Pharma contract manufacturing on the rise in India
The past few decades have been very
productive for India, as it took a major leap from pharmaceutical production,
to include contract manufacturing.
According to the president of the Indian Drug
Manufacturers' Association (IDMA), S V Veerramani, the overall pharma contract
manufacturing industry is growing at 20%, providing a burgeoning opportunity
for small and medium enterprises, reports Brand India Pharma. The current market value is
estimated at 50% of the domestic production, which roughly translates to $5.3
billion. Multinationals hold a generous 20%-25% stake in the domestic
pharmaceutical market.
For the basic manufacture of medical products
and drugs, India has a far superior edge over nations such as China, Vietnam
and Ireland, due to resources including manpower, technically knowledgeable
work force, and World Health Organization-Good Manufacturing Practice- approved
production premises. A substantial 40% lower cost of operation and production
is clearly the highlight for multinationals to consider India for their
outsourcing needs.
Waiver
to Phase III studies of certain drugs in India an incentive
With the advent of multinational pharmaceutical
organizations, and their rapidly growing presence in the country, the concept
of contract manufacturing has steadily evolved and quickly adapted, so as to
encompass services such as basic manufacturing of medicinal products,
formulation development, stability studies, and various stages of clinical
trials. In addition, scale-up of drug syntheses, and late clinical trial
studies have also been profitable protocols in this sphere. The Drug Technical
Advisory Board (DTAB) has agreed to grant a waiver to Phase III studies of
certain drugs in India, which are from the regulated markets of the USA and
European Union. This step is an incentive for many pharmaceutical organizations
to focus on India, as the cost savings could be enormous.
Also it is estimated that patented drugs
worth $85 billion in potential annual sales in the USA would be off patent
during the period 2014-2020. Price competitiveness and manufacture of these
generic drugs in the most cost efficient manner would be the key drivers boosting
the prospects of the Indian players as India is known to have the world's best
known low-cost manufacturing centers, with the highest number of US Food and
Drug Administration (USFDA) approved manufacturing plants outside the US.
The government is also looking at
incentivizing the upgradation of Schedule M facilities to WHO GMP complaint
units with the help of soft loans, which would lead to additional 1000 units
being certified WHO-GMP compliant, further corroborating the manufacturing
processes.
MNCs
outsourcing to Indian producers
P V Appaji, director general of Pharmexcil,
India’s Pharmaceutical Export Promotion Council, mentioned that multinational
companies in India have stopped manufacturing some of their products and have
outsourced to Indian manufacturers. Products which are even brand leaders in
its segments are also outsourced to many Indian companies and yet could retain
its market share.
The rising cost of manufacturing and some of
the aging plants of Europe reaching their life cycle conclusion may open up
enormous opportunities to India's companies in contract manufacturing as
European companies are also considering to either relocate those units in cost
efficient centres like India or to outsource to India manufacturers.
Beside, over the last five years or even more
the innovative products introduced do not command vary large market value and
are not blockbusters as they used to be earlier. Research pipelines, though now
getting moderately filled, may have only moderate advantage over the existing
products and hence very few of them may go on to become real blockbusters.
Hence MNCs are now adopting the strategy of marketing the brand even after the
product goes off patent by slashing down their brand's price to the level of
generics.
Therefore, to get the maximum mileage of
their brands, they are looking to outsource their manufacturing to more cost
efficient, centres, like India and yet retain their quality and brand image.
This is a newer opportunity of contract manufacturing opening up.
This trend is on the rise in the domestic
market and India is making an appropriate move by inviting Japan's pharma
industry to locate their units in India either wholly-owned or in joint
partnership with India companies. Japan's companies are considering India's
offer with keen interest. "Our idea is to promote Indian generics in the
international markets. Around 20 Japanese companies have already evinced
interest in leveraging the contract manufacturing benefits from the US Food and
Drug Administration-approved facilities in India," Dr Appaji said.
The contract manufacturing space in India is
expected to gain grounds in the near future and expected to grow by 17%-18% on
a compound annual growth rate basis as efficiency in manufacturing and maturity
of business models would lead to containment of cost of manufacturing to a
great extent.
Source: http://www.thepharmaletter.com/article/pharma-contract-manufacturing-on-the-rise-in-india
Comments
Post a Comment