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Asian regulatory update: Indian medical device manufacturers push for changes

Fri, 05/28/2010 - 10:39am
Mass Device

A group of Indian medical device manufacturers is lobbying for changes in the current duty structure on medical devices, currency stability, cheaper credit for exporters and greater representation of their interests in a medical export council.

Pacific Bridge logoThe All India Medical Devices Industry wrote a letter to the commerce and industry minister of India in February 2010 proposing that either the Pharmexcil (an organization representing pharmaceutical exporters) broaden its scope to include the interests of the medical device industry, or a new Medical Export Promotion Council be established.

Local medical device manufacturers also recommended that medical devices across all Indian states be subject to a standardized value-added tax. This uniform tax could decrease market distortions, because each state has a different VAT that are currently present in the medical device industry in India. In addition, they urged the government to stabilize the currency. Since the medical device industry in India is centered on exports, the local manufacturers are often vulnerable to currency fluctuations that inhibit their ability to engage in long-term contracts.

Furthermore, the medical device manufacturers suggest that the government offer cheaper credit for exporters, which would allow them to become more competitive in the industry. Lastly, the medical device manufacturers are lobbying for reform in the current duty system that appears to favor imports.

China SFDA hosts meeting of U.S.-China Joint Commission on Commerce and Trade

The U.S.-China Joint Commission on Commerce and Trade's Pharmaceutical and Medical Devices Subgroup meeting took place April 13 in Chengdu, China. The Director General of the Dept. of Medical Devices in the SFDA, Wang Baoting, presented on the SFDA's efforts to finalize "The Supervision and Administration Measure of Medical Devices." This measure outlines the responsibilities of various medical device regulation agencies and is slated to be published later this year.

Wang stated that a Center of the Medical Device Standards Administration will be established. This Center will research standards systems, focus on device classification, and supervise standardization committees.

The Director General also reported that the SFDA has had an increase in capacity and in staffing given the increase in regulations and in medical device imports.

At the meeting, the Medical Device Task Force discussed requirements on clinical trials, country of origin registration, combination products, and classification of diagnostic imaging equipment and IVDS. For each of these agenda points, the Director General Wang answered questions from US medical device industry experts about the complexities and problems that arise from existing regulations The Director General stated that these concerns would be taken into consideration as medical device rules and regulations are drafted.

China issues priorities for national healthcare reform

Last month, the Chinese government announced sixteen new priorities of the ongoing Health Care Reform. These priorities draw attention to public hospital reform, medical insurance, and essential drugs. They will take top precedence from April 2010 until the end of March next year.

There are two priorities with regards to hospital reform. The first is to reduce drug price markups at hospitals by providing government subsidies. The second is to create a system called the DRG (diagnosis related group) to rein in medical expenses on more than forty types of diseases.

Priorities for medical insurance reform include higher reimbursement rates for both urban and rural residents under their respective insurance programs for inpatient expenses. The government is also pushing to reimburse patients at the time of discharge, as opposed to making delayed reimbursements. In addition, greater government subsidies will be allocated towards cases of leukemia and congenital heart disease in children.

Priorities for essential drug reform include pushing the SFDA for a rise in production standards for all types of national essential drugs. Additionally, a National Development and Reform Commission is being tasked to examine the market supply and demand of essential drugs and adjust respective prices accordingly.

The Philippines cracks down on drug price reduction violations

The Philippine Dept. of Health has found that more than 100 drugstores and hospital pharmacies have not been complying with the price reduction programs that were established in August 2009.

The Government Mediated Access Price (GMAP) and Maximum Drug Retail Price (MDRP) programs were set up to increase accessibility of affordable medicines to the poor. The first round of price cuts took place in August 2009, and a second round in March 2010.

Secretary of Health, Ms. Esperanza Cabral, has since warned drugstores and hospital pharmacies that continued defiance of the price cut programs would result in penalties. Cease and Desist Orders, and fines ranging from 1,000 to 50,000 Philippine Pesos (20 to 1,000 USD), were issued to drug retail outlets that were in violation of the MDRP and GMAP this April. Repeated violators could face up to 5 million Philippine Pesos (100,000 USD) in fines.

Vietnam officials meet to curb rising drug prices

In April 2010, various officials of the Drug Administration Agency, Ministry of Health, and drug companies met in Hanoi to have a discussion on the rising cost of drugs in Vietnam. In recent years, there has been growing public outcry against the price increase. The public claims that low income patients are currently unable to purchase essential drugs. However, even after this meeting, the government still offers no solution.

The Vietnamese government passed a law on drug prices five years ago. Because drugs are traded goods, their prices are determined by the market. Government policy cannot control drug prices. Some officials argue that drug costs are in fact stable when compared to other goods in the consumer price index. Others, such as the Vice Chairman of the Committee on Social Affairs at the National Assembly Office, called for the government to control at least several hundred essential drugs. The public currently uses more than 20,000 different kinds.

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