Friday, January 18, 2008

SLMC appalled at Health Minister’s threat

The Sri Lanka Medical Council (SLMC), the country’s apex body representing the medical profession, in a written communication to Health Minister Nimal Siripala de Silva has stated that it is quite in order for doctors to include the brand name of a drug together with the generic name. This is provided for in the cosmetics, Devices and Drugs Act of 1992, it said.

The letter, forwarded by the Council Registrar, Dr. N. J. Nonis, adds: "We are appalled that the Minister of Health should threaten doctors with imprisonment for prescribing drugs using their brand names. There are many crimes which may need imprisonment but this is not a crime and does not warrant such punishment. It is unbecoming for a Minister of Health in a civilized country to castigate doctors in this fashion."

The SLMC wrote to the Minister, subsequent to a statement made by him and broadcast on television that doctors who prescribe drugs by brand name would be imprisoned.

Dr. Nonis has told the Minister:

"When a doctor prescribes a drug, he must be certain in his own mind that the drug has the desired effect, without deleterious side effects. This responsibility cannot be delegated to the pharmacist. Who ultimately will take the responsibility? Will it be the prescribing doctor or the dispensing pharmacist or sales person? There is an acute shortage of pharmacists in the country and it would be still worse if the responsibility is given to an unqualified, unregistered person.

"Some generic productions may be as potent and safe as the original brand. A branded drug is manufactured in technologically advanced pharmaceutical industries at great cost. The parent company retains the patent rights for a few years and thereafter various pharmaceutical companies produce the drug at a lower cost. Hence, such drugs are cheaper than the original drug for which expenditure was incurred for research and development," he said.

"In Sri Lanka, there is no scientific evaluation of bio-equivalence of a drug in a laboratory in testing each and every drug imported to the country. To perform chemical analysis, quality assurance, bio-availability etc. would be a severe strain on the financial resources of the Health Ministry. Besides, highly trained persons and sophisticated equipment are required for all this. At present, only a few drugs can be tested for their quality and the above parameters.

"It is impossible for any authority or organization to determine the need for a drug. Medicine is a rapidly advancing science and new discoveries of drugs are highlighted in the medical literature every day. Further, even laymen, because of the easy accessibility of information are aware of new discoveries and indications. Is it fair to deprive a patient of such a discovery which often may be life-saving?"

"There are also drugs which cannot be written in generic names such as multi-vitamin tablets, compound preparations, paediatric preparations with a peculiar palatability and inhalers used in asthma. The quality of drugs also depends on transport, storage and shelf-life. Hence, all generic drugs may not be of equal efficacy."

"Before drastic changes to the present policy of drug prescribing, opinions of a broader section of the medical professionals including professional organizations and practicing doctors should have been obtained. We are of the opinion that it is quite in order for the brand name of a drug to be included along with the generic name as stated in the Regulations under the Cosmetics, Devices and Drugs Act published in 1992."

by Brian Tissera, The Island