Pharma News Aug04

PHARMA NEWS
AUGUST 2004
ACNielsen ORG-MΑRG Private Limited
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PHARMA_NEWS AUGUST 2004
HEADLINES
1. ALTERNATIVE MEDICINES ________________________________________6
1.1 3 Indian biotech firms to invest in Germany _________________________________ 6
1.2 Aloe vera for alcoholism ________________________________________________ 6
1.3 ‘Safety should be watchword in traditional medicines too' ______________________ 6
1.4 Leisure activities cut risk of dementia ______________________________________ 7
1.5 Tomato juice may cut clotting in diabetics __________________________________ 7
1.6 Chocolate offers blood vessel boost: Study __________________________________ 7
2. INDUSTRY NEWS __________________________________________________7
2.1 Pharma industry still reeling under slow growth ______________________________ 7
2.2 Ranbaxy touching tempestuous 50 ________________________________________ 8
2.3 Wellquest becomes first Indian Clinical Research Organization to receive Statement
of Good Clinical Practices compliance from UK- Medicines & Healthcare Products
Regulatory Agency_____________________________________________________ 8
2.4 RPG gets cyclosporin patent _____________________________________________ 8
2.5 India stays number one in drug filings______________________________________ 9
2.6 States decide not to issue licenses for new fixed dose combinations; DCC brings
about consensus among drug controllers ____________________________________ 9
2.7 Penicillin makers curtail production — Fall in prices of end products _____________ 9
2.8 Indian drug companies sweat for new chemical entities dream__________________ 10
2.9 Pep pill: USFDA may branch out to India__________________________________ 10
2.10 Glenmark scouting for partner to market new drugs __________________________ 10
2.11 RPG Life Sciences plans new plant for fermentation biz ______________________ 11
2.12 Nicholas Piramal India Ltd. in deal with French Co. for Paediatric Drug__________ 11
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2.13 Internal Revenue Service TP norms may mean better earnings for Indian BPO units 11
2.14 Bitter pill awaits pharma MNCs _________________________________________ 12
2.15 United States Food and Drugs Administration want to set India office ___________ 12
2.16 Drug companies for changes in patents bill_________________________________ 12
3. OTC _____________________________________________________________13
3.1 K-Link Healthcare to market local product _________________________________ 13
3.2 Dr. Reddy's launches cream for treating dry skin conditions____________________ 13
3.3 Dabur to acquire OTC Brand ____________________________________________ 13
4. GOVERNMENT POLICIES / REGULATORY NEWS ____________________14
4.1 ‘Covering more drugs under price control will lead to costlier imports' ___________ 14
4.2 NPPA devises new norms for pricing controlled drugs ________________________ 14
4.3 Fresh bill likely on spurious drugs makers _________________________________ 14
4.4 Bill for 8-digit classification code for excise introduced _______________________ 15
4.5 Government mulls printing production cost on medicine packs _________________ 15
4.6 National Pharmaceutical Pricing Authority to monitor prices of drugs with
Rs.1-crore turnover ___________________________________________________ 15
4.7 National Pharmaceutical Pricing Authority fixes prices of 11 formulation packs____ 16
4.8 Registration of drug manufacturers with Directorate General Quality Assurance
not required _________________________________________________________ 16
4.9 'Excessive price control may result in drugs shortage'_________________________ 16
4.10 Indian government rejects Ranbaxy's application seeking Exclusive Marketing
Rights for Cipro ______________________________________________________ 17
4.11 Goa government to cut sales tax on medicines ______________________________ 17
5. NEW DUGS / RESEARCH __________________________________________17
5.1 Dabur Pharma gets approval for Phase II trials of cancer drug __________________ 17

5.2 Orchid's generics foray progresses strongly_________________________________ 17
5.3 Targretin shows promise against psoriasis__________________________________ 18
5.4 Ranbaxy gets tentative nod from FDA for Gabapentin ________________________ 18
5.5 Genetic Engineering Approval Committee approval for anti-hepatitis clinical trials _ 18
5.6 Glenmark files for Phase I trials on asthma drug in UK _______________________ 19
5.7 Ranbaxy gets Food and Drug Administration nod for Loratadine syrup... _________ 19
5.8 New stent system helps prevent stroke ____________________________________ 19
5.9 Heart attacks more likely during cold weather ______________________________ 20
5.10 Estrogen helps fight MS, arthritis ________________________________________ 20
5.11 Vioxx, in certain doses, triples heart attack risk _____________________________ 20
5.12 Major HIV drug trial stopped ___________________________________________ 21
5.13 Glenmark acquires 2 FDA-approved products from Clonmel___________________ 21
5.14 Food and Drug Administration approves Parcopa (carbidopa-levodopa) orally
dissolving tablets for Parkinson's disease __________________________________ 21
5.15 Food and Drug Administration approves of scent-free Nasonex (mometasone
furoate monohydrate) nasal spray ________________________________________ 21
6. WORLD NEWS ____________________________________________________22
6.1 Japan's Tsumura to expand herbal drug output capacity 20% ___________________ 22
6.2 Japan's Eisai to establish global supply system for 2 key drugs _________________ 22
6.3 Japan's Kyorin, Merck tie up in antibiotic development, sales __________________ 22
6.4 Jubilant eyeing US after Euro expansion ___________________________________ 23
6.5 Italy's Acraf picks up 10% stake in elder___________________________________ 23
6.6 China passes first law curbing AIDS ______________________________________ 23
6.7 Global drug giants rediscover India _______________________________________ 23

7. THE NIB _________________________________________________________24
7.1 Only 100 drug firms follow the best packaging practices ______________________ 24
7.2 Grandix Pharma to set up formulation plant near Chennai _____________________ 24
7.3 Indian corporate turns HIV-friendly ______________________________________ 24
7.4 Ranbaxy's anti-malarial drug in human clinical trial stage _____________________ 24
7.5 State say no to advance Vat regime on drugs _______________________________ 24
7.6 Dabur, Bengal government in talks for cancer drug facility ____________________ 25
7.7 New chemical may now prevent AIDS ____________________________________ 25
7.8 World Health Organisation withdraws Ranbaxy AIDS drugs ___________________ 25
7.9 Italian company picking up 10 pc stake in elder pharma_______________________ 25
7.10 Dabur India plans Rs.20-crore manufacturing facility ________________________ 26
7.11 EU manufacturing technology firms to serve Indian drug makers _______________ 26

1. ALTERNATIVE MEDICINES
1.1 3 INDIAN BIOTECH FIRMS TO INVEST IN GERMANY

Three Indian biotechnology companies are in advanced stages of talks to set up operations in
Germany, Europe’s largest economy. The proposed investments by the Indian companies would be
in the form of research and development facilities at the Frankfurt Innovation Centre for
Biotechnology (FIZ), a biotech cluster in the German State of Hessen. Among the facilities at the
innovation centre was an R and D lab, spread over 6,000 sq mt with a capacity to accommodate
over 200 people, he stated. In July, the FIZ had entered into an agreement with the Karnataka
Biotechnology Development Council to facilitate partnerships and investments between German
and Indian biotech companies.
Deccan Herald: August 24, 2004
1.2 ALOE VERA FOR ALCOHOLISM

