manual on management of drugs

CHAPTER 2
POLICY FRAMEWORK
1.The Government of the Democratic Socialist Republic of Sri Lanka
undertakes to provide free health care services to every citizen in the country.
Primary Health Care is the key approach to attaining this goal. The supply of
essential drugs is a major element in this approach.
2. (i) Cosmetics Devices and Drugs (CDD)Act
The Cosmetic, Devices and Drugs Act No. 27 of.1980 (as amended by Act
No. 38 of 1984, No. 25 of 1987 and No 12. of 1993) provides the legislative
framework to control the use of cosmetics, medical devices and medicinal
drugs in the country. The regulations under the CDD Act were published in
Gazette Extraordinary No. 378/3 of 02/12/1985 and further amendments were
made from time to time.
The Act controls:
(a)Registration
(b)Manufacture
(c)Importation
(d)Transportation
(e)Sale ( Retail and Wholesale )
(f)Labelling
(g)Advertising
(h)Distribution of drug samples
(i)Testing
(j)Disposal of outdated or spoilt drugs
Steps are being taken to amend the existing Act to strengthen the areas such
as clinical trials, neutraceuticals, dietary supplements and functional foods.
(ii) Poisons, Opium and Dangerous Drugs (Amended) Act.
Poisons, opium and dangerous drugs ordinance (Chapter 218) as amended by
Act No 13 of 1984 regulates,
(a)Importation
(b)Storage
(c) Distribution and
(d) Use
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