On January 14, I withdrew a petition that I filed six years ago in October 2018 before the Delhi High Court questioning the continued sale of three drugs whose initial approvals by the Drug Controller General of India have been under a cloud of suspicion for over a decade now. My decision to withdraw the petition was driven primarily out of sheer litigation fatigue. This petition was listed no less than 24 times before the Delhi High Court over the last six years with no substantial arguments taking place on any of the issues that I raised before court.
The origins of this petition lie in the findings of the 59th Report of the Parliamentary Standing Committee on Health, tabled before Parliament on May 8, 2012, excoriating the Central Drug Standards Control Organisation on a number of issues. One that featured prominently was the manner in which the drug regulator had approved new drugs despite the lack of adequate clinical evidence that they demonstrated therapeutic efficacy claimed by their manufacturers.
The other issue that shocked the committee was the fact that approval files for certain drugs that it sought to investigate were missing from the CDSCO. These included the fixed dose combination of Flupentixol and Melitracen, one of the drugs whose approval I had challenged before the High Court. The parliamentary committee demanded that the government investigate how the approvals were ever granted by the CDSCO and also act against the drugs in question and the bureaucrats who granted those approvals.
One would have expected the government act urgently given the nature of the drugs in question. For example, one of the drugs was Buclizine, which was approved as an appetite stimulant that allegedly helped children gain weight despite there being no rigorous clinical evidence to substantiate the claim. Anxious parents who worry about their child’s physical development go to extremes to use untested therapeutics in India. The parliamentary committee flagged other drugs including those used to treat depression, infertility in women and abdominal pain.
Approximately six years after this report was tabled in the Parliament, I started working on a book project with Prashant Reddy T on drug regulation in India. During the course of the initial research, it came to our attention that subsequent to the 59th report, the Drugs Controller General of India, who heads the Central Drug Standards Control Organisation, had set up an inquiry committee on March 26, 2013, chaired by Professor Tribhuban Mohan Mohapatra to investigate how some of the drugs flagged by the Parliamentary Committee were approved – except that the CDSCO never published the final report.
When my co-author sought to obtain a copy of the report under the Right to Information Act, he was told by the office of the Drugs Controller General of India and the Ministry of Health that the report submitted by the inquiry committee was “untraceable”. Missing files are supposed to be investigated under the Public Records Act, 1993, as a criminal offence under the law.
The government’s evasive replies in the Mohapatra Committee report raised my suspicions. Initially, in 2018, I submitted a petition to the Prime Minister’s Office asking for an inquiry into the illegal drug approvals. Much like other petitions I make to the Ministry of Health and Family Welfare, I did not receive any response from the PMO. I then approached the Delhi High Court asking it to order the Ministry of Health to reconsider whether these three drugs, originally flagged by the parliamentary committee and two of which were to be investigated by the inquiry committee, had any therapeutic rationale at all. If these drugs lacked therapeutic rationale, the government was obliged to exercise its power under Section 26A of the Drugs and Cosmetics Act to prohibit the sale of these drugs in the country.
Initially, the Delhi High Court was reluctant to admit the petition, questioning my locus standi to file such a petition. Two months later, on December 7, 2018, the court did issue notice to the government asking it to respond to my petition. Almost immediately after the court issued notice, the government issued an order under Section 26A on December 13 banning the use of Buclizine as an appetite stimulant while anonymously denying to the press that the ban was in response to my petition.
Buclizine could still be sold in the market per its original approval, which was that of an anti-histamine, but its packaging would now have to carry a warning that the drug was not to be used as an appetite stimulant. I wonder why the government waited six years to force a warning on the label for this drug – it is not as if it had any new data from its manufacturer to consider. A few months later in March 2019 when I commissioned a private investigator to study whether the ban was actually being implemented, it came to light that the stock of Buclizine being sold in the market did not carry the required warning on its label. Meanwhile, the government continued to delay filing a response before the court for most of 2019.
As 2020 rolled in and the Covid-19 pandemic swept across the globe, the office of the Drugs Controller General of India finally disclosed a copy of the Mohapatra Committee report to my co-author, merely hours before the Central Information Commission was to hear his appeal. The Drugs Controller General of India explained that it sourced a copy of the report from Professor Mohapatra himself, although even then it failed to provide copies of the annexures to the report that were copies of the original approval files from the DCGI’s office.
To its credit, the Central Information Commission took serious note of the government’s handling of records and ordered the Drugs Controller General of India to digitise its records and also provide copies of the annexures to us. Regrettably, it did not order the government to investigate the matter under the Public Records Act, 1993 despite its own precedents requiring such an investigation be conducted any time a public record is reported as missing.
