Longish Thread 👇
Most of us have heard of 'Regulatory Capture' by the industry. But have you heard of 'Capture of Law Making Process' itself?
Fasten your seatbelts.
A sordid tale of how lobbying has almost succeeded in getting its masters a free pass from accountability
1/n
Most of us have heard of 'Regulatory Capture' by the industry. But have you heard of 'Capture of Law Making Process' itself?
Fasten your seatbelts.
A sordid tale of how lobbying has almost succeeded in getting its masters a free pass from accountability
1/n
2/n
Remember this happened?
livemint.com/science/health…
During the peak pandemic period, batches of a drug called Remdesivir manufactured by a Gujarat based pharma company were found to contain bacterial endotoxins which when administered to patients manifested in severe adverse
Remember this happened?
livemint.com/science/health…
During the peak pandemic period, batches of a drug called Remdesivir manufactured by a Gujarat based pharma company were found to contain bacterial endotoxins which when administered to patients manifested in severe adverse
3/n
events. Endotoxins are not supposed to be present in injectibles, the way to make sure your drugs are not contaminated is to run a series of tests prescribed in the Indian Pharmacopiea before you ship them the market. The Pharmacopiea sets the standards and tells us what
events. Endotoxins are not supposed to be present in injectibles, the way to make sure your drugs are not contaminated is to run a series of tests prescribed in the Indian Pharmacopiea before you ship them the market. The Pharmacopiea sets the standards and tells us what
4/n
quantities of “related substances” often called impurities are acceptable in a formulation.
As it stands now, any drug that failed standards set by the Indian Pharmacopoeia Commission would be prosecuted: ipc.gov.in
This is going to change with the new bill.
quantities of “related substances” often called impurities are acceptable in a formulation.
As it stands now, any drug that failed standards set by the Indian Pharmacopoeia Commission would be prosecuted: ipc.gov.in
This is going to change with the new bill.
5/n
Section 56(e) of the new Bill proposes lowering punishments for drugs that have been declared "Not of Standard Quality" (NSQ) due to any of the 43 defects listed in the fourth schedule of the Bill.
Lets look at some of these defects, shall we:
Section 56(e) of the new Bill proposes lowering punishments for drugs that have been declared "Not of Standard Quality" (NSQ) due to any of the 43 defects listed in the fourth schedule of the Bill.
Lets look at some of these defects, shall we:
6/n
Look closely at item 27 in this list; it is a catch-all term for identifying and quantifying “impurities” in your medicine. Unlike items 4 and 9, which relax the acceptable limits for what is in your medicine and how long it takes to dissolve in your gut,
Look closely at item 27 in this list; it is a catch-all term for identifying and quantifying “impurities” in your medicine. Unlike items 4 and 9, which relax the acceptable limits for what is in your medicine and how long it takes to dissolve in your gut,
7/n
item 27 has NO limits specified. If this proposed law goes into effect, chances are, manufacturers of this supposed “medicine” which has contaminants like "endotoxins" will be let off with nothing more than a slap on their wrist.
item 27 has NO limits specified. If this proposed law goes into effect, chances are, manufacturers of this supposed “medicine” which has contaminants like "endotoxins" will be let off with nothing more than a slap on their wrist.
8/n
Why did the committee which drafted this law do this?
The answer is simple, the pharma industry asked for it and the drafting committee agreed to do so.
Why did the committee which drafted this law do this?
The answer is simple, the pharma industry asked for it and the drafting committee agreed to do so.
9/n
Look closely at who organized this meeting. Its @nppa_india , which falls under the Dept. of Pharmaceuticals. And what was the purpose of the meeting?
And so, to make it easier to “do business” the @MoHFW_INDIA sets up a panel which
Look closely at who organized this meeting. Its @nppa_india , which falls under the Dept. of Pharmaceuticals. And what was the purpose of the meeting?
And so, to make it easier to “do business” the @MoHFW_INDIA sets up a panel which
10/n
recommends “removal of penal provisons where a drug or a medical device has no harmed a patient”
economictimes.indiatimes.com/industry/healt…
recommends “removal of penal provisons where a drug or a medical device has no harmed a patient”
economictimes.indiatimes.com/industry/healt…
11/n
Isnt that nice! Ever wonder who was speaking for #patientsafety or for #publichealth at these meetings?
And so, the expert committee drafts this amendment which goes way beyond what was recommended by the panel.
Isnt that nice! Ever wonder who was speaking for #patientsafety or for #publichealth at these meetings?
And so, the expert committee drafts this amendment which goes way beyond what was recommended by the panel.
12/n
The bare reading of the proposed amendment takes penal provisions out for all kinds of failures, including those that result in bodily harm to patients. Go figure!
The bare reading of the proposed amendment takes penal provisions out for all kinds of failures, including those that result in bodily harm to patients. Go figure!
13/n
And now for the icing on the cake:
And now for the icing on the cake:
14/n
“Compounding” means the prosecuting drug controller has the discretion to waive a trial and prison time as long as the accused pharmaceutical company agrees to pay the fine. In effect, the industry has achieved its goal of total “decriminalization”.
“Compounding” means the prosecuting drug controller has the discretion to waive a trial and prison time as long as the accused pharmaceutical company agrees to pay the fine. In effect, the industry has achieved its goal of total “decriminalization”.
15/n
And, if this wasn’t bad enough, look at what else is in the proposed amendment:
And, if this wasn’t bad enough, look at what else is in the proposed amendment:
16/n
The administration will have the power, if this amendment becomes the law to expand the list of exceptions in the fourth schedule.
Any bets on how long that will eventually be?
The administration will have the power, if this amendment becomes the law to expand the list of exceptions in the fourth schedule.
Any bets on how long that will eventually be?
17/n
If there is one reason why the Minister @OfficeOf_MM should just junk this amendment and get an independent group of experts to advise him on what really is needed to reform the Drugs and Cosmetics Act, this is it.
A pig with lipstick is still a pig.
If there is one reason why the Minister @OfficeOf_MM should just junk this amendment and get an independent group of experts to advise him on what really is needed to reform the Drugs and Cosmetics Act, this is it.
A pig with lipstick is still a pig.
• • •
Missing some Tweet in this thread? You can try to
force a refresh
