Medical Device Also Need To Be Halal-Certified

The halal or haram status of a material is not entirely stated in detail in the Al-Qur’an and Hadith. Therefore, it is necessary to have a deeper review to find out if a product contains haram or unclean ingredients.

As it is known, after going through various stages of the process with certain technology, the contents of a product can no longer be seen with bare eyes. It is not surprising that almost every product has a critical point of prohibition. It is the potential that causes the product to have a non-halal status.

“Laboratory tests are not the main method to determine the halal status of a product. It may be that the final product does not contain unclean ingredients. But if we follow the process, we might find pig-derived materials that are involved in the production,” said the Director of Halal Audit Services of LPPOM MUI, Dr. Ir. Muslich, M.Si. 

Apart from medicines, medical devices are also one thing that cannot escape from halal certification. This departs from the regulation of Act Number 33 of 2014 concerning Halal Product Assurance (UU JPH).

Article 4 of the act states that products entered, circulate and trade in the territory of Indonesia must be certified halal. One of the things that are meant by-product is used goods. Medical devices fall into this category.

(Also read:Four Reasons Medicines Need to be Certified Halal)

“There are several medical devices that are used to be inserted into the body. For example, heart rings or surgical threads that sometimes come from animals,” said the Director of Pharmaceutical Production and Distribution, Ministry of Health of the Republic of Indonesia (Kemenkes RI), Dr. Dra. Agusdini Banun Saptaningsih, Apt., MARS.

There are many critical ingredients in the production of drugs and medical devices. The critical point must be verified and assessed for compliance with certification standards. This can be seen from the materials used, the production process, to the facilities used.

In drug production, materials commonly used include active ingredients, excipients, auxiliary materials, cleaning agents, and media for validating washing results. In the elixir dosage form drug process, for example, using ethanol. There are two types of ethanol. From the liquor industry, it is unclean and haram. Meanwhile, if the ethanol from other sources, for example, corn fermentation, is clean or permitted.

“Another example, in the form of a solution, there is the use of syrup, which uses flavor. Well, this flavor material can be a lot, maybe it can consist of 70 ingredients. We can’t see everything on the label, so we need knowledge about the process and the material,” explained Muslich.

Solid dosage forms, he continued, such as capsules also have a high critical point of imperfection. The majority of capsule shells are sourced from gelatin. The largest source of gelatin comes from cow or pork skin or bones. Some claim that they can produce gelatin from fish or seaweed, even though the portion is still very small.

Likewise with tablet solids, one of the auxiliary ingredients used is magnesium stearate. The source of stearic acid used can be animal or vegetable origin. If it comes from an animal, it must be ensured that it comes from halal animals slaughtered according to Islamic ways.

What the pharmaceutical industry seldom realizes is the critical point of imperative validation media. According to Muslich, in some cases, vaccine production uses vaccine seed growth media, one of which comes from porcine. The same thing often happens when the process of producing microbial products which generally uses growth media, such as drugs to stimulates the formation of red blood cells and glycoproteins.

“In the final product, porcine DNA will not be found, but the product has come into contact with haram substances that make it contaminated. This process is the most common. We will pay attention to whether this unclean thing can be purified in the next process through Islamic purification, “explained Muslich.

Likewise with the production facility. Prioritize separating facilities for producing halal products from haram materials. According to the MUI fatwa, all facilities that come into contact with materials or products must be free from unclean. If you have ever been exposed to uncleanness, Islamic purification must be done. (YN)

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