The Uncertainty of Drug Regulation in India

That the Indian health policy is full of flip-flops and uncertainties is a given.  The sector falls under the purview of two different ministries (the Ministry of Chemicals and Fertilizers and the Ministry of Health and Family Welfare) and this leads to confusion on who regulates what.  This lack of a common agenda for the sector catalyzes the perception of the free-fall in policy making.

The glaring gap was contrasted recently when the Drug Regulator (under the purview of the Ministry of Health and Family Welfare) “blinked” on two issues – the stringent compensation norms to patients in clinical trials and the reconsideration of a ban on the sales of three drugs. Both these issues had galvanized different sections of the broader health care sector to action.

Stringent norms for Clinical trials

To begin with the Regulator let loose completely creating a glut of approvals.  In 2008 the DCGI granted 65 approvals for trials, in 2009 approvals rose sharply to 391 and a whopping  500 global trials were allowed in 2010 and 325 in 2011 followed by 262 approvals in 2012. Analysts estimated that the clinical trial market would cross $ 1 billion by 2016. But as reports of mishandling of the trials caused the death of a shameful 2,868 during 2005-2012, the lackadaisical attitude of the Regulator allowed self-styled activist groups and NGOs to fill the vacuum of governance.

It is obvious that the concerns raised by the human rights activist and NGO groups are genuine, but the knee-jerk response to the furore is disappointing. The Regulator’s rejecting or delaying the approval to the applications for conducting clinical trials is in no way a solution to the problem. The industry responded by taking trials to other countries. In 2013 there were only 70 applications and 12 approvals until April. America’s National Institute of Health called off over 40 clinical trials in India.

Under intense pressure for drafting untenable norms for clinical trials, India’s health ministry blinked and amended guidelines for compensation of participants in trials on the advice of the Drug Technical Advisory Board (DTAB).

Ban of widely used drugs

Late last month, the government banned the use of three popular drugs – Deanxit (used to treat anxiety), Analgin (a painkiller) and Pioglitazone (a relatively affordable medicine to treat diabetes). While the ministry unnecessarily dilly-dallied on withdrawing Analgin and Deanxit for years despite pressure from a parliamentary panel, the decision on the diabetes drug pioglitazone took the industry completely by surprise. To be fair, France had already banned it, while in the US it is sold with a boxed warning on potential side effects.

It is widely believed that a letter from prominent diabetologist and Padma Shri awardee Dr. V. Mohan reporting 8 cases of bladder cancer, influenced the government’s decision to ban pioglitzone! One letter! Instead of simply ordering a larger investigation (as was done by the US in the case of rosiglitzone), the government took the extreme step.

In the face of criticism and pressure from patient activist groups, industry bodies and doctor associations, the suspension is likely to be revoked. This decision is also influenced by the DTAB. It met July 19, 2013 and recommended that pioglitazone be put back on the market in India, albeit with a boxed warning about bladder cancer.

Why does the Indian drug regulator make such an ass of itself time and again? Does it pursue a hidden agenda as has been insinuated? Was the ban on pioglitzone a move to appease the US government after it criticized the fluidity in the Indian patent system?

It seems that the Drug Regulator’s Office is simply uncertain about how to manage a complex environment. When people died, it went into a spasm and dried up the approvals for new clinical trials. When an individual objected, it banned a drug that was used by millions of diabetics. When foreign regulatory agencies pulled up domestic companies for manufacturing and quality defects, it was quick to abdicate responsibility by putting the onus of reporting such incidents on the companies.

The agenda of India’s Drug Regulator seems to set by others – the media, individual opinion leaders and the actions of foreign regulatory agencies.

It is no wonder then that when the US Congress recently questioned India’s regulatory capabilities, our Ambassador to America had to convince them that laws were “rigorously enforced.” India’s Drug Regulator, whose job is exactly to ensure that, unfortunately could not.

7 thoughts on “The Uncertainty of Drug Regulation in India

  1. Really an impressive blog to open the eyes of the deregulators. The knee jurk reactions at places undesired and tortoise speed in matters of importance is all driven by regulators. Obviously as rightly mentioned by you sir, under either the influence of media or KOL or foreign agencies or the vivid dreams that our regulators get during there mostly nonworking week days..


  2. An eye opener write up salil. Very aptly written on the shoddy state of affairs of the ìndian fda.


  3. Hi Salil.. Deanxit ban has been revoked. So has pioglitazone. Seems like Dextropropoxyphene is next. What do you make of the revoke ? Has ministry done insufficient research ? I thought they (ministry) finally developed some teeth and were going for the jugular.. but things are taking a different turn now. What do you make of it ?


    1. Frankly I am quite unimpressed with the ministry, as you could probably tell 🙂 I think they do not have enough political backing to take on the channel unions, companies or various other stakeholders who benefit when these bans on drugs are withdrawn.


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