Aloe vera has been found to benefit a variety of biological ailments and systems. When used in a
systematic manner, it acts as a potent detoxifier of the liver and other body organs. Detoxification is
very much essential in alcoholic conditions. Alcoholism affects people in unique ways. What starts
off as social drinking soon turns into compulsive drinking and after a while, alcoholics need no
excuse to hit the bottle. Long-term alcohol consumption may lead to brain damage, duodenum
problems, damage to the pancreas, nervous system and the immune system. After being consumed,
alcohol is broken down in the liver, constant drinking inhibits the liver’s production of digestive
enzymes, affecting the body’s ability to absorb proteins, fats and vitamins A, B, D, E and K. The
toxic effect of alcohol causes excessive amount of fat to accumulate in the liver.
1.3 ‘SAFETY SHOULD BE WATCHWORD IN TRADITIONAL MEDICINES TOO'

In gearing up to meet the growing global demand for health care alternatives, India will have to
address new challenges thrown up in the Indian system of medicines (ISM) segment, Special
Commissioner, Indian Medicine and Homeopathy, said. While the country had a definite advantage
given its knowledge base in old and well-documented systems of medicine, it would have to face
emerging problems such as the dwindling supply of genuine herbs, lack of transparency and market
research, obsolete production processes absence of standardisation and the lack of brand equity
abroad. The other concerns were adherence to World Health Organisation guidelines on traditional
medicines, sanitary measures and pursuing patent laws. Countries like the United States and the
United Kingdom spent over $2000 million, while Malaysia spent $500 million on traditional

medicines. The Indian Diasporas was a potential market that could be tapped.
Hindu: August 13, 2004
1.4 LEISURE ACTIVITIES CUT RISK OF DEMENTIA

A study in the New England Journal of Medicine has determined that leisure activities--such as
reading, playing board games, playing musical instruments, and dancing-- were associated with a
reduced risk of dementia. One finding: People who solved crossword puzzles four times a week
reduced their risk of dementia to nearly half that of subjects who did puzzles only once a week.
www.altmedicine.com
1.5 TOMATO JUICE MAY CUT CLOTTING IN DIABETICS

For people with type 2 diabetes, tomato juice may help stave off the heart troubles that often
complicate the disease. Researchers have found that drinking tomato juice for three weeks had a
blood-thinning effect in people with the disease. The juice reduced "platelet aggregation" - the
blood's ability to clot.
Journal American Medical Association: August 18, 2004
1.6 CHOCOLATE OFFERS BLOOD VESSEL BOOST: STUDY

Chocoholics may have another reason to smile. A new study finds that dark chocolate appears to
aid cells that line blood vessel walls, making the vessels more flexible and perhaps preventing
hardening of the arteries, the Associated Press reported. Some experts approached the finding by
Greek researchers at Athens Medical School with caution, however, noting that the probable weight
gain from eating lots of chocolate would cancel any cardiovascular benefit, the wire service account
said. Dark chocolate contains lots of flavonoids, which are natural antioxidants that have been
shown to prevent heart disease. But chocolate also is high in fat, which is why experts aren't
suggesting that binges could prevent heart attacks, the study reported.
www.drugdigest.org
2. INDUSTRY NEWS
2.1 PHARMA INDUSTRY STILL REELING UNDER SLOW GROWTH

The Indian pharmaceutical industry continues to be impacted by slow growth, with the month-on-
month growth rate in July 2004 touching just 5.3 percent. The pharmaceutical industry registered a
higher growth rate at 8.5 percent on a cumulative basis from Jan to July 2004. On a moving annual
turnover (MAT) basis, the growth for July 2004 was 8.1 percent. The main reason for the slow
growth rate was a significant degrowth in anti-infective and the absence of any blockbuster new

molecule launches. Sales of antibiotics usually increase during the monsoon period, but in 2004, the
pharmaceutical industry has not witnessed any significant increase in this segment.
Economic Times: August 27, 2004
2.2 RANBAXY TOUCHING TEMPESTUOUS 50

Ranbaxy Labs (Ranbaxy) is set to establish nearly 50 subsidiaries in the overseas markets, in line
with its strategy to gain significant presence in all potential markets across the globe. The Company
is in the process of setting up two subsidiaries in Canada and Portugal, apart from its envisaged
subsidiary in Australia expected to be operational in the next few weeks and another subsidiary in
the $1 billion market in Pakistan. Ranbaxy currently has 42 subsidiaries globally. The Company
also anticipates the US business to contribute 45-50 percent of its total revenues, European market
at 20 percent, Brazil, Russia, India and China and rest of the world at 30 percent. Ranbaxy aims to
become a $2 billion company by 2007.
Financial Express: August 26, 2004
2.3 WELLQUEST BECOMES FIRST INDIAN CLINICAL RESEARCH

ORGANIZATION TO RECEIVE STATEMENT OF GOOD CLINICAL
PRACTICES COMPLIANCE FROM UK- MEDICINES & HEALTHCARE
PRODUCTS REGULATORY AGENCY
Wellquest, the independent clinical research division of Nicholas Piramal India Ltd. (NPIL),
becomes the first Indian CRO (Clinical Research Organization) to receive the Statement of GCP
(Good Clinical Practices) Compliances from the UK MHRA (Medicines & Healthcare Products
Regulatory Agency), for clinical studies carried out to support the registration of generics products
in the international regulated markets.
Hindustan Times: August 24, 2004
2.4 RPG GETS CYCLOSPORIN PATENT

The Registrar of Patents, Republic of South Africa, has granted a patent to RPG Life Sciences Ltd.
for its novel drug delivery system in cyclosporin. This is the first patent to be granted through the
Patent Co-operation Treaty route. RPG Life Sciences has five manufacturing facilities spread across
Navi Mumbai, Pune and Ankleshwar. The Company says that the drug has passed clinical tests of
bio-equivalency and switchability and is now being widely prescribed in India.
Business Line: August 31, 2004

