Vol. 3, No. 10 October, 1999

Number	Subject
031001	Wockhardt Files for Patents in the US
031002	Glaxo Considering Fully Owned Subsidiary for Research, Exports
031003	Micro Labs' Ambitious Plans
031004	Wockhardt Plans to Set-up Cardiac Care Unit at Bhandup
031005	Ranbaxy to Receive $ 10 Million in First-half of 2000
031006	Haematinic Products Okayed by Government
031007	B-complex Drugs Banned by Government
031008	Ranbaxy in Talks to Acquire Ind-Swift
031009	Cadila Healthcare Restricted in Using Promotional Material
031010	US Alleges $ 1 billion IPR Losses in India, Argentina
031011	OPPI Recommends Electronic Lodgement Facility for OTC Products

031001 Wockhardt Files for Patents in the US

Wockhardt has filed patent claims in the US for four novel drug delivery systems (NDDS). The abbreviated new drug applications (ANDAs) will be filed over the next six months with the US authorities.

Three are cardio-vascular products and one is an anti-ulcerant. However, the drugs being identical to the company's existing products, it was not possible to sign a deal similar to the one signed by Ranbaxy with Bayer.

031002 Glaxo Considering Fully Owned Subsidiary for Research, Exports

Glaxo Wellcome, the British multi-national is considering a fully-owned subsidiary in India for research and exports. However, the subsidiary will not compete with the existing company, Glaxo India, in products and processes. The company is biding its time till intellectual property protection is stronger in India.

031003 Micro Labs' Ambitious Plans

The Micro Labs group (sales: Rs 200 crore) is planning to launch ten new drugs. In addition, the company is planning to set up a research and development unit at Rs 10 crore, expand and modernise its plant over the next few years.

The new products will be in the areas of cardiac, psychiatry and orthopaedic drugs. The company's products cover the entire therapeutic segment. The research and development unit will focus on new drug delivery systems (NDDS) and research on product processes till the 2005 deadline. However, the group is averse to research on new molecules. It plans to become a licensee of global pharmaceutical companies to manufacture and market their products in India on a royalty basis after 2005. It also plans to supply these multi-nationals with formulations at lower costs. The group has marketing offices in Moscow, Singapore, Sri Lanka and Vietnam and is setting up a joint-venture plant in Abu Dhabi.

The group's Micro Nova Pharmaceuticals is being merged with the flagship, Micro Labs. The company is also on the lookout for suitable acquisitions. A subsidiary, Brown & Burk Pharmaceuticals is setting up a new formulations plant, meeting MCA standards, for an estimated cost of Rs 15 crore.

031004 Wockhardt Plans to Set-up Cardiac Care Unit at Bhandup

Wockhardt which had earlier acquired Merind is planning to set up a super speciality cardiac care unit at Merind's 30-acre estate at Bhandup, a suburb of Mumbai. The facility used to manufacture Vitamin B-12, sterile formulations and injectables. All these activities have been stopped. The company is also considering other venues for setting up such units.

The company already has set up a heart institute in Bangalore. This operation is expected to contribute Rs 20 crore to the company's turnover. It also has set up a speciality Kidney Institute at Calcutta which manages all kinds of kidney ailments.

031005 Ranbaxy to Receive $ 10 Million in First-half of 2000

Having licensed its novel drug delivery system (NDDS) of anti-infective ciprofloxacin to Bayer Ag, Ranbaxy will receive around US $ 10 million in the first half of 2000 as milestone payment. The company has already received US $ 10 million as signing fees. Reportedly the next payment would coincide with the US Food and Drug Administration's permission to start clinical trials in the US. The total payment due would amount to US $ 65 million.

031006 Haematinic Products Okayed by Government

In a U-turn of sorts the government has reversed its earlier ban on fixed dose combination of haemoglobin in any form (natural or synthetic) and pancreatin. This decision will benefit Franco Indian's Rs 56-crore brand Dexorange Plus (market share: 18 per cent), Raptakos Brett's Rs 22-crore brand Hepatoglobine (market share: 7.3 per cent) and Cadila Pharma's Rs 18 crore Haem-up (market share: 6.8 per cent).

The central government has amended its earlier gazette notification with a new notification to this effect recently. Fixed dose combination of pancreatin or pancrelipase, containing amylase, protease and lipase with any other drug have been okayed by the government. This segment named 'haematinics' is the eighth largest with a market size of Rs 312 crore and market share of 2.4 per cent and is estimated to grow from 12 per cent to 15 per cent every year.

031007 B-complex Drugs Banned by Government

Fixed-dose combinations of Vitamin B1, B6 and B12 will be banned by the government from January 1, 2000. This will grind to a halt the lucrative Vitamin B-complex segment dominated by multi-nationals with sales of Rs 367 crore.

In a gazette notification the government has banned the manufacture, sale and distribution of fixed dose combination (FDC) Vitamin B1, B6 and B12 for human use. The ban is apparently in the public interest as these drugs allegedly do not have the therapeutic values they claim.

The top brands in this segment are: Becosule (Rs 71 crore), Polybion (Rs 48 crore), Cobadex (Rs 31 crore), Zevit (Rs 22 crore) and Beplex B12 (Rs 17 crore). This segment has grown by 20.5 per cent in 1998. Pfizer is the leader in the segment with sales of Rs 78 crore and a market share of 21 per cent followed by Glaxo with sales of Rs 50 crore.

031008 Ranbaxy in Talks to Acquire Ind-Swift

Reportedly, Ranbaxy Laboratories is in talks to acquire Chandigarh-based formulations-manufacturer Ind-Swift. Ranbaxy is interested in a buy-out or a majority stake while the company is offering only a stake of between 15 per cent to 20 per cent. Ind-Swift's stock has risen on the Bombay Stock Exchange in anticipation of the acquisition.

031009 Cadila Healthcare Restricted in Using Promotional Material

A judgement has been delivered restricting Cadila Healthcare from printing, publishing, advertising and packaging the drug formulations Enalapril Maleate in a form identical to that of Envas of competitor Cadila Pharmaceuticals. Copyright infringement has been given as the reason for the restricting action. The companies were split into two four years ago.

031010 US Alleges $ 1 billion IPR Losses in India, Argentina

An aggrieved US has alleged that its pharmaceutical industry loses US$ 1 billion annually (Rs 4,000 crore) through patent violations in India and Argentina. The US is now threatening to use Super 301 as cudgel to warn potential investors that their intellectual property may not be safe in these countries.

This could affect Indian interests as traditional Indian medicines and plants have not yet been given patent protection. With the deadline for implementing trade-related intellectual property rights (TRIPS) closing (January 1, 2000) India has to act fast to patent its traditional medicines as after this deadline and implementation of the WTO regime traditional Indian medicines will be open to exploitation throughout the world. For example, a company in the US could patent an Ayurvedic medicine and obtain control over its marketing rights throughout the world. These issues will be discussed at the WTO meeting in Seattle.

031011 OPPI Recommends Electronic Lodgement Facility for OTC Products

The Organisation of Pharmaceutical Producers of India (OPPI) has suggested a computerised system that will enable the government to monitor over the counter products all over the country.

Named electronic lodgement facility (ELF), it will provide a data bank of every product by brand name which has been given OTC status along with data on safety, efficacy, quality and standardisation. The system proposes to connect all state drug controllers' offices with the drug controller general of India in New Delhi. Any company wanting to sell their products over the counter will have to first lodge it with the ELF. Such a system is in place in Australia and will curb spurious drugs which make unsubstantiated claims without containing any potential ingredients.