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The Jan Vishwas Bill should seek to achieve its twin objectives of not just ease of doing business, but also ‘ease of living for citizens’, points out the All India Drug Action Network (Aidan).
“The objective should be to fully ensure the quality of medicines manufactured in India in order to protect the hapless patients as well as to protect the legitimate interests of the pharma manufacturers,” the organisation said, adding that otherwise the exercise would be a “wasted opportunity”.
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Calling for the strengthening of the regulatory ecosystem, Aidan said, the 2008 guidelines that helped decide on non-standard quality medicines (NSQ), needed to be amended. It also called for strengthening the regulatory system, and action on unscientific fixed dose combination medicines.
The guidelines “should clarify that first time NSQ report of a life-saving antibiotic or other such life saving medicine is not a minor defect and therefore not compoundable; likewise, a first time NSQ report of a manufacturer whose factory shows gross deficiency on inspection or a manufacturer whose mala fide intentions are clear, should not be given the option of compounding. Neither would the courts permit such irresponsible compounding,” the note said.
However, the note pointed out, the controversy over this issue was misleading. It clarified, “only first time offences which are due to NSQ drugs with Minor Defects can now be dealt with through compounding but repeat offences cannot be (per second proviso in Sec 32B). All other NSQ related drug offences will be subject to the existing provisions of punishment under Sec 27 (d).” Further, it added, this change tantamounted to “decriminalization as much as leading towards a quicker closure of litigation.”
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Aidan called for “substantial strengthening (with enhanced transparency and accountability) of grossly inadequate State FDA oversight mechanisms”. Pointing to the “plethora of unscientific Fixed Dose Combinations (FDCs), i.e., combinations which have not been recommended by any renowned medical authority or standard pharmacology literature,” the note called for Government action on these products.
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