Sri Lanka Orders Withdrawal Of Indian Vaccine

Sri Lankas premier medical body has recommended immediate withdrawal of a vaccine imported from India and the re-vaccination of over three million children who were earlier given doses of the drug that doctors have described as sub-standard.

The Government Medical Officers Association (GMOA) said the DPT vaccine (to immunise infants against diphtheria, tetanus and whooping cough) imported from India in 1996 was not only sub-standard but also purchased from a manufacturer not approved by the World Health Organisation (WHO).

This came to light when doctors found that there has been a manifold rise in cases of whooping cough, GMOA spokesman Ajit Amarsinghe said. In 1996 there was only a single case of whooping cough reported at the Lady Ridgeway Childrens Hospital in Colombo. But in the last three months alone, the number of cases shot up to 22, Dr Amarasinghe said.

 

Health Minister de Silva ordered that the entire quantity of the affected vaccines be discarded.

The whooping cough epidemic, which was almost eradicated with the help of a UNICEF programme from 1990 to 1995, is again on the rise. After UNICEF provided high standard vaccines free of cost during that period, the number of cases of whooping cough which was 271 in 1990 came down to 25 in 1993.

After the UNICEF programme was concluded in 1996, the DPT vaccine was imported by the State Pharmaceuticals Corporation (SPC). In 1996 there were 171 cases of whooping cough reported and the number is expected to increase this year.

The DPT vaccine was imported from the State Trading Corporation (STC) of India. The STC apparently supplied the vaccine which was manufactured by Haffkine Bio-Pharmaceuticals Corporation Ltd.

Attorney-at-law D A Wijewardene, appointed by health minister Nimal Siripala de Silva to inquire into the matter, handed over his findings to the Sri Lankan government yesterday.

Wijewardene said in his report that tender procedures were flouted by placing the order with the STC as the STC of India has not been approved by WHO and does not conform to the BP standards.

The report stated that the epidemiologist who inspected the vaccines had reported that The STC India has not been a WHO approved vaccine supplier and also has not supplied this item before. The epidemiologist observed doubts on the quality of the vaccine offered, the commission report said.

GMOA Secretary Amarasinghe said over two million doses of low standard triple vaccine were imported by SPC from the Indian supplier.

GMOA vice-president Dr Lakumar Fernando accused the SPC of flouting tender procedures when strict adherence to rules is essential on import of medicines and vaccines.

The SPC has violated the Cosmetic Devices and Drugs Act by importing the vaccine from a non-approved agency, Dr Fernando said. Normally the disease will be identified at the final stage and at that stage we cannot find a remedy to cure a patient. Whooping cough is one the dangerous diseases which needs vaccination in time.

Dr Fernando added that although the GMOA had to recommend re-vaccination, under the normal circumstances it is not done because it would not be good for babies as there would be side-effects.

The Island newspaper, in an editorial, said government officials should confess their errors, particularly when public health is concerned, instead of trying to find scapegoats.