Challenge No 3: Policy issues

Updated on 17 May 2012

Beijing adopted a model similar to Anhui in 2006, but abandoned it soon after since it met considerable resistance from regional medical facilities. After a three years pilot program, stakeholders in the healthcare system are questioning whether such the model should be adopted in other administrative regions.

Besides government tendering, Dr Bhuwnesh Agrawal of Roche Diagnostics says custom duties on healthcare products increase the cost for patients "who have to deal with emotional issues, health problems and also huge costs, pushing many below the poverty line". He suggests a waiver on duties to help reduce financial burden on patients and make healthcare more affordable.

Dr Mallik Sundaram, CEO, Mitra Biotech, India, has a similar view on costs. "High taxation for imported goods in India means most equipment that we use in our labs cost us almost twice as it does in the US."

Continuing to share trends in China on new GMP guidelines, Mr Ling Sun says, "In February 2011, the State Food and Drug Administration (SFDA) in China issued Order 79 on GMP for pharmaceutical products. These guidelines are the strictest in China's history, and will lead to major changes in the Chinese pharmaceutical industry."

According to him, "all new pharmaceutical manufacturing facilities must obey the more stringent standards, effective immediately, while existing manufacturing plants that produce sterile drugs, including blood products and vaccines, must implement the new standards and practices before the end of 2013". The new GMP guidelines will put great pressure on small- and medium-sized (SME) domestic drug manufacturers, which account for nearly 90 percent of the 5,000 pharmaceutical companies in China, he points out. "Furthermore, the SFDA made public statements warning that at least 500 SMEs will be shut down if they do not comply with the guidelines. As a result, it is expected that pharmaceutical companies will need to invest $ 31.6-47.4 billion ( CNY200-300 billion) to fully meet the new requirements."

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Randal Gates 20 June 2012 at 12 AM

It's interesting to hear about the pharmaceutical challenges facing other countries. Hopefully these new rules won't stress the Chinese and Indian working classes too much more. a href="http://www.cebos.com/quality-management-system/" quality Randal Gates /a

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