meditag - Ministry of Health

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SPEECH BY YB DATO’ DR CHUA SOI LEK, MINISTER OF HEALTH MALAYSIA,

AT THE LAUNCH OF THE MEDITAG TM LABEL AWARENESS CAMPAIGN AT

HOTEL SHANGRI-LA, KUALA LUMPUR, ON 24 MAY 2005 AT 10.30 AM

Y Bhg Dato’ Dr Mhd Nordin bin Mohd Nor, Chairman, Mediharta Sdn Bhd.

Y Bhg Dato’ Che Mohd Zin bin Che Awang,

Director of Pharmaceutical Services, Ministry of Health Malaysia.

Distinguished guests, ladies and gentlemen,

Good morning to all of you.

1. First of all I would like to thank Mediharta Sdn Bhd for inviting me to launch today’s Kempen Kesedaran Label Meditag TM .

2. The idea of using security labels for products such as medicines was first mooted by our former Prime Minister, YAB Tun Mahathir Mohamad during his budget speech in 2002. Consequently, the Ministry of Health Malaysia had looked into the feasibilty and practicality of using such security labels for products registered by the Drug Control Authority (DCA). This was for the purpose of enabling consumers to differentiate between registered and unregistered products and for enforcement officers to use the security labels as a tool for product authentication.

3. The subsequent influx of unregistered products promoting slimming and men’s health, and cough and cold preparations adulterated with scheduled poisons further strengthened the need for a mechanism by which such products could be readily identified. This was necessary in order for our Pharmacy Enforcement officers to take appropriate actions against those found to be dealing in such products. Moreover, with the use of standardized security labels, consumers will be able to identify products registered with the DCA. In this way, consumers cannot be hoodwinked and deceived by unscrupulous people who may sell unsafe and unregistered products of questionable quality to them. These formed the basis for the decision to use the Meditag TM label.

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4. As the Meditag TM labels can only be supplied to licenced manufacturers and importers, it will be quite difficult for counterfeiters to affix these labels on counterfeited products. Also, since the Meditag TM labels are serialised, companies will have records of the serial numbers for their products. This will serve as an easy mechanism for them to identify counterfeits on the market should they find products with different serial numbers.

5. The Meditag TM labels are being supplied to the industry at a cost of 5.6 sen per label. We are aware that the industry will have to bear some additional costs to affix these labels to their products, and some of these costs may ultimately be passed onto the consumers. However, the few additional sen that the rakyat may have to pay for the Meditag TM labels on authentic products far outweigh the cost and risks that would be incurred by using unregistered or counterfeit products. Just to illustrate, an article in the New Straits Times last year (Oct 30, 2004) reported that some 190,000 people are killed and 2.5 million are hospitalised annually in a country nearby where the market is plagued by fake and poor quality medicines.

6. Some may argue that the quantum of counterfeit products in Malaysia is small and does not justify the use of the Meditag TM labels. In this respect, we would like to highlight that while counterfeits may not be a very big problem in Malaysia, the availability of unregistered products is a major issue. For instance, in 2003, the

Pharmacy Enforcement Division seized RM6.5 million worth of unregistered products. This figure escalated to RM26 million in 2004. Moreover, these unregistered products are often promoted as wonder drugs and do not come cheap.

7. The use of the Meditag TM labels will be officially enforced from 1 May 2005. All products manufactured or imported after this date will have to carry the security labels. However, products already in the market need not be recalled. As such, there may still be some products in the market up till the end of 2005 which may not be carrying the Meditag TM labels.

8. All products registered with the DCA are required to carry the Meditag TM labels. The exceptions are cosmetics, injectibles and external personal care products such as medicated soaps, shampoos and toothpastes which are not required to

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carry the Meditag TM labels yet. Details are available on the DCA’s website at www.bpfk.gov.my

.

9. As the use of these security labels is implimented as part of the labeling requirements by the DCA for registered products, non-compliance will carry the same penalty as for other offences under the Sale of Drugs Act. Possession for sale of such unlabelled products is an offence under the Drug and Cosmetics Regulations

1984. Any individual who commits an offence under these regulations can be fined up to a maximum of RM25,000 or a jail sentence not exceeding 3 years or both for the first offence; and a fine not exceeding RM50,000 or a jail sentence not exceeding

5 years for the second or subsequent offences. A company found guilty can be fined up to RM50,000 for the first offence and up to a maximum of RM100,000 for the second or subsequent offences.

Ladies and gentlemen,

10. The Ministry of Health has put into place a good system to evaluate the safety, efficacy and quality of products to be sold in the Malaysian market in order to safeguard the well being of the public. The use of the security labels is an attempt by the Ministry to counter the influx of unregistered products which are being sold to the unsuspecting public. The public are therefore advised to check the labels of products to ensure that they carry the Meditag TM labels before purchase.

11. As there may be some products which were put on the shelves prior to the implimentation date of 1 May 2005, and thus may not carry the Meditag TM labels, consumers are advised to check with the suppliers on the authenticity of these products before purchasing them.

12. The industry is advised not to take advantage of the implementation of these security labels to hike the prices of products. The industry should view this exercise as a social responsibility to ensure that only authentic products which have been approved by the DCA are on sale in this country. With that, ladies and gentlemen, I have pleasure in launching the Meditag TM awareness campaign. Thank you.

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