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Startling disclosure on Drugs Authority : running without funds for 23 years

The health care system in the country we know is in the hands of the medical and the nursing professions mostly and also the medicinal drugs play no small part in this scenario.

Last week health page was invited to attend a seminar on the Drugs Authority - The theme was - Do we need a National Drugs Regulatory Authority. what was disclosed at this seminar organised by the Sri Lanka Association for the Advancement on Science (SLAAS) in relation to the Drugs Authority was so unbelievable and shocking we thought of mirroring in this page a few of the disclosures for the public to know so that the Authorities would not hesitate to take remedial action for the public good.

Dr. Lucian Jayasuriya former Additional Secretary Ministry of Health and presently Medical Advisor Glaxosmithkline said the DRA, the country's drugs regulatory authority, a very responsible body in the maintenance of health care since its inception 23 years ago has been running without funds - (a separate vote) with the Ministry meeting its financial needs from the Ministry miscellaneous vote.

Dr. Jayasuriya said "the strange thing here is that this pennyless DRA having no vote of its own earns a massive Rs. 34 million annually by way of registration of drugs and pharmacies, which all go to the consolidated fund.

It was also revealed in the course of the discussion that the DRA had to request a pharmaceutical firm to make rubber stamp it wanted as it had no money to pay for it. Also the Authority had to seek the help of the private sector recently to provide labourers and even a vehicle to transport its files from the Ministry to the Family Health Bureau.

Such being the plight of this Authority, the remedy he said is to make it a statutory body under the Ministry so that it can function more authoritatively with an independent budget and staff of its own who would remain permanently attached to it. In 1997 the then Minister of Health A.H.M. Fowzi appointed a Five Member Committee to examine the need to set up an autonomous National Drug Control Authority, the Committee comprising Dr. Lucian Jayasuriya, Prof. Colvin Goonaratna, Prof. Anoja Fernando, Dr. Desmond Fernando, Dr. Reggie Perera (present Secretary Ministry of Health Welfare and Nutrition) and Mr. S.A.C.M. Zuhyle stated.

A. H. M. Fowzie, Minister of Health, Highways & Social Services appointed a committee to examine the need to set up an autonomous National Drug Control authority and, if such a need is justifiable, to propose a model. The Committee consisted of: Dr. Lucian Jayasooriya, Prof. Colvin Goonratna, Prof. Anoja Fernando, Dr. Desmond Fernando, Mr. S. A. C. M. Zuhyle.

Dr. Reggie Perera was also later appointed to the Committee.

The committee studies the available documents and publications,the functional limitations in the powers and implementation of the present Cosmetics, Devices & Drugs Act and its overall structure, and the regulatory authorities in other countries such as India, Indonesia and Bangladesh. The committee also obtained the services of a consultant from the World Health Organization.

According to the existing Act, the Director General of Health Services is the Drug Authority with provisions to delegate his powers and authority. There are limitations in this Act such as lack of clarity and specificity with regard to the duties and functions of various bodies and its management. There are also certain ambiguities with regard to the powers and responsibilities of the Minister, the Director General of Health Services, the Director, Medical Technology & Supplies to whom the functions have been delegated by the Director General, the Drug Evaluation Sub Committee (DESC) and the Technical Advisory Committee (TAC).

Another limitation in the existing system is the delegation of the powers of the CDD Authority to Director, Medical Technology & Supplies. At his level and grade it is not possible to deal effectively to recruit and train staff, acquire equipment, disburse funds effectively and implement decision without going through the hierarchy of more senior public officials. The DESC practically functions at the Medical Faculty of the Colombo University which comes under the Ministry of Education. As a result, there are certain communication limitations between the two Ministries. Furthermore, the authority of the Director for enforcement is fragmented with the majority of enforcement officers coming under the control of Provincial Directors of Health.

The National Drug Quality Assurance Laboratory is under-utilised. The Director, National Drug Quality Assurance Laboratory is at the same level of seniority as the Director, Medical Technology & Supplies and as such it is difficult to establish a line of command.

According to the existing act the TAC is an advisory body to the Minister. In fact it has become a decision-making body. Further the key members of the DESC, such as the Professor of Pharmacology of the Colombo University and the Director, Medical Technology & Supplies, are also members of the TAC.

The present functioning of the Drug Authority has many weaknesses; inadequacy of professionally trained staff (eg: Pharmacists and Clinical Pharmacologists), shortage of logistical facilities; absence of a comprehensive surveillance programme; weak enforcement programme of retail outlets; lack of drug information centers etc.

The WHO consultant identified some of the weaknesses and recommended three phases of development.

The first phase is to strengthen the present system with the establishment of a new Department of Drug Regulatory Control headed by a Director, Drugs Control at the level of a Deputy Director General of Health Services, secondly to elevate him to a Drugs Controller General and the third phase is to set up an autonomous authority. The committee thought it would not be practical to establish new cadre posts and departments within the existing Department of Health in a short period of time, and it will be difficult to dismantle them after one or two years.

Hence the committee decided to propose a semi-autonomous authority with a Board of Directors consisting of 21 members nominated by various bodies, to function within the Ministry of Health, but independent of the Department of Health.

The committee discussed the draft with professional medical associations, University Departments of Pharmacology and Pharmaceutical Traders' and Manufacturers' Associations, obtained their views and accommodated their views in finalising this draft Act to establish a National Medicinal Drug Authority.