2.5 INDIA STAYS NUMBER ONE IN DRUG FILINGS
The Indian drug makers have made 43 drug master files (DMF) with the US Food and Drug
Administration (US FDA) in total, indicating 27% of all global filings for 2Q 2004. These filings,
distributed among 25 Indian companies, indicate the increased competition between the companies
to supply active pharmaceutical ingredients (API) to the US generic companies. Some of the
companies that participated in the filing are Cipla, which topped the list with 5 filings, Matrix with
4 filings, Reddy's and Lupin with 3 each, Ranbaxy, Sun, Orchid and IPCA with 2 filings each. The
filings are mainly due to the investments made by the companies with the aim of setting up US
FDA-approvable facilities necessary for entering the lucrative US market. These filings target co-
exclusivity candidates, commodity products and cephalosporin-statin markets. During 1H 2004, 74
DMFs were filed by Indian companies which are 30% of global filings.
The Indian Pharmacist: August 31, 2004
2.6 STATES DECIDE NOT TO ISSUE LICENSES FOR NEW FIXED DOSE
COMBINATIONS; DCC BRINGS ABOUT CONSENSUS AMONG DRUG
CONTROLLERS
The drug controllers from all major states of India have decided to restrain manufacturing licenses
for new fixed dose combinations (FDCs), as requested by the DCC and the Drug Controller General
of India (DCGI). Despite the decision for detaining the licenses for new FDCs, there could be
marketing and manufacturing of already licensed irrational combination products unless and until
the centre intrudes and bans the products in the country. The state drug controllers have however
given rights to ban the already licensed irrational combination products. The animosity between the
central and state departments in issuing manufacturing licence for existing drugs has made the
central authority helpless in restriction or cancellation of licenses issued by the state departments.
According to the DCC sub-committee, Tamil Nadu Drug Control Department has issued maximum
number of such licenses in India during 2000-2004 followed by Himachal Pradesh. On the other
hand the Gujarat Food and Drug Control Administration (FDCA) has geared up to cancel all the
150 odd drug manufacturing licenses it had issued for FDCs after May 2002, subsequent to DCGIs
order in this regard.
The Indian Pharmacist: August 31, 2004
2.7 PENICILLIN MAKERS CURTAIL PRODUCTION — FALL IN PRICES OF END

PRODUCTS
Penicillin production in India has been reduced significantly this month largely on account of
developments in the international market. A sharp fall in prices of penicillin's end products abroad
has slowed Indian exports and, thereby, brought down penicillin's demand here. Simultaneously,

the import of a relatively cheap-end product, Amoxycillin, has worsened the situation. Penicillin-G
is the building block of about 40 per cent of antibiotics. SPIC, Alembic, J.K. Pharmachem and
Gujarat Torrent Biotech are among its major producers. Generally, the onset of the monsoon in
June leads to a rise in sales of antibiotics. The current development has come on the heels of a bad
year for penicillin makers because of a steep fall in its price. Downstream antibiotics makers have
also been hurt this time because the problem has come out of their markets, said industry sources.
Industry sources said that the current crisis may be the worst faced by the industry. This was the
first time that all the manufacturers had reduced production or even suspended it, they added.
2.8 INDIAN DRUG COMPANIES SWEAT FOR NEW CHEMICAL ENTITIES

DREAM
Research and development (R&D) has emerged as a top priority for Indian pharmaceutical
companies for the first time. This is because they will not be able to survive for long after 2005 by
focusing on developing imitation products of original molecules. Multinational companies (MNC)
in the pharmaceutical sector have come out with blockbuster drugs that have completely changed
their fortunes. Prominent examples of these are Glaxo's Zantac, Eli Lily's Prozac and Pfizer's
Viagra. Indian pharma companies, now on the threshold of the product patents regime, are going all
out to develop their own innovative products based on either new chemical entities (NCE) or novel
drug delivery system (NDDS) platform. These companies are hoping that if they are able to deliver
a single new molecule, it would transform their entire business outlook. While NCE is a high-risk
business, it also brings in higher rewards.
2.9 PEP PILL: USFDA MAY BRANCH OUT TO INDIA

The US Food and Drugs Administration are considering the option of establishing a branch office
in India. This follows the constant thrust by Indian pharma companies on the US generics market
and the fact that the product patent regime is just around the corner. It is considering locations such
as New Delhi, Mumbai and Hyderabad for setting up its branch office. India has the largest number
of USFDA approved pharmaceutical plants outside of the US. The country presently has 61
USFDA approved pharma plants.
2.10 GLENMARK SCOUTING FOR PARTNER TO MARKET NEW DRUGS

Glenmark Pharmaceuticals Ltd. is looking for a licensing partner to market the drugs for asthma
and diabetes. The asthma drug candidate, GRC 3886, was expected to go for Phase-I clinical trials

in the UK in Jul 2004. The Company has tied up with Quintiles for trial of the asthma drug
candidate. Glenmark intends to adopt a similar strategy for the diabetes drug candidate. The
diabetes drug candidate is scheduled to go on Phase-I trial during October-December 2004.
2.11 RPG LIFE SCIENCES PLANS NEW PLANT FOR FERMENTATION BIZ
RPG Life Sciences Ltd. plans to set up a new plant for the fermentation business. The Company has
also set a target of almost doubling its export turnover by the end of this fiscal. The new plant for
Doxorubicin will be adjacent to the RPG Life Science’s existing plant in Ankleshwar. The
Company will be investing around Rs.5-crore for this new plant and will be commissioning by the
end of this fiscal. The Company has set a target of achieving a turnover of around Rs.40-crore as
against Rs.20-crore last year in the fermentation bulk drug business.
2.12 NICHOLAS PIRAMAL INDIA LTD. IN DEAL WITH FRENCH CO. FOR
PAEDIATRIC DRUG
Nicholas Piramal India Ltd. (NPIL) of Mumbai has entered into a product-licensing deal with
Ethypharm of France for the technology to produce paracetamol flash tablets for children. Under
the agreement, NPIL is to source raw material from Ethypharm and manufacture dispersible
formulations using the technology at its Pithampur facility. NPIL is to market the formulation under
its own brand name in India.
2.13 INTERNAL REVENUE SERVICE TP NORMS MAY MEAN BETTER EARNINGS

FOR INDIAN BPO UNITS
The US Internal Revenue Service (IRS) has made certain amendments wherein services will require
price based on comparability principles, at cost plus, close to what would be charged by an
unrelated third party. The proposal by the IRS states that some service operations may have greater
value, such as R&D. In such cases, the IRS would insist on adoption of a profit-split method or any
other more suitable method that appropriately measures the benefit to the recipient and thus the
payment to the provider. The US entity, providing R&D or other high-value services would share
the profits of the parent company, in India or in any other country outside the US. These proposals
could prove to be a hurdle for several Indian companies that have set up affiliates in the US. On the
other hand, this could actually assist Indian tax authorities in determining the prices for services
either to India or from India. In the case of services from India, it would ensure that Indian entities
are paid a better price, which would translate to better tax revenues if the Indian entity is not

availing of a tax holiday. Based on this proposal of the IRS, the tax authorities in India can insist
that higher prices be paid to the Indian entity.
2.14 BITTER PILL AWAITS PHARMA MNCS

There could be some bad news for pharma multinationals in India. They have argued over a period
that data exclusivity is a must if they were to step up R&D investments and clinical trials in India
but some arms of the government seem to think otherwise, even after a careful reconsideration of
MNC demand which was once shot down. These government departments have agreed with the
predominant view in the domestic pharma industry circles that data protection policies are a clear
ploy for ever greening of patents, which can extend the life of a patent even when the patent is
invalidated. Data exclusivity is defined as protection for new drugs/agrochemicals data furnished
with the authorities for regulatory clearances, from unfair commercial use by anybody other than
the innovator. Given the positions taken by key ministries, what best the MNCs can now hope for is
a mere protection of the data they furnish with the regulators from unfair commercial use. That is,
they would not, in any case, get what they really wanted, that is, a tool to extend the market
exclusivity beyond the period of original patent protection.
2.15 UNITED STATES FOOD AND DRUGS ADMINISTRATION WANT TO SET

