The Economic Times reported today of my petition to the Prime Minister to hold the Ministry of Health and Family Welfare to account for all the promises it made to the Parliament of India over several years regarding its opaque and unscientific decisions regarding several drugs that continue to be on the market today. A copy of the petition is here.
I was asked why I decided to petition the Prime Minister now, almost after two years since the highest court in the land refused to listen to plea calling it academic. For the sake of context, I am reproducing my responses to the questions I was asked below:
Why have you petitioned the PMO now, when it has been years since these developments took place and also two years since you were told by court that you could petition the government?
After I withdrew my PIL from the Indian Supreme Court, I did prepare an extensive report backed by substantial data and submit it to the Ministry of Health (MoH). Thereafter, the administration did take some small steps toward improving quality of our supply chain, including an effort at making BE and Stability testing compulsory. These were two key recommendations that I had made in my report to the MoH. While K L Sharma was the Health Secretary, it appeared that he was trying to address the concerns I raised in my report, including defending the decision to ban irrational FDCs in the Indian Supreme Court.
While these efforts address how we do things going forward, it is important to understand how these four drugs got on the market in the first place. In our report, we had documented to the extent which statutory bodies like DTAB had dragged their feet when it came to issues of BE and Stability. Unfortunately, despite many attempts, we couldn’t get any data substantiating the reasons why the DCGI approved these drugs in the first place. While the observations in the Parliamentary Standing Committee Reports are scathing; none of the Action Taken Reports actually tell us how these approvals came about. In fact, despite representations to the Parliament, the MoH seems to conveniently forget its commitments to the people of India. In order for us to fix this problem, we need to understand what happened to get us to this place so that such mistakes do not happen going forward. We need to invest in correcting our processes and building our institutions so that they are not held hostage or unduly influenced by special interests as has been pointed out by the Standing Committee.
The administration has not yet taken any action on these 4 drugs despite the fact that I had flagged these in my report in 2016. Over the last year, even the 2011 ban on using Letrozole for infertility treatment has been revoked in the most opaque manner. Deanxit is back on the market after the MoHFW lost its case not once but twice now in the court. Since the MoHFW clearly lacks political will, it is time now to petition the Prime Minister – if no positive action is forthcoming from the PMO, I have been advised to approach the judiciary once again; this time with conclusive evidence that the government is not acting despite a visible threat to public health. After the recent Supreme Court judgment that Parliamentary Reports can be considered as evidence, my lawyers are confident that a second petition will be successful.
I hope it doesn’t have to come to that and that the PMO orders the MoHFW to follow up on its promises to the Standing Committee to conduct an inquiry. I am not asking for anything new – I am only asking for the Ministry to fulfill its own written committment to the Parliament.
Has the PMO responded to your petition? If yes, what have they said? If no, what follow up action are you planning to take?
Its been just two weeks – I think we should give the PMO a little more time to respond.
Have you also reached out to the health ministry and the Drug Controller General of India about this issue this year? If not, why not?
As mentioned above, the report summarizing my findings was sent to the MoH – there has been little action by the Ministry – the one officer who was doing some good work has been transferred to a punishment posting. I don’t see any point of reaching out to the Ministry when no action has been taken on my earlier extensive report. More importantly, it has been five years now since Ranbaxy pled guilty to seven counts of criminal felony in my case in the US. This has led to discovery of numerous instances of data integrity violations and outright fraud among Indian pharmaceutical companies that has been documented by regulators from the USA, France, Germany and the European Union. While these foreign regulators work to protect their drug supply, precious little has been done by the MoH to protect ours. The MoH doesn’t seem to be interested in talking to me about how to stem this behavior. What confidence do you think I ought to have given their track record to reach out to them again this time?
If you have approached the health ministry and DCGI, what response have you received?
I was asked to meet K L Sharma two years ago, subsequent to me sending my report to the MoH. The meeting was promising, but there has been no follow through – there are powerful interests at play here and unless we have a Minister with political will, nothing will change. I’m told the PMO has that political will to effect some positive change regarding our drug supply and hence the petition to the PMO.
Our primary responsibility in holding the elected and bureaucracy accountable is to demand that the promises made to us are fulfilled. More often than not, these promises are conveniently swept under the rug, and we go on with business as usual. Unless we learn from history, and find out what was done wrong, how do we expect those who govern to correct the processes and do the right thing going forward?
Really mind boggling efforts from your side, Sir. Please continue this fight for the sake of Indian Healthcare Standards.
It’s a challenge to deal with the MoH&FW . Industry runs away from regulations but Medical Devices industry has been seeking regulations and its only because of leadership of Shri KL Sharma that after a decade of fruitless meetings with MoH&FW and CDSCO that Schedule MIiI to delink pharmaceutical GMP based requirements were delonked from medical devices in D&C Act and new Medical Devices specific Rules came out . Next steps was separate Medical Devices Act but after rewarding of Mr KL Sharma with a punishment posting the Draft of this legislation is buried in the ministry and reminders to Health Secy n team has Zero response to at least start consulting Stakeholders on draft of the Bill . Some bureaucrats push for reforms and others enjoy blocking them and maintaining status quo. The minister is inaccessible so we wonder if this is a government By the people ? For the people ? Of the people ? Why no steps being taken to address patient safety concerns on medical devices ? Meanwhile ICMED certification by Quality Council of India should be encouraged . I can fully empathise with the challenges being faced by Mr Dinesh Thakur as a well meaning citizen of the country and an industry insider