Pharmaceutical Manufacturers Find Supplier Alternatives

The Food and Drug Supervisory Agency (BPOM) RI has instructed Balai Besar / Balai POM throughout Indonesia to monitor and withdraw products that do not meet the requirements, including those containing pig DNA. Based on official information, the results of surveillance on products on the market through sampling and testing of products on the market through sampling and testing of pig DNA parameters, it was found that two products proved positive to contain pig DNA, namely Viostin DS production PT Pharos Indonesia with POM SD.051523771 batch authorization number BN C6K994H, and Enzyplex tablet production of PT Medifarma Laboratories with NIE DBL7214704016A1 batch number 16185101.

BPOM has instructed Pharos Indonesia and Medifarma Laboratories to stop production and / or distribution with the batch number. BPOM explains that Pharos Indonesia and Medifarma Laboratories have pulled out the products of Viostin DS and Enzyplex with NIEs and batches from the market, and stopped production of the product. Vincent believes this incident is not the intent of the manufacturer. According to him, BPOM has a test tool to detect the halal of highly sensitive products, so it does not allow pharmaceutical manufacturers to make a deliberate use of materials and production processes are not kosher.

Associated with the obligation to implement halal certification for food and pharmaceutical products, Vincent said the association requested an extension to the government to prepare because it is not easy to implement halal certification for all pharmaceutical products. In addition, some Muslim-majority countries also do not all implement halal certification for pharmaceutical products. He mentioned, halal certification for food products will be implemented this year and for pharmaceutical products in 2019.

Product Withdrawal

Meanwhile, Ida Nurtika, Corporate Communications Director of Pharos Indonesia, said that as the producer of Viostin DS which has been established in Indonesia since 45 years ago very maintain the quality of all products produced, ranging from testing raw materials to finished products produced. When there is an indication of contamination by the POM at the end of November 2017, the company carries out a handling effort in accordance with BPOM directives, which starts from batch production of products suspected of being contaminated, stopping production, and selling Viostin DS.

Internally, Pharos Indonesia is actively searching for sources of suspected contamination of raw materials used and finished products, quality of raw materials, storage of raw materials, and also in other places where contamination is possible. Based on the search results, Ida said, it found that one of the ingredients of making Viostin DS, namely chondroitin sulphate, imported from overseas suppliers and used for the production of certain batches, later known to contain contaminants.