A few weeks ago, it was reported that the GoI was considering an overhaul of the drug approval process. On behalf of CASEM, I sent yet another petition to the @MoHFW_INDIA to setup a committee for a comprehensive relook of the stability testing requirements for generic drugs 1/n
Here it is: casemindia.org/a-petition-to-…
Establishing stability is extremely important to ensure drug quality because most drugs are inherently unstable over the long run.
If there is even a slight error in the mfg. process, the drug will degrade because of heat/humidity/light 2/n
Establishing stability is extremely important to ensure drug quality because most drugs are inherently unstable over the long run.
If there is even a slight error in the mfg. process, the drug will degrade because of heat/humidity/light 2/n
An unstable drug will either not have therapeutic efficacy or like in the recent Ranitidine case, result in potential carcinogens as it degrades.
When I began researching Indian laws 5 years ago, I was shocked to learn that 'stability testing' was not compulsory 3/n
When I began researching Indian laws 5 years ago, I was shocked to learn that 'stability testing' was not compulsory 3/n
for generic drugs in India despite a DCC meeting in 2013 recognizing that this was a 'serious lacunae' in Indian law: casemindia.org/wp-content/upl…
In 2015 draft amendments were introduced to make stability testing compulsory for all generic drugs but for whatever reason 4/n
In 2015 draft amendments were introduced to make stability testing compulsory for all generic drugs but for whatever reason 4/n
they never became law: casemindia.org/wp-content/upl…
In 2016 I sent a report to the Ministry of Health pointing out a number of issues including this one; thereafter a fresh process was started to make stability testing compulsory.
5/n
In 2016 I sent a report to the Ministry of Health pointing out a number of issues including this one; thereafter a fresh process was started to make stability testing compulsory.
5/n
In 2018, a new set of rules were enacted making stability testing compulsory but they were pointless because they did not specify the precise requirements for testing and establishing stability of drug formulations: casemindia.org/wp-content/upl…
6/n
6/n
In 2019, I sent a letter to the Health Secretary asking her to enact guidelines to lend clarity to the stability testing process: dineshthakur.com/wp-content/upl…
7/n
7/n
After receiving no response for a long time, we filed RTI applications asking for status of what we had suggested and after much pestering I got this sketchy document: casemindia.org/wp-content/upl…
8/n
8/n
Clearly, this is still not enough - we need a lot more clarity when it comes to stability testing - it is the most important parameter to test after a shipment goes out to the market and I hope the Minister follows through - if not, it is back to the courts!
9/n
9/n
