Drug Controller General of India. It costs $1,500 to register the to the antibiotics, the top 10 lists also include steroids, such as
manufacturing premises and $1,000 to register each individual beclometasone and hydrocortisone; lactulose, an old, large volume
drug. The registration process is considerably more expensive and product that is associated with the dairy industry; pancreatin, which
complicated in China. Before the Chinese Import Drug Licence is often derived from pork pancreas; and ubidecarenone (co-enzyme
is issued, the dossier is reviewed at the SFDA with quality testing Q10), which is used as a cardiotonic and antihypertensive.
performed at a testing institute. The application fee charged by the
Teva holds the most Indian registrations. Since Teva does not have
SFDA is approximately $6,600, with additional fees for quality testing.
a dose manufacturing site in India, the API sales must be to third
Since their introduction in India in January 2003, approximately 1,200
parties or toll manufacturers. Also on the list are a number of major
registration certifi cates (not counting re-registrations or multiple
pharmaceutical companies, including Schering-Plough and Sanofi -
registrations for the same product from the same corporate group)
Aventis, which presumably supply APIs primarily to their own dose
have been issued in the country. Chinese companies hold more
manufacturing sites, and large volume API manufacturers such
Indian registrations (36%) than companies from any other country.
as BASF, DSM and Kyowa Hakko. In China, meanwhile, the large
Approximately 55% of the registrations belong to groups based in
volume-dedicated API manufacturers Kyowa, Ajinomoto and DSM
regulated markets. By comparison, in China only 400 unique Chinese
hold the top three slots, while major pharmaceutical companies make
Import Drug Licences have been approved since January 2004,
up most of the rest of the top 10 list.
with approximately 80% from corporate groups based in regulated
Table 1: Companies selling into India
markets. Only about 10% of the Chinese registrations are from India.
We believe that the larger number of Indian registrations can be
Company Country of origin Number of certifi cates
Teva Israel 45
explained by India’s technology gaps, demand for high-quality APIs for
Schering-Plough US 39
use in fi nished-dose products for regulated markets, and the cheaper
BASF Germany 37
product registration process.
Sanofi -Aventis France 26
DSM Netherlands 26
Antibiotics
Kyowa Hakko Japan 23
Novartis Switzerland 20
In both India and China, antibiotics are associated with the most
Pfi zer US 16
registrations. When we examine top products coming in from
E.ON Germany 16
regulated markets, we see a greater product mix. In addition Source: Thomson Reuters' Newport Horizon Premium
41
Scrip World Pharmaceutical News Supplement August 2009
cphi.com | icsexpo.com | p-mec.com | bioph-online.com
wherepharmameets.com | scripnews.com
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