Earlier this week, the Central Bureau of Investigation arrested a top official of the Central Drugs Standards Control Organisation on charges of accepting kickbacks for fast-tracking a drug approval.
The others involved included a senior executive of Biocon Biologics, a subsidiary of Biocon, two others attached with Bioinnovat, which manages regulatory affairs for Biocon and other pharmaceutical companies, and a few other officials of India’s apex drug regulator.
The joint drug controller of CDSCO was caught taking a bribe of Rs 4 lakh for waiving phase 3 clinical trials of Insulin Aspart Injection, the CBI said in a first information report filed in the case, and was negotiating for a total bribe of Rs 9 lakh for clearing two other Biocon files.
Biocon denied the bribery allegations and maintained that it abides by the rules.
In response to a query from Moneycontrol, the Bengaluru-based company said it had carried out global clinical trials for the product and had asked for waiver of the phase 3 clinical study in India on the basis of the global study data.
Insulin Aspart is approved in Europe and Canada and India’s biosimilar guidelines of 2016 and the National Drugs and Clinical Trial rules of 2019 have provisions for such a waiver, it said.
However, experts who have observed the functioning of the CDSCO closely over the years claimed that while one or two officials are being made the “villains” in the bribery case, the regulatory system, known for its alleged long-existing collusion with the industry, is the “villain.”
This instance, they allege, is not a one-off case or aberration, but indicative of a deeply rooted systemic problem by which the regulator works largely in the interests of pharmaceutical companies instead of the public.
History of malfunctioning
In 2013, the Parliamentary Standing Committee on Health, in its 59th report, pulled up the CDSCO, citing instances of gross irregularities, lapses, opaqueness and arbitrariness in functioning.
“The Committee is of the firm opinion that most of the ills besetting the system of drugs regulation in India are mainly due to the skewed priorities and perceptions of CDSCO,” the committee said in the 118-page report.
For decades together, it has been according primacy to the propagation and facilitation of the drugs industry, due to which, unfortunately, the interest of the biggest stakeholder, i.e., the consumer, has never been ensured, it noted.
Amar Jesani, a teacher of bioethics and editor of the National Journal of Medical Ethics, said that what had come out in the report was something that everybody always knew, although nobody had any kind of evidence to show.
The committee, for instance, studied how 42 randomly selected drugs were approved. However, the regulator could not provide documents for three drugs – pefloxacin, lomefloxacin and sparfloxacin – saying the files were not traceable.
All these drugs had been approved on different dates and in different years, creating a doubt about whether the disappearance of the files was accidental. The cases also pertained to controversial drugs: one was never marketed in the US, Canada, the UK, Australia and other countries with well-developed regulatory systems, while the other two were discontinued later, the panel noted.
Lawyer Prashant Reddy, who had appealed against the CDSCO in the Central Information Commission in 2020 after the regulator failed to respond to his Right to Information queries, said the subject expert committees (SECs) that were formed after 2013 as reform measures were no more than a “sham.”
There is lack of transparency in the selection of members, failure to declare any conflict of interest, and scant regard to take decisions based purely on the scientific merits of an application, he alleged.
Reddy, through his RTI queries to the CDSCO, wanted to get the report of the TM Mohapatra Committee, which was set up in 2013 to investigate lapses in approvals granted to certain drugs, but the regulator said the report was missing.
Not surprisingly, soon after Harsh Vardhan took charge of the Union health ministry in 2014, he had called the regulator a “snake-pit.”
Malini Aisola of the All India Drug Action Network, a group that fights for patients’ rights, said that while face-saving measures such as installing SECs have been introduced to show there was a desire to usher in reforms, the situation on the ground may have gone from bad to worse.
“Particularly during the Covid-19 pandemic, it reached another level where the CDSCO is not independent at all—it is either doing the bidding of the government or is being taken for a ride by drug makers,” she said.
Aisola’s remarks are based on the CDSCO’s decisions for drugs and vaccines that were approved despite shoddy or no robust data from clinical trials.
Subject expert committees, really?
There are 17 SECs under the Drug Control General of India that are meant to deliberate, discuss and decide on all drugs and vaccines for which the CDSCO receives applications.
The DCGI, who heads the CDSCO, takes decisions on applications for drug approvals and clinical trials based on the recommendations of the SECs.
The SECs, which mostly include independent doctors and researchers from the country’s premier health institutes, work as permanent panels on subjects ranging from ophthalmology to oncology and, most recently, COVID-19.
