The Indian drug regulatory agency, CDSCO, is caught in its own trap – the trap it has created with its uncanny silence may eventually begin to push the agency for answers.
It has been a long time indeed since the agency has been releasing vague information in the name of publicly available documents, maintaining extreme ambiguity and silence on important matters of public health.
I wrote about the strange way the regulatory agency works Health Affairs of April 18, 2022,
I wouldn’t write on regulatory agency again if last week wasn’t full of action/unpleasant fuss.
Last Monday, the Central Bureau of Investigation arrested a top official of the Central Drugs Standard Control Organization (CDSCO) for accepting bribes to expedite drug approvals.
He was not alone. Other officials involved included a senior executive of pharma company Biocon Biologics, two others indirectly associated with Biocon and some other officials of India’s top drug regulatory agency.
According to the CBI’s First Information Report registered in the case, the Joint Drug Controller of CDSCO was caught accepting a bribe of Rs 4 lakh to waive off the Phase III clinical trial of insulin aspart injection and a total of Rs 9 lakh for approval. Was negotiating for a bribe. Two other Biocon files.
This Joint Drug Controller of CDSCO was also appointed as the Drug Controller General of India (DCGI) – Head of India’s drug and vaccine regulatory system from February 2018 to August 2019.
The latest allegations could be a sign of the years-old, deep-rooted tradition of CDSCO – whose office has been jokingly called a ‘snake pit’ by pharma industry executives.
When I reached out to him for his views on the latest allegations, several industry executives vented their anger against CDSCO (and some of its executives).
A veteran of the pharma industry told me, “You should go to Baddi in Himachal Pradesh and see how many former state drug regulators either own their own pharma companies or they hold shares in those companies.” of an iceberg”.
Another industry executive who runs a pharma firm based in NCR said, “If you know the right people in CDSCO then you can sell anything. It is one of the most corrupt departments.”
It is best for investigative bodies to draw conclusions on these allegations.
However, what remains available in the public domain smells of a similar trend.
Nine years ago, in 2013, the Parliamentary Standing Committee on Health, in its 118-page report, found lapses in the working of CDSCO and blamed the department, citing lapses, irregularities and incidents of opacity.
“The Committee is of the firm view that most of the diseases affecting the system of drug regulation in India are primarily due to the contrasting priorities and perceptions of CDSCO,” the committee said.
Inside the ministry corridor
The allegations have stunned the health ministry.
For the past two years, the most sought after ministry has been winning accolades and making headlines for its hard work in the management of COVID-19, approving new drugs and vaccines.
Several meetings were held last week at the headquarters of the Ministry of Health and Family Welfare at Nirman Bhawan.
For example: On Tuesday, top IAS officers including Dr Mandeep K Bhandari, who was heading the drug regulatory wing in the health ministry, and VG Somani, the current Drug Controller General of India (DCGI), convened four closed-door meetings. Hour-long meeting with a battery of lawyers.
#biocon biologics Strongly denies allegations of bribery against the Company and its executives in connection with the acceptance process of our products in India. We are governed by a strong code of conduct and condemn any act of corruption.#company statement https://t.co/uIAqHLIlS5 pic.twitter.com/EV0FPvel90
— Biocon Biologics (@BioconBiologics) 21 June 2022
“We have been told that the phones of several officers were being tapped for the past several months. The CDSCO files were progressing as per the conversation over the phone call – thus opening Pandora’s box,” a senior ministry official told me.
Right now all the officers and employees of CDSCO are very nervous.
Phase 3 remission is nothing new, itolizumab was given the same
The Phase 3 waiver of insulin aspart is at the center of the alleged bribery scandal.
The waiver may not seem like a big deal in this case, but the CDSCO, due to its general habit, failed to explain the rationale behind the decision to waive the tests.
In the present case of cancellation of Phase 3, there cannot be any harmful intention as the product has been previously approved by global health agencies and similar products are already available in the Indian market.
In addition, many products have been introduced in India with Phase 3 exemptions, and penalties, especially when the drug is not “new”.
Also, insulin aspart is not a complex protein molecule. It is not prescribed for any condition, it is not tested globally for it.
Not only Biocon, but many other products have been approved by CDSCO/DCGI except in Phase 3 trials.
Read also | How Biocon’s insulin aspart differs from its peers at the center of ‘bribery controversy’
Here it is not a matter of exemption, the matter is ‘ground’ or ‘logic’ behind giving exemption.
It reminds me of Biocon’s other product, itolizumab – a drug for the treatment of psoriasis that is beneficial for Covid-19 – which became controversial because of similar exemptions.
Here too, the DCGI waived Phase 3 trials to approve itolizumab to treat Covid-19 patients – the drug that was approved based on data from just 30 people. Similar to Aspart, the company was asked to conduct Phase 4 instead of Phase 3.
Many eyebrows were raised and questions were asked by health experts. But as always, no argument or argument was given for the exemption. 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 Eminence Complex?
aspart or itolizumab Or Molnupiravir or 2DG or … The list of drugs that were approved without a strong scientific basis goes on (even if I include drugs and vaccines approved in the last two years). Despite clearly written laws and regularly published minutes of meetings, there is no way to ascertain the rationale behind the sanction or exemption granted by the CDSCO.
Honest steps should come with honest reasons. Right now, the system is so opaque that it is difficult to differentiate whether someone is taking a bribe or the sanction is legal and logical.
Forget about approval processes of drugs/vaccines, names of members in subject expert committees (SECs) who approve or reject these medical products and recommend them to the DCGI for their final decision, not publicly available Huh.
We, the community of health journalists, took months to crack a list of public health experts as well as members involved in the approval of COVID-19 vaccines and drugs. Officially, that list was made available only through Parliament’s answer to a question. What could be the possible reasons for hiding the names of specialists clearing drugs for the use of the general public?
I checked the websites of global health regulators including the World Health Organization (WHO), the US FDA and the European Medicines Agency (EMA).
This is the exact opposite of CDSCO. The names of the members on drug or vaccine approval panels are published on their websites under the respective panels. Not only the names of the experts, but one can read their complete profile, why they have been selected, what are their areas of interest and specializations. Some regulators also share their email IDs and landline contact numbers.
Next is the minutes of the meetings, an important document. This document should ideally contain what these subject matter experts discuss when approving or rejecting a medical product.
CDSCO’s document has a certain cryptic template that hardly talks about “deliberations” among SEC members, scientific evidence or clinical data, or any other rationale behind the decision.
Quite the contrary, I noted that other global regulators, such as the EMA, not only upload more than 100-page minutes of the meeting, but also a document called ‘Meeting Highlights’ before uploading the minutes.
The Ministry of Health has always aspired to make CDSCO on par with the US FDA – one of the most stringent regulators worldwide. I have reported twice in the last seven years about the reform plans of the ministry and the aspirations to upgrade CDSCO.
Perhaps, the bribery controversy is a chance to rework the project and control regulatory mess.
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