manual on management of drugs

(Medical Technology & Supplies) No 120, Norris Canal Road, Colombo 10.
(Tel: 011-2695173, 011-2687743, 011-2687744, Fax: 011-2 2689704, Email:
cdda@health.gov.lk ).
8. Registration of Drugs
Registration of drugs is one of the main functions of the CDDA. The first step of
drug registration procedure is the evaluation of the manufacturer for compliance
to Good Manufacturing Practices (GMP) standards. Applications for registration
of drugs are accepted only if the production facilities of the relevant
manufacturer conform to required standards of GMP. Evaluation of foreign
manufactures is done by evaluating their company profiles while local
manufactures are inspected by a team of officers attached to the Office of MT&S
and the National Drug Quality Assurance Laboratory (NDQAL) for GMP
compliance. Every foreign manufacture has to appoint an agent in Sri Lanka
who is responsible for registration and other activities related to their products in
Sri Lanka.
The manufacturer should submit registration applications to the Office of
D/MT&S through the local agent along with samples for quality testing. The
DESC comprises of specialists in medical and pharmaceutical fields and,
administrative sector of the Ministry of Health makes recommendations on
registration of drugs. Quality, safety and efficacy are considered as the main
criteria for registration. The DESC makes use of the WHO GMP certification
scheme on the quality of pharmaceutical products moving in international
commerce to assess GMP standards and registration status of the product in the
country of manufacture. Approval of the product for registration or refusal of the
same by the D/MT&S is based on the recommendations of the DESC. The
registered drugs are entered in a register maintained at the D/MT&S office and
periodically published through government gazette notifications. Work pertaining
to drug registration is carried out at the office of the D/MT&S with the assistance
of the NDQAL.
9. The operational policies adopted by the government to ensure adequate supply of
essential medicines to all patients seeking care at government institutions are:
a) Procurement of drugs which are registered with the CDDA based on their
generic names, wherever generic names are available;
b) To encourage local manufacturers to produce essential Medicines within
the country in a phased manner subject to their techno-economic feasibility
and granting a duty free concession for all raw material used in their
pharmaceutical formulations and 20% rebate for locally manufactured
products;
c) Development and periodical revision of a List of Essential medicines for Sri
Lanka with separate lists for different levels of health care institutions
depending on the services provided and facilities available.
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