Justice is Everywhere

The justice system in Ancient China was simple and practical. Back then each town will have its own court. This is followed by provincial court and then of course the equivalent to the Appeal Court in Malaysia the Ministry of Justice or something like it at the Ancient China Capital (Peking.. Beijing.. not really sure ;>). The highest authority however is the Emperor himself who can give Royal Pardon to any accuse. But what make this really interesting is that the Town Courts presided by magistrate. These town judges who often would be appointed by the government will conduct hearing right in the middle of town. They start by announcing impending trials by hitting the drum or wooden sticks to the floor. Here is when the court gates will be open to the public and everyone can enter and hear the proceedings. Next the accuse is brought before the judge. Any complainant and witness alike would have to show respect the court or else the judge has at his disposal an array of punishment like slapping the mouth and flogging the backside finger clamps and even leg clamps. The plus point for this is that the members of the public present in the court will know about what constitute an offence under the Empire law and what's the punishment. These very people will then leave the court and spread the court's happenings by word of mouth. This way the community that reside in that town will be informed. With time however this method is super seeded by technology and the power of the media. Currently the media play a major role as the eyes and ears of the public to report court cases. Cases dealt with in the interior district needs media exposure to spread awareness especially to the people that reside in that district. Such cases like the following news clipping is for the people of Kudat and Kota Marudu. Parting message.. justice is everywhere..

Our Reach is Far and Wide

If the particular shop is situated far from the main towns and it's dealing with scheduled medicine, we will hunt them down diligently. It doesn't mean that all the 12 of us is not enough to go around the state. Even if we are overwhelmed with the task at hand, we always have the public to work and cooperate with us. The case above involve a grocery shop in Membakut. It is the same old story of possession for sale of scheduled medicine. Mind you the shop had Dexamethasone (a steroid) and Sulfanilamide (an antibiotic) in stock. Wonder how many Ben Johnson's (no offence there Ben...) and super bugs that they have produced in Membakut....

Selling of Medicine Without Prescription

In Malaysia it is an offence to sell controlled medicine (CM) without a valid prescription. This applies to Group B CM (e.g. anti hypertensives, antibiotics etc.) even for a Pharmacy or from the dispensary counter at a medical clinic without direct consultation from a registered medical practitioner. Such act not only exposes the buyer to health risk but has a wider bigger impact to the general population like antibiotic resistance. As reported in a newspaper, an accused found out the hard way...

We do The Talking via Our Action

One thing for sure is, we don't utilise the press that much. Unlike other enforcement agency in this country we seldom hold press release of seizure and operation success as such. We seldom see articles in the press publicising our operations. It is not too much to state that Pharmacy Enforcement is an underrated enforcement entity especially here in Sabah. This is not helped by our small contingent of 12 hardworking officers. However we don't benchmark ourselves with the other enforcement agencies. Compare to the their workforce, logistics and facilities we are no way near their strengths. However press coverage on our enforcement activity can only be seen at the end stage which is the reports on court cases. For this a big thank you to the diligent reporters based at the courts.

All in all we prefer to do the talking on our own term even though lambasted and criticised by some quarters who don't have all the facts on our background and activities. These are the same people who claim that we are not doing enough. We don't owe anyone an explanation because we do all the work from behind the scene...

The case above involved a Kota Kinabalu based medical practitioner in possession of unregistered psychotropic medicine. In the same court a sundry shop proprietor in Kota Marudu was fined for possession of controlled medicine without authorization.

Our Campaign in the West Coast

This is the West Coast district. Our consumer education campaign here started back in 2003 targeting business wholesaler and retailers. In 2004, we shifted our target group to the general consumers or should we say the plain Joe and Jane of the community. With our Regional Headquarters situated in Kota Kinabalu City and the towns being within reach of the office, it is only natural that these neighbouring towns should be eradicated from unregistered products. Although we can't claim that we manage to achieve 100% eradication but it is not too much to state that most licensed premises in this locality don't sell unregistered product openly.

The lady owner seems happy and she's very cooperative even though her unregistered medicine was seized

A Tamparuli grocery store that we inspected, look at the colonial-era wooden shop house design.. difficult to find such shop in the city..

The eye said it all... this Indian national according to the travel documents issued to him is allowed to work as a Restaurant helper... instead he became a medicine peddler in a makeshift stall in Ranau... go figure

These are the unregistered product containing schedule poison that he was peddling. Clariderm Astringent and RDL Tretinoin Babyface Solution (the red and the orange box respectively) contain hydroquinone, a hair dye bleaching agent that can harm the skin if used without proper professional medical advice Even a clothing store is getting into the act of selling unregistered medicine

Toiletries and medicine section of the clothing store in Ranau

Unregistered skin ointments from China (the boxes in the middle) labelled as containing scheduled poisons anti fungals

The lack of pharmacy and a limited number of medical clinics.. medicine shop such as above is thriving in the rural area. Don't be surprised if they sell controlled medicines just like in any pharmacy or clinic.

