India’s regulated medical devices to further face price regulation
The Indian government collaborated with the National Pharmaceutical Pricing Authority (NPPA) to evaluate the pricing of medical devices that are regulated under the Drugs and Cosmetics Act. The most noticeable finding was that these regulated medical devices can vary drastically in terms of selling price.
Catheters were given as an example. Low value sophisticated catheters in India are currently priced at approximately USD $250, but the most expensive catheters are closer to USD $1,800. This trend in highly varied prices is quite common amongst the medical devices controlled by the Drugs and Cosmetics Act. The medical devices that are regulated under the Drugs and Cosmetics Act include orthopedic implants, stents, heart valves and more. Upon reviewing this finding, the Indian government is looking to address the price disparity.
Currently, the NPPA has been summoned to investigate medical device pricing outside of India. With that new information, the Indian government plans to create a new Schedule (i.e. government notice) to regulate medical device prices. India is still exploring the opportunities for comprehensive medical device regulation, so there is a chance that price regulations will not be effective until the overarching medical device Schedule is implemented.
China’s 2011 healthcare reform priorities
China continues to distribute the $125 billion of government funds that have been allocated for improving China’s healthcare. The priorities for this year will be improving public hospitals and providing better preparation to general practitioners, and healthcare improvements in the countryside.
Public hospitals have been a focus of the reforms since the beginning, but Vice Premier Li Keqiang emphasized that this year will be particularly focused on county-level hospitals. Since county-level hospitals cater to more than 900 million individuals, developing these hospitals will lead to a recognizable difference in the nation’s health. China also envisions significant growth in these county hospitals because they often provide health services at lower costs compared to large city hospitals.
China also intends to provide additional training to the general practitioners healthcare institutions below the Tier 3, 2 and 1 hospitals. This is the only component of the healthcare reforms that centers on developing technical skills rather than making structural changes such as building new hospitals. These "grass-roots" facilities serve a large number of rural citizens. The added training will lead to considerable increases in the nation’s well-being.
With the increased focus on suburban and rural health, China’s healthcare market is expected to grow substantially as more people obtain access to medical devices and drugs. In ten years, China’s healthcare market is expected to triple from the current estimate of over $200 billion to over $600 billion by 2020.
Upcoming change to Japan’s GMP compliance audit authorities
On January 19, 2011, newspapers in Japan published an announcement from the Ministry of Health, Labour and Welfare (MHLW) on an upcoming change to the good manufacturing practice (GMP) compliance audit. It had been previously announced that manufacturers creating products that are sold in Japan who have completed the first of their annual GMP audits with the Pharmaceuticals and Medical Devices Agency (PMDA) will subsequently be inspected annually by prefectural and city governments. This would be change from the current system where the PMDA conducts all of the initial and subsequent GMP audits.
The latest announcement explains that the transition to this new model will occur soon. Near the end of March, the Order for Enforcement of the Pharmaceutical Affairs Act will be revised. Following three months of preparation time, relevant notices will be released and implemented as of July 1, 2011.
The overall goal of this change is to shorten GMP processing time.
In Japan, GMP refers specifically to pharmaceuticals. Annual GMP audits have been required in Japan since 2005. PMDA Notification No. 1130005 was released on November 30, 2005, and it includes guidelines for GMP audits.
Singapore to merge medical regulations under Health Products Act (HPA)
Following its recent medical device regulation overhaul, Singapore’s Health Sciences Authority (HSA) is planning to carry out further adjustments to the nation’s medical regulations. At present, there are a number of different notifications that collectively operate to control the importation, sales and marketing of medical products in Singapore.
By mid-2011, the Health Products Act (HPA) will likely be the single source for regulations on medical products, ranging from poisonous items to cosmetics. Currently, the HPA only focuses on cosmetics and medical devices.
Along with this merge, other medical products that currently do not have a risk classification system are also expected to begin incorporating risk classifications.
Medical companies will need to follow these new Singapore regulations to be successful there. Regulations in Singapore are normally strictly enforced.
Ames Gross is president and founder of Pacific Bridge Medical, recognized nationally and internationally as a leader in the Asian medical markets. Founded in 1988 PBM has helped hundreds of medical companies with business development and regulatory issues in Asia. Contact PBM at info@pacificbridgemedical.com.
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