KABUPATEN BEKASI – Inforayanews.co.id, – Menteri Kesehatan, Budi Gunadi Sadikin telah mengunjungi 156 rumah dari 241 pasien dari data terakhir kasus gangguan ginjal akut progresif atipikal per 21 Oktober. Budi mengatakan setidaknya ada puluhan obat sirup yang sebelumnya dikonsumsi oleh pasien yang saat ini dirawat di RSCM.

Pasien anak yang ada di RSCM, kata Budi, dari hasil tes yang dilakukan di dalam darahnya ditemukan cemaran etilen glikol, dietilen glikol, dan etilen glikol butyl ether.

Budi menjelaskan, bila senyawa kimia tersebut masuk dalam tubuh, mampu merusak fungsi ginjal karena berubah menejadi kristal-kristal tajam yang merusak ginjal dan BPOM telah menarik 5 Obat Sirup dengan Etilen Glikol Lebihi Ambang Batas Sirup obat yang diduga mengandung cemaran etilen glikol (EG) dan dietilen glikol (DEG) kemungkinan berasal dari 4 bahan tambahan yaitu propilen glikol, polietilen glikol, sorbitol, dan gliserin/gliserol.

Sejatinya, keempat bahan tambahan itu bukan merupakan bahan yang berbahaya atau dilarang digunakan dalam pembuatan sirup obat. Namun, BPOM sudah menetapkan ambang batas aman atau Tolerable Daily Intake (TDI) untuk cemaran EG dan DEG sebesar 0,5 mg/kg berat badan per hari, menunjukkan adanya kandungan cemaran EG yang melebihi ambang batas aman pada 5 produk tersebut dan masih dilakukan penelitian terhadap obat sirup lainnya, Terhadap hasil uji 5 sirup obat dengan kandungan EG yang melebihi ambang batas aman, menurut BPOM untuk produk yang melebihi ambang batas aman akan segera diberikan sanksi administratif.

Terkait adanya temuan BPOM terhadap obat sirup yang melebih ambang batas menurut praktisi hukum Ulung Purnama,SH,MH. yang ditemui oleh media inforayanews.co.id di ruang kerjanya yang beralamatkan di ruko Cortes Jababeka, desa Simpangan, Kecamatan Cikarang Utara, Kabupaten Bekasi, Jawa Barat, kepada media dirinya menyampaikan bahwa, “Kejadian tersebut tentu saja harus dipandang permasalahan serius karena melebihi ambang batas beresiko tinggi oper dosis, mengingat sudah banyak anak-anak yang meninggal dunia akibat gagal ginjal akut tersebut”.

Selain itu Ulung Purnama,SH,MH. selaku Direktur KBH Wibawa Mukti mendorong Pemerintah untuk menerapkan sanksi hukuman sebagaimana diatur oleh Undang-Undang Kesehatan dan Undang-Undang Konsumen dan Pemerintah memastikan pelaku usaha bertanggung jawab memberikan ganti rugi bagi korban karena kerugian akibat melebihi ambang batas yang ditentukan tersebut bertentangan dengan Undang-Undang Nomor 8 Tahun 1999 Tentang Konsumen,Pasal 4 angka (1) Hak atas kenyamanan, keamanan, dan keselamatan dalam mengkonsumsi barang/jasa dan terhadap korban yang meninggal dunia menurut angka (8) Konsumen memiliki hak diantaranya: hak untuk mendapatkan kompensasi, ganti rugi dan/atau penggantian, apabila barang dan/atau jasa yang diterima tidak sesuai dengan perjanjian atau tidak sebagaimana mestinya.

Kewajiban Pelaku Usaha Pasal 7 ayat (f) Memberi kompensasi , ganti rugi dan/atau penggantian atas kerugian akibat penggunaan, pemakaian dan pemanfaatan barang dan atau jasa yang diperdagangkan.
Selain itu memberikan ganti rugi sanksi pidana dapat dikenakan bagi pelaku usaha dan/atau pengurusnya.

Pasal 62 ayat (3) terhadap pelanggaran yang mengakibatkan luka berat, sakit berat, cacat tetap atau kematian diberlakukan ketentuan pidana yang berlaku dan Pasal 63 terhadap sanksi pidana sebagaimana dimaksud Pasal 62 dapat dijatuhi hukuman tambahan, berupa: a. Perampasan barang tertentu, c. Pembayaran ganti rugi., e.Kewajiban penarikan barang dari peredaran atau f.Pencabutan izin Usaha.

Sesuai Pasal 89 Undang-Undang Nomor 36 Tahun 2009 Tentang kesehatan Pasal 98 ayat (3) ketentuan mengenai pengadaan , penyimpanan, pengolahan, promosi, pengedaraan sediaan farmasi di alat kesehatan harus memenuhi standar mutu pelayanan farmasi yang ditetapkan dengan peraturan pemerintah dan Sanksi pidana dalam pasal 196 Setiap orang yang dengan sengaja memproduksi atau mengedarkan sediaan farmasi dan/atau alat kesehatan tidak memenuhi standar dan atau persyaratan keamanan, khasiat atau kemanfataan , dan mutu sebagaimana dimaksud pasal 98 ayat (2) dan ayat (3) dipidana dengan penjara paling lama 10 (sepuluh) tahun dan denda paling banyak Rp.1.000.000.000,- (satu milyar rupiah).

Atas adanya kejadian tersebut, KBH Wibawa Mukti mendorong pemerintah harus memberikan sanksi hukum bagi pelaku usaha yang melakukan pelanggaran ambang batas tersebut bukan hanya sanksi administrasi saja.(123d)

 

 

 

 

Disampaikan:
Ulung Purnama,SH,MH.

89 thoughts on “Kajian & Bantuan Hukum Wibawa Mukti (KBH-WM) Menilai “Produsen Obat Yang Melebihi Ambang Batas Yang Sudah Ditetapkan Harus Diberi Sangsi Hukum Serta Memberikan Ganti Rugi Kepada Korban””
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