INDIA OFFICE
With the product patent regime round the corner and the ever increasing thrust on the US generic
markets by the Indian pharmaceutical companies, the United States Food and Drugs Administration
(USFDA) is contemplating branching out to India. Besides Delhi, cities like Mumbai and
Hyderabad are being considered for locating its branch office. Indian pharma companies are
expected to notch a turnover of $12 billion by 2008 as against the current revenues of $7 billion.
2.16 DRUG COMPANIES FOR CHANGES IN PATENTS BILL

Even as the cabinet is likely to take up the Patent (Amendment) Bill recently, domestic pharma
companies have warned that the bill in its original form could lead to evergreening of patents and
rise in prices of drugs. In a representation to the commerce ministry, the industry has said the
government should use the flexibility available under the TRIPS agreement. The Indian
Pharmaceutical Alliance, which represents leading domestic pharma firms, pointed out if the
government allowed patenting of marginal changes or improvements to previously patented
compounds, as was proposed in the previous bill, it will lead to evergreening of patents and delay

the entry of generics. Seeking exclusion from patentability for new forms of previously patented
compounds and right of hearing in pre-grant opposition proceedings, IPA said ignoring these two
points could lead to foreign companies claiming patents on products that are already in Indian
market. IPA said this was evident from the fact that more than 4,000 patent applications have been
filed in the Mail Box.
3. OTC
3.1 K-LINK HEALTHCARE TO MARKET LOCAL PRODUCT

K-Link Healthcare, the Indian arm of Malaysian direct sales company, K-Link International, is
procuring its first local product from a Kochi-based contract manufacturer, Arjuna Herbal Extracts.
The new product, made of flax seeds, supposedly the richest source of essential fatty acid (EFA), is
to be marketed as a dietary supplement. In India, K-Link Healthcare, so far has been importing 15
products and selling mainly through a network of 25,000 distributor-members. Sales turnover
achieved by K-Link Healthcare during 2003-2004 was around Rs.18-crore.
3.2 DR. REDDY'S LAUNCHES CREAM FOR TREATING DRY SKIN CONDITIONS
The Stock Exchange, Mumbai (BSE) made the following corporate announcement: Dr. Reddy's
Laboratories Ltd. has informed BSE that Venusia, a skin moisturizing cream indicated for the
treatment of dry skin conditions, has been launched by the Company as part of its portfolio of
dermatology products. Venusia, which is available in 50g jars, is a prescription product.
3.3 DABUR TO ACQUIRE OTC BRAND

Dabur India is all set to acquire an over-the-counter (OTC) healthcare brand: a cough-n-cold
product in the herbal domain, soon. While exact details are not known, Dabur is believed to have
finalised the deal and is waiting for a final approval from the Board. The Company is looking at
possible acquisitions in personal care and healthcare space. The possible acquisition, industry
sources said, will be used by the FMCG major to drive its OTC business, which has been identifed
as a future growth area by the company. In the coming days, the company is expected to make some
aggressive forays into the Rs.2,500-crore OTC category led by an acquired product in the herbal
based cough and cold domain, they said. Simultaneously, the company is also believed to be
working on new OTC products and reviving some of its prescription based ayurvedic products to
market them as OTC products. The Company has been working on giving its OTC portfolio a focus

since last year when it restructured its Ayurvedic Specialities Division as Consumer Healthcare
Division (CHD) to market both OTC and prescription-based ayurvedic medicines.
4. GOVERNMENT POLICIES / REGULATORY NEWS
4.1 ‘COVERING MORE DRUGS UNDER PRICE CONTROL WILL LEAD TO

COSTLIER IMPORTS'
The Indian Drug Manufacturers' Association (IDMA) has urged the Government of India not to go
ahead with the proposal to bring a wider range of pharmaceutical products under price control. Over
74 drugs are currently under price control, and the Centre is looking at expanding coverage of the
order to over 300 drugs. IDMA says that expanding the purview of price control order would only
result in costlier imported drugs coming into the market.
4.2 NPPA DEVISES NEW NORMS FOR PRICING CONTROLLED DRUGS

The National Pharmaceutical Pricing Authority (NPPA) has notified the norms for conversion cost
(CC), packing charges (PC) and process loss (PL) for determining the manufacturing cost of
controlled drugs, based on a comprehensive study carried out by the Cost Account Branch (CAB)
of the Ministry of Finance. The new norms came into force from August 11.Norms have been
prescribed for certain category of items for the first time. The norms for CC and PC, by and large,
have increased over the existing ones, while the norms for PL of materials have come down for all
items. The norms, depending on the form and composition of the medicines, factor in a 3-76%
actual increase in CC and a 5-40% actual increase in PC, compared to the existing norms.
Counterweighing the hikes will be a 25-50% reduction in PL. They are expected to result in a 1-5%
drop on 51% of controlled formulations. In case of the other 39%, prices will increase by 1-5%,
while 10% of formulations will see a sharper price hike of 5-10%. On an aggregate basis, however,
the new norms will be consumer-neutral. In order to incentivise efficiency, the CC and PC were
worked out at a two-thirds cut-off level of efficient production, as well as on the basis of weighted
average of two-thirds production of the 22 manufacturing units studied by the CAB. With the
adoption of the new norms, the authority can now issue fresh price orders.
Chemical weekly August 24, 2004
4.3 FRESH BILL LIKELY ON SPURIOUS DRUGS MAKERS

The Government of India plans to introduce a fresh bill for enhancing the penalty for manufacture
of spurious drugs. The Government had introduced the bill in December 2003 and it lapsed due to

the dissolution of the Lok Sabha. The bill is expected to propose stiffer penalties, including capital
punishment. The bill will also make offences pertaining to spurious drugs non-bailable and
cognisable.
4.4 BILL FOR 8-DIGIT CLASSIFICATION CODE FOR EXCISE INTRODUCED

The Government of India has introduced a Bill in Parliament that seeks to achieve a common eight-
digit classification code for levy and collection of excise and customs duties, administering import
trade control policy and collecting statistics. Enactment of the Central Excise Tariff (Amendment)
Bill 2004 would enable the Revenue Department to adopt the Harmonised System of
Nomenclature-based eight-digit classification code for excise purposes. The department has already
adopted eight-digit classification for levy of import duty with effect from 1st February 2003. The
Bill also aims at incorporating standard units of measurement as recommended by the World
Customs Organisation.
4.5 GOVERNMENT MULLS PRINTING PRODUCTION COST ON MEDICINE

PACKS
The Government plans to examine the legalities of printing the cost of production on medicine
packs along with maximum retail price. The Chemicals and Petrochemicals minister stated this
during the interactive session held in Delhi with Finance Ministers/Health Ministers of states to
evolve a common strategy to ensure availability at reasonable prices and quality of medicines. The
retail sale price should not be more than double of the cost of production, said the Minister. The
retail price comprises ex-factory price and excise duty component apart from wholesaler/retailer
margins. In case manufacturers tend to give inflated manufacturing cost, they will have to pay
increased excise duty as well. The Minister has decided to meet with the drug manufacturers in the
country soon to deliberate on the possible solutions.
Express Pharma Pulse: August 26, 2004
4.6 NATIONAL PHARMACEUTICAL PRICING AUTHORITY TO MONITOR

