The Health Ministry has issued withhold notices to hospitals regarding certain medicine following recent issues such as finding glass particles in medicine vials. An extensive examination is being carried out to make sure if the particular medicine is of good quality by an Experts Committee.
Following the committee report, the medicine will be used again or a withdrawal notice will be issued by the Health Ministry.
Addressing the media yesterday at his Ministry, Healthcare and Nutrition Minister Nimal Siripala de Silva said an extensive probe is being conducted regarding recent issues in the health sector such as the Rubella vaccine, discovery of particles in drug vials, reported in several hospitals throughout the country.
The Minister said all varieties of drugs are imported to Sri Lanka only after they are examined by an Experts Committee comprising professors, doctors and knowledgeable personnel in the health sector. Only drugs that are with the Health Ministry are imported to the country. Before registration, drugs have to undergo a series of tests conducted by the Experts Committee called Desk. The Committee looks into the quality, reliability of the producer and whether the drugs tally with the World Health Organisation (WHO) standards.
Similarly, the Rubella vaccine was also registered under the approval of the Desk and imported to the country by following an open tender procedure. The foreign manufacturer was a concern already approved by WHO. Not only our country but also many other countries including European countries import Rubella vaccine from the same manufacturer who supplies Rubella vaccine to Sri Lanka. However a death has been reported and a Ministerial inquiry is being conducted in addition to the WHO investigations into the death, Minister de Silva said.
A proper procedure is followed when importing medicine. Under this procedure, the medicine has definitely been registered in the country. After that a Technical Evaluation Committee will be established to look into the quality of the drug. The committee will conduct a sample checking process probably in two stages as basic sample checking and free shipment sample checking. At the free shipment sample checking process, a randomly taken sample is checked prior to shipment. All these measures ensure that the medicines imported to the country are not low quality or substandard, he noted.
Speaking on the manufacture and expiry dates mentioned on the container or on the vial, Epidemiology Unit Director Paba Palihawadana said there was no need of mentioning the manufacture date on the container or on the vial under WHO guidelines. Therefore the manufacture date is not mentioned on primary packages but the expiry date.
However in the future both manufacture and expiry dates will be clearly mentioned even on primary packages as advised by the Ministry to the manufacturers, Palihawadana said.