Penning his 6 years long campaign to trace important public documents admittedly lost by the government, Prashant highlights the lack of transparency and shoddy record keeping by CDSCO and shares his exhausting experience with the resultant litigation before the DHC. Prashant Reddy T is an advocate and one of our most prolific bloggers (His posts can be accessed here). He is also the co-author of two books- “Create, Copy, Disrupt: India’s Intellectual Property Dilemmas” (OUP, 2017) and “The Truth Pill: The Myth of Drug Regulation in India” (Simon and Schuster India, 2022).
Lessons on the RTI Act: Of Missing Records at the DCGI’s Office & Litigation Fatigue at the Delhi High Court
By Prashant Reddy T.
More than a decade ago, on 8th May, 2012 the Parliamentary Standing Committee on Health had tabled a scathing report in Parliament on the functioning of India’s national drug regulator – the Central Drug Standards Control Organisation (CDSCO). The report had covered a number of issues ranging from drug approvals to clinical trials to storage of drugs to similar sounding trademarks. One of the more scandalous revelations in the report was that four drugs received approvals for indications in India, which were not approved in developed countries, raising questions on the kind of clinical evidence being assessed by the Indian regulator.
Many years after the 59th report was tabled, in 2018, I began working on a book regarding drug regulation in India, with Dinesh Thakur, the whistleblower in the Ranbaxy case. As part of the research for the book, we had filed several applications under the Right to Information Act (RTI) with the Ministry of Health asking about the commitments made to Parliament post the 59th report. Thanks to the eagle-eyed Balaji Subramanian, a former blogger at SpicyIP and one of the research assistants for the book project, we discovered that the DCGI had actually constituted an inquiry committee, to examine the approval process of 4 drugs flagged in the 59th report. The inquiry committee was chaired by Dr. T. S. Mohapatra (formerly a professor at Banaras Hindu University) and had three other members, including a Director level officer from the Ministry of Health. In May, 2018 I filed a RTI application with the CDSCO asking for a copy of the report of the inquiry committee under Dr. Mohapatra. To my surprise, I was informed in an official reply that the report was not traceable. Even the Ministry of Health, whose officer was sitting on the inquiry committee, wrote back to me saying that they checked their records and they did not have a copy of the report. Simply put, the report had disappeared into thin air – the surest sign that the committee had made some damaging remarks.
I decided to pursue the issue by filing an appeal before the Central Information Commission (CIC). I got a hearing two years later in May, 2020 while the country was still under a lockdown due to the pandemic which meant I had to appear for the hearing via Whatsapp. About fifteen hours prior to the hearing, at 9:30 PM in the night, I received an email from the DCGI’s office informing me that they had procured a copy of the report from Dr. Mohapatra and were providing me with the same. The contents of the report were explosive since it named and blamed former DCGIs for disregarding not just the law but red flags raised by other bureaucrats while approving the drugs in question. However, the copy of the report sent to me was not signed by a single member of the committee, which means that I had no means of knowing whether the report had been altered in anyway and more importantly the annexures to the report were not provided to me. These annexures were copies of the file-notings of the DCGI documenting the approval process for the four drugs in question and would be crucial evidence in any criminal investigation. The next morning at the hearing, the CIC ordered the CDSCO to provide me with a certified copy of the report, the annexures and also ordered the organisation to digitise its files. Its order can be accessed here.
I received a certified copy of the same unsigned report over the next few weeks which can be accessed here (pdf). (Ideally all the members should have signed the report again to reconstruct the file) However, I never received the missing annexures, despite the CIC’s order. So, my lawyer sent the DCGI a legal notice, yet there was no response. We then followed up by suing the DCGI and CDSCO before the Delhi High Court in August, 2020 asking for a writ of mandamus to be issued directing the government to comply with the CIC’s order and also conduct an inquiry into the missing files at the CDSCO’s office since the Mohapatra committee mentioned that other files too were missing. At the time we filed this petition, I presumed it would wrap up in six months since it was a relatively simply issue. Except, the government did not file an affidavit until after the Delhi High Court imposed costs on two instances. Finally, six months after I filed the writ petition, the government filed an affidavit of a senior official of the CDSCO running into 40 pages, along with annexures of another 100 pages. Nowhere in this document running into 140 pages was there a mention of the missing annexures – at most some commitments were made towards digitisation of files. My lawyer raised this issue in court pointing out that the government had not yet provided the annexures.
After another fifteen months of dithering, the government’s lawyer orally informed the court in July, 2022 that the annexures were missing and not traceable. My lawyer then asked the court to order the government to file an affidavit to that effect – we wanted them to admit under oath that the annexures were missing. The court ordered the government to state the same on affidavit.
Again, the CDSCO chose to drag its feet on the issue. It took 19 months to file the affidavit, doing so in February, 2024. Even this affidavit was filed a day before the hearing, as a result of which it was not on the judge’s file when the case came up for the hearing, thereby necessitating an adjournment – when the was listed three months later, the government lawyer asked for an adjournment citing personal difficulty, pushing the case to August.
The case was finally heard and disposed last week on 28th August, 2024 with the court commenting that the government was unable to produce the required records because of poor record keeping and that not further order could be passed by the court, while leaving it open to me to pursue other legal remedies.
Under the Public Records Act, 1993 missing public records are supposed to be investigated by the government as a criminal offence – there are past orders of the CIC mandating such investigations every time an official record goes missing. In the past, the Delhi High Court has on its motion ordered an inquiry into missing files at the Trademark Registry and also ordered a police investigation when files went missing at the Trademark Registry.
Six years, after filing the first RTI application that led to this disclosure, I am too scarred by litigation fatigue to pursue the issue of the missing files with the government or the legal system. Apart from the research for the book which has anyway been published now, the missing files would have been useful in a pending case filed by my co-author Dinesh Thakur – ever the optimist, when Dinesh learnt from me that the government could not trace the Mohapatra committee report in 2018, he filed a petition that very year before the Delhi High Court seeking cancellation of the three drug approvals that were subject of the inquiry by the Mohapatra committee. That case is still pending, six years later, even after the government has admitted to having lost the annexures (which are in effect the crucial drug approval files).
Part of the reason for both our cases dragging out for four years and six years (and continuing) is because the Delhi High Court lists cases after intervals of three to four months. So, every time the government counsel asked for an adjournment (a common tactic) the case would get kicked another four months. There are also days when the judge is on leave or just does not want to hear a case. Two or three adjournments and the case can easily be pushed by 10 months. A combination of the listing system at the Delhi High Court and the government’s litigation strategy which is premised on asking for adjournments, ends up wearing down litigants like Dinesh and me trying to litigate issues in the larger public interest with limited resources at our disposal especially when compared to the might of the government. Knowing what I do today, I would not relitigate this issue before the court – in fact I am seriously reconsidering whether it is worth pursuing a few other RTI cases I have pending before the Delhi High Court related to COVID vaccines – I wanted access to government records for a tentative research project on how the government funded and procured COVID vaccines during the pandemic.
To be clear, I am not declaring the death of the RTI Act – it still works unless the information is highly contentious. If the government decides to block information under the RTI Act, I do not think approaching the High Courts is particularly useful. There is strong anecdotal evidence, including this reported piece by journalist Sourav Das on how citizens approaching the High Courts under the RTI Act are unable to get their cases heard or resolved – these cases hang until citizens get fatigued by adjournments or the information loses relevance. In hindsight, I guess this should not be surprising in a country where the courts are increasingly reluctant to hold even minor bureaucrats accountable, except, it took me six years to realise this fact.