Email Artikel ini STUDI KOMPARATIF PERATURAN PENARIKAN PRODUK OBAT DI INDIA DAN INGGRIS
Abstrak
Lembaga yang berwenang dalam peredaran obat, seperti Medicines and Healthcare products Regulatory Agency (MHRA) di Inggris dan Central Drugs Standard Control Organization (CDSCO) di India, memiliki tanggung jawab dalam mengawasi peredaran obat agar tetap aman dan berkualitas hingga ke tangan pasien. Drug Recalls atau penarikan obat merupakan suatu tindakan menarik kembali obat yang telah beredar karena tidak memenuhi standar keamanan, efikasi dan kualitas. Pencarian referensi dilakukan dengan menggunakan kata kunci “CDSCO Product Recall, MHRA Product Recall” di google, google scholar, dan PubMed. Referensi yang didapat sebanyak 12 sumber. Artikel ini bertujuan untuk membandingkan regulasi penarikan produk di negara dengan produksi obat terbesar di dunia, yaitu Inggris dan India. Hasil dapat dilihat bahwa masing-masing negara memiliki perbedaan dalam penarikan obat seperti jumlah klasifikasi, prosedur serta jangka waktu dalam penarikan obat. Secara keseluruhan Inggris memiliki keunggulan dalam kecepatan penarikan obat cacat dari peredaran dibandingkan dengan India.
Kata Kunci: CDSCO, MHRA, Penarikan Obat
Teks Lengkap:
PDFReferensi
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DOI: https://doi.org/10.24198/farmaka.v18i2.27305
DOI (PDF): https://doi.org/10.24198/farmaka.v18i2.27305.g14722
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