Upon the first approval of the Ministerial Cabinet in 1979, the appointed Thai Pharmacopoeia Committee has since carried out its tasks to establish the Thai Pharmacopoeia with the following major objectives:
a. to establish official standards for pharmaceutical products imported,
manufactured and sold in the country;
b. to develop more economical, yet reliable, methods of analysis
independent of sophisticated and more expensive instruments;
c. to serve as an official compendium to be recognized and used;
d. for use as a reference handbook for physicians, pharmacists and those in
the pharmaceutical profession.
Some changes are to be noted. The Thai Pharmacopoeia, second edition, or
TP II, combines monographs of raw materials and their pharmaceutical preparations in a single publication for convenience.
To fulfill the aforementioned objectives, the criteria for drug selecting and preparations have been revised to the following:
1. As some identical pharmaceutical substances and preparations listed inthe Pharmacopoeiae promulgated by Thai Minister of Public Health have different methods of analysis or standards, appropriate methods or their modifications are adopted to suit the Thai pharmaceutical industries.
2. Modern drugs which are not listed in the Pharmacopoeiae promulgatedby Thai Minister of Public Health will be considered based on one or more of the following criteria:
2.1 Medicines must be registered in Thailand in at least two categories, original and generic. Capability of local manufacturers to produce the selected preparations is also considered.
2.2 Medicines listed in the Thai National List of Essential Medicines, WHO Model List of Essential Medicines as well as medicines used in hospitals with high consumption are of priority.
2.3 Certain essential medicines which are not listed in the Thai National List of Essential Medicines, such as life-saving drugs, orphan drugs and antineoplastic drugs are also taken into account.
2.4 For medicines in the same category, only those with high consumption or high import value will be selected.
2.5 For medicines in the same category and with similar mode of action, only the items with top-ranking consumption will be selected. At least one preparation from each class will be considered.
2.6 For medicines with various dosage forms, only suitable dosage forms will be selected.
3. Herbal drugs, both raw materials and their preparations following thepolicy of the Ministry of Public Health, are considered.
4. The selected medicines must have sufficient scientific evidence andsupportive information to establish the monographs on such medicines.
5. Other pharmaceutical substances and preparations suggested by theSubcommittee on Drug Selection.
The appendices appeared in the Thai Pharmacopoeia II (2011) are only those referred to in the monographs; some appendices from TP I have been removed.
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