cross-posted from: https://lemmy.ml/post/39145986
It seems most of the people only barely remember what happened a few months ago in Madhya Pradesh and Rajasthan. Due to a Faulty Cough Syrup, namely 'Dextromethorphin Hydrobromide' several young innocent souls lost their lives. Great outrage was seen back then, but what now? Where is the Anger, Desire for Change. Nobody even knows what the Goverenment regarding this issue. Sending Notices to a company is one thing but what happened that day was not just a Company's failure but the whole system's failure, a system which fails to find faults is a useless system.
That is why I introduce a solution to this problem.
For a very long time, there have been only talks that the State FDA (Food and Drug Administration) and CDSCO (Central Drugs Standard Control Organization) need to improve their coordination and no action has been taken. The Current structure is that each batch of medicine first goes to the State FDA for assesemnt and approval. If approval is provided, the medicine is released in Market, if not, then it goes to CDSCO for reassesement, if the batch still does not get approval, the batch is cancelled, if approved it is released in Market. My reform Proposal has 3 newly introduced Sub- Reform, which are:-
The State FDA and State wing of CDSCO and all the Zonal and Sub-Zonal Ofiices of CDSCO (Of the respective state) need to be merged to form a Unified Drug and Medicine Control Authority(UDMCA) in states where these events are very common or I would even say in all states. Point to be noted that the Individuality of each organisation namely State FDA and CDSCO will remain, their individual tasks like Licensing a medicine in their respective state will still remain and will be carried out in the name of State FDA. Only in the matter of Assesement of Batches of Medicine, this centralised organisation will come in play. Approval to each batch will be given in the name of UDMCA. This will enhance Responsibility as now there will be only one organsiation to blame if things go wrong. Also there will be improve in coordination, lack of which has been a major cause of the mess that has been happening before.
"Three Strike Rule" I call this the Three Strike rule. The Current structure is that each batch of medicine first goes to the State FDA for assesemnt and approval. If approval is provided, the medicine is released in Market, if not, then it goes to CDSCO for reassesement, if the batch still does not get approval, the batch is cancelled, if approved it is released in Market. I suggest that even if after the rejection of State FDA the CDSCO approves the batch of medicines, still after the approval of CDSCO in the UDMCA, it will still need the approval of the respective State FDA. If again rejected, it will again go to the CDSCO for approval, also at this time State FDA due to being in UDMCA with CDSCO, will coordinate and keep it's views on why rejecting the batch. If the CDSCO again approves it but upon State FDA approval the third time, it still fails, then the batch will be Cancelled. This will enhance coordination and Security and the Fishy medicines will be Checked multiple times to avoid casualties.
Zonal and Sub-Zoanal CDSCO Notification:- The CDSCO also has many Zonal and Sub-Zonal Ofiices in all the districts. What they do is that they take medicines from the market itself and do tests on them. If the medicines are found unfit, it reports to the Higher authorities for action. What I think it should also do is that it should release a Notification in the UDMCA as well regarding the medicine that failed in the fitness test, upon this notifiaction, the medicine of that specific company should be assesed more strictly by both State FDA and State wing of CDSCO and if required also halt the release of that medicine if required. There was no procedure regarding this in the current system and I thought it was important enough and would make this framework formal enough, so I added it.
I know guys, not only this but other things are required as well for this system of mine to succeed like training of fresh and new officers for UDMCA, which will ensure it's smooth functioning etc.
This was my view and my opinion on this topic. And I will be very glad if you could review this structure of mine and please, don't hesitate in Criticising or Praising my syatem, also if you have ideas for improving this system, please feel free to share your views and enlighten us. I told about this system of mine to a relative of mine who works in MPFDA (Madhya Pradesh Food and Drug Authority) and he liked it and called this very practical so thought it was worth sharing.
Please Join our Community 'BharatReforms' because there we discuss exactly such things, events and their solutions at systemic Level.
With this said, Adios, we will meet agin very soon.
Jai Hind
Jai Bharat