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Nicorette Chewing Gum : The drug that helps quit smoking

by W. A. Karunaratne

A very exciting product is now in the market, called Nicorette chewing gum. It serves as an adjunct to smoking cessation therapy. Smoking is one of the causes of disease. It has been established beyond reasonable doubt that smoking causes cardiovascular disease, coronary heart disease, angina, peripheral vascular disease, aneurysm of the aorta, and respiratory diseases such as chronic bronchitis, emphysema and lung cancer.

Further, it can be responsible for causing cancer of the mouth, throat, gullet, pancreas, kidney and bladder, as well as peptic or duodenal ulcers. therefore, people should take heed, and try every means available to them to give up smoking.

Cigarette smoking is an addiction and dependent on the nicotine that is in tobacco. It is a very tenacious habit which is often associated with the social behaviour of people at work, at play and at meal times. It may also have an emotional aspect and become a ritual.

Nicorette chewing gum contains nicotine, which is a powerful poison. Therefore, it has to be used in the form of a chewing gum which liberates nicotine in small doses.

Historical note

The idea of using, nicotine to help smokers quit the habit originated in 1968 when two Swedish physiologists brought the concept to a chemist working for a pharmaceutical manufacturer in Helsingborg. This chemist was a heavy smoker who was unable to quit smoking. So he was intrigued with the idea of using nicotine to quit smoking. Over the next seven years, he and his colleagues worked out a system of binding nicotine into a chewing gum with an ion-exchange resin that released nicotine at a slow rate when it came into contact with saliva. Since nicotine penetrates the mucous membrane of the mouth only in an alkaline medium, antacids were included to permit the nicotine to be absorbed. This formula began producing astounding results.

Clinical trials of nicorette were carried out in several countries. The use of it in conjunction with counselling, increased the initial quit rate of smokers by 47 to 90 per cent, when compared to controls given placebos.

Clinical trials have been carried out successfully in Sri Lanka. Very heavy smokers who smoked over 50 cigarettes a day have completely given up smoking by using nicorette.

Help from doctors needed

In other countries surveys have shown that 9 out of 10 smokers would like to give up this habit if there was an easy way out, and millions have tried to give up the habit at least once. They have had little help from doctors so far. In Sri Lanka many doctors have given up smoking which is a good example,. Doctors have a powerful influence on patients, therefore, they should take the trouble to give brief advice and help on a routine basis to those who smoke. They should also advise them on the use of Nicorette to help them give up smoking.

Precaution

Every patient cannot use nicorette chewing gum. It is not recommended for heart patients, or those who suffer from peptic ulcers, or for pregnant women. Since nicotine enters breast milk the doctor will have to decide whether it should be given to nursing mothers.

Method of Treatment

A number of experiments have shown that nicorette is most effective if it is used for 16 weeks. Anyone starting on nicorette should quit smoking cigarettes entirely, since the chewing gum will relieve the physical withdrawal symptoms. Cutting down on cigarettes merely prolongs the agony. A nicorette tablet should be chewed slowly for about 30 minutes whenever there is the urge to smoke. This enables one to extract sufficient nicotine at a rate that will permit it to filter through the mucous membrane. The average quitter will use about 10 tablets a day. The maximum number of tablets taken should not exceed 30 a day.

The dose should then be gradually reduced so that by the end of 14 weeks the number of tablets taken should not be more than three a day, making it easier to stop completely by end of 16 weeks.

Sri Lankan Family Physician, 1985, 8, 53-54

Further advice and information on quitting smoking can be obtained from Sri Lanka National Federation on smoking and health No. 1, Dias Place, Pepiliyana Road, Nugegoda.

A reader from Matara Somapala Liyanage has sent this article on Nicorette Chewing Gum who has given up smoking. We have sent it to Dr. Dennis J. Aloysius in our medical advisory panel for observation. While we await his views on this article which had been published in Sri Lanka Family Physician in 1985, we would like to get the views from the medical profession on this.

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What a woman looks up to in a man

This is generally for the young men who are looking out for marriage. Just see how far you measure up to the qualities which a woman generally expects in a man with whom she wants to get married, as given by Dr. M. Zakir Molvi of Pakistan in his book on Marriage and Marriage problems for use in this page.

Under the heading - Man's lovable qualities he writes:-

"What most men believe is true that a woman usually falls for a man who is handsome, romantic, powerful on a glamorous showman of art screen, or sports. She may have a go even at a boaster who may superficially impress her. These qualities in a man stand out for initial romantic attraction.

However, love differs from romantic attraction in that, instead of a few apparent physical or social attributes, the whole personality of the other person is loved with consistency. Any of the above qualities is no bar to a woman's love they may rather prove to be an added attraction.

A woman loves a man who is self assured, sincere, trustworthy and respects her as a person and does not consider her a mere sex object. She wants to love to be loved. It is neither glamour or riches nor good looks that generate love. Only love breeds love, which glows even after initial passion fades.

We at the Health would like to hear from you, what you think about Dr. Zakir's views expressed in this article. Please write to co-ordinator Health Daily News, Lake House, Colombo Fax 429210.

Next week: Dr. Zakir on what a man looks up to in woman he wants to marry.

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