Vol. 5, No. 2 February, 2001

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It has been found that the nifedipine molecule, so far used to treat hypertension has some properties which can reduce heart attacks. Recent studies in cardiovascular drug therapy is targeting endothelium, the innermost lining of the blood vessels. Factors like hypertension, diabetes, lipid disorders, obesity and smoking induce adverse changes in endothelial tissue and thereby restrict the dilation of arteries. This leads to plaque formation and arteries become narrow leading to heart attacks. Nifedipine reverses this endothelial dysfunction and ensures proper dilation of arteries.

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Sun Pharma has launched Edegra, its equivalent of Viagra, the sildenafil citrate drug. It is available in dosgage forms of 25 mg 50 mg and 100 mg at Rs 12, Rs 18 and Rs 28 respectively. Aimed at treating erectile dysfunction other companies who have recently launched similar drugs include Torrent Pharma, Ranbaxy Laboratories, Cadila Healthcare and Unichem Laboratories.

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Wockhardt Hospital plans to commission two new cardiac hospitals by 2002 in Mumbai and Bangalore under the Wockhardt-Harvard Medical International alliance. These hospitals, equipped with contemporary facilities, will be much bigger than existing ones. The company has set aside Rs 300 crore for the project. Team medicine, the modern method of treatment gives extraordinary importance to nursing care and training facilities for nurses are being given due importance. Also envisaged is partnership between healthcare providers and insurance companies to take care of the cost of providing healthcare. In a managed care environment consumers can access medical services without paying for it. Harvard Medical International is a subsidiary corporation of Harvard University and draws upon the resources of Harvard Medical School.

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Kopran has tied up with E Merck to co-market rofecoxib, a new generation anti-inflamatory and analgesic drug. Kopran will market the drug as Zilflam while E Merck will introduce it under the brand name Acrobat. Kopran already co-markets the cardiovascular atorvastatin with E Merck.

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Indian herbal medicine is catching on in the west and Ranbaxy is not letting this opportunity go waste. Ranbaxy is contemplating the research and development route to develop new herbal medicines which is increasingly gaining acceptance abroad. Ranbaxy will also use its presence abroad to market these medicines there. The company has already sold the licensing right to its new drug to Bayer and is keen on extending its research and development activities into the herbal segment. Currently Dabur, Zandu and Himalayan Drugs are some of the companies exploiting the international market for herbal drugs.

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Following the take-over of Schein Pharmaceuticals by another generics company, Watson Pharmaceuticals, US, Ranbaxy has dissolved its joint venture with Schein. Ranbaxy Schein Pharma was a collaboration between Ranbaxy Pharmaceutical Inc. of the US and Schein Pharmaceuticals. Another Indian company, Dr. Reddy's also terminated its collaboration with Schein for bulk drugs and finished dosages. Ranbaxy has now initiated talks with customers and distributors to market its generic products like ranitidine directly. Dr. Reddy's is also contemplating on entering the market directly. Ranbaxy has two subsidiaries in the US, Ranbaxy Pharmaceuticals Inc and Ohm Laboratories Inc. through which it has notched up sales of $ 62 million in the calendar year 2000.

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Morepen Laboratories (sales: 332 crore) has tied up with the Swedish MiaMed (sales: 200 million) to enter the Indian diagnostic market. Morepen is the exclusive seller of DiaMed products in India. DiaMed specialises in laboratory diagnostic and blood transfusion products. Initially DiaMed will market a malaria diagnostic kit named OptiMal and a system for identifying blood groups and antibodies called ID Micro Typing System. Morepen will also manufacture these products in India depending on the demand. The company is expecting sales of Rs 30 crore from these products in the first year. These products will be marketed by a specially created diagnostic division of 30 sales people. DiaMed gets a royalty on sales and the government has waived import duty on these products. The malaria test OptiMal will deliver quicker test results for Rs 150 compared to Rs 70 to Rs 100 at present using other methods.

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ICI India which has a technical collaboration with Astra-IDL has given the no objection to AstraZeneca's acquisition of the Hinduja stake in Astra-IDL. The multinational AstraZeneca had proposed acquisition of IDL Industries' 25.75 per cent stake in the joint venture at Rs 670 a share. The FIPB has cleared the takeover deal.

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The UB Group is in talks with P Rajarathinam for takeover of its pharmaceutical subsidiary UB Pharma. Rajarathinam is know for his take over of Benares State Bank and Thungabhadra Sugars. The UB Group has a group of small pharmaceutical companies. However, it is not clear whether the deal is for the entire pharmaceutical business of the UB Group or just UB Pharma.

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Glenmark and Cipla have started marketing an obesity management drug at a fraction of the price of an imported equivalent. Sibutramine will be sold at Rs 15 per 10 mg capsule as against Rs 100 per capsule at which it is being imported by Knoll Pharma. Glenmark and Cipla has received the Drug Controller's go ahead to market the drugs in India. Cipla's brand is called Obestat and Glenmark's brand is called Sibutrim. This is yet another case of product patent being not valid in India and the same drug being manufactured by a different process as India only recognises process patents. Knoll is selling the drug under the brand name Reductil. Subutramine affects the appetite control centres in the brain and is used for patients with a certain type of obesity. Meanwhile Hoffman La Roche's obesity brand Xenical is expected to be launched in India by Nicholas Piramal.

