In Malaysia, health supplement products require to be approved by the Drug Control Authority (DCA) under the Control of Drugs and Cosmetics Regulations 1984 prior to sale. Health supplement products are evaluated based on their safety and quality. Every registered product is given a registration number, which must be printed on its package label. These numbers start with MAL and ends with an extension alphabet of ‘X’ or ‘N’ for health supplement product i.e. MAL12345678N.
Sheep Placenta Extract
Placenta is an organ which links the fetus to the mother. It transfers oxygen and nutrients to the fetus from the mother and removes fetal waste products to the mother. Placenta has a long history of being used in traditional medicine. It is stated in a published article that dried sheep placenta is sometimes used as traditional medicine in Nigeria to facilitate labour. Sheep placenta extract is categorized as a health supplement active ingredient in Malaysia. Therefore, a product containing sheep placenta extract in a pharmaceutical dosage form, will require to be registered with the DCA before sale or use in Malaysia.
To date, the allowable claim for a registered product containing sheep placenta extract is ‘Used as a health supplement’.
The strength of sheep placenta extract is measured by its extraction ratio. The higher the ratio of freshly extracted sheep placenta would mean it contains a higher level of placenta extract. For example, a 200mg of sheep placenta extract with an extraction ratio of 1:20 is equivalent to 4000mg of fresh placenta. The strength of registered sheep placenta extract products ranges from 150mg-600mg, equivalent to 3000mg-30000mg fresh placenta.
The most common sheep species used as source of sheep placenta is Artiodactyla Ruminata Bovidae Ovis Aries. This sheep species is also generally known as the common domestic sheep.
Are there actually any health benefits to consuming placenta?
Placenta products mainly contain placental proteins, hydrolyzed proteins, lipids, enzymes and other nutrients. These nutrients are involved in various metabolic processes. Even though there have been numerous health benefits claims made by manufacturers of placenta products, there is insufficient clinical evidence to substantiate these benefits. As such, no therapeutic claim other than that as a health supplement has been allowed for placenta products registered by the DCA.
What are the health risks?
Registered placenta products are safe if consumed within the specified recommended doses.
Does the Ministry encourage such a practice?
Health supplement products are evaluated based on their safe use and quality of the product. Sheep placenta products have to be hormone free. Applicants have to show laboratory evidence that the active ingredient or finished product is free from hormones such as testosterone, estrogen and progesterone.
How to check whether product containing sheep placenta extract is registered?
You may perform an online product search by searching for the product registration number, product name, product registration holder or name of manufacturer. The database is a cumulative list comprising of products registered with the Drug Control Authority since 1985 and cosmetics notified with the Director of Pharmaceutical Services. Please visit the NPCB website at www.bpfk.gov.my and check whether the product is registered via the search engine ‘Product Search’. If the product is registered with the DCA, the product information will be listed. However, if the product is not registered, the search result will show ‘No Record’. Therefore, it is advisable not to take that product as the safety and quality of the product has not been evaluated and may pose health risks.
Adverse reaction after consuming sheep placenta extract product
If it is suspected that you are suffering an adverse reaction to any health supplement product including sheep placenta extract product, please see a doctor immediately. Also, please report the incident to the Malaysian Adverse Drug Reactions Advisory Committee either through the ADR reporting form or even by email. All information on the name of the product, its ingredients and source (if known) should be included. In order to facilitate better assessment and to allow further action to be taken, if possible, please include the label/packing material of the product. If it is suspected that the product is contaminated with some other medications such as steroids, painkillers, hypoglycemic agents etc., please include a sample of the product to enable chemical analysis to be performed.
It is best to consult a pharmacist or doctor before taking any sheep placenta extract products. In addition, there is lack of information of sheep placenta extracts tested in pregnant or lactating women. Hence, the usage of sheep placenta extract products by these group of people are discouraged.
- Nair B, Elmore AR. (2002) Final report on the safety assessment of human placental protein, hydrolyzed human placental protein, human placental enzymes, human placental lipids, human umbilical extract, placental protein, hydrolyzed placental protein, placental enzymes, placental lipids, and umbilical extract. Int J Tocicol, 81-91
- National Pharmaceutical Control Bureau. Drug Registration Guidance Document. Retrieved from http://portal.bpfk.gov.my/index.cfm?&menuid=137.
- Lilly M (2006) Ovis aries [Photograph]. Retrieved April 1, 2014 from http://commons.wikimedia.org/wiki/File:Ovis_aries_001.jpg
- Onuaguluchi G., Ghasi S. (1996) The pharmacological basis for the use of dried sheep placenta in traditional obstetric practice in Nigeria. Journal of Ethnopharmacology 54; 27-36.
|Last Reviewed||:||02 September 2014|
|Writer||:||Kam Kher Li|
|Accreditor||:||Datin Shantini Thevanderan|