The Region Where We Enforce The Law

This is Sabah, Malaysia where where we currently enforce 4 laws pertaining to medicine, chemical and health product. Sabah land mass is about 73,631 sq. km area, the northern most part of the island of Borneo and east of the capital city of Malaysia,Kuala Lumpur. It is known as the Land Below the Wind (a name coined by an Englishwoman Agnes Keith, a writer). In our language we term it as "Sabah Negeri di Bawah Bayu". Sabah basically consist of 5 main districts. There are (please see map above) clockwise from top Kudat, Sandakan, Tawau, Interior and West Coast. Currently up to this date, we have a strength of 12 enforcement officers to cover the whole of Sabah. 2 officers based in Tawau, 1 each in Sandakan and Keningau and the rest at our HQ in Kota Kinabalu. Simple math tells you 1 enforcement officer per 6,135 sq. km, a daunting task but we relish the challenge.

The relevant laws that we enforce are;
1. Poisons Act 1952

- An Act to regulate the importation, possession, manufacture, compounding, storage, transport, sale and use of poisons

2. Sale of Drugs Act 1952 -

An Act relating to the sale of drugs

3. Medicines (Advertisement and Sale) Act 1956

- An Act to prohibit certain advertisements relating to medical matters and to regulate the sale of substances recommended as a medicine

4. Dangerous Drugs Act 1952

- An Act to make further and better provision for the regulating of the importation, exportation, manufacture, sale, and use of opium and of certain other dangerous drugs and substances, to make special provision relating to the jurisdiction of courts in respect to offences thereunder and their trial, and for purposes connected therewith

Make a Point to Read the Label of Your Medicine

Have you been asked the name of your current medicine?
Can you name the medicine that you are taking?
Do you check the label for each medicine that you receive from the hospital, clinic or retail pharmacy?

If you answer “no” to any of the questions above please spend time to read this article now.

Compulsory Requirement for Labelling of Medicine

According to the Poisons Regulations 1952, when any poisons is supplied as a dispensed medicine it shall be labelled with certain details. This includes the name and address of the supplier or seller (in this case the Clinic, Hospital and Pharmacy it was obtained), name of the person whom the medicine is for, name of the medicine and adequate direction for the use of such medicine. Tthe medicine pack should also have the reference number as in the record called the ‘Prescription Book’ and the words ‘Controlled Medicine’.

(Pic above shows the proper labelling of dispensed medicine)

Consumer Responsibility

The government always advocates Malaysians to be smart consumers. One small step to achieve this aspiration is to read the medicine label and to know the medicine supplied to you. It’s not a surprising fact that certain members of the public neglects to read the label of their medicine. Whether this medicine is obtained from hospital, clinic, or retail pharmacy, many of us don’t take the time to read or to ask about the medicine we received. Please find the time at the end of this article to check your medicine cabinet and look at the medicine label that many of us are currently taking, it’s not surprising to find dispensed medicine labelled with the words ‘Sakit Perut’, headache, ‘muntah-muntah’, ‘cuci darah’, and many more. Some might find this amusing and strange but the bottom line it’s a sad reality. The paradigm shift in medical care is to encourage the patient to play an active role in treatment of their illnesses. The patient can play this role by taking the initiative to ensure that their medicine is clearly and completely labeled. Request the doctor or pharmacist who supplies the medicine to label the medicines properly. All patients whether adults or children have the right to expect the medicine supplied to them are appropriate, safe and effective. By fulfilling this basic consumer responsibility it is hoped that consumer will be familiar with the medicine that they are taking and take more responsibility in their treatment.

Supplier Responsibility

An example of professional duty in the medical field is to inform matters related to any diseases or medicine involving such patients in accordance with the standard clinical guidelines that focuses on the patient (patient centered). All doctors, dentists or pharmacist must ensure that the label of dispensed medicine conforms to the law. In any government medical institutions, labeling of medicine with generic or chemical name has become a norm. Such practices should be implemented in all private hospitals, clinics and retail pharmacies for the benefit of the patients. For example the common painkiller medicine containing the chemical Mefenamic Acid has been registered undert the names like Ponstan, Beafemic, Dyfenalic, Fenagesic, Hamitan, Mefemic etc. The practice of labelling using chemical name is important because it allows the consumer to know the active ingredients in each medicine and help to avoid any toxicity that might arise due to the administration of different medicines with the same active ingredients. .

