JAKARTA – Inforayanews.co.id, – Keluarga korban gagal ginjal akut (acute kidney injury/AKI) telah menggugat beberapa perusahaan farmasi distributor, beserta Badan Pengawas Obat dan Makanan (BPOM) dan juga Kementerian Kesehatan (Kemenkes) ke Pengadilan Negeri (PN-red) Jakarta Pusat.
Kurang lebih ada sembilan pihak yang digugat oleh keluarga korban gagal ginjal akut. Adapun tergugat pertama adalah PT Afi Farma. Sebab, obat sirup dari PT Afi Farma dikonsumsi oleh 11 anak hingga meninggal dunia
Pada hari Jumat 18 Nopember 2022 telah didaftarkan secara online Gugatan Class Action kepada Pelaku Usaha, Suplayer Obat, dan BPOM, Kementerian Kesehatan sebagai pihak yang digugat.
Hal itu telah disampaikan oleh Ulung Purnama,SH,MH salah satu tim kuasa hukum yang mengajukan gugatan di Pengadilan Negeri Jakarta Pusat dan pengajuan gugatan ini menggunakan mekanisme Class Action sebagaimana diatur dalam Perma No.1 Tahun 2002 tentang Mekanisme Gugatan Perwakilan kelompok (Class Ation) Adapun pemberi kuasa korban didasarkan kepada kerugian dari jenis obat yang diminum, seperti ibu Safitri Puspa Rani orang tua anak bernama Panghegar yang telah meninggal dunia bersama 10 orang tua lainnya yang anaknya telah meninggal pula. Dikelompokan sebagai wakil kelompok I dan Ibu Windi Riani orang tua yang masih berjuang anaknya masih sakit disebut sebagai kelompok II.
“Adapun dasar gugatannya dikarenakan sudah ada 195 orang anak yang sudah meninggal dunia dan masih ada anak yang butuh perawatan lebih lanjut dibantu dari pemerintah yang menyangkut korban lain di seluruh Indonesia”. Ungkapnya
Adanya perbuatan melawan hukum, dikarenakan Pelanggaran Undang-Undang 8 Tahun 1999 tentang Konsumen, Undang-Undang No 36 Tahun 2014 tentang Kesehatan termasuk Peraturan Presiden Nomor 80 tahun 2017 tentang BPOM yang mana kerugian dari akibat perbuatan melawan hukum tersebut dapat dilakukan tuntutan ganti rugi bagi para korban. Jelasnya.
Selain itu, sambung dia, “Akibat adanya penggunaan obat sirup yang mengandung Etilen Glikol (EG) dan Dietilen Glikol (DEG) yang diproduksi oleh PT.AFI FARMA dan PT.UNIVERSAL PHARMACEUTICAL dipasok dari bahan dasar pemasok obat yang patut diduga berasal dari zat EG dan DEG yang ternyata termasuk zat berbahaya mengandung racun sebagaimana diketahui adanya Surat Pembatasan Penggunaan Obat Berbahaya dalam peraturan Menkes Nomor 472 Tahun 1996 ,Peraturan Menteri Perindustrian Nomor: 23/M-IND/PER/4/2013 tentang perubahan atas Peraturan Menteri Perindustrian Nomor 87 tahun 2009 adalah untuk mengharmonisasi standarisasi kriteria klasifikasi bahaya bahan kimia global dan nasional; Izin Edar harus sesuai dengan standar Cara Pembuatan Obat yang Baik (CPOB) dengan memberikan sertifikat CPOB dan sebagai dasar mendapatkan sertifikat CPOB harus mendapatkan Sertifikat Of Analisis (COA) untuk semua bahan obat yang dipergunakan oleh karena itu, berdasarkan Peraturan BPOM Nomor 13 Tahun 2016 tentang penerapan Pembuatan Obat yang baik”. Terang Ulung Purnama
Dan untuk setiap bahan berbahaya memiliki LDK (Lembar Data Keselamatan) yang wajib dicantumkan secara jujur hal ini yang dijadikan modus oleh pemasok bahan obat untuk dilakukan perubahan label atupun tanpa label oleh karena itu seringkali zat EG-DEG menjadi ditukar atau digunakan secara diam-diam untuk bahan dasar obat sirup hingga berakibat meninggalnya anak-anak kecil di Indonesia. Ucapnya
Adapun akibat adanya pelanggaran tersebut pihak tergugat dianggap melanggar hukum Pasal 1365 KUHPerdata yang mana akibat kerugian ini dapat dimintakan ganti rugi. Adapun tuntutan Para Penggugat meminta Pelaku usaha dihukum untuk bertanggungjawab memberikan ganti rugi kepada korban, dan bagi BPOM dan Kemenkes dihukum untuk memperbaiki sistem dan standar obat yang baik secara tegas dan agar Kementerian kesehatan menyatakan Kondisi Luar Biasa (KLB) karena banyaknya korban yang meninggal dunia akibat meminum obat sirup yang mengandung EG dan DEG tersebut. Tandasnya(124y/123d)
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