Indian Drug Firms Under US FDA

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Mohammad Shahbaz Alam

New Delhi: Thanks to American and European Union regulatory authority for taking
Indian pharma companies seriously because issues comes when we expand our
wings and start getting share of global pharma giants. Our quality of medicine is
world class and that is why Indian pharma firms majorly exports and targets to USA,
Russia and EU. India is the first country in the world with approximately 700 USFDA
approved plant.
Out of the eleven warning letters issued so far by the Office of Manufacturing Quality
of the US Food and Drug Administration's (US FDA) this year-2015, six were issued
to India-based drug companies. While some of the units of major Indian drug
companies such as Wockhardt and Sun Pharma have been struggling for a few
years now to comply with the ever-increasing stringent current Good Manufacturing
Practices (cGMP) norms of the US drug regulator, the warning letters issued this
year were for relatively smaller-sized firms. These include Mylan Laboratories'
acquired facility Agila Specialties' units in Bangalore, Hyderabad-based contract
testing laboratory Sipra Labs Limited, Ahmadabad-based active pharmaceutical
ingredients
maker
Mahendra
Chemicals,
Ahmedabad-based
Cadila
Pharmaceuticals, Bangalore-based Micro Labs and Apotex Research Lab's facility in
Bangalore.
In 2014, the Office of Manufacturing Quality had given only five warning letters to
Indian companies out of a total of 19 issued. At the receiving end last year were firms
like Cadila Pharmaceuticals, Marck Biosciences, Sun Pharma, Smruti Organics and
USV Limited. Normally the FDA issues a warning letter after detailed inspections and
giving time to rectify the defects observed in its inspection report. In the case of most
of the Indian firms, the violations are not so serious and are related to lack of proper
data maintenance or issues with manufacturing processes at plant level.
More Indian drug companies were coming under the FDA lens because of the huge
volume of drug production from the country. Presently the market size of the
pharmaceutical industry in India stands at US$ 20 billion and as on March 2014 and
in 2015 it touched to US$ 25 billion. By 2020 Indian pharma companies will be
touching US$ 50 billion in export. CDSCO, FOPE, IDMA,IPHAX and Pharmaxil are
working with Indian pharma firms together to achieve mission 2020.
Data management is an important issue for many drug companies worldwide which
often attracts scrutiny from the regulators. The FDA does not discriminate against
any particular company or a nation", Howard Sklamberg, the US FDA Deputy
Commissioner for Global Regulatory Operations and Policy had told in March, while
reacting to allegations that Indian drug companies were increasingly found guilty of
poor data maintenance and in many cases falsified data.
European and American companies are outsourcing regulatory and
pharmacovigilance services from Indian and doing wonderful business globally.
China is also outsourcing serveces from India. Indian pharma companies on the
other hand rely on in-house team and that is why wastes time, money and ultimately
looses business. Email:-medicarechief@gmail.com