global locations.
|
|
|
|
|
|
|
|
TOPICS
|
That foods might provide therapeutic benefits is clearly not a new concept. ...
|
|
|
|
|