Vol. 4, No. 10 October, 2000

Calcium Sandoz will be turned into an over the counter (OTC) product by Novartis India. The brand is four decades old and is a household name. Its annual sales range around Rs 12 crore according to ORG-MARG and is growing at around 30 per cent. Research has indicated that making it an OTC product can increase sales. The puppy-shaped pack will be available in two sizes, regular of 30 tablets and an economy pack of 60 tablets. Two flavours of the chewable tablet is also being launched: ‘American Ice Cream’ and ‘Orange.’ The company can also promote the product through advertisements, which are allowed for OTC products.

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DRF 1042, Dr Reddy’s anti-cancer drug has been given approval approved for clinical trials by the Drugs Controller General of India (DCGI). The drug is the first from Dr Reddy’s research arm DRF to receive approval for clinical trials. Every drug has to be tested on human beings before being approved for safety and effectiveness. DRF’s anti-diabetic drug is already undergoing clinical testing outside the country in collaboration with Novo Nordisk, a Danish company. Besides Dr Reddy’s two other Indian companies conducting clinical trials are Ranbaxy Laboratories for a prostatic drug and Torrent Pharma for a cardio-vascular compound.

Phase one of the trials will be conducted in the Nizam’s Institute of Medical Sciences, Hyderabad and the Tata Cancer Hospital in Mumbai. According to the agreement with Novo, Dr Reddy’s will market the product in India while Novo will market it outside the country with a royalty being paid to the former. Dr Reddy’s will also earn a milestone payment from Novo for every phase of clinical trials completed.

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Nicholas Piramal has an arrangement with the government-owned Central Drug Research Institute (CDRI) to commercially exploit drug molecules researched by them. It has successfully commercialised the anti-malarial drug Bulaquin and is now in the process of acquiring two more compounds in the therapeutic segments of cardiology and diabetes for commercial exploitation.

The two compounds are in the final stage of clinical trials. The director general of the Council for Scientific and Industrial Research (CSIR), Dr R A Mashelkar has taken initiatives to ensure that there is increasing collaboration of this type between government-run research organisations and industry. The CSIR’s Centre for Biotechnology is also thinking of setting up two major facilities for pharmacogenomics as part of its alliance with Nicholas Piramal. Besides Nicholas Piramal is also conducting research in phytomedicine through the Quest centre acquired from Hoechst Marion Roussel. Two of this centre’s products – Rejoint and Ostop – have grossed over Rs 10 crore in the first year of launch.

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The Ranbaxy-promoted Fortis Healthcare (FHL) has tied up with two US-based hospitals to implement modern medical systems in India. Under the new alliance, FHL will act as an international scientific affiliate of Massachusetts General Hospital and the Birgham Women’s Hospital for collaboration on patient care and educational and medical research.

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Ranbaxy has entered into a marketing collaboration with Ajanta to market the latter’s natural products in countries of South-East Asia like Malaysia and Myanmar. The products include Carofit, a carrot-based anti-oxidant, the revitaliser Thirty Plus, skin toner Beauty Plus, liver protection Livo Plus, slimming agent Figurin and anti-inflammatory Rheumarub. Ajanta will sell the finished dosage forms to Ranbaxy which will sell these product abroad. This will be mutually beneficial as Ajanta will not incur any marketing costs and Ranbaxy can maximise its marketing and distribution infrastructure. This is Ranbaxy’s second such collaboration, the earlier one being with Knoll Pharmaceuticals to market its Digene, Epilex and Nausidome.

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The prescription-drug-company Kopran has decided to use the marketing muscle of its sister company Kopran Pharmaceuticals to market its over the counter (OTC) products. Kopran which markets the ‘Smyle’ range of products in India is utilising the infrastructure of its sister company to market to South Asia, the Middle-East, West Indies, Russia and UK. Kopran is also in the process of raising Rs 125 crore from investors to reduce its debt burden and expand the formulations business. It also proposed to spin off its speciality bulk drugs and diagnostics business. Earlier Kopran had launched the digestive Yum Tum.

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Boots Piramal, the joint venture between Boots, UK, and Piramal will market a series of prescription drugs from the BHI group company Hermal from next year. Hermal, Germany, is a company specialising in skincare.

