Pharmaceutical Technologist - March 2008 - (Page 23)

Q&A are interested in setting up businesses here. The biggest advantage for India is its strong base of technical skills. There is a huge number of pharmacy graduates and engineers, and many of them speak English, which is an added advantage in R&D, manufacturing and QA/QC. Indian institutes, such as the Indian Institute of Management and the Indian Institute Of Technology, are held in high regard by other leading business schools worldwide. It is estimated that 15% of research scientist in US MNCs are Indian. Many of these are now returning to India because of the country’s strong potential. More and more outsourcing jobs are coming to India and everyone in the country wants to be part of the pharmaceutical growth. People feel this is a growing sector and are investing in stocks of companies such as Ranbaxy; DRL, Sun; Cipla; Zydus; Aurobindo; Lupin; Elder; and Glenmark. People have high expectations from the industry and appreciate the efforts of Indian companies to become global players. Goldman Sachs has projected that India will be third largest super power after China and the US by 2050. Most MNCs have already been operating in India for many years. Now, they have also transferred their outsourcing to Indian companies, as the country offers: ● cost-effective operations ● cheaper skilled workers ● knowledgeable scientists ● English language ● IPR protection. Custom manufacturing for innovators stands out as most attractive proposal for outsourcing. The same can be said for R&D and clinical trials. The Indian pharma industry is evolving into a global player by adopting global regulatory standards. There has also been a paradigm shift in the quality of medicines during the last decade — from testing to total cGMP compliance. India’s drug controller general is making efforts to ensure compliance by acting as a facilitator. India now has the largest number of FDA-approved sites (more than 100 in 2007) after the US. What are the lessons Indian companies can learn while setting up facilities in Europe and the US? It is essential to have a thorough knowledge of regulatory requirements. There are two types of major operations: marketing and manufacturing, each of which must possess a strong regulatory and quality team to ensure compliance. It is imperative to remember that these markets have a population that is aware of its needs and quality standards — care must be taken to ensure patient safety and product quality. In addition to cGMP, manufacturing plants must comply with environmental protection requirements, employee safety regulations, and good packaging, warehousing and distribution systems. In Europe, imported batches must be retested locally before they are released onto the market. This makes the effective monitoring of outsourced or in-house testing facilities crucial. ADR monitoring and compliance is also a necessity. Regulators must be informed of any ADRs recorded in time-bound programmes. There are many instances of FDA issuing 483 observations to US companies because the latter fail to monitor or share ADR information with FDA. The case is similar in the EU. Regulators are very strict and particular in these areas. Validation of transport system is also important, and an added advantage while working in these regions. Finally, proper documentation as evidence of compliance is a must. Which areas of industry (e.g., generics, biopharmaceuticals) do you see as key growth areas and why? In my opinion, generics will have a huge share of the market. During the next 3–5 years, more than 30 different products will lose patent protection. This is a big opportunity for generic businesses. Sales of generics are growing in all major markets across the world. The US generic market is projected to grow from $16 billion in 2005 to $30 billion in 2010; western Europe from $10 billion to $15 billion; and world market is likely to reach $94 billion. More and more outsourcing jobs are coming to India and everyone in the country wants to be part of the pharmaceutical growth. If we look at the Indian scenario, approximately 25% of abbreviated new drug applications (ANDA) filed in the US are by Indian companies. For example, Ranbaxy Laboratories ranks highly amongst global generic companies in terms of sales and is ranked much higher in the number of US ANDA filings. API filings are driven by India and China, but by the end of 2005, India represented 43% of drug master file filings in the US. The global generic business as a whole has a great future. PT What advice would you like to give to the next generation of pharmaceutical scientist? Based on my 38 years of industrial experience, I would suggest that new scientists be: ● More and more knowledgeable. ● Innovative in their use of technology. ● Be transparent in their work. ● Focus on quality of work. ● Proactive. ● Able to play the role of enabler and team builder. They should also keep in mind that the “patient’s safety is the ultimate goal”. www.ptemagazine.com 23 http://www.ptemagazine.com

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Pharmaceutical Technologist - March 2008 Contents News Morpheus Market Watch E-procurement Means Lean Procurement The Rational Enquirer Simulating for Success Q&A

Pharmaceutical Technologist - March 2008

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