MUMBAI: Natco Pharma's success in getting the country's first compulsory licence approval on exorbitantly-priced cancer
drug—Nexavar—has paved the way for another generic company to follow
suit. Little-known BDR Pharma has now filed an application with the
Mumbai Patent Office, seeking compulsory licence to market a crucial
cancer drug, dasatinib, at nearly 90-95 % cheaper than the patented
version sold in the country. This is the country's second compulsory
licence application and more could follow.
The drug, Sprycel (dasatinib ) used for chronic myeloid leukemia, is marketed under a patent by Bristol-Myers Squibb
(BMS) and is priced around Rs 1.6 lakh for a month's dose. Sprycel
(dasatinib) is protected by a patent granted by Indian Patent Office,
Mumbai in 2006.
In an application filed on March 4,
Mumbai-based BDR Pharma has sought approval to manufacture and market
its generic version of Sprycel, on grounds of non-availability and 'high
price' of the product. In its application, BDR, set up in 2003, has
offered to sell at Rs 8,100 for a month's treatment.
Confirming this, BDR Pharma founder and CMD Dharmesh Shah told TOI; "We
are waiting for the reply of the patent authorities on our application
of compulsory license." BMS did not respond to queries.
Under the World Trade Organization
TRIPS Agreement, compulsory licences are legally-recognized means to
overcome barriers in accessing affordable medicines, where a government
allows a company to manufacture a patented drug, without the consent of
the innovator company. Natco's application seeking approval to
manufacture generic Nexavar through the compulsory licence was cleared
on similar grounds last year, bringing down its price by 97%.
Sources said BDR first sought a voluntary licence from Bristol-Myers
Squibb on the drug in February last year. The drug MNC raised certain
queries which were not "valid" , after which, the company decided to
apply for a compulsory licence from the patent office.
Incidentally, dasatinib is one of the three cancer drugs on which the
government plans to issue a compulsory license. A committee established
by the health ministry has recommended that the government consider
issuing compulsory licences on three other cancer drugs — trastuzumab,
ixabepilone and dasatinib. The three drugs are patented in India and
cost approximately Rs 70,000 ($1,290) per vial, Rs 60,000 ($1,110) per
vial and Rs 2,700 ($50) per tablet, respectively. The department of
industrial policy and promotion has been examining the proposal for some
time now.
Says Shah of BDR: "We are as of now working on
identifying products similar to dasatinib , which are not available as
well as not affordable for patients in India. The company which calls
itself a "software pharmaceutical'' company, is also in the news as it
is planning to launch the generic version of sunitinib in the country at
an affordable price. The drug is marketed by Pfizer as Sutent at Rs 61,000 for 50 mg tablets (seven tablets) and Rs 31,500 for 25 mg tablets (seven tablets).
Zydus Cadila to launch molecule for diabetes
Pharma major Cadila Healthcare
may soon become one of a handful of Indian companies to launch an
indigenously developed molecule. The company has been working on a new
molecule for diabetes
dyslipidemia, which is expected to be called 'Saroglitizar' . The name
is believed to have been derived from the Gujarati word 'saro' , meaning
good. Cadila Healthcare, part of the Zydus Cadila group, has been working on the project since 2004.
When contacted by TOI, a company spokesperson said: "We have several
molecules in our research pipeline which we hope to bring to the market.
At this juncture we are unable to provide any further details."
LALIT SHARMA
PGDM
2nd SEM
No comments:
Post a Comment