Advantage of Proper Labeling

The advantages of having a proper label of medicine are as follows;
1.The patient can obtain further information about that particular medicine from reliable information sources or by referring the medicine by name to doctors and pharmacists
2. Improve patients compliance to maximize the treatment effectiveness
3. Patients able tell the name of medicine they are taking to doctors or pharmacist to avoid duplication of therapy especially for those seeking second opinion from different healthcare provider for a particular illness.
4. If adverse effects or allergic reaction occur, it will be easy for patient to recognize the medicine that causes it and to report the matter to their medical provider.
5. The patient will be able to stop taking medicine which has an active ingredient which is banned
6. Easy to understand the direction, frequency and duration of treatment for that particular medicine
7. Know the medicine proper and safe storage
8. Avoid cases of medicine mistakenly consume by individuals living in the same house.

In conclusion, by taking the initiative to ensure your medicines are labelled properly, all of us choose to become smart consumers and take full charge in the treatment of our illness.


© Sabah State Pharmacy Enforcement Branch

Health Product Registration in Malaysia

Many of us in this lifetime have bought and taken medicines. What is the probability that some of the medicines that we have been using is not registered with the Ministry of Health of Malaysia? The Control of Drugs and Cosmetics Regulations 1984 require all products imported, manufactured or sold to be registered with the Drug Control Authority (DCA). Any individual who contravenes this Regulations commits an offence and can be fined up to a maximum of RM 25,000.00 or a jail sentence for a term not exceeding 3 years or both for the first offence. For the second or subsequent offences the fine is not exceeding RM 50,000.00 or jail sentence for a term not exceeding five years or both. A company found guilty can be fined up to RM 50,000 for the first offence and up to a maximum of RM 100,000.00 for the second or subsequent offences.

Under this Regulations DCA has been established as the executive body to regulate product registration in Malaysia. The main task of this Authority is to ensure the safety, quality and efficacy of pharmaceuticals, health and personal care products that are marketed in Malaysia. Registered producs have been evaluated and tested for its efficacy, safety and quality. A registration number will be given when a product is registered with DCA. The registration number is specific to the product registered with the name, identity, composition, characteristics, origin (manufacturer) and marketing authorization holder as specified in the registration documents. It may not be used for any other product. Every registered product must have their registration number printed on its label or package. A security label (hologram Meditag®) is affixed to a registered product so that patient and enforcement officers can identify genuine products. The security label is only one of the many means that is used by the ministry to complement its enforcement activities to ensure public safety. The requirement for affixation of this security device to product label is only applicable to pharmaceutical product including health supplement and traditional product.

Registration number can be identified as a set of numbers with the alphabets “MAL” in front, followed by eight digits of number and ended with one or more alphabets. Registration of product in Malaysia has been divided into 3 categories. Each category of product can be identified by the first alphabet after the eight digits.
1) Alphabet “A” - for product containing scheduled poison as defined in the Poisons Act 1952
2) Alphabet “X” - for product not containing scheduled poison as defined in Poisons Act 1952
3) Alphabet “T” - for traditional product
Other alphabets used include C, E, R, S & V which is usually printed after the three main alphabet A, X, and T .

Monitoring of the quality of registered product in the market is carried out continuously by the Authority. Sample of products registered by the DCA may be taken and tested for compliance with official or pharmacopoeia standard or specifications. If the sample fails the test the market authorization holder will be issued a directive to recall of the product. The marketing authorization holder also is required to identify the source or cause of quality defect and action to be taken to improve quality. The registration of any product may be rejected, cancelled or suspended by the DCA if there are major deficiencies in safety, quality or efficacy of the product or failure to comply with conditions of registration.
Public is advised to report any adverse or side effect experienced due to the product consumed or used to the authority. Such reporty will be discussed by MADRAC (Malaysian Adverse Drug Reaction Committee) for further action.

MOH urged the public to stop using unregistered products. Unregistered products have not been tested for its safety, quality and efficacy and thus pose a treat to the public health. It also might be adulterated or contaminated with heavy metals or banned substances. The authenticity of the MAL number can be verified through the website, http://www.bpfk.gov.my/.


© Sabah State Pharmacy Enforcement Branch

Types of Product Being Registered

Photo showing products controlled by Drug Control Authority (DCA), Malaysia
(Note: Cosmetics has been recategorized into a different class of goods)

The Products currently monitored by DCA includes;
1. Controlled Medicine Product
2. Over The Counter (OTC) Product
3. Traditional Product
4. Veterinary Product

5. Active Pharmaceutical Ingredient (API)