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Gov't: Regulations on herbal products in place
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I refer to the article titled ‘ Herbal products need better regulations ’ that appeared in your web page dated Oct 11, 2010.

The writer has lamented on the inadequate labeling requirements for herbal products in Malaysia. The Ministry of Health (MOH) appreciates and understands the concerns expressed by the writer on the issue of the public being exposed to sub standard products particularly in the case of herbal products that have such wide patronage among our society.  

Unlike in some countries, products that are categorised as herbal or natural products are regulated in this country. They are subjected to requirements as regards to safety and quality before they are registered and allowed to be marketed in Malaysia.

Additionally, importers of these products need to show proof that they are marketed in the country of origin and the manufacturers of these products will also need to furnish evidence that they comply with ‘good manufacturing practice’ requirements. Only products that fulfill all these requirements are allowed to be registered by the Drug Control Authority (DCA) and marketed in Malaysia.

The control of herbal products is further strengthened by a post marketing surveillance programme that actively seeks out products already in the market and analyzes them to ensure product quality. In the year 2009 a total of 1183 natural product samples were picked up from the market for monitoring.  

Of these 93 products were found to be in non-compliance and were subjected to various punitive measures that ranged from immediate de-registration of the products and revocation of manufacturer’s license (in the case of locally manufactured products) to recalls and warnings.

The product label package inserts are also checked to ensure compliance and the claims not misleading to the public.

This activity has been on going for many years and has been of immense benefit in thwarting any untoward incidents involving the safety of the consumers.

It is a requirement for registered natural products to be labeled in the national language or in English. Other languages are optional. In addition to this there are also certain compulsory requirements that have to be on a product label such as

  • the source of ingredients derived from animal origin, including the capsule shell,
  • indication,
  • registration number (MAL),
  • dosage and administration,
  • contraindications/precautions (if any),
  • warning labels (if any)
Information regarding the compulsory labeling requirements for a registered natural product can be found in the Drug Registration Guidance Document available at the web page of National Pharmaceutical Control Bureau (NPCB) at www.bpfk.gov.my .

The writer has also mentioned of product labels not in Bahasa Malaysia or English. It is important to realise that these are in actual fact illegal products and not registered with the DCA, and thus have not undergone any evaluation or testing process that a registered product would have been subjected to.

While the MOH’s enforcement division conducts numerous raids aimed at identifying premises that sell these products, it is also important for the consumers to be more responsible and stop buying such unregistered products. An unregistered product is an unknown entity whose safety and quality profile is unknown and consumers are exposing themselves to unnecessary risk.

All registered products can be identified through the MAL number and the hologram. Information regarding unsafe products is readily available in the web page of the NPCB. In situations that warrants it, the MOH has also been issuing press statements periodically to warn consumers of unsafe products already in the market.

The MOH wishes to reiterate its commitment to public safety by ensuring that registered products placed in the Malaysian market are fully evaluated for their safety and quality for herbal products. The MOH wishes to dispel any doubts in the minds of readers arising from the above article with regards to safety of herbal products currently in the market and approved by the DCA.

The MOH will not hesitate to apply appropriate regulatory actions to remove immediately any product in the market that is found to have compromised its adherence to existing standards.

Eisah A Rahman is senior director of pharmaceutical services, Ministry of Health Malaysia.

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