¹ Fuchs VR. Who shall live? New York, Basic Books, 1974. Quoted in: Grabowski HG & Vernon JM. The regulation of pharmaceuticals: balancing the benefits and risks. Washington, DC, American Enterprise Institute for Public Policy Research, 1983.

² Penn RG. The state control of medicines: the first 3000 years. British journal of clinical pharmacology, 1979, 8:293-305.

³ Lasagna L. The pharmaceutical revolution: its impact on science and society. Science, 1969, 166(3910): 1227-1233.

⁴ Lee PR & Herzstein J. International drug regulation. Annual review of public health, 1976, 7:217-235.

⁵ Dukes G. The effect of drug regulation. A survey based on the European Studies of drug regulation. Lancaster, UK, MTP Press Limited, 1985.

⁶ Silverman M, Lydecker M & Lee PR. The essential role of the government. In: The prescription drug industry in the third world. Stanford University Press, Stanford, California, 1992.

⁷ Chapman RA. Development of a national drug control agency: need, legislative authority, organization and operation. Geneva, World Health Organization (unpublished document PDT/76.1).

⁸ Grabowski HG & Vernon JM. The regulation of pharmaceuticals: balancing the benefits and risks. Washington, D.C, American Enterprise Institute for Public Policy Research, 1983.

⁹ Hodges M & Appelebe GE. Control of the safety of drugs, 1868-1968 (part I). The pharmaceutical journal, 1987, August 1, 119-122.

¹⁰ WHO. The rational use of drugs. Report of the Conference of Experts. Nairobi, 25-29 November 1985. Geneva, World Health Organization, 1987.

¹¹ WHO. World Health Assembly 39.27: The rational use of drugs. Geneva, World Health Organization, 1986.

¹² Jayasuriya DC. Medicinal products regulation in developing countries: concepts, issues and approaches.(unpublished document).

¹³ Inman RP. Market, governments, and the “new” political economy. In: Auerbach AJ & Feldstein M, eds. Handbook of public economics, vol. II. Elsevier Science Publishers, 1987.

¹⁴ Lexchin J. Interactions between physicians and the pharmaceutical industry: What does the literature say? Journal of the Canadian Medical Association, 1993, 149(10): 1401-1407.

¹⁵ Chen MM, Landefeld CS & Murray TH. Doctors, drug companies and gifts. Journal of the American Medical Association, December 22/29, 262(24):3448-3451.

¹⁶ Kennedy hearings say no more free lunch - or much else from drug firms. Journal of the American Medical Association, January 23/30, 265(4):440-443.

¹⁷ Two US clinical researchers indicted. Scrip, 1998, 2262:63.

¹⁸ US researcher sentenced in fraud case. Scrip, 1998, 2299:12.

¹⁹ WHO. Use of the WHO Certification Scheme on the quality of pharmaceutical products moving in international commerce. Geneva, World Health Organization (unpublished document WHO/DAP/94.21).

²⁰ WHO. Report of the informal consultation on the control and safe trade in starting materials for pharmaceutical products, 25-27 May 1998. Geneva, World Health Organization, (unpublished document).

²¹ Lexchin J. Pharmaceutical promotion in the Third World. The journal of drug issues, 1992, 22(2):417-453.

²² Lexchin J. Canadian marketing codes: how well are they controlling pharmaceutical promotion? International journal of health services, 1994. 24(1):91-104.

²³ Office of Technology Assessment, Congress of the United States. Drug labeling in developing countries. Washington, DC, US Government Printing Office, 1993 (document O-330-066:QL3).

²⁴ Silverman M. The epidemiology of drug promotion. The international journal of health services, 1977, 7(2): 157-166.

²⁵ Herxheimer A, Stålsby Lundborg C & Westerholm B. Advertisements for medicines in leading medical journals in 18 countries: a 12-month survey of information content and standards. International journal of health services, 1993, 23(1): 161-172

²⁶ Health risks made in Germany: grandfather drugs. Buko pharma news, 1996, 1:1-4.

²⁷ WHO/Ministry of Health, Bahrain. Proceedings of the Eighth International Conference of Drug Regulatory Authorities (ICDRA), Bahrain, 10-13 November 1996. ‘ Geneva, World Health Organization, 1997, (unpublished document WHO/DMP/ICDRA/1997.1).

²⁸ Jayasuriya DC. Regulation of pharmaceuticals in developing countries: legal issues and approaches. Geneva, World Health Organization, 1985.

