Warning To Medicinal Or Health Food Manufacturers That Adulterate Their Products With Scheduled Poisons

Press Release By Minister Of Health Malaysia In Conjunction With Official Visit To The Pharmaceutical Services Division On 5 August 2010

It is alarming to note the trend of irresponsible parties who adulterate their products in traditional medicines, food or beverages and cosmetics with poisons (controlled medicines). Among the prevalent adulterants are :

1. active ingredient used for male sex stimulants such as sildenafil, tadalafil, verdanafil or their analogues,
2. active ingredient used to suppress the appetite like sibutramine or their analogues,
3. anti-inflammatory agents like dexamethasone and chemicals of Non-Steroidal Anti-Inflammatory Drugs (NSAID) group,
4. cosmetics that are adulterated with whitening agents like hydroquinone and tretinoin.

Sildenafil, tadalafil and verdanafil are active ingredients used for the treatment of erectile dysfunction and only can be supplied to patients by a doctor or a licensed pharmacists upon a prescription issued by a doctor. These medicines have severe documented adverse effects if taken without proper management by a doctor like heart attack, stroke, brain hemorrhage, increase in blood pressure, loss of hearing and loss in vision that may be permanent. 

 Sibutramine is used in the treatment of reducing body weight by suppressing appetite.   The use of this medicine is by proper diagnosis from a doctor or supplied by a licensed pharmacists upon a prescription issued by a doctor. Among the side effects of this medicine are heart failure, kidney failure and cardiovascular effects.

Hydroquinone is a chemical that is not allowed in any cosmetic preparations and it gives toxic effects to the skin which include darkening, skin cancer, dryness and itchiness. In high doses it may lead to breath difficulties and an asthmatic attack. Tritinoine normally is being used in the treatment of acne which have its side effects such as burning of the skin, itchiness, skin damage, dryness and the skin may develop sensitivity to ultra- violet.

What is more worrying is when manufacturers with Good Manufacturing Practice (GMP) status are involved in this pharmaceutical crime through their involvement in their own factories or accomplice with illegal manufacturers that claim themselves as food or cosmetic manufacturers.

Their clandestine activities were discovered by the Pharmacy Enforcement Officers that continue to monitor the distributions which ended up in continuous raids and seizures. The statistics on raids and seizures done by the Pharmacy Enforcement Division for the past three years show that the activities still persist. The total seizures each year are high with 4,617 products valued at RM5,719,861 in year 2007, 9,679 products worth RM13,663,854 in year 2008, 10,458 products with value of RM6,756,315 in year 2009 and between January to June 2010 a total of 6,632 products valued at RM4,546,906 were seized.

Recent seizures on 1 July 2010 show the greed of these entrepreneurs on their illegal products where it was discovered that the same source of active ingredient being used in producing at least 23 different types of products with market value of up to RM4,933,760. These products are available as traditional medicines, beverages in the form of coffee and tea, candies, food that are based on milk and collagen. The appearance on the packaging and labels of these products are very attractive and convincing with creative illustrations purposely to deceive the public.

The rise in sale of several brands of products indicates the activities are capable of making lucrative profits by deceiving the public, claiming that their products are from herbs or of natural sources.However these products contain active ingredients that are harmful if ignorantly taken and without proper consultation by health professionals like doctors or pharmacists.

Besides the undesirable effects on the Malaysian public, these products are also exported to foreign countries with claims as traditional medicines, health food and cosmetics. The negative perception of the world community at large on our Malaysian-made products that are adulterated with harmful ingredients will cause serious implications. This will jeopardize our aspiration to be the hub for traditional products within the international arena by such shameful and irresponsible acts.

The Ministry of Health warns all those involved in these activities to stop immediately as it endangers public health and jeopardize the country’s image and potential. This warning is also directed to distributors, either retailers or through direct sellingthat they do not abet with these activities.The distributors or retailers should check the status of the products prior to marketing. They are advised to surf the website of the National Pharmaceutical Control Bureau at www.bpfk.gov.my or the Pharmaceutical Services Division at www.pharmacy.gov.my to know the status of these products.The ministry’s enforcement officers will not stop from taking punitive actions against irresponsible entrepreneurs to protect the public.

The control on pharmaceuticals and food-based products or beverages that are adulterated with drugs or controlled medicines is under the Sale of Drugs Act 1952.  Upon conviction, a fine of RM25, 000 or three years imprisonment or both for individuals and a fine of RM50, 000 for a company can be imposed.

Realising the need to impose more deterrent penalties such offenders and profiteers, the Pharmaceutical Services Division is in the process of reviewing the relevant existing Acts. A new Act will be introduced soon that imposes a more severe penalty to deal with crimes that jeopardize public health.