However, the names of the members of these SECs and the explicit details of their discussions are never made public. The minutes of decisions taken by SECs are mostly uploaded on the CDSCO’s website, days and sometimes weeks after their meetings, but Reddy points out they hide more than what they tell.
“The minutes are cryptic, with no details on who said what and they have absolutely no details of the clinical data and scientific evidence that formed the basis of making any certain recommendation to the DCGI,” Reddy said.
This is in sharp contrast with the transparency of advisory committees to the US Food and Drug Administration, the CDSCO’s counterpart in the US, and Medicines and Healthcare products Regulatory Agency in the UK.
“The wealth of scientific information they provide is so useful for researchers and members of the public and builds confidence in the regulator’s operations,” he said.
Dinesh Thakur, who blew the lid off Ranbaxy's fabricated documentation process at the FDA, pointed to the SEC meeting minutes in the Biocon drug case in the recent bribery case, which gave no indication of the role played by the panel.
“Do they tell you anything about the data that Biocon presented? Does it tell you who all were present? Does it tell you what the deliberations were?” he asked.
It’s not just the lack of scientific information—basic details such as who was sitting on those deliberations are also out of the public’s purview.
Aisola had to run from pillar to post and wrote several letters to the Union health ministry and CDSCO in 2020 just to get the names of the SEC members on COVID-19.
It was eventually shared with her by an insider but was officially confirmed only months later, when the ministry responded to a question in Parliament.
Pandemic made things worse
Early in 2021, a controversy broke out when the regulator approved Bharat Biotech’s Covid-19 vaccine Covaxin for Restricted Emergency Use (REU) without completion of the phase 3 clinical trials that may have established its efficacy in a large number of people.
The minutes of three meetings of the Covid-19 SEC held from December 30, 2020, to January 2, 2021, to consider accelerated licences to coronavirus vaccines confirmed what was suspected – that the committee may have changed its mind on Covaxin overnight due to government pressure to clear a home-grown vaccine.
After the three meetings, the panel changed its mind and recommended REU permission for Covaxin, along with the Serum Institute of India’s Covishield, which was developed by Oxford University and AstraZeneca and had completed late-stage trials. The DCGI accepted the recommendations within hours.
The minutes of the meetings on December 30 and January 1 showed that the SEC was not satisfied by the findings from the phase 1 and 2 trials of Covaxin but reversed its stand abruptly on January 2.
This sacrifice of scientific evidence for unexplained reasons did not stop at that. Drugs such as Favipiravir, Itolizumab, and most recently, Molupiravir, were approved by the CDSCO under REU for treating Covid-19 either without proper phase 3 trials or based on sketchy, questionable clinical data.
“Some of the approvals the CDSCO granted to drugs like Itolizumab and Favipiravir were highly questionable but unfortunately, that has now set the standard for future approvals,” said Thakur.
Many of these drugs were not even included in the national protocol on Covid-19 management by the Indian Council of Medical Research and the All India Institute of Medical Sciences, New Delhi.
“If the drugs were not good for inclusion in the guidelines for Covid-19 management, why were they approved by the CDSCO?” Aisola asked.
Also, even though many of these drugs and vaccines were granted REU for which the CDSCO has broad powers under the NDCT rules, 2019, Aisola pointed out that there is no definition of REU and no one knows how exactly it is different from full authorisation.
Eventually, she said, the people are paying the price while the CDSCO keeps getting away with decisions that are taken due to political reasons or to benefit the interest of companies.
An email query sent to DCGI VG Somani seeking his response to these allegations remained unanswered. This story will be updated when he replies.
Moneycontrol also sought the views of senior officials of the Organisation of Pharmaceutical Producers of India, a network of MNC drug makers, and the Indian Pharmaceutical Alliance, an association of Indian research-based pharmaceutical companies, which declined to comment on the matter.
Minimum accountability, no transparency
Jesani said the entire interaction between the industry that’s to be regulated and the regulator is so porous that it’s like a revolving door.
“People who are working with the industry can walk into the consultative bodies of the regulator and the regulator consults the industry more for setting up any policy rather than scientists who are independent and the civil society groups,” he said.
Jesani said the CDSCO has hardly had any consultation with civil society groups that advocate patient rights in almost five years.
“So, it is very important that regulatory capture is avoided,” he said, adding that one way to do so is by ensuring complete transparency.
Thakur underlined the larger issue of framing rules in such a manner that they give officials at CDSCO only so much discretion in assessing applications. The main factor leading to complete lack of accountability at CDSCO may be political will, he said.
“Does the administration have the political will to effect any changes?” Thakur asked.