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Zydus Cadila has entered into research collaboration with Danish biotech firm Pantheco. The three-year research and development agreement will focus on joint research in anti-bacterial compounds. Pantheco will profile the anti-bacterial drug candidates and carry out the pre-clinical and early clinical development studies. Each company will meet its own research costs. If a drug candidate clears the clinical trials the profits will be split equally among the two firms.

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Ranbaxy is in the process of talk to buy out the Speciality Labs stake in their joint venture Speciality Ranbaxy. Speciality Ranbaxy is Asia's largest pathological testing laboratory and is one of the few reference labs approved by the government. Reportedly the move has been initiated because of the US company's reluctance to bring in additional funds for expansion. Speciality Ranbaxy has a centralised testing laboratory in Mumbai and intends to expand into other cities in India and Asia.

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The Indian pharmaceutical industry is waiting for the 2000-01 budget with bated breath. On the cards are several expectation which naturally has been raised sky high. The pharmaceutical sector has been growing at 11 per cent per annum despite the occasional price cut by the regulators like NPPA. Another worry is the implementation of the WTO regime and product patents by 2005. Indian manufacturers will not be able to side-step product patent requirements by manufacturing drugs using a different process.

Expected is a revision in the DPCO (Drug Price Control Ordinance) with a reduction in the industry's turnover under price control. Currently companies with individual (for one drug) annual turnover of one crore rupees or more with 90 per cent or more market share and annual turnover of 4 crore or more and market share of 40 per cent or more come under price control. Price controls ordinances are unexpected and often arbitrary and the industry would like it to be more streamlined. Also the current 100 per cent mark up for DPCO drugs is expected to be increased to a better mark up for companies investing in research and development. In the last budget the finance minister had announced two committees to review DPCO but both committee's recommendations have not been implemented. A ten-year tax holiday for companies with the primary aim of research and development which have registered between April 2000 and March 2003 was also announced which is expected to be amended to include those companies who have invested in research earlier.

On the tax front exemption from tax is being sought for capital expenditure on land and building dedicated to research and development and cost of seeking international regulatory approval and milestone payments and royalty. This will benefit companies like Ranbaxy, Dr. Reddy's, Torrent, Sun and Wockhardt.

Another announcement being awaited with concern is the levy of duty on imported live-saving drugs 254 of which are exempt from duty at present. Local manufacturers are clamouring for at least a 16 per cent countervailing duty (equivalent to the excise duty) to be imposed on such imports. However there is no expectation of a drastic reduction in import duties. The ceiling on foreign direct investment (FDI) is supposed to be increased from 74 per cent at present to 100 per cent to attract more investments from multinationals. Also what is worrying industry innovators is the introduction of excise duty on maximum retail price (MRP) rather than on cost plus some margin at present. If excise duty gets paid on the MRP it could lead to manufacturers having to pay more. In short, the budget is full of land mines and unexpected panacea for the pharmaceutical industry.

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A Massachusetts Institute of Technology (MIT) team is in India to explore the setting up of the Indian equivalent of the US Media Lab that pioneered collaboration between industry and academia. Indian has been chosen in preference over China because of availability of trained manpower and research facilities.

Media Lab will focus on making sound education accessible to all children, providing latest public health tools and medical information to all and will have the knowledge, opportunity and access required to start and run their own small businesses. The team will visit Lucknow, Kanpur, Pune, Mumbai Chennai and Bangalore and meet the union IT minister. Later it will also meet the chief ministers of UP, Karnataka and Maharashtra.

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Zydus Cadila has set up a 24-hour medicine helpline at its headquarters in Ahmedabad. From this centre free medicine will be supplied to doctors, hospitals and voluntary medical organisations when the need arise. The helpline numbers are: Phone: 079 - 6770100 and Fax: 079 - 6732365/66.

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In a market dominated by off-patent generic products Indian drug manufacturers were so far marketing branded generic drugs. This was because the drugs were basically generic but given a brand name for easy recall by doctors. Also the manufacturer could add a small premium because it was a branded product. Now companies like Cipla, Alembic and Rhone-Poulenc with a strong stake in branded segment have come out with what are known as 'generic generic' products. These are unbranded, off-patents drugs which basically mean they are generic. Paracetamol is being sold as 'Paracetamol' instead of Crocin (the branded product). This could be a precursor to more of such drugs being available in the market.

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ORG-MARG has estimated that the Indian pharmaceutical industry has grown by 10.5 per cent due to the general slow down in the economy in the calendar year 2000. The value of sales is Rs 14,152 crore in 2000 compared to Rs 12,804 crore in 1999. The growth in 1999 was 10 per cent and this year has shown a very minuscule improvement of 0.5 percentage points. Though the growth was good between January and October 2000 (12 per cent) it became sluggish in the latter part of the year. However, ironically, there has been a considerable increase in volume of sales. GlaxoWellcome has grown at 6.9 per cent, Cipla has grown by 22.2 per cent, Ranbaxy has grown by 10.7 per cent and Sun has grown by 25.3 per cent in the calendar year. A slew of new products have also been launched. The industry is expected to grow from 11 to 12 per cent in the coming calendar year.

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