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International Drug Regulatory Monitor. 1979 Jul; (74):3-10.The legal text of Pakistan's new rules for labelling and packaging drugs and a description of the Drug Act of 1976, establishing the government's regulatory powers and the administrative machinery for carrying out these regulatory duties, are presetned. The rules for labelling and packaging were developed in accordance with the WHO guidelines established in a symposium held the previous year. The rules went into effect July 1, 1979. According to the rules all labels must include 1) the registered name of the drug, or in some cases, the non-proprietary name recommended by WHO; 2) a description of all active ingredients; 3) the name and address of the manufacturer; 4) the drug license number; 5) the drug registration number; and 6) the batch number, expiration date, and retail price. Other provisions refer to requirements for 1) drugs intended for export; 2) drugs containing poison or alcohol; and 3) drugs fully prepared for treatment. Drug labels must contain, when appropriate, notification that the drug is 1) for external use only; 2) for veterinary use only; 3) intended for use by a government agency only; 4) intended to be used as a doctor's sample only; and 5) not sterile. Initials designating standards cannot be used unless the drug is in accordance with those standards. Under the 1976 Drug Act, the federal government has the power to regulate the import, export, and manufacture of drugs, and the provincial health departments have the power to regulate the sale, distribution, and storage of drugs. The federal government controls manufacturing practices through a licensing board, composed of members representing both the federal and provincial levels of government, and imported drugs must be registered with a board of medical and drug experts. The law is administered through a Drug Controller under the Director General of Health in the federal government and through assistant drug controllers in each province. The 1976 law also provides for inspection and laboratory services both at the federal and provincial level.
San Francisco, San Francisco Press, 1974. 292 p.Despite its high effectiveness, lack of side effects, ease of use, and low cost, condom utilization has declined in the U.S. from 30% of contracepting couples in 1955 to 15% in 1970. The present status of the condom, actions needed to facilitate its increased availability and acceptance, and research required to improve understanding of factors affecting its use are reviewed in the proceedings of a conference on the condom sponsored by the Battelle Population Study Center in 1973. It is concluded that condom use in the U.S. is not meeting its potential. Factors affecting its underutilization include negative attitudes among the medical and family planning professions; state laws restricting sales outlets, display, and advertising; inapplicable testing standards; the National Association of Broadcasters' ban on contraceptive advertising; media's reluctance to carry condom ads; manufacturer's hesitancy to widen the range of products and use aggressive marketing techniques; and physical properties of the condom itself. Further, the condom has an image problem, tending to be associated with venereal disease and prostitution and regarded as a hassle to use and an impediment to sexual sensation. Innovative, broad-based marketing and sales through a variety of outlets have been key to effective widespread condom usage in England, Japan, and Sweden. Such campaigns could be directed toward couples who cannot or will not use other methods and teenagers whose unplanned, sporadic sexual activity lends itself to condom use. Other means of increasing U.S. condom utilization include repealing state and local laws restricting condom sales to pharmacies and limiting open display; removing the ban on contraceptive advertising and changing the attitude of the media; using educational programs to correct erroneous images; and developing support for condom distribution in family planning programs. Also possible is modifying the extreme stringency of condom standards. Thinner condoms could increase usage without significantly affecting failure rates. More research is needed on condom use-effectiveness in potential user populations and in preventing venereal disease transmission; the effects of condom shape, thickness, and lubrication on consumer acceptance; reactions to condom advertising; and the point at which an acceptable level of utilization has been achieved.