The contents of the Mohapatra Committee report, accessible here, were scandalous. I discovered that the report had been submitted to the Drugs Controller General of India back in 2014 and was suppressed by the government until 2020 when it was forced to disclose the report due to the pending proceedings before the Central Information Commission. A reading of the report made it clear as to why it was suppressed. With regard to Buclizine, the committee first noted that the file pertaining to its approval as an anti-histamine in 1982 had gone missing from the Drugs Controller General of India’s office.
On the issue of the additional approval as an appetite stimulant, the committee noted that the manner in which the Drugs Controller General of India approved Buclizine as an “appetite stimulant” was “arbitrary, whimsical and inconsistent with the provisions of the law”. The committee drew similar conclusions about the approval of a fixed dose combination of Aceclofenac and Drotaverine, which was the second drug that I had questioned in my petition. As noted by the committee, these drugs had not received similar approvals in any other country. Patients in India were being sold drugs that were never proven to be safe or therapeutically effective.
Here is an extract of the some of the observations made by the Mohapatra Committee:
Given the scandalous findings of the Mohapatra report, I remember thinking back in 2020 that the court would now pull up the government, except that the case continued to languish in court either due to requests by the government lawyers or because the court did not have the time to hear the case. From March 2021 to March 2022, the case was automatically adjourned because of the chaos of the pandemic.
In July 2022, there was yet another development: the government admitted before the Delhi High Court, in response to a petition filed by my co-author seeking disclosure of the annexures to the Mohapatra Committee, that it had lost the annexures, ie, copies of the drug approval files being investigated by the inquiry committee. This disclosure strengthened my case and my lawyers amended the pleadings in September 2022 asking the court to cancel the approvals since there was no clinical data to show that these drugs were safe or had any therapeutic efficacy.
In theory, given the number of irregularities in the approval process as noted by the Mohapatra Committee and the loss of the annexures containing copies of the approval files, I thought I had a slam-dunk case for public health. Except that, I got caught in a hopeless loop of adjournments, either because the government dragged its feet when it came to filing counter-affidavits or because the court did not have the time to hear my case despite it being on the hearing list for the day.
My petition was listed on no less than eight occasions before four different judges between September 2022 and January 14, 2025 when I finally gave up and decided to unconditionally and unilaterally withdraw my petition. There was not even a faint sliver of light at the end of the tunnel.
This is not my first disastrous experience before Indian courts. Back in March 2016, Ihad filed two public interest litigations before the Supreme Court seeking regulatory reform – both petitions were dismissed in under five minutes. I was hoping, this time round, things would be different given the sheer scale of administrative malfeasance on part of the government when it came to approving these drugs which are used on vulnerable populations such as children and people with mental health concerns.
Misplaced and hastily resurrected inquiry reports should be cause for judicial sledgehammers against the government. Yet, nothing of that sort happened in this case. All three drugs whose approvals I challenged continue to be available in the Indian market even today. One of the drugs in question, which is a fixed dose combination of Flupentixol and Melitracen, is used to treat clinical depression. None of the reputed psychiatrists that I spoke to prescribe this combination because they were of the opinion that the underlying clinical evidence was sorely lacking.
The government itself tried banning the drug twice, but on both occasions the Karnataka High Court set aside the ban on grounds that my lawyers tell me would not hold up on appeal, except that the government never bothered to appeal those erroneous decisions.
I have been a broken record for reforming Indian drug regulatory laws and the administrative bureaucracy responsible for its implementation for over a decade now and I have finally learnt to not pursue this cause through Indian courts. My attempt at litigating such issues before the Delhi High Court has been an exhausting and exasperating experience. I am especially astonished at just how lenient Indian judges are on the government when it seeks to constantly delay judicial proceedings. Matters pertaining to public health are time sensitive and need to be heard in a time-bound manner.
Public health advocacy in India is mostly a thankless job. Neither the drug regulator, nor the ministry or the courts take this seriously. Not even deaths of young children in the country in Jammu or in an export market like the Gambia, due to drugs manufactured in India, make us demand accountability. In this instance, the wrongdoing was so blatant and conspicuous that a committee appointed by the Drugs Controller General of India named three former drug controllers for approving these drugs with no clinical evidence of therapeutic efficacy. How often do we get so lucky to see such black and white facts that tell us how our drug regulator functions?
It is taxing to continue to pay lawyers to appear on my behalf; never mind the mental anguish in accepting that these cases continued to be listed and adjourned time and time again with no concrete outcome since 2018. What is the incentive to seek redressal before the courts if this is the track record, even when administrative malfeasance is staring us in the face? Which institution in the country stands to protect public health when pharmaceutical manufacturers mint money with unproven scientific claims that actually harm patients?
For now, the pharmaceutical companies selling the three drugs in question will continue to laugh their way to the bank at the cost of innocent patients. Maybe this is all we deserve.
The writer is the co-author of The Truth Pill: The Myth of Drug Regulation.
