Governance Report 2011 - Transparency International Sri Lanka

Abstract - Regulating medical supplies in the health sector
Access to safe and affordable health care considered a basic need is assured
by various national and international mechanisms, with recognition that
robust systems of standards and regulatory mechanisms are vital. While the
World Health Organization has spearheaded the global movement for safer
and affordable health care, Sri Lanka has taken pioneering steps to ensure
that the health-care needs of its people are met.
This chapter highlights the positive features of the country’s health sector,
providing an insight into the overall framework within which it functions. A
policy framework, however, is useful if supported by programmes, guidelines
and enforceable laws.
The objectives of this chapter are to identify the scope and mandate of
different components of the regulatory system in the health sector, assess
their effectiveness while focusing on shortfalls that need strengthening and
also review the scale and operations of the supply of medicines to the public.
The National Medicinal Drug Policy (NMDP) has been adopted under which
the National Medicinal Drug Regulatory Authority (NMDRA) has been given
the mandate of regulating and assuring the quality of medicines.
Most medicines in pharmacies are imported and although importation is
regulated, the efficacy is very poor. Therefore, this chapter explores why there
is continued availability of substandard drugs and devices in the market,
despite the media highlighting this fact as well as a follow up being carried
out by the authorities on complaints. Taking into consideration affordability,
the chapter recommends the adoption of the United States Food and Drug
Administration standards until a reliable system of providing generic brands
is developed.
The role of the Sri Lanka Medical Council established in 1988 as the main
regulatory body of the medical profession and medical education is also
studied in this chapter which brings out the fact that the engagement of the
public in monitoring the regulatory system is marginal. The only civil society
organization focusing on this aspect is the People’s Movement for the Rights
of Patients.
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