Indian pharma must step up r&d, compliance focus for global play

1. Indian Pharma Must Step Up R&D,
Compliance Focus for Global Play
Cos' profitability to come under pressure from higher
cost of compliance, developing new products
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2. Contd..
What takes one from A to B doesn't necessarily help in moving from B to C.
That's the situation with the Indian pharma industry as it grows to tap the
opportunities in the global healthcare market. The industry has reaped the
low-hanging fruits of low-cost generics, making Indian pharma companies
one of the most profitable ones globally. But, the future is likely to be tough
with profitability coming under pressure.
The cost of compliance is slated to increase in the years ahead. US FDA and
other drug regulators, especially from developed markets, have stepped up
scrutiny and are penalising companies not complying with their good
manufacturing practices. Companies have little option but to increase
compliance especially to avoid severe punitive actions like import bans and
revocation of drug approvals.
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3. Contd..
Given the regulatory clamps faced by Indian pharma companies from foreign drug
regulators, the Indian drug regulator is considering bridging the gap between the
compliance standards of India and those recommended by World Health
Organization. This means increased cost on compliance at home as well as in
offshore markets.
To remain competitive and relevant in the global drug industry, Indian firms will
have to increase investment towards research and development from the current
average of 6-7% of their revenues. The cost of filing new drug appli cations with the
US FDA has already increased since the Generic Drug User Fee Act was enforced in
the US.
The firms also have to contend with growing pricing pressures in domestic and
overseas markets. Globally, there is a tendency among governments to pull down
healthcare cost. Thus, price control pressures are likely to prevail or even intensify
in some markets.
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4. Contd..
Consolidation is rampant in the global pharma landscape with Indian
companies also buying assets to scale up inorganically . But, valuations
are not cheap for healthy assets, and distressed assets come with
regulatory issues.
To cut dependency on a single market, companies are diversifying
geographic footprint. This increases their risk profile as they are subject
to the vagaries of the different markets they enter. For instance,
companies faced pricing pressure in Germany and currency volatility
was a problem in Russia and CIS countries.
The overall risk profile of the pharma sector has changed in the recent
years.Make no mistake. It's no longer a classic defensive sector.
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