JAKARTA, SRIWIJAYAPLUS.COM – Kepala Badan Pengawas Obat dan Makanan (BPOM) Penny K Lukito mengakui pihaknya selama ini tidak melakukan pemeriksaan rutin terhadap adanya cemaran etilen glikol (EG) dan dietilen glikol (DEG) pada obat sirop.
Penny menyebut hal itu terjadi lantaran menurutnya hingga saat ini, belum ada pakem internasional yang mengharuskan dan mengatur soal pemeriksaan kedua senyawa itu dalam komponen pembuatan obat sirop, dilansir oleh CNN Indonesia (24/10)
“Itulah kenapa kita tidak pernah menguji karena memang belum dilakukan di dunia internasional pun. Inilah standar yang harus kita kembangkan sekarang sehingga menjadi bagian dari sampling rutin dari BPOM,” kata Penny di Istana Kepresidenan Bogor, Senin (24/10).
Kendati demikian, Penny memastikan BPOM memiliki kegiatan untuk melakukan pemeriksaan sampling secara rutin. Selain itu, ia mengklaim BPOM memiliki perencanaan pre market yang dilakukan sebelum memberikan restu izin edar obat yang didaftarkan oleh produsen farmasi.
Ia mengatakan, dalam proses pengajuan pendaftaran izin edar tersebut, maka produsen obat perlu melaporkan bahan baku pembuatan obat sirop, sekaligus kandungan dan analisis yang harus disampaikan kepada BPOM.
“Tapi juga ada kewajiban dari pelaku usaha untuk melakukan pengujian sendiri. Kita melakukan evaluasi pada saat pre market, namun kita juga melakukan pengawasan dengan sampling dan pengujian di post market terhadap produk yang setelah diberikan izin edar itu diedarkan,” ujar Penny.
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