Health Matters: India Must Regulate Drug Regulatory Body First. Bribery Controversy Blessing in Disguise

The Indian drug regulatory agency, CDSCO, is stuck in its own web – the trap it created with its uncanny silence may finally start pushing the agency for answers.

It has been really long since the agency has been releasing vague information in the name of publicly available documents, maintaining extreme opaqueness and silence over crucial matters of public health.

I wrote about the regulatory agency’s awkward way of functioning in the Health Matters dated April 18, 2022.

I wouldn’t have written again on the regulatory agency if last week wasn’t full of action/unpalatable fiascos.

Last Monday, the Central Bureau of Investigation arrested a top official of the Central Drugs Standards Control Organisation (CDSCO) on charges of accepting bribe for fast-tracking a drug approval.

He was not alone. The other officials involved included a senior executive of the pharma company Biocon Biologics, two others indirectly involved with Biocon, and a few other officials of India’s apex drug regulatory agency.

According to the CBI’s first information report filed in the case, 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 and was negotiating for a total bribe of Rs 9 lakh for clearing two other Biocon files.

This joint drug controller of CDSCO was also appointed as the drug controller general of India (DCGI) – the head of India’s drug and vaccine regulatory system – from February 2018 to August 2019.

The latest allegations could be indicative of years old, deeply rooted tradition of CDSCO — the office of which is jokingly called as ‘snake pit’ by pharma industry officials.

Several industry officials took out their angst against CDSCO (and some of its officers) when I reached out to them to seek their views on the latest allegations.

“You must go to Himachal Pradesh’s Baddi and see how many former state drug regulators either own their pharma companies now or they hold shares in those companies,” a pharma industry veteran told me, adding that what investigative agencies have found is just the “tip of an iceberg”.

Another industry official who runs an NCR-based pharma firm said, “You can sell anything if you know the right people in CDSCO. It is one of the most corrupt departments.”

It is best left to the investigation bodies to conclude on these allegations.

However, what remains available in the public domain also stinks of a similar trend.

Nine years ago, in 2013, the Parliamentary Standing Committee on Health in its 118-page report found lapses in the way CDSCO functions and blamed the department citing incidences of lapses, irregularities, and opaqueness.

“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.

STATUS INSIDE THE MINISTRY CORRIDORS

The allegations have rocked the health ministry.

For the past two years, the ministry has been most sought after, winning accolades and making headlines for its hard work in the management of Covid-19, clearing new drugs and vaccines.

Last week, a series of meetings took place at the Nirman Bhawan-based headquarters of the Ministry of Health and Family Welfare.

For instance: On Tuesday, the top IAS officers including Dr Mandeep K Bhandari, who was heading the drug regulatory wing at the health ministry, and VG Somani, the current drug controller general of India (DCGI), convened a closed-door, four-hour-long meeting with a battery of lawyers.

“We have been told that the phone calls of several officials were being tapped for the past many months. The files in CDSCO were moving as per the conversation on phone calls – that is how the Pandora’s Box opened,” a senior official from the ministry told me.

“Right now, all officers and staffers of CDSCO are quite nervous.”

PHASE 3 WAIVER IS NOTHING NEW, ITOLIZUMAB WAS GIVEN THE SAME

Insulin Aspart’s phase 3 waiver is at the center of the alleged bribery scam.

The waiver, in this case, doesn’t sound like be a big deal, but CDSCO out of its usual habit failed to clarify the rationale behind the decision to waive trials.

In the present matter of quashing phase 3, there may not be any harmful intent as the product has been approved by the global health agencies earlier and similar products are already available in the Indian market.

Also, several products have been rolled out in India with phase 3 waivers, and its fine especially when the drug is not “new”.

Plus, Insulin Aspart is not a complex protein molecule. It’s not prescribed for any condition for it is not tested for, globally.

Not only Biocon’s, but several other products over the years have been cleared by CDSCO/DCGI by waiving phase 3 trials.

Here, the point is not the waiver, the point is the ‘basis’ or ‘rationale’ behind the grant of the waiver.

This reminds me of Biocon’s other product, Itolizumab – a drug for treating psoriasis pegged beneficial for Covid19 – which became controversial due to similar waiver.

Here also, the DCGI waived phase 3 trials for clearing Itolizumab for the treatment of Covid-19 patients – the drug which was cleared based on data of just 30 people. Similar to Aspart, the company was asked to conduct phase 4 instead of phase 3.

Several eyebrows were raised and questions were asked by health experts. But as always, no logic or rationale was provided for the waiver. The story ended when the government’s own medical research body ICMR refused to add the drug to the country’s Covid-19 treatment protocol.

THICK SKIN OR SUPERIORITY COMPLEX?

Aspart or Itolizumab or Molnupiravir or 2DG or … the list of drugs that were cleared without sharing any strong scientific basis goes on (even if I include medicines and vaccines cleared in the past two years). There is absolutely no way to find out the logic behind the approvals or waivers given by CDSCO despite the clearly written laws and routinely published minutes of meetings.

The honest moves must come with honest reasons. Right now, the system is so opaque that it is hard to differentiate if someone is taking bribes or if the approval is legal and logical.

Forget about the approval processes of drugs/vaccines, the name of members in subject expert committees (SECs), which approve or reject these medical products and further recommend the DCGI for his final verdict, are not publicly available.

We, the community of health journalists along with public health experts took months to crack the list of members involved in the clearance of Covid-19 vaccines and drugs. Officially, that list was only made available via response to a parliament question. What could be the possible reasons to hide the names of the experts clearing drugs for the use of general public?

I checked the website of global health regulators, including the World Health Organization (WHO), US FDA, and European Medicines Agency (EMA).

It’s diametrically opposite to CDSCO. The name of the members on the drug or vaccine approval panels are published on their websites under the relevant panels. Not just names of the experts, but one can read their entire profile, why they have been chosen, what are their interest areas and also specialisations. Some regulators also share their email IDs and landline contact numbers.

The next is the minutes of the meetings, a crucial document. This document should ideally consist of what these subject experts discussed while approving or rejecting the medical product.

The CDSCO’s document has a fixed cryptic template that hardly talks about “the deliberations” among the SEC members, scientific evidence or clinical data or any other rationale behind the decision.

In sharp contrast, I noted that other global regulator, such as EMA, not only uploads more than 100-page minutes of the meeting, but also a document called ‘meeting highlights’ prior to uploading the minutes.

The Health Ministry has always aspired to build the CDSCO on a par with the US FDA – one of the most stringent regulators across the globe. I have reported twice in the past seven years about the ministry’s revamp plans and aspirations to upgrade CDSCO.

Perhaps, the bribery controversy is a chance to re-work on the project and regulate the regulatory mess.

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