PRICES OF DRUGS WITH RS.1-CRORE TURNOVER
In a bid to prevent the unusual price hike of essential drugs, the Government has decided to monitor
the price hikes of drugs with a turnover of Rs.1-crore. Currently, the National Pharmaceutical
Pricing Authority (NPPA) monitors the prices of drugs that have a turnover of Rs.4-crore and
above. Under this new initiative, the Government will keep an eye on almost 80 per cent of the
pharmaceutical market. But on the issue of having a uniform sales tax, the States felt that the

Empowered Committee to look into value-added tax (VAT) should decide on drugs as well. The
Minister had asked the States to exempt them from local taxes or at least advance the
implementation of VAT regime for drugs.
4.7 NATIONAL PHARMACEUTICAL PRICING AUTHORITY FIXES PRICES OF 11

FORMULATION PACKS
The National Pharmaceutical Pricing Authority (NPPA) fixed/revised prices of 11 formulation
packs, imported in finished form, on 11 August 2004. The formulation packs are based on bulk
drug insulin and methyl prednisolone sodium succinate. NPPA had received applications from
Novo Nordisk and Pharmacia Ltd. The authority has also notified norms for conversion cost,
packing charges and process loss of materials.
4.8 REGISTRATION OF DRUG MANUFACTURERS WITH DIRECTORATE

GENERAL QUALITY ASSURANCE NOT REQUIRED
The Government of India's Ministry of Defence issued the following press release: Drug Firms are
not required to register with Directorate General Quality Assurance (DGQA) for manufacturing
drugs. In order to be eligible for making supply to Defence a drug manufacturing firm should be
either registered with DGQA or should hold WHO GMP Certificate by State / Central Authority
and should have a turnover of more than Rs.20-crores. As on date, there are 78 Drugs
Manufacturing firms registered with DGQA. This information was given by the Defence Minister
Shri Pranab Mukherjee in a written reply to Shri Prabhunath Singh in Lok Sabha today.
4.9 'EXCESSIVE PRICE CONTROL MAY RESULT IN DRUGS SHORTAGE'

The Government of India plans to monitor the prices of essential drugs in the country. The
pharmaceutical industry thinks that excessive price control is likely to result in shortages of drugs.
Pharmaceutical companies are likely to discontinue production of drugs, if the prices are unviable.
The National Pharmaceutical Pricing Authority has been controlling the prices in the country in the
past.

4.10 INDIAN GOVERNMENT REJECTS RANBAXY'S APPLICATION SEEKING
EXCLUSIVE MARKETING RIGHTS FOR CIPRO
The Indian government has rejected an application by Ranbaxy aboratories seeking Exclusive
Marketing Rights for a ciprofloxacine composition. The Indian Patent Office respectively has also
turned down Hoffman La Roche and Smith Kline Beecham Plc (UK) applications for Saquinavir
and Rogiglitazone Maleate. Applications of Bayer for Moxifloxacin Hydrochloride, Schering
Plough Corporation's US PEG-interferon-alpha, Nicholas Piramal and Council of Scientific and
Industrial Research Bulaquine and Cholroquine (anti malaria) are pending with the Indian patent
office. Eli Lilly's application for EMR for Tadafil tablet is also pending with the Government which
is also yet to clear Panacea Biotech's application for Nimesulide injection, sources said.
Asia Pulse: August 23, 2004
4.11 GOA GOVERNMENT TO CUT SALES TAX ON MEDICINES

The Government of Goa has decided to reduce sales tax on pharmaceutical products by 50 percent
from April 2005. This will result in a loss of Rs.5-crore of revenues to the Government of Goa. The
sales tax in Goa will be cut from 8 percent to 4 percent from next summer. The annual sale of
medicines in Goa is estimated at Rs.90-crore.
The Navhind Times: August 23, 2004
5. NEW DUGS / RESEARCH
5.1 DABUR PHARMA GETS APPROVAL FOR PHASE II TRIALS OF CANCER

DRUG
Dabur Pharma Ltd. (DPL), a subsidiary of Dabur India Ltd. (DIL), has received the Drug Controller
General of India's (DCGI) approval to commence Phase II clinical trials of its cancer drug
Paclitaxel Nanoparticle. The Company has also commenced Phase II clinical trials on its new
chemical entity (NCE) molecule called DRF 7295. Paclitaxel Nanoparticle is mainly used in the
treatment of cancer. The Company is developing the new product as a Novel Drug Delivery System
(NDDS) drug, which will help it file for an Abbreviated New Drug Application (ANDA).
5.2 ORCHID'S GENERICS FORAY PROGRESSES STRONGLY

Orchid Chemicals & Pharmaceuticals Limited issued the following press release: The Chennai-
based pharma major, Orchid Chemicals & Pharmaceuticals Ltd., today announced that it had filed
its seventh Abbreviated New Drug Application (ANDA). These seven ANDAs cover various
finished dosage forms of 3 cephalosporin antibiotic products (2 sterile products and 1 oral product).

The combined current retail market of these 3 products in the US is estimated at over USD 1
billion. Orchid's ANDAs are filed from the state-of-the-art oral and sterile cephalosporin
formulation facilities at Irungattukottai, near Chennai. The plant is designed for USFDA
compliance standards and is expected to go in for USFDA inspection once the regulatory agency
reviews the ANDAs submitted.
5.3 TARGRETIN SHOWS PROMISE AGAINST PSORIASIS

Targretin (bexarotene), a drug that is used to treat lymphoma of the skin, also appears useful against
the scaly skin condition psoriasis, Dutch researchers report. In a trial involving patients with severe
psoriasis, Dr. Jurgen V. Smit of the University Medical Center in Nijmegen and colleagues
investigated the safety, tolerability and effectiveness of Targretin. Patients received treatment for 12
to 24 weeks. There were no serious side effects and the drug was well tolerated in most patients,
according to the researchers. The most frequent side effects were high blood levels of triglycerides
and low levels of thyroid hormone.
Journal of the American Academy of Dermatology, August 2004.
5.4 RANBAXY GETS TENTATIVE NOD FROM FDA FOR GABAPENTIN

Ranbaxy Laboratories Ltd. has received a tentative approval from the US Food & Drug
Administration for generic anti-depressant, Gabapentin, in capsule form. According to the FDA, the
approval is for "oral capsules" in 100 milligram, 300-mg and 400-mg strengths. Gabapentin is the
generic name of US drug company Pfizer Inc's Neurontin. The total market sales for Gabapentin
capsules were at $1.7 billion annually as on June 2004, Ranbaxy said. A tentative approval letter is
issued from the FDA to an applicant when all scientific and procedural conditions are met; however
the approval has a delayed effective date usually because some form of marketing exclusivity,
according to the US FDA Web site, blocks product marketing. An approval with a delayed effective
date does not become final until the FDA issues an approval letter. A tentative approval does not
allow the applicant to market the generic drug product. Gabapentin is indicated for the management
of "postherpetic neuralgia" in adults, according to a Ranbaxy statement.
5.5 GENETIC ENGINEERING APPROVAL COMMITTEE APPROVAL FOR ANTI-

