Quality control of essential drugs.

1106 Vol 350 • October 11, 1997 3 WHO. Management Sciences for Health in Collaboration with World Health Organization Action Programme on Essential Drugs. In: Management drug supply. Hartford: Kumavian Press, 1997. 4 Market News Service. Pharmaceutical Raw Materials/Essential Drugs, International Trade Centre, UNCTAD/GATT in collaboration with the World Health Organization. August, 1997. Indeed, WHO’s guidelines on good manufacturing practices and procurement recommendations endorse this principle. The MNS does not promote individual suppliers in the newsletter, but clearly states that “information on the exact source” is available from the seller to subscribers who use the contact service. WHO condemns the sale of outdated products. The MNS prefers the current edition of pharmacopoeias, but specifications based on the previous edition are acceptable as a transition measure. This practice reflects the constraints of equipment, reagents, and training requirements for new tests. The practical implications of this approach vary according to the individual product. For example, you cite the use of the 1988 British pharmacopoeia (BP88) standards for rifampicin. Yet for rifampicin, as for many other drugs, BP88 and main edition BP93 standards are identical. Irrespective of which edition of a pharmacopoeia is used, the products themselves should be of recent manufacture. WHO guidelines on good manufacturing practice and WHO’s certification scheme provide specific measures to prevent the use of outdated and substandard ingredients. Contrary to the suggestion in your editorial, WHO contends that the production of essential drugs is appropriate only when drug quality can be assured. A producer who is unable to confirm the quality of raw materials as well as finished products should not be producing pharmaceuticals. The MNS was established as an information service. To address the issue of drug quality, WHO actively works with countries to strengthen the quality assurance capacity of national authorities and improve adherence to good manufacturing practice. Specific initiatives have also been undertaken in such areas as control of counterfeit drugs and certification of pharmaceutical raw materials. Since its inception in 1992, the MNS has evolved in light of comments received from MNS subscribers, WHO governing bodies, WHO experts, external evaluators, industry, and other concerned parties. WHO cannot accept the suggestion that the organization is anything but fully committed to promoting improved drug quality.