Pharmaceutical Technologist - November 2007 - (Page 34)

INNOVATION Multicard and polytalented The future innovators of India Profile: Cadila Pharmaceuticals Ltd Cadila Pharmaceuticals Ltd (Ahmedabad) is long established in India and could soon make global headlines. Established in 1951, the company has transformed into a vertically-integrated, multidisciplinary player with a strong emphasis on R&D — the field that makes India such a promising territory for the future of the global life sciences industry. From APIs to machinery, finished dosages and vaccines, Cadila has developed an intuitive approach to what is required from the industry today. It is, therefore, unsurprising that contract research and manufacturing (CRAM) activities have been added to its list of capabilities. Indravadan A. Modi, the company’s chairman, explains that Cadila’s “CRAM activity is nascent. We have three small ongoing projects, all involving foreign partners. We have also just entered an agreement with one of the multinationals to develop two new generic products.” This illustrates once again the rapid rise in interest on the part of multinationals to the cost and time-saving opportunities held in India. Cadila is a good example of a company that has successfully managed the transition into the post-2005 patent regime. It opens the doors of its formulation units to foreign companies and is making a point of respecting intellectual property, said Dr Bakulesh Khamar, Cadila’s executive director for research. Although Cadila’s profile is largely in generics, it is investing heavily in R&D to develop a hybrid profile and to bring new chemical entities to the market, in particular in the field of adjuvants. The company is also working on drug delivery systems. Recognizing the dual nature of his organization, Khamar adds: “We support the large generic companies as far as APIs are concerned and work in partnership with them, but today we also have a platform to work with the innovating companies on a partnership model.” Cadila is representative of various players that may soon bring additional value to the industry, both locally and globally. Modi, who has been at the forefront of the sector as president of the Indian Drug Manufacturers’Association (IDMA) and chairman of the Basic Chemicals, Pharmaceuticals, and Cosmetics Export Promotion Council (CHEMEXCIL), has been credited many times over for his belief in the strength of the public–private partnership and the positive impact of the 1970 Indian Patents Act on the industry. Today, he aims to provide a clear international approach to his organization and is proud to point out his company’s five abbreviated new drug applications with FDA. The applications will be followed by two or three more this year, and as many as six in 2008. Meanwhile, on the API front, Cadila, under the leadership of Rajiv Varma, president of the company’s API business, has 15 drug master files and will be submitting 10–12 per year. It seems clear, therefore, that Cadila’s dynamism isn’t about to wane — rather, Cadila is a company to watch. PT Indravadan A. Modi Made-in-India Excellence: Dabur India’s oncology market isn’t one of the big sectors in the pharmaceutical industry, but rather a specialized, niche market. With two finished-dosage form plants and one active pharmaceutical ingredient plant in India, plus a finished-dosage form plant in the UK, one particular company does, however, stand out. Dabur (New Delhi) has the critical mass required to be a global player. CEO Ajak Vij is clear on what’s at stake: “For any serious pharmaceutical company, it is important to be operated on a global scale. Also, the US represents 50% of the global pharmaceutical market, while Europe represents 25%. Together, they represent 75% of the global market. Can any manufacturer afford to stay away from them?” he asks. Dabur is working hard to find its place in the sun: it recently launched a novel drug delivery system product, and has a pipeline of new drugs coming to the deregulated markets, plus some existing products for regulated markets. The company has filed nine abbreviated new drug applications in the US and has more pending. When approaching regulated markets, challenges differ widely, explaines Vij: “In the US, challenges are to be able to bring the first products upon patent expiry and to be amongst the first players to have their products approved by FDA. In Europe, it is to put together a good commercial system, which will serve the European market in its diversity.” Already marketing its medicines in Thailand, the Philippines, the CIS region, Russia, and Latin American countries, Dabur recently opened an office in Fort Lauderdale (FL, USA) and is about to launch products in Europe. When asked about the challenges faced by the industry at large, Vij answers: “Challenges for the Indian industry are twofold: as the industry is growing on the back of a strong demand, the temptation for smaller players to use shortcuts is great. Meanwhile, price erosion is taking place, and at the back end, costs are increasing. So, the first challenge is to maintain consistency of quality and keep the reputation of the industry. The second challenge is to live with the growing competitive pressure on all markets, and make the most out of this stimulant.” 34 November 2007 l pharmaceutical technologist

Table of Contents Feed for the Digital Edition of Pharmaceutical Technologist - November 2007

Pharmaceutical Technologist Contents Editor's Comment News Morpheus Feeling the Pressure Legal Crusaders The Holy-Grail of Start-Up Biotech Special Feature Q&A

Pharmaceutical Technologist - November 2007

For optimal viewing of this digital publication, please enable JavaScript and then refresh the page. If you would like to try to load the digital publication without using Flash Player detection, please click here.