The Long Road Ahead

Pic showing an officer explaining the registration of health product to a stall owner / retailer
Pic showing the use of consumer education tools (phamplet and postcard) in the education campaign

Being an enforcement agency, it's not all about flexing enforcement muscle and hard punishments. In fact the best form of enforcement is consumer education. We call this as 'proactive' enforcement. This method allows the reduction of demand from the consumer thus disrupting the "demand-supply chain" of unregistered health product. This is made possible by empowering the retailers to choose to sell registered helath product only. This effort involve an intelligent planning, precise execution and a lot of patience before reaping the desired results. On our part at CPF Sabah we have so far embarked on a few education campaign targeting multi-level members of the society. It is important to get the cooperation of everyone to ensure the success of law enforcement on medicine and pharmaceuticals. It's a long road ahead.

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

Importation Of Drug Into Malaysia

Many of us today take a lot of pride in using imported cosmetic product and also consuming imported medications. But have any one of us wondered how these products enter Malaysia? It is not as straight forward as some of us may think. This article is written with the hope to increase the public’s awareness regarding importation of drug and also cosmetic product.
In general, importation of drug into Malaysia is controlled by the Poisons Act 1952 and Control of Drugs and Cosmetics Regulations 1984 to ensure ‘Controlled Medicines” are imported by licensed pharmacists and to ensure medicines imported are safe, efficacious and of quality.
Before any drug can be considered to be imported into Malaysia, it must first be registered with the Drug Control Authority. Public can check whether a product is registered or not by contacting the National Pharmaceutical Control Bureau at 03-78835400 or search the website http://www.bpfk.gov.my/ . After the product is registered, the importer has to apply for an import licence to import the registered product.
Under the Poisons Act 1952, poisons means any substance listed in the first column of the Poisons List. You need an appropriate licence to import poisons. Type A license is for a licensed pharmacist to import all poisons . A type B license can be issued to any person deemed proper or fit by a licensing officer to import industrial chemicals controlled as poisons and a Type E licence to import sodium hydroxide. Application of any of the above license can be done through the Pharmacy Enforcement Division (Cawangan Penguatkuasa Farmasi). Any person found guilty of committing offences under this Act, is liable to a fine not exceeding RM 5000 or imprisonment not exceeding 2 years or both.
Starting this year (2008) under the Control of Drugs and Cosmetics Regulation 1984 importer must notify the DCA the cosmetics they intend to put in the market. Prior to this cosmetics also need to be registered with DCA, This is in-line with the harmonization requirement amongst ASEAN countries. For any query, don’t hesitate to call the local Pharmacy Enforcement Division near you.

© 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

Pharmacy Enforcement Branch: An Introduction

The Sabah State Pharmacy Enforcement Branch was established since 30 August 1978. It was known then as the Drug Inspection and Enforcement Unit. The first area office was located at 1st Floor, Block A, Warehouse, Karamunsing, Kota Kinabalu. At that time it was the only branch in Sabah with one pharmacy enforcement officer and a pharmacy assistant. From this humble beginning, the office has since extended to having three other area branches in Tawau, Sandakan and Keningau.

The Pharmacy Enforcement Branch is a unit under the Sabah State Health Department, a federal department under the Ministry of Health, Malaysia. Authorized officers who work in this unit are known as Pharmacy Enforcement Officers. What do enforcement officers do? Other than inspecting and raiding shops, there are also other activities that they do. This article will explain the entire picture as a whole.

The Pharmacy Enforcement branch has an important role to protect the health and well-being of the public from the harm of unregistered product. This is done by enforcing the Control of Drugs and Cosmetics Regulations 1984 to control the importation, manufacture, supply, storage, sale, possession and usage of pharmaceutical products. In other words, pharmacy enforcement activities ensure health products used in this country are of good quality, safe and effective.