HEPATITIS CLINICAL TRIALS
The Genetic Engineering Approval Committee (GEAC) has permitted Cadilla Healthcare to
conduct phase III clinical trials on recombinant human interferon alpha, which is used for the
treatment of Hepatitis B and C. The Company can start its clinical trials subject to clearance by the

Drug Controller General of India (DCGI). In its meeting held recently, the committee has sought
further clarifications from the DCGI on issuing an ex-post facto approval to Hyderabad-based
Virchow Biotech Pvt. Ltd. for conducting phase III clinical trials and permission to manufacture
and market recombinant human platelet-derived growth factor. The committee has also sought
additional data from Bangalore-based Biocon before permitting the company to import a drug from
Cuba-based Centre of Molecular Immunology to conduct phase II clinical trials on Indian cancer
patients.
5.6 GLENMARK FILES FOR PHASE I TRIALS ON ASTHMA DRUG IN UK

Glenmark Pharmaceuticals S.A. (Switzerland) has filed for Phase I clinical trials of GRC 3886, its
novel drug candidate for asthma and chronic obstructive pulmonary disease, in the UK. The trials
are likely to be completed by March 2005, a company communication said. The Company, a wholly
owned subsidiary of the Mumbai-based Glenmark Pharmaceuticals Ltd., made the filing with the
Medicines and Healthcare Products Regulatory Agency in the UK. The Phase I study will be
conducted in the UK by Quintiles, a global contract research organisation, and is expected to
commence in September. It will be conducted using single and multiple oral doses on healthy
volunteers.
5.7 RANBAXY GETS FOOD AND DRUG ADMINISTRATION NOD FOR

LORATADINE SYRUP...
Ranbaxy Laboratories Ltd. today announced that the company has received approval from the US
Food and Drug Administration (FDA) to manufacture and market Loratadine syrup (5 mg/5 ml) as
an OTC product. In August 2003, the company had received approval from the FDA for selling
Loratadine as 10 mg tablets.
Business Standard: August 24, 2004
5.8 NEW STENT SYSTEM HELPS PREVENT STROKE

The U.S. Food and Drug Administration has approved Guidant Corp.'s Rx Acculink carotid stent
system, which is designed to keep the main artery that pumps blood to the brain from becoming
clogged, reducing the risk of stroke. The first-of-its-kind device was approved for people who have
symptoms of impending stroke or whose carotid artery is at least 80 percent clogged, but who aren't
candidates for more invasive surgery. Stents, which are hollow metal mesh tubes, are designed to
prop open blood vessels and keep them from becoming clogged. The devices have been used for
years in heart arteries.

www.drugdigest.org
5.9 HEART ATTACKS MORE LIKELY DURING COLD WEATHER

As the weather gets colder and a person's blood pressure rises, so does the risk of a heart attack, a
new study find? Cold weather makes the blood vessels constrict, posing more of a danger to people
with high blood pressure than the average person, French scientists at the University of Burgundy
found. Heart attack risk among people with high blood pressure also rose when the temperature
dropped by at least 10 degrees on the day of the heart attack, regardless of how cold it was, the
sources reported.
www.AP.com
5.10 ESTROGEN HELPS FIGHT MS, ARTHRITIS

U.S. researchers said they have found how estrogen can fight the effects of multiple sclerosis,
arthritis and diabetes. Researchers at Oregon Health & Science University and the Portland
Veterans Affairs Medical Center have uncovered the mechanism by which estrogen, produced in
high volumes during pregnancy, can boost the expression and number of certain regulatory cells
that are key to combating the effects of MS and other autoimmune diseases. For years, doctors have
suggested the best treatment for multiple sclerosis is pregnancy. Now, the researchers have shown
how the hormone strengthens the function of T cells known as CD4+CD25+, and a regulatory
protein called FoxP3. The cells are important for protecting mice against a model for human MS
called experimental autoimmune encephalomyelitis, or EAE.
www.nlm.nih.gov
5.11 VIOXX, IN CERTAIN DOSES, TRIPLES HEART ATTACK RISK

A study conducted by the U.S. Food and Drug Administration on prescription pain relievers has
determined that one of them, Vioxx, triples a person's chances of having a heart attack in higher
doses. To compound the problem for Vioxx's manufacturer, Merck & Co., the FDA found that the
drug's major competitor, Celebrex, may be safer. According to the, the fallout from the study,
which was presented Wednesday at a conference in France, could be that health maintenance
organizations would reconsider at what strength Vioxx should be prescribed. Vioxx and Pfizer
Inc.'s Celebrex belong to a class of pain relievers known as cyclooxygenase-2 (cox-2) inhibitors.
Their primary advantage in treating painful ailments such as arthritis is that they don't irritate the
stomach as many over-the-counter medications do.
www.AP.com

5.12 MAJOR HIV DRUG TRIAL STOPPED
A major HIV human vaccine trial in Cambodia has been shelved amid claims it violated people's
human rights. The trial was supposed to be one arm of an international study to see if Tenofovir,
which is used to fight HIV, can also protect uninfected but sexually active adults against the virus
that causes AIDS. Some 960 sex workers were slated to take part in the trial, partly funded by the
Bill and Melinda Gates Foundation, but they boycotted it, saying they wanted medical insurance for
side effects for up to 40 years after the study, according to wire service reports.
www.drugdigest.org
5.13 GLENMARK ACQUIRES 2 FDA-APPROVED PRODUCTS FROM CLONMEL

Glenmark Pharmaceuticals Inc of the US, the wholly owned subsidiary of Glenmark
Pharmaceuticals, has acquired two FDA-approved products from Clonmel Healthcare Ltd of the
Republic of Ireland. The two products have an estimated market size of $50 million in the US.
Glenmark plans to launch the products in 2005- 2006, and expects to capture a 25 percent market
share for each product within one year of launch. The US subsidiary of Glenmark plans to file 8-10
Abbreviated New Drug Applications on its own label in 2004-2005.
5.14 FOOD AND DRUG ADMINISTRATION APPROVES PARCOPA (CARBIDOPA-

LEVODOPA) ORALLY DISSOLVING TABLETS FOR PARKINSON'S DISEASE
Schwarz Pharma, Inc., announced recently that it has received approval from the U.S. Food and
Drug Administration (FDA) to market Parcopa (carbidopa-levodopa orally disintegrating tablets), a
unique formulation of carbidopa-levodopa that dissolves rapidly on the tongue. Parcopa, which will
be available in pharmacies September 27, 2004, is designed to provide patients suffering from
Parkinson's disease improved access to their medication. Schwarz Pharma will use patented
RapiTab Technology to develop a family of prescription pharmaceutical products for use in primary
care, gastroenterology and neurology. Sinemet (carbidopa-levodopa) is a registered trademark of
Merck & Co., Inc.
www.docguide.com
5.15 FOOD AND DRUG ADMINISTRATION APPROVES OF SCENT-FREE

