The new patent regime has infused a fresh vigour into the country's drug discovery research. With the product patent era in force, not only the top notch firms in India but a good number of mid-cap players also have made a strong foray into drug discovery and related research disciplines by rising their R&D outlays considerably.
The focus is to meet future challenges of globalisation and patent regime by concentrating more on research & development (R&D) activities. The investments in R&D will help to accelerate efforts towards development of new chemical entities, new drugs delivery system and generics products. To overcome the stiff competition in the international as well as domestic market, the Indian companies are investing huge amounts to launch new innovative drugs.
Though the Indian companies are relatively new entrants into R&D area, these companies are taking advantage of availability of excellent talent pool in the country. This will help them to launch new upgraded and cost-effective drugs in the markets. The Indian companies have already established their brand image and giving a tough time to international giants.
The major drugs companies have stepped up their investments in R&D during last couple of years. For instance Dr Reddy's Laboratories, the largest investors in R&D as per cent of sales in India, has incurred R&D expenditure of Rs 184.20 crore during the nine months ended December 2004. This worked out to 15.3 per cent of it net sales of Rs 1202 crore in the first nine months of current year. The largest Indian pharma entity, in terms of net sales, Ranbaxy pushed its R&D spending to Rs 327 crore for the year ended December 2004. Similarly, Lupin, Nicholas Piramal, Sun Pharmaceutical and Torrent Pharmaceuticals spent Rs 55 crore, Rs 39 crore, Rs 52 crore and Rs 36 crore respectively during the first nine months of 2004-05.
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Several other leading companies like Wockhardt, Orchid Chemicals, Cadila Healthcare, Aurobindo Pharma, Ipca Laboratories, Glenmark, JB Chemicals, Suven Life Sciences, etc. are spending huge funds on R&D. The Indian companies are also in tie-ups with international giants in R&D area to get early results.
The government is also helping pharmaceutical companies by offering several concessions. The department of Chemicals and Petrochemicals is planning to set up a National Mission to boost the R&D activities and exports of pharmaceutical segment. This will help Indian pharma companies to turn India into a global research and development hub. The department of Science and Technology has a pharma R&D fund of Rs 150 crore. Further, the Commerce and Industry ministry has already been identified pharmaceutical sector as athrust area.
Indian companies are increasing their presence mainly in antibiotics, vitamins, cephalosporins, cholestrol reducers, anti-acne and anti-infectives. They triumph in having the highest number of DMFs approved by USFDA and also filing more such applications in Europe. Cadila Healthcare has filed 13 ANDA upto October 2004 and planning 13-14 more in the year 2004-05. The company is planning to increase its R&D spending from 6.5 per cent of total sales to 8 per cent of total sales by 2007.
Recently, Ranbaxy Laboratories has received tentative approval from the USFDA for Donepezil hydrochloride, a medicine used to treat Alzheimer's disease. Hikal Ltd, a Rs 160-crore Mumbai company, has also received USFDA approval for it two drugs viz., gabapentin, an epilepsy drug and bupropion HCl, an anti-depressant drug.Torrent Pharmaceutical has entered into a major strategic R&D alliance with AstraZeneca to develop a novel drug candidate for the treatment of hypertension. Natco Pharma, a Hyderabad based company, has launched Rizatriptan tablets in 5 mg and 10 mg dosage under the brand name Ritza for migraine. Zydus Cadila Ltd also introduced a new drug pitavastatin to control cholesterol recently. A team of USFDA has visited Orchid's formulations facility at Chennai. It has filed 7 ANDAs coveringthree antibiotic products in the cephalosporin family.
Sun Pharmaceuticals has spent so far Rs 300 crore on R&D. Its R&D expenditure is around Rs 75 crore in the current year with active programmes in drug discovery and dosage form development. Nicholas Piramal is focusing on low-cost R&D for the development of new drugs. It has set-up a new Rs 100 crore R&D center at Mumbai to undertake all the stages of drug development, including clinical trials indigenously. Biocon, a Bangalore based company, is developing oral insulin in collaboration with a US biotech firm Nobex Corporation. The collaboration would combine the company's peptide production capabilities with Nobex's peptide oral delivery techno-logy. It is mainly focusing on insulin-based molecules. Biocon has already entered supply arrangement with Bristol-Myers Squibb for the supply of its r-human insulin. The company launched Insugen, a branded human recombinant insulin.
Dishman is investing Rs 100 crore for expansion and a new R&D centre at its Bavla facility in Gujarat. Its R&D Lab is likely to be operational shortly. The company has around 150 research projects in hand. Lupin has filed two ANDAs, four DMFs with USFDA and one COS with the EDQM during the first nine months of current year. The company filed so far 25 DMFs with USFDA.
The R&D expenditure of 15 top Indian companies increased by 56.5 per cent during 2003-04 to Rs 1053 crore as against Rs 672.98 crore in the previous year. This worked out to 6.85 per cent of the total turnover.
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