²⁹ The Network Association for Rational Use of Medication in Pakistan. Openness in drug regulation. Newsletter of The Network Association for Rational Use of Medication in Pakistan, 1998, 7(1): 10.

³⁰ Rizvi M. Special report. The rescue act. The news on Sunday (Pakistan), August 9 1998.

³¹The Medicines and Allied Substances Control Act, Chapter 15:03, August 1997. Zimbabwe.

³² FDA salaries and expenses. Scrip, 1998, 2348:15.

³³The National Drug Policy and Authority Statute, 1993. Uganda.

³⁴ World Bank. World development report 1997. The state in a changing world. New York, Oxford University Press, 1997.

³⁵ Grabosky P & Braithwaite J. Of manners gentle. Enforcement strategies of Australian business regulatory agencies. Melbourne, Oxford University Press, 1992.

³⁶ Ayres I & Braithwaite J. Responsive regulation: transcending the deregulation debate. New York, Oxford University Press, 1992.

³⁷ Lexchin J & Kawachi I. The self-regulation of pharmaceuticals: initiatives for reform. In: Davis P, ed. Contested ground: public purpose and private interest in the regulation of prescription drugs. Oxford, Oxford University Press, 1996:221.

³⁸ Official communication with the Royal Pharmaceutical Society of Great Britain, 24 September 1998.

³⁹ Society consults widely on proposed new disciplinary legislation. The pharmaceutical journal, 1998, 260:622.

⁴⁰ Réseau Médicament et Développement, 1992-1993, unpublished studies.

⁴¹ WHO. La qualité des médicaments sur le marché pharmaceutique africain. Etude analytique dans trois pays: Cameroun, Madagascar, Tchad. Geneva, World Health Organization, 1995 (unpublished document WHO/DAP/95.3).

⁴² Stenson B, Tomson G & Syhakahang L. Pharmaceutical regulation in context: the case of Lao People’s Democratic Republic. Oxford, Oxford University Press, 1997.

⁴³ Bremer K. Financial and managerial plan for the Food and Drug Quality Control Centre of Lao People’s Democratic Republic. 1998 (unpublished document).

⁴⁴ Chounlamountry K. Drug control system in Lao PDR. Presentation at the Interregional Workshop for Decision-makers on Combating Counterfeit Drugs, 3-5 November, Hanoi, Vietnam, 1997 (unpublished document).

⁴⁵ Fernandez A, Galang R & Rago L. Evaluation of the WHO Computerized Drug Registration System. Mission report 17 July - 19 August 1997. Geneva, World Health Organization (unpublished document).

⁴⁶ Wondemagegnehu E. Report of the assessment of the problem of counterfeit drugs in Myanmar and Viet Nam. 1998 (unpublished document).

⁴⁷ Mantik RFB. Review of drug inspection procedure and implementation of good manufacturing practices in pharmaceutical industries: Bangladesh, Myanmar, Nepal and Sri Lanka. Assignment report, 26 March - 6 June 1997. New Delhi, World Health Organization Regional Office for South-East Asia, 1997 (unpublished document SEA/Drugs/121).

⁴⁸ Van Truyen T. Governmental drug quality control system - an important factor in combating against counterfeit and sub-standard drugs in Viet Nam. Presentation at the Interregional Workshop for Decision-makers on Combating Counterfeit Drugs, 3-5 November, Hanoi, Vietnam, 1997 (unpublished document).

⁴⁹ Mantik RFB. Mission report in Viet Nam. (Undated, unpublished document.)

⁵⁰ Fefer E. Drug regulation in Latin America. Drug policy issues, 20 March 1996.

⁵¹ Ivanov K & Persson H. The pharmaceutical study of Pakistan. Technical report: findings and recommendations. Vienna, United Nations Industrial Development Organization, 1993 (unpublished document DP/ID/SER.A/).

⁵² Medicines Policy of the Dutch Ministry of Health, Welfare and Sport, October 1997.

⁵³ FDA Thailand. FDA Thailand, 2^nd ed. Nonthaburi, Thailand, The Office of Food and Drug Administration, 1995 (TC - 95-01).

⁵⁴ Official communication with the National Drug Authority of Uganda, 21 October 1998.

⁵⁵ Information posted at the Medicines Control Authority (United Kingdom) Website at http://www.Open.gov.uk/mca/mcahome.html, 1998.

⁵⁶ US Food and Drug Administration. The Food and Drug Administration Modernization Act of 1997. Section 406(b): Communicating with our stakeholders.