The Pharmacy Enforcement also processes various licenses and permits applications under the Poisons Act 1952 and its Regulations :
Poisons License Type A - for pharmacist to deal with all poisons

Poisons License Type B - for non-pharmacists to import and do wholesale of industrial chemicals which are controlled as poisons. Sodium Hydroxide Permit - for companies to buy and use Sodium Hydroxide

Apart from issuing poison licenses, the branch also carry out routine checks on clinics, pharmacies and licensed wholesalers of poisons. The main aim is to ensure all poisons are handled, transacted and labeled properly for the safetyof members of the public. During inspection, poisons are checked to ensure they are stored properly - in a room under lock and key. Checking of records on all transactions involving s poisons is to ensure all transaction is legal. Poisons here includes medicines that can cause harm to the public if misused. For instance, medicines that contain poisons can only be supplied by doctors and pharmacists. Other establishment i.e. non-licensed premises and roadside sellers are also inspected to ensure they do not sell medicines containing poisons. Further information can be obtained from the website http://http://www.pharmacy.gov.my/.

Dduring routine checks unregistered products will be confiscated if they are found.. These are products that do not have a specific assigned ‘MAL number’ and hologram sticker. Unregistered products here are medicines including traditional medicines that are not registered with the Drug Control Authority. These products have not been evaluated for their safety, quality and efficacy. Information on registration of products is available at http://www.bpfk.gov.my

Another important enforcement activity by the branch is the control of advertisements of medicinal products and advertisement relating to health or medical services in the mass media and other forms of advertisement eg banners and pamphlets. Advertisements which are approved by the Medicines Advertisement Board are given “KKLIU” approval number and can be published

Activities carried out at the entry points involve screening of import document, checks on parcel post and checks on passengers to prevent entry of unregistered health products and importation of chemical without authorization at the sea port, airport terminals and post-office. Unregistered products or consignements which do not have proper authorizations will be confiscated.

Over the years the Pharmacy Enforcement branch has intensified its activity to contain the problem of unregistered producst. Looking at the figures for the year 2006, the raids themselves contributed to RM476,673.00 worth of poisons and unregistered products seized from traditional medicine stores, unlicensed wholesalers, beauty saloons and pharmacies while seizures of products at entry points amounted up to RM850,000.00.

With the advent of globalization and the limited resources that are available, the Pharmacy Enforcement branch will continue to evolve to meet challenges ahead. Recognising the influence the public have on purchasing trends of pharmaceutical products, healthcare products and cosmetic in the country, the focus of Pharmacy Enforcement will be unto public enlightenment. It is important that the public takes responsibility to ensure the medicines they buy are safe. They must be able to differentiate between ethical and unethical advertisements. We can only achieve these health goals if everyone is in it together. Pharmacy Enforcement branch is here to protect the public from the harm of unregistered products. If the public require any information on the handling or sale of chemicals or health products you can visit us on the 9th Floor, Block D of the KWSP Building, off Karamunsing Road, Kota Kinabalu or call the number 088-231609 / 231610 or by mail to P.O. Box 10607, 88806 Kota Kinabalu or e-mail to cpf@sbh.moh.gov.my. In the near future we will be moving to the 6th Floor of the Federal House, Jalan Mat Salleh, Kota Kinabalu.

© Sabah State Pharmacy Enforcement Branch

The Use of Registration Number for Product Identification

Each 'Unit of Use' (for consumer use) of the registered product carry specific ID no. with assigned alphabets according to their type. This is called the Product registration no. It starts with the alpahabet "MAL" followed by an 8 digit no. and the alphabet that denote that particular type of product. The one's that can be found in the market include;
1. MAL07052345A - Controlled Medicine
2. MAL06039876X - OTC product
3. MAL05073233T - Traditional product

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)

This is how a hologram on a Registered Product in Malaysia Looks like

More than half of the world population surfing this site is wondering what this sticker is for. It is being used by the authorities here in Malaysia to control health product in the Malaysian market. It serve a multi function role to tell the public that the product is registered. It also serve the industry to differentiate their product from wannabe imitations thus safeguarding their brand and income. It is also a useful tool for enforcement to facilitate their duties.