NASONEX (MOMETASONE FUROATE MONOHYDRATE) NASAL SPRAY
Schering-Plough Corporation announced that the U.S. Food and Drug Administration (FDA) have
approved a new scent-free formulation of Nasonex (mometasone furoate monohydrate) prescription
nasal inhaled steroid. Nasonex remains the first and only once-daily prescription nasal inhaled
steroid approved to help prevent most seasonal nasal allergy symptoms, including nasal congestion,

in adults and children 12 years of age and older and the only nasal inhaled steroid approved to treat
nasal allergy symptoms, including nasal congestion, in patients as young as 2 years of age. The
FDA approval of this new formulation was based upon extensive review of the safety and efficacy
data from the original formulation of Nasonex Nasal Spray.
www.docguide.com
6. WORLD NEWS
6.1 JAPAN'S TSUMURA TO EXPAND HERBAL DRUG OUTPUT CAPACITY 20%

Tsumura & Co. said that it will spend 3.8 billion yen (US$34 million) to expand its facilities that
produce powdered extracts for herbal medicine to increase its overall output capacity by more than
20 per cent to 2,500 tons annually in fiscal 2006. The major producer of traditional Chinese
medicines has been operating its powder production facilities at full capacity and aims to meet the
expected growth in demand for herbal remedies. The Company will start dismantling idle
equipment at its plant in Ibaraki Prefecture starting this fiscal year. It plans to begin building
facilities for extracting and drying herbal medicines there next fiscal year with an eye toward
bringing them onstream in January 2007. The firm plans to use its funds on hand for the expansion.
The boosted capacity will help decrease the burden on existing facilities and spread out risks.
6.2 JAPAN'S EISAI TO ESTABLISH GLOBAL SUPPLY SYSTEM FOR 2 KEY

DRUGS
Eisai Co. plans by fiscal 2007 to have a worldwide supply system in operation for its two key
pharmaceutical products: Pariet, an ulcer treatment, and Aricept, an Alzheimer's disease treatment.
The system will be able to respond flexibly to increases in demand in various regions of the world
by making the best use of production sites in Japan, the U.S. and China. At present, Eisai produces
the drugs at two plants in Japan and one in the U.S. state of North Carolina. By 2006, the company
plans to increase output capacity at its plant in Suzhou, China, and have a total of four sites that
produce the two drugs. If one of the four cannot keep pace with production demands, others will aid
it.
6.3 JAPAN'S KYORIN, MERCK TIE UP IN ANTIBIOTIC DEVELOPMENT, SALES

Kyorin Pharmaceutical Co. said recently that it has entered into an exclusive licensing agreement
on infection-fighting drugs with Merck & Co. Under this agreement, Kyorin holds development and
sales rights in Japan to antibiotics that the companies co-develop, and Merck has rights overseas.

Each company intends to take advantage of the other's strengths, with Kyorin aiming to improve
R&D efficiency through the partnership. The Companies stepped into the licensing agreement
because of improved prospects of identifying compounds for making the synthetic drugs. The
Companies undertook joint studies of antibiotics 10 years ago. They are expected to market the first
products under the agreement, oral agents and injectable solutions, as soon as four or five years
from now. In Japan, Kyorin will gain development rights to Merck's products and conduct
development and sales activities jointly with Banyu Pharmaceutical Co. a Japanese subsidiary of
Merck.
6.4 JUBILANT EYEING US AFTER EURO EXPANSION

Indian chemicals company Jubilant Organosys looks set to continue its expansion into international
markets with an acquisition in the US, shortly after completing the takeover of two Belgian
companies.
Novis Pharmaceutical News: August 16, 2004
6.5 ITALY'S ACRAF PICKS UP 10% STAKE IN ELDER

Azeinde Chimiche Riunite Francesco Angelini (Acraf), the euro 1.6 billion Italian pharmaceutical
companies, has picked up a 10 percent stake in Elder Pharmaceuticals based in Mumbai.
6.6 CHINA PASSES FIRST LAW CURBING AIDS

China recently passed a law strengthening AIDS prevention measures and ensuring victims of
infectious disease such as AIDS or SARS are not discriminated against, the first such legislation of
its kind.
6.7 GLOBAL DRUG GIANTS REDISCOVER INDIA

Major international pharmaceutical companies are planning to establish base in India owing to the
introduction of product patent regime from January 2005 and low costs. Global companies
including Ivax Corporation of the US and Taro Pharmaceuticals of Israel are planning to acquire
local drug companies or set up plants in India. Hexal AG of Germany has decided to set up a
formulation plant in Bangalore at an investment of 10 million euros. Other global pharma
companies such as Roche, Bayer, Aventis and Chiron have decided to make India their regional hub
for active pharmaceutical ingredients and supplies of bulk drugs.

7. THE NIB
7.1 ONLY 100 DRUG FIRMS FOLLOW THE BEST PACKAGING PRACTICES
India has one of the best packaging standards for pharma products but unfortunately only about 100
companies follow these specifications out of 6,700 registered pharmaceutical companies here.
Deputy Director, Indian Institute of Packaging, Hyderabad, said, in a session on pharmaceutical
packaging organised by Goa Pharmaceutical Manufacturers Association (GPMA)
7.2 GRANDIX PHARMA TO SET UP FORMULATION PLANT NEAR CHENNAI

Grandix Pharma, a company owned by 490 doctors, is to open a formulation plant shortly on the
outskirts of Chennai. The Rs.11-crore plant has been designed and built to meet US regulatory
norms. Grandix's shareholders are all doctors, and the company has been engaged in marketing
formulations since 1996.
7.3 INDIAN CORPORATE TURNS HIV-FRIENDLY

HIV stopped being an alien word in the Mumbai corporate world from Thursday. With about 1,500
corporate houses on its rolls, the Bombay Chamber of Commerce and Industry has prepared a non-
discriminatory HIV policy for companies. Half of these corporate houses have already adopted the
guidelines.
Indian Express: August 21, 2004
7.4 RANBAXY'S ANTI-MALARIAL DRUG IN HUMAN CLINICAL TRIAL STAGE

Ranbaxy Laboratories Ltd. and Medicines for Malaria Venture have obtained authorisation from
Medicines and Healthcare Products Regulatory Agency to carry out clinical trials of their anti-
malarial drug in the UK. The drug, codenamed, OZ277/RBx11160 is currently being assessed under
a Phase I study for its safety, tolerability and pharmacokinetics in humans in the UK.
7.5 STATE SAY NO TO ADVANCE VAT REGIME ON DRUGS

Andhra Pradesh recently rejected the Centre’s demand that the Vat regime be advanced in
medicines, in order to slash prices of essential medicines. Andhra Pradesh was supported by several
other States. The States have agreed on a proposed drug price monitoring system to bridge the gap
between high retail rates and much lower manufacturing cost.
Deccan Chronicle: August 19, 2004

7.6 DABUR, BENGAL GOVERNMENT IN TALKS FOR CANCER DRUG FACILITY
Dabur Pharma is holding talks with the Government of West Bengal for establishing an anti-cancer
drug manufacturing facility in the state. The Company has identified land at Mungpoo in the
Darjeeling hills to set up a medicinal plantation and extraction facilities. It plans to set up a nursery
for a particular herb in the State-sponsored Cinchona plantation. The herb will be grown by local
farmers and sold back to the company for extraction. The company recently set up a formulation
plant at Kalyani in West Bengal.
7.7 NEW CHEMICAL MAY NOW PREVENT AIDS

