Ban proposed on drugs having serious side effects

A society, which looks after the detection, assessment and prevention of adverse effects of drugs on humans, has proposed a ban on codeine--used to relieve cough and treat pain-- claiming that it has serious side effects.

Founder and patron of Pharmacovigilance India (SOPI) Prof. KC Singhal said that nearly a dozen drugs in India need deregulation but codeine sulfate (used in cough syrups and pain killers), which gets ‘converted into morphine’, needs to be immediately removed from the market.

"There are variations in each individual in conversions of codeine to morphine and each individual reacts differently. However, there is no facility in India to measure the enzyme which converts codeine to morphine. Excessive morphine in some individuals can be disastrous leading to several side effects including abnormal heart rhythms," he said, speaking on the sidelines of a conference on pharmovigilance.

"Painkillers and cough syrups containing codeine are unsafe, addictive, ineffective and should not be used by children," he warned adding that a Canadian Journal of Medicine in an editorial had even sought a ban on this drug.

Stressing on the need for imposing Pharmacovigilance stringently, Singhal said that unfortunately in India, there was no significance or importance attached for monitoring drugs that caused adverse reaction. Hence the Society for Pharmacovigilance was formed in 1980s with little support from Indian Council of Medical research. Eventually, the Indian government launched a national programme for monitoring drugs.

Based on the recommendation of SOPI, other systems of medicine have also been brought under monitoring. Initially it was thought that Ayurveda, Unani Siddhi and Homoeopathy drugs were safe and not harmful, but the Society convinced the authorities that there was a need for monitoring and so the Pharmacovigilance of Ayurveda Siddhi and Unani (ASU) drugs were formed.

“The World Health organisation has provided Rs 30 lakh for establishment of monitoring centres,” he noted.

Singhal said that many pharmacists and physicians are not ready to accept the side-effects of many drugs and most of them which have to be taken only with a prescription are available over the counters.

Realising the need for pharmacovigilance, the government established a centre for Adverse Drugs Reaction monitoring at Ghaziabad which has more than 60 centres. However, even though the reports on adverse reaction of drugs are analysed, the data is not disclosed as there is no proper central recording system. “The society has stressed on the need for regulatory measures and to release the data to public,” he said.

Singhal said that Society for Pharmacovigilance will be holding its 14th meeting on November 1-3 at Aligarh where the National President of The Indian Medical Association has been invited and several recommendations will be made to the government including request for regular meeting with experts who can analyse the data and publicly release adverse drug reaction report data. He also said that there was a need to energise these centres, besides imposing penalty on doctors and pharmacists for not reporting adverse drug reactions.