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INDIA IS DEFEATING CHINA IN AMERICAN

MARKET
Mohammad Shahbaz Alam
From New Delhi, medicarechief@gmail.com
China leads in bulk drugs by a wide margin, while India is ahead in production and export of
generic drugs, especially to regulated markets. India has some 700 US FDA approved facilities,
while China has about 600 such US FDA approved plants. However, India got approvals for
more than 300 drug master files (DMFs) accounting for nearly a third in the US market, whereas
China lagged with around 150 DMFs approved, according to an Edelweiss report of November
2014.
US FDA approved list counts 2,515 Finished Dosage Form Facilities (FDF) and API Facilities.
Among them, 921 companies produce APIs only and 927 facilities produce APIs as well as FDF
(some including Analytical Testing). 667 Facilities manufacture Finished Dosage Forms only.
The list clearly shows that about 70 % of the APIs and FDFs are produced outside of the US. The
largest producers outside of the US are India followed by China, Italy, Germany and Canada.
India already counts for 23.7% of the API and FDF facilities listed and is by far the largest
country exporting to the US. Even China counts for less than a half of the FDF and API facilities
exporting to the US, compared to India.
A long spell of sluggish approvals for generic drugs in the US may be nearing an end with early
signs of a rebound. A backlog of as many as 4,000 pending applications at the US Food and Drug
Administration (USFDA), of which a fourth is estimated to have been filed by Indian firms, is
awaiting clearance. Fortunes of generic drug makers to a great extent hinges on their approval
timelines. Experts say going by the current run rate, the FDA may clear at least 470-500 such
products this year, a sharp uptick from 409 approvals in 2014.
The biggest barriers of lagging behind of China by India in registering pharmaceutical product
across the globe is Chinese official language. A reliable source from Tanzania reason out why
Chinese companies are not registering product frequently in comparison to china is only about
incompetency in dossier compilation and translation from Chinese to English. He said that one of
the biggest government pharma company from china is eager to outsource dossier compilation
services and translation work directly from China. Chinese, Russian and African companies are
already signed contract with Meher Pharma International for regulatory services, said Anita
Shahbaz-Director International Legal Affairs.
Interestingly, Chinese drug firms have begun luring senior scientists from Indian companies with
strengths in documentation and English language to gain competence in the formulations
segment. This trend is picking up at a time when India is trying to cut down its dependence on
the Chinese supplies for bulk drugs or raw materials that go into making medicines. The
poaching from across the border could threaten the Indian drug makers and further heat up
competition between the two Asian economies.
Chinese companies of late are increasingly hiring the cream of Indian pharmaceutical scientists
with strengths in formulations, some of whom are currently working with Indian pharmaceutical
companies with operations in China. At least, 50-60 Indian pharmaceutical professionals were
recruited by the Chinese firms in the management cadre over the past two years."Chinese
pharmaceutical companies are offering tempting pay packages, nearly 2.5-3 times more than
what the Indian firms are paying, to attract Indian scientists to Chinese firms, said Ashraf Ali,
Director of Moraf Pharma from Tanzania.

Chinese government and companies are scouring across the globe for talent by organising job
fairs to attract specialised workforce, given their swelling need for a well trained workforce to
support plans to move up the value chain in the life sciences sector. Chinese drug makers that are
increasingly hiring Indian talent pool have their facilities in the provinces of Zhejiang,
Guangdong, Jiangsu and Hebei
It could be aimed at augmenting filing of abbreviated new drug applications (ANDAs) in the US
and other regulated markets as China is currently building huge capacities to produce copycat
medicines. We guess this trend should over a period of time help Indian companies increase their
presence in China and vice versa."
Pharmaxel and its sister concern IPHAX inviting more than 500 pharmaceutical paid importers
every year and then Indian exporters sit together for business negotiation. IPHAX started this
event in 2013 and they are organising every year in the month of May. Meher Pharma
International is guiding upcoming exporter and established exporters from very scratch as how to
start a new export venture. Meher assists exporters from product selection to product registration,
dossier, AMV and DMF compilation to resolving queries. Meher assists in organising meeting
with buyers and regulatory consultants of global pharma market. We should join hands together
for export augmentation of more and more products.
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