Introduction:
Although still heavily reliant on drug imports, Thailand’s domestic pharmaceutical market is steadily growing. The Thailand pharmaceutical market is currently valued at about $4.3 billion. The Thai generic sector is expanding as the government is encouraging the use of generic drugs over patented drugs to cut costs.
The Thai government is continuing to support the universal healthcare system in the country. Since April 2009, the government raised the per capita health expenditure budget from 2,202 baht ($74) to about 2,400 baht ($81) per capita. According to the World Health Organization, the total expenditure on healthcare was about 6.6% of Thailand’s GDP in 2010.
Pharmaceutical Laws and Regulations:
The legislative basis for Thailand pharmaceutical market regulation is the Drug Act BE 2530 of 1987. According to the Drug Act, medicines in Thailand are classified into two categories: modern drugs or traditional drugs. Revisions are currently being made to this Drug Act. When the changes become effective, many features regulating pharmaceuticals will be changed. Changes may include:
- drug types will be re-classified into 3 new categories: prescription-only, pharmacy-dispensing, and household remedies, instead of the original categories of modern and traditional medicines,
- manufacturers who are unable to adhere to the Good Manufacturing Practices (GMP) principles cannot proceed with pharmaceutical businesses,
- the Drug Committee will be authorized to withdraw any drug products if later evidence proves that the products are not scientifically effective.
Pre-Marketing Control: Licensing
The Thai Drug Control Division is the licensing and registration authority for the manufacturing, sale, and import of drugs. The Thai government requires that anyone who wishes to sell, import, or manufacture drugs into Thailand must obtain a license from the licensing authority. License applications must first be submitted, and facility inspections will then follow. If the inspection confirms that the applicant has met all requirements, then a license will be issued. Nine different types of licenses are currently issued and four of these licenses include:
- a Manufacturing License for modern medicines,
- an Import License for modern medicines,
- a Manufacturing License for traditional medicines,
- an Import License for traditional medicines, etc.
Drug Registration:
The drug registration process for Thailand ensures the quality, safety, and efficacy of the drugs being marketed in Thailand. A Product Registration Certificate is valid for 5 years after the issuing date. The registration process falls under 2 categories, which differ in degrees of control and dossier submission: 1. the registration of general medicines, and 2. the registration of Thai traditional medicines.
Traditional medicines are those, according to the Thai government, that are intended to be used in indigenous medical care as monographed in the official pharmacopoeia of traditional medicines. The control and registration of traditional medicines are generally less stringent than those for general medicines. There are over 2,000 registered traditional medicines in Thailand.
General medicines can be further defined by the following:
- Generics: only dossiers on product manufacturing and quality control along with product information are required for registration
- New Medicines: a complete set of product dossiers is required for registration
- New Generics: dossiers of bioequivalence studies in addition to the required dossiers for generics submission is required for submission
There is a two-year safety-monitoring program for new drug products. For at least 2 years, new drugs will be approved for use only in hospitals or clinics. Afterwards, safety reports are required to be submitted for consideration as to whether general marketing should be allowed.
Pharmaceutical Marketing:
For foreign companies who want to advertise their products in the Thailand pharmaceutical market, they need to have a Thai local agent. A Thai local agent, located in Thailand, can include:
- a subsidiary of the foreign company,
- an independent 3rd party agent, or
- a local Thai distributor.
In The News:
Merck:
In January 2011, the pharmaceutical company Merck & Co. and its Thai subsidiary have decided to use Thailand as its ASEAN hub for distributing chemicals and pharmaceuticals to neighboring countries. Once the ASEAN Economic Community is created in 2015, Merck Thailand, will distribute Merck products to Cambodia, Burma, and Laos. The company will also export its products to southern China as well as Vietnam.
Sanofi-Pasteur:
On June 11, 2011, the French drugmaker, Sanofi-Pasteur announced plans to launch its dengue vaccine in the next four years. The launch date of the vaccine depends on the clinical trial results. This is the first dengue vaccine to undergo advanced “Phase III” clinical trials. Approximately 4,000 children in the central Thai province of Ratchaburi are participating in the clinical research. Ratchaburi is one of the worst affected areas in the country by dengue.