Medical Devices Also Need to Pass Halal Certification

The Halal or non-Halal status of a material is not fully detailed in Halal standards. Therefore, a more in-depth review is necessary to determine whether a product contains non-Halal or unclean ingredients.

As is well known, after passing through the various stages of certain technologies, a product's contents can no longer be seen with the naked eye. It is no surprise that almost every product has a prohibition critical point. This is what leads to the possibility of a product having non-Halal status.

"Laboratory testing is not the primary method for determining a product's Halal status. It may be that the final product contains no unclean ingredients. But if we follow the process, we may find porcine-source materials involved in production."

Besides pharmaceuticals, medical devices are also something that cannot escape Halal certification. Law No. 33 of 2014 on Halal Product Assurance (UU JPH) stipulates that medical devices must meet the requirements of this law.

Article 4 of the law stipulates that products entering, circulating and traded within Indonesia must be Halal-certified. Medical devices fall into this category.

"There are several medical devices used for implantation in the body. For example, sometimes heart rings or surgical threads come from animals," said Dr. Dra. Agusdini Banun Saptaningsih, Apt., MARS, Director of Drug Production and Distribution at the Ministry of Health of the Republic of Indonesia (Kemenkes RI).

There are many key ingredients in the production of drugs and medical devices. It must be verified and assessed whether the critical points meet the certification standards. This can be seen from the materials used, the production process, to the facilities used.

In drug production, commonly used materials include active ingredients, excipients, processing aids, cleaning agents, and media for validating cleaning effectiveness. In processing drugs in elixir dosage forms, for example, ethanol is used. There are two types of ethanol. From the liquor industry, it is unclean and unlawful. Meanwhile, ethanol from other sources, such as corn fermentation, is clean or permitted.

Another example: in solution forms, syrup is used, which uses flavorings. There can be many kinds of flavorings, and we cannot see everything on the label, so we need to understand the process and materials.

Solid dosage forms, such as capsules, also have a high defect critical point. Most capsule shells come from gelatin. The largest source of gelatin comes from cowhide or pigskin or bones. Some claim they can produce gelatin from fish or seaweed, although this market share is still small.

Similar to solid tablets, one of the auxiliary ingredients used is magnesium stearate. The source of the stearic acid used can be animal or plant. If it comes from an animal, it must be ensured that it comes from a Halal animal slaughtered according to Halal slaughter standards.

The pharmaceutical industry is rarely aware of the critical point of mandatory validation media. According to Muslich, in some cases, vaccine production uses a vaccine-seed growth medium, one of which comes from pigs. The same thing often happens in the production of microbial products, which usually use growth media, such as drugs to stimulate the formation of red blood cells and glycoproteins.

In the final product, no porcine DNA will be found, but the product has come into contact with a harmful substance that contaminates it.

The same goes for production facilities. All facilities that come into contact with materials or products must be free of unclean substances. If you have ever come into contact with uncleanliness, Halal cleansing must be performed.