Pharmaceutical Technologist - March 2008 - (Page 22)

Q&A ● results. These trials will improve understanding of diseases, and link genomic and clinical data. Predictive medicines are likely to be in the form of vaccines. Compliance monitoring will become more prominent, which will be in the interests of patient safety. Companies will employ new technologies in manufacturing, R&D and QC to personalize monitoring as a value added service to patients. There is still much to do, but, in my opinion, the Chinese pharmaceutical industry is taking the necessary steps to improve the situation. ● ● New technologies will drive R&D, and there will be a focus and more stringent clinical evaluation of molecules and products. During the last decade, many products have been withdrawn from the market because of ADRs. In the future, all aspects of safety will be critically studied before a product is launched. Greater international regulatory cooperation will help regulators share safety and efficacy data, and it is likely that a global regulatory system will be formed. This will help the Industry as there will be a quicker approval process. It will reduce the cost of regulatory compliance, and products could also be launched faster. doing an excellent job by introducing initiatives to educate the industry and simplify operations. Initiatives such as QRM and PAT have set the standard for compliance in the industry. Various agencies are cooperating more than ever, which will lead to further improvements. Personally, the industry would appreciate a global regulatory cGMP system. Today, various agencies have different requirements and it is time consuming and expensive to cope with the mixed demands. If agencies could speed up review and inspection processes, it could mean the faster approval and launch of a new product. Current approval time is 15–24 months, which can be reduced to 12–15 months. Harmonization in data requirements, batch requirements, stability batches and CTD formats would also be very much appreciated. What are your thoughts on China and the issues surrounding its pharma industry? I must admit that China is a great country to be reckoned with. Western countries are flooded with products that are made in China, mainly because of the attraction of cost-effectiveness. During my last visit to China I was surprised by the positive changes that had been made. The Chinese government has been trying to put the industry on the right path through tax and R&D incentives. China used to be known for its traditional herbal medicines, but this label is changing. Many multinational companies (MNC) are opening businesses in China for advantages such as tax and R&D incentives by the Chinese government. However, China needs to ensure compliance with international standards. Experts have expressed many concerns regarding the quality of Chinese products because of the country’s good clinical practice and ethical standards. This is now changing for the better as more and more companies are ensuring compliance. There is still much to do, but, in my opinion, the Chinese pharmaceutical industry is taking the necessary steps to improve the situation. Another concern in China is the lack of intellectual property rights (IPR), which is a common scenario in other Asian countries as well. However, China may address this because of mounting international pressure. Other than China and India, who do you think will be main pharmaceutical players? Many local companies have growth at the top of their agenda and are now seeking global operations and MNCs to extend their presence in the Asian region. China and India are two of the most attractive locations for expansion, with Singapore, Indonesia and South Korea next in sight. Singapore is poised to become a leading country, mainly because of stronger IPR record. It also has a proactive government policy that aims to support the pharma industry. Indonesia is not far behind and will maintain growth pace. There are many players in the Asian markets who are searching for more merger and acquisition (M&A) opportunities. Ranbaxy Laboratories and Dr Reddy’s are examples of successful global players, and they are continuously looking for acquisitions. Similarly many other Asian companies are also moving towards acquisitions. South Korea is also favoured because of its strength in the biopharma industry and its API manufacturing facilities. Meanwhile, the South Korean FDA is taking steps to strengthen its regulatory compliance, and is moving towards compliance of lCH norms as well. What is the feeling in India regarding its domestic pharma industry? I am proud of India’s growth. The world is looking at India as a strategic partner and many investors Your expertise is in regulatory and QA. What suggestions would you have for agencies such as FDA/EMEA to promote a global outlook? Regulatory agencies are already The benefits of PAT ● ● ● ● ● Reduction of waste, such as reworking, rejections and reprocessing. Optimizing use of equipment for higher productivity. Improved speed of operations. Timely in-line analysis. Consistency in manufacturing. 22 MARCH 2008 PHARMACEUTICAL TECHNOLOGIST

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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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