|
The World Trade Organisation's (WTO) intellectual property
agreement has signalled a significant change in India's
pharmaceutical industry. India has agreed to recognise pharmaceutical
patents by 2005, encouraging firms to switch their efforts
from producing generics, and actively engage in research
and development of their own.
This is evident in the alliance between the German company
Bayer and one of India's major players, Ranbaxy. Ranbaxy
is developing a new and patentable dosage form of Bayer's
antibiotic Ciprobay (ciprofloxacin) before patent expiry.
Similarly, another leading Indian firm, Cipla, has developed
a new dosage form of AstraZeneca's anti-ulcerant Losec.
A major development has been the work carried out by Indian
companies on developing entirely new molecules - one such
company is Dr Reddy's Laboratories, which has several original
molecules in its pipeline.
Dr Reddy's has collaborated with Danish company Novo Nordisk
on two products, both for diabetes and related illnesses.
Novo Nordisk is testing these products in clinical trials,
with the first product potentially on sale by 2005. Likewise,
Ranbaxy is conducting patient trials on a new molecule to
treat enlarged prostate glands in ageing men.
To support developments of this kind the Indian government
is providing a range of tax concessions designed to encourage
R&D, including a ten-year tax holiday on income arising
from R&D. The aim is to at least double the domestic pharmaceutical
industry's level of R&D expenditure, which is low by international
standards, by 2005.
There is also the expectation that the new tax regime will
attract inward investment
by multinationals, which would benefit Indian academic institutions,
CRO's or their own subsidiaries.
A pioneer of new product R&D has been Dr Reddy's which,
in 1993, started a major R&D effort by expanding activities
in India and setting up a US base. Though the company has
increased its R&D budget this year by 20% to around US$3.5
million, the expenditure is still small in comparison to
Western counterparts.
Indian companies have been known to put the cost of developing
a novel drug delivery system at less than £1 million due
to India's cost advantages in research and development.
|
Company
|
Sales
US$m
|
Top
Therapeutic Classes
|
| Cipla
|
110-120
|
J1
antibiotics systemic & R3 bronchodilators |
| Glaxo
India |
90-95
|
A11 vitamins & D7 corticosteroids topical |
| Lupin
|
80-85
|
J1
antibiotics systemic & J4 antimycobacterials |
| Ranbaxy
|
80-85
|
J1
antibiotics systemic & A11 vitamins |
| Hoechst
Marion Roussel |
70-75
|
A10
antidiabetics & J7 vaccines |
| Pfizer
|
70-75
|
A11
vitamins & R5 cough & cold therapies |
| Alkem
|
65-70
|
J1
antibiotics systemic & B3 antianemics |
| Knoll
(BASF) |
65-70
|
A10 antidiabetics & M1 antirheumatics systemic |
| Cadila
|
60-65
|
J1
antibiotics systemic & A2 antiacids |
| Dr
Reddy's Laboratories |
50-55
|
J1
antibiotics systemic & A2 antiacids |
Source:
Pharmaceutical Company Directory
The above table lists the top ten companies
operating in India using company information from the publication
Pharmaceutical Company Directory (PCD).
PCD sales figures represent a sales range for the company
in India only, for the 12 month period ending June 1999, and
are derived from data processed for IMS HEALTH's MIDAS
service. Of the ten companies, the majority are domestic Indian
manufacturers with a high proportion of their revenues arising
from sales of antibiotics.
The Indian Patent Act of 1970 provides only seven years of
process patent protection for pharmaceuticals, providing a
huge opportunity for the domestic industry to produce generics.
The lack of product patents has deterred investment from many
foreign companies as the lack of protection can cost the originators
US$500 million annually.
Under the 1994 WTO Trade-Related Intellectual Property aspects
(TRIPs) agreement, India has a maximum of ten years to bring
its patent laws into compliance, which will involve recognising
product patents and extending the patent protection period
to 20 years.
IMS HEALTH's Pharmaceutical Company Directory contains details
on over 160 companies operating in the Indian market, with
a worldwide coverage of 5,400 companies in over 70 countries.
In depth healthcare environment information on the Indian
market can be obtained from IMS HEALTH's Pharma
Prognosis Asia 2000-2004.
Patent information on over 1,200 commercially significant
compounds can be found in IMS HEALTH's publication Patents
International. |
