JAPAN ISSUES NEW REGULATION TO DEVELOP GENERIC DRUG MARKET
Japan’s Ministry of Health, Labor, and Welfare (MHLW) issued a new regulation on September 22, 2005, which outlined changes in the drug application process for new generic drugs containing one active ingredient. The application will now require pharmaceutical companies that apply for approval of a new generic drug with one active ingredient to state the generic name of the drug, the active ingredient, dosage form, and quantity, as well as the pharmaceutical company name. The previous regulation only required the applicant to list the brand name of the drug, dosage form, and quantity.

Japan ’s generic drug market continues to lag behind that of the U.S. and Europe, due in part to Japanese people’s preference for brand name drugs and the perception that generic drugs are inadequate to their brand name counterparts. Moreover, some Japanese doctors are accustomed to prescribing brand name drugs and would prefer to endorse a widely known patented drug instead of an unfamiliar generic drug. When a doctor writes a prescription for a brand name drug, the pharmacy must issue the specified brand name drug. However, when a doctor writes a prescription using the name of the active ingredient, the pharmacy can choose from the generic drugs it has available. It is hoped that this regulation will help to increase awareness within the medical community that generic drugs contain the same active ingredients as brand name drugs, but cost significantly less. Eventually, both doctors and patients could be encouraged to use generic drugs.

Because the Japanese government is being confronted with rising medical costs, it is seeking lower-priced alternatives in medical care. It hopes to benefit from the new generic drug regulation through the increased usage and reduced costs of generics, as well as from the decreased usage of expensive brand name drugs.

INDIAN MINISTRY OF HEALTH ISSUES NOTIFICATION ON MEDICAL DEVICE REGULATION
In October 2005, the Indian Ministry of Health and Family Welfare issued notifications that essentially constitute the regulation of medical devices. The notifications amended the Drugs and Cosmetics Act of 1940 by reclassifying certain medical devices as drugs in order to bring them under the purview of the Drug Controller General of India (DCGI). S.O. 1468(E) specifies ten medical devices that will now be classified as drugs, while G.S.R. 627(E) specifies that those ten drugs must be licensed for manufacture, sale, or distribution by an approved central licensing authority.

Some of the ten in vivo devices initially included in the notification are stents, heart valves, catheters, intra-ocular lenses, bone cements, and hip and knee implants. Eventually, in vitro devices will also be included. In addition, special committees will be set up to evaluate and monitor device quality and to ensure that manufacturing processes and plants are in compliance with Indian Good Manufacturing Practice.

It is likely that the regulation of medical devices will be similar to the European model, whereby the manufacturer would determine the risk classification of its own device and then submit technical data for review. Following approval, the manufacturer would be subject to periodic surveillance and assessment of product’s production process, safety, and quality.

Until now, medical devices in India have largely been an unregulated industry. The push for these notifications arose after the Maharashtra Food and Drug Administration (MFDA), a state-level agency, refused to allow drug-eluting stents to be imported for sale in Maharashtra without a drug license from the DCGI. The MFDA clamped down on imports of the device after the discovery that illegal stents had allegedly been implanted into thousands of patients. During the ban, stents approved by the U.S. FDA or with European CE certification were permitted to be imported to treat current patients. The resulting uproar from the public and the medical community over the stent scandal is one of the key factors that compelled the Ministry of Health to address the need for regulation of medical devices.

CHINA ’S SFDA INTRODUCES PUBLICITY CAMPAIGN TO REDUCE FALSE ADVERTISING
China ’s State Food and Drug Administration (SFDA) initiated a publicity campaign on October 15, 2005, to decrease false and illegal advertising of drugs, medical devices, and health foods. The campaign, entitled “Care for Life and Health: Say No to False Advertisements of Drugs, Medical Devices and Health Foods,” is an initiative designed by the General Office of the State Council to assist the public in identifying misleading and illegal advertisements. False and illegal advertisements have been a significant and growing problem in China.

Through SFDA-sponsored activities, such as official information desks, media promotion, and distribution of publications, numerous SFDA departments will, at least in theory, provide the public with the resources to monitor drug, medical device, and health food advertisements so that illegal practices can be immediately identified and corrected. The campaign will also assist the media in revising its advertising methods and emphasize the necessity of ethical advertising practices.

MALAYSIA :  PROPOSED BILL TO REGULATE MEDICAL DEVICES UNDER WAY
A draft of Malaysia’s Medical Device Bill has been completed and submitted to the Attorney General for review, according to a statement made by Malaysian Minister of Health Dr. Chua Soi Lek in September 2005. One of the requirements in the proposed legislation, which is expected to be implemented from 2007, is the registration of all health care equipment with the Ministry of Health. Dr. Chua stated that although enforcement of the Medical Device Bill will not begin until 2007, voluntary registration of health care equipment would begin by the end of this year.  The proposed bill will apply for all medical devices within Malaysia.

Malaysia does not presently have a medical device regulatory authority and wants to implement a system that is in line with standards of other Asian countries.  Under the proposed bill, a supervisory body would be established within the Ministry of Health to ensure the safety of all health care equipment. The main responsibilities of this supervisory body would be to oversee the registration, enforcement, and monitoring of all laser and health care equipment.

PHILIPPINE GOVERNMENT INVESTMENT AGENCY TO PROVIDE FUNDING FOR LOW-COST DRUG PROGRAM
The National Development Corporation (NDC), the investment arm of the Philippines Department of Trade and Industry, announced in October 2005 that it would raise P100 million (approximately US$1.8 million) in funding for the government’s national drugstore program. Through this program, which is being implemented by the state-run Philippine International Trading Corporation (PITC), special “Botika ng Bayan” accredited drugstores will offer quality, low-cost drugs at discounted prices. The NDC funding will be disbursed to PITC Pharma, Inc., a recently established company that is majority-owned by PITC. PITC Pharma, Inc. will oversee the pharmaceutical marketing and distribution operations of the drug program.

Under the “Botika ng Bayan” program, PITC Pharma, Inc. will procure and source essential, low-cost drugs from local suppliers, as well as through parallel drug importation. It will then make these drugs available at “Botika ng Bayan” drugstores, which will sell the drugs at prices 30% to 50% lower than other drugstores. The drugs sold at these stores include antibiotics and medicines that treat asthma, hypertension, and diabetes. In addition, the pharmaceutical firm GlaxoSmithKline recently entered into an agreement with PITC to make its branded medication available at all “Botika ng Bayan” drugstores throughout the country. There are currently about 600 “Botika ng Bayan” accredited drugstores throughout the Philippines. PITC Pharma, Inc. is aiming for a target of 1,500 stores by the end of the year, and 3,000 by 2010.

The Philippines government is also close to establishing a new Drug Prices Regulatory Board that will control the high price of medicine. Three legislative measures addressing the high cost of medication in the Philippines have been gaining support in Congress and local governments in recent months. Filipino House Bill 3830 calls for the creation of a Drug Prices Regulatory Board, which will regulate drug prices, and House Bill 305 aims to lower drug prices through a more effective drug regulatory system. Also, House Bill 499 proposes the shortening of the time period of patent protection of pharmaceutical products from 20 years to 10 years.

The National Drug Policy Program of the Department of Health (NDPP-DOH) has conducted studies which show that the prices of drugs and pharmaceutical products in Philippines are among the highest in the ASEAN region. Through all of the initiatives discussed above, the Philippine government is taking active steps to achieve its goal of cutting drug prices in half by 2010. The Philippines government’s commitment to make low-cost medication available to the majority of Filipino citizens is outlined in its Medium-Term Philippine Development Plan for 2005 – 2010.