Boots Piramal was supposed to launch the brands a few years earlier but the drug registration process had taken some time. One of the products being launched is Aknemycin, a treatment for acne. The range will also include treatments for dermatitis, scabies, sunscreens and moisturisers. Boots Piramal’s previous year’s business was split between prescription and OTC products like Strepsils, Icy and Sweetex. The company is also in the process of bringing BHI’s ibuprofen brand Nurofen into India provided the government allows it to be switched to the OTC category. Nurofen is the OTC version of the painkiller ibuprofen which is also sold in prescription form as Brufen by Knoll.

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The pharmaceutical industry feels that the constant changing of ministers at the centre can hamper reforms and issues like paring of drug price controls, giving incentives to original research and preparing or a product patent regime. Suresh Prabhu, till recently minister for chemicals and fertilisers has been shifted to the power ministry. This is the second time in three years that the ministry has seen a change of minister. Mr. Prabhu was putting the finishing touches on a new drug pricing policy and was working on the criteria for disbursing Rs 150 crore for research and development when he was shifted.

The government had instituted two committees nearly two years ago to make recommendations on reducing price controls and formulating a policy on research and development. However, the new minister will have to be educated fast on the issues before he can take decisions. Industry representatives have swung into action and are setting up meetings with the new minister.

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October 5. The Indian Prime Minister has invited foreign direct investment (FDI) in the pharmaceutical and petro-chemical industries and said that India offers world-class production facilities at one-tenth the cost in advanced countries. He has also announced that the government has set up a Rs 1.5 billion fund for research in pharmaceuticals. He has also announced that the government has set up task-forces on infrastructure, knowledge-based industries and finance sectors.

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The alliance of major Indian pharmaceutical companies, The Indian Pharmaceutical Alliance (eight major Indian companies including: Ranbaxy, Dr. Reddy’s and Sun Pharma), has submitted a detailed note to the government suggesting modifications to the drug policy. The note contains recommendations like paring the number of drugs under price control and establishing an independent regulatory authority for the pharmaceutical sector.

Instead of the price control regime the alliance has offered to supply drugs at a discount to the public distribution system and bear the subsidies. This way the drugs will be available at a discount in the public distribution system and the cost of this will be offset by higher prices in the market. The IPA has also included guidelines for clinical trials on new chemical entities and the time period for evaluating the results of different phases of clinical trials of a drug. The IPA has suggested that if there is a delay in assessment by the clearing authority the applicant should automatically be allowed to go ahead to the next phase of testing without delay.

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Henceforth pharmaceutical multi-nationals setting up wholly-owned subsidiaries in India may be exempt from manufacturing drugs from its basic stage. The policy is awaiting clearance from the Cabinet Committee on Economic Affairs will also lead to changes in the foreign direct investment policy.

The proposal comes after the multi-national Pfizer sought permission for contract manufacturing of drugs in its newly set up 100 per cent subsidiary. Hitherto drug multi-nationals were allowed to set up units if they manufacture drugs from the basic stage. Pfizer sought to manufacture five drugs including Sulbacum, Slucanzole and Droloxylene and permission was granted to them in December last year on the basis that they will manufacture from the basic stage. Pfizer is believed to have gone back to the ministry seeking a cancellation of the condition and allowing it to sub-contract manufacturing to another entity.

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The Indian pharmaceutical industry is aiming to capture 20-25 per cent of the world generic market by 2010. D S Brar, CEO and managing director of Ranbaxy Laboratories, stated this at the India-Chem ’00 conference. At present India supplies $ 30 billion worth of generic products to the global market which has potential for growth. India has an advantage in terms of volume and price. The Indian industry has potential to develop as an out-sourcing destination for manufacturing, research and development, marketing and general administration.
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The current bloodbath in stock markets has witnessed erosion of market capitalisation of pharmaceutical stocks by 35 per cent. This is after these stocks have dominated the market during the boom days. Over the past seven months the market capitalisation of 71 actively traded pharma stocks have plunged 35 per cent or by around Rs 18,000 crore. Four pharma stock (Dabur India, German Remedies, Knoll Pharma and Wockhardt) from the specified group hit their 52-week low recently.

Recently the government expanded price control to several formulations used for treating asthma, malaria and allergy. Reportedly this is believed to have led to an adverse reaction from the market.

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