Medical Council backs doctors’ right to prescribe brands

The Sri Lanka Medical Council (SLMC), representing the medical profession, has told Health Minister Nimal Siripala de Silva the Council is of the opinion that it is quite in order for the brand name of a drug to be included with the generic name.

In a letter signed by Council Registrar Dr. N. J. Nonis, the Council has told the Health Minister that, “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 pharmacists. Who ultimately will take the responsibility? Will it be the prescribing doctor, or the dispensing pharmacist or sales person? There is a serious shortage of pharmacists in the country and it would be still worse if the responsibility is given to an unqualified, unregistered person.”

The Sunday Times FT in an exclusive report on January 6 highlighted the problems of the doctors and drug companies after the Health Ministry said drugs should be prescribed in the generic name only.

The forthright letter follows a decision take by the Council at a meeting on January 4 to write to the Health Minister regarding a statement made by him and broadcast on television to the effect that doctors who prescribe drugs by brand name would be imprisoned, according to a statement to the media issued by the Council.

“We are appalled,” the Council states, “that a Minister of Health should threaten doctors with imprisonment for prescribing drugs using their brand names. There are many crimes that may need imprisonment but this does not warrant such punishment. It is very unlikely that a Minister of Health in a civilised country would castigate doctors in this manner.”

The Council has pointed out that it has instructed doctors to follow the procedure of writing the generic name of the drug when prescribing with the brand name within parenthesis as required by regulations under the Cosmetics, Devices and Drugs Act published in the Government Gazette of 6th July 1992.

The Council has stated that while some of the generic products may be as equally 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,” the letter explains.

The Medical Council has also told De Silva that, “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 lay persons, 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 practising 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.”