Scientists in the US claim to have identified a chemical which could help fight diseases like AIDS
and leukaemia. Researchers at the University of Georgia have found an amino acid called
tryptophan that could stop so-called retroviruses in their tracks and prevent the spread of such
diseases in humans.
Asian Age: August 19, 2004
7.8 WORLD HEALTH ORGANISATION WITHDRAWS RANBAXY AIDS DRUGS

The World Health Organisation (WHO) has withdrawn three generic AIDS drugs manufactured by
Ranbaxy Laboratories Ltd. (RLL) from the list of approved medicines owing to concerns about the
studies that demonstrated their safety. According to WHO, the three drugs did not meet the required
standards.
7.9 ITALIAN COMPANY PICKING UP 10 PC STAKE IN ELDER PHARMA

Angelini Acraf Spa of Italy is set to acquire a 10 percent stake in Elder Pharmaceuticals Ltd. of
Mumbai. The board of Elder Pharma has cleared allotment of 15,99,000 equity shares of the
company, representing 10 percent of its expanded equity, to the Italian firm at a price of Rs.160 per
share. The first phase of the greenfield project will be completed by October 2005 at a cost of
Rs.75-100-crore, while the entire project will be completed in 2006. Elder Pharma already has a
marketing alliance with the Italian group for the marketing of Tantum and NACID, a non- steroid,
anti-inflammation drug.

7.10 DABUR INDIA PLANS RS.20-CRORE MANUFACTURING FACILITY
To give an aggressive push to its export business, Dabur India plans to set up an FDA approved
manufacturing facility in the country with an estimated investment of Rs.20-crore. The proposed
plant will manufacture only healthcare products and will cater exclusively to overseas markets.
7.11 EU MANUFACTURING TECHNOLOGY FIRMS TO SERVE INDIAN DRUG

MAKERS
European ‘intelligent’ manufacturing-technology companies, particularly in pharmaceuticals, would
soon start taking care of the needs of Indian drug makers who earn nearly half their revenue from
exports. The Indo-Italian Chamber of Commerce and Industry is bringing a delegation of European
firms specialising in the use of technology such as real time sensing, machine control, information
systems, and robotic control in the manufacturing process to India in December for collaborations
with Indian drug makers and machinery makers.

Pharma News Aug04

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PHARMA NEWS

ACNielsen ORG-MΑRG Private Limited

1. ALTERNATIVE MEDICINES ________________________________________6

1.1 3 Indian biotech firms to invest in Germany _________________________________ 6

1.2 Aloe vera for alcoholism ________________________________________________ 6

1.3 ‘Safety should be watchword in traditional medicines too' ______________________ 6

1.4 Leisure activities cut risk of dementia ______________________________________ 7

1.5 Tomato juice may cut clotting in diabetics __________________________________ 7

1.6 Chocolate offers blood vessel boost: Study __________________________________ 7

2. INDUSTRY NEWS __________________________________________________7

2.1 Pharma industry still reeling under slow growth ______________________________ 7

2.2 Ranbaxy touching tempestuous 50 ________________________________________ 8

2.4 RPG gets cyclosporin patent _____________________________________________ 8

2.5 India stays number one in drug filings______________________________________ 9

about consensus among drug controllers ____________________________________ 9

2.9 Pep pill: USFDA may branch out to India__________________________________ 10

2.10 Glenmark scouting for partner to market new drugs __________________________ 10

ACNielsen ORG-MARG Pvt. Ltd. - Library & Information Center - Baroda. 2

2.14 Bitter pill awaits pharma MNCs _________________________________________ 12

2.16 Drug companies for changes in patents bill_________________________________ 12

3.1 K-Link Healthcare to market local product _________________________________ 13

3.3 Dabur to acquire OTC Brand ____________________________________________ 13

4. GOVERNMENT POLICIES / REGULATORY NEWS ____________________14

4.3 Fresh bill likely on spurious drugs makers _________________________________ 14

4.5 Government mulls printing production cost on medicine packs _________________ 15

4.6 National Pharmaceutical Pricing Authority to monitor prices of drugs with

Rs.1-crore turnover ___________________________________________________ 15

4.7 National Pharmaceutical Pricing Authority fixes prices of 11 formulation packs____ 16

4.8 Registration of drug manufacturers with Directorate General Quality Assurance

not required _________________________________________________________ 16

4.9 'Excessive price control may result in drugs shortage'_________________________ 16

4.10 Indian government rejects Ranbaxy's application seeking Exclusive Marketing

Rights for Cipro ______________________________________________________ 17

4.11 Goa government to cut sales tax on medicines ______________________________ 17

5. NEW DUGS / RESEARCH __________________________________________17

ACNielsen ORG-MARG Pvt. Ltd. - Library & Information Center - Baroda. 3

5.3 Targretin shows promise against psoriasis__________________________________ 18

5.6 Glenmark files for Phase I trials on asthma drug in UK _______________________ 19

5.8 New stent system helps prevent stroke ____________________________________ 19

5.9 Heart attacks more likely during cold weather ______________________________ 20

5.10 Estrogen helps fight MS, arthritis ________________________________________ 20

5.11 Vioxx, in certain doses, triples heart attack risk _____________________________ 20

5.12 Major HIV drug trial stopped ___________________________________________ 21

5.13 Glenmark acquires 2 FDA-approved products from Clonmel___________________ 21

5.14 Food and Drug Administration approves Parcopa (carbidopa-levodopa) orally

dissolving tablets for Parkinson's disease __________________________________ 21

5.15 Food and Drug Administration approves of scent-free Nasonex (mometasone

furoate monohydrate) nasal spray ________________________________________ 21

6. WORLD NEWS ____________________________________________________22

6.3 Japan's Kyorin, Merck tie up in antibiotic development, sales __________________ 22

6.4 Jubilant eyeing US after Euro expansion ___________________________________ 23

6.5 Italy's Acraf picks up 10% stake in elder___________________________________ 23

6.6 China passes first law curbing AIDS ______________________________________ 23

6.7 Global drug giants rediscover India _______________________________________ 23

ACNielsen ORG-MARG Pvt. Ltd. - Library & Information Center - Baroda. 4

7.2 Grandix Pharma to set up formulation plant near Chennai _____________________ 24

7.3 Indian corporate turns HIV-friendly ______________________________________ 24

7.4 Ranbaxy's anti-malarial drug in human clinical trial stage _____________________ 24

7.5 State say no to advance Vat regime on drugs _______________________________ 24

7.7 New chemical may now prevent AIDS ____________________________________ 25

7.8 World Health Organisation withdraws Ranbaxy AIDS drugs ___________________ 25

7.9 Italian company picking up 10 pc stake in elder pharma_______________________ 25

7.10 Dabur India plans Rs.20-crore manufacturing facility ________________________ 26

7.11 EU manufacturing technology firms to serve Indian drug makers _______________ 26