The 2013 Indian Drugs and Cosmetics (Amendment) Bill will not deliver rational, safe, and effective regulation of drugs, according to a new analysis by legal and health experts.
Policy makers in India are grappling with how best to address the serious problems facing the country’s drug regulation system. Reports have repeatedly highlighted multiple concerns, including weak regulatory infrastructure and poor performance, lack of access to safe and effective medicines, badly regulated clinical trials, and the proliferation of fixed-dose combinations (FDCs)—formulations comprised of two or more drugs combined in a fixed ratio of doses and available in a single-dosage form.
The Drugs and Cosmetics (Amendment) Bill introduced in the Indian Parliament in August, 2013, is the latest attempt to deal with some of the concerns. Last month, two of its key proposals—creation of a new Central Drugs Authority with greater powers than the current regulator, the Central Drugs Standard Control Organisation (CDSCO), and extension of the regulatory system to cover exported medicines—were rejected by the same parliamentary committee whose scathing criticism of CDSCO in May, 2012, ushered in the Bill.
The Drugs and Cosmetics (Amendment) Bill 2013 fails to provide a rigorous foundation for putting effectiveness, safety, rationality, and need at the heart of India’s drug regulatory system. Indeed, it does not even attempt it. Rather, it is another patch on the 74-year-old, pre-Independence Act whose structural design has arguably been stretched beyond breaking point.
Lawmakers might wish to consider further amendments to the Bill to strengthen its provisions from a public health perspective. [Source]
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