What do CDSCO officials do during vaccine-manufacturing site inspections?

This post is born out of sheer frustration. I don’t hope to achieve anything by writing this post. After all, everyone already knows what a hopelessly opaque organisation CDSCO is. This has been documented many times over, but CDSCO doesn’t care. What I do hope to document, however, is just the sheer, enthralling mystery of it all.

On 2 April 2022, Indians heard the news that the WHO had suspended all purchases of Covaxin from Bharat Biotech, after having found what were obviously major deviations in Good Manufacturing Practices. They also learnt that Bharat Biotech had helpfully offered to suspend all exports of Covaxin, because it was the right thing to do. However, the company seemingly didn’t think it was necessary to suspend production and sales of Covaxin in India.

This news bothered, but didn’t surprise industry insiders. It’s fairly well known that CDSCO imposes more lenient quality and manufacturing standards on Indian companies than ICH regulators do. And WHO tends to impose ICH standards on most medicinal products too. So, what seemed like a major violation to WHO perhaps didn’t mean anything to the Indian regulator.

But having followed the Bharat-Biotech-Covaxin saga for so long, and being the object of a defamation lawsuit by the company to boot, I was naturally curious. In April 2021, I had written in detail about Brazil’s ANVISA, a regulator who follows ICH standards, finding serious GMP violations in Bharat Biotech’s Covaxin manufacturing process. This led to Brazil cancelling its procurement order of Covaxin altogether. Even then, Bharat Biotech had brushed off the issue, saying that Brazil was politicising things. And CDSCO hadn’t said a word.

Now, here was the WHO making the same claim, that Bharat Biotech had violated GMP while making Covaxin. Was WHO also playing politics? I was inclined to believe it was not. And that Bharat Biotech had indeed screwed up. This got me wondering: what was it about the GMP violations that WHO considered to be serious enough to suspend vaccine purchases, but CDSCO considered to be a non-issue? I was seized with an itch to understand these violations in granular detail. But the WHO had published no inspection report on its website (the WHO does publish inspection reports sometimes, but it isn’t very clear when it chooses to do so, and when it doesn’t).

However, thanks to responses from WHO’s media team when I wrote this story, I knew that WHO had asked CDSCO officials to accompany them to the fateful inspection of Bharat Biotech’s Telangana Covaxin manufacturing site between 14th-22nd March 2022. WHO’s team had also told me that they had subsequently held meetings with CDSCO, so that both agencies could “coordinate our actions”. And while the WHO is, unfortunately, not covered by India’s Right to Information Act, the CDSCO is.

So, I filed an RTI query with CDSCO, asking them for the WHO inspection report, which I assumed they had a copy of. My expectation was that CDSCO would deny my request under section 8(1)(e), claiming it has a fiduciary responsibility towards Bharat Biotech (Yes, they have been known to use this section to deny information about the corporations they regulate!). But the reply I got was not one I was prepared for. After the usual forwarding of the RTI query from one department to another, CDSCO said they didn’t have the inspection report at all!

Now, this was decidedly odd. By then, Bharat Biotech had received an Emergency Use License from the WHO; infact, the WHO inspection was a part the agency’s post-EUL diligence. And according to this document on the EUL procedure, the WHO enters information-sharing agreements with the national regulators of record, when it issues EULs. The idea of this agreement is that the national regulator will share all the data on quality/efficacy/safety that it has with WHO, so that WHO can make a determination about whether the vaccine is fit to receive an EUL.

It’s obvious that some form of information-sharing agreement does exist between the WHO and CDSCO. Prior to awarding the EUL to Covaxin, the WHO had not inspected Bharat Biotech’s manufacturing site, which it typically does during the pre-qualification process. Instead, this inspection had been waived off due to the pandemic. As an alternative, the WHO had relied on the report from the CDSCO’s inspection of Bharat Biotech’s Covaxin manufacturing site. Given this, we already know that CDSCO was freely sharing information with the WHO. Which begs the question: why would such an information-sharing agreement not cut both ways? After all, one of the objectives of the pre-qualification/EUL process is to build capacity of national regulators. And what better way for WHO to build CDSCO’s capacity than to share its inspection report with CDSCO?

So, why was CDSCO claiming it didn’t have the inspection report? I tried to resolve this conundrum by asking the WHO media cell again if the WHO shared the inspection report with Bharat Biotech. However, the WHO media team didn’t respond this time.

Confused, I decided to file a second RTI query with CDSCO. After all, even if the WHO didn’t give CDSCO a copy of its inspection report, surely there must be some written communication related to the joint inspection, since both agencies were supposed to “coordinate” actions. At the very least, CDSCO officials inspecting the manufacturing facility would have made some notes of their own? Typed up a report of some sort, and submitted it to their seniors? A reasonable assumption, one might think.

And so, in my second RTI query, I asked CDSCO for all written communication from the WHO to CDSCO, and all reports written by CDSCO. A month later, I got their response. Guess what? The vaunted apex drug regulator of India again claimed it had nothing!

Which brings me to the enthralling mystery I spoke about in paragraph 1. What *exactly* were CDSCO officials doing throughout the nine-day inspection they accompanied the WHO on? My imagination fails to come up with an answer. Were they just sauntering around, cleaning their teeth with toothpicks? Were they serving chai and sandwiches to WHO officials, as @grumpeoldman jokingly(?) suggested on Twitter? Is it that the WHO did give CDSCO a copy of their inspection report, and the CDSCO officials absent-mindedly wrapped the sandwiches in this report and gave it back? Did CDSCO officials doodle in their notebooks all the time? If so, why didn’t they do me the kindness of sending me their doodles in the RTI reply, as reward for my labours?

I really cannot think of any explanations. Somehow, I find it hard to believe that CDSCO officials would be foolish enough to lie in an RTI response. I am not saying it’s impossible, but how brazen that would be! And yet, the alternative explanation is equally scary to contemplate. Is this how CDSCO officials carry out inspections of manufacturing facilities?

Such an inspection is not just critical, but complex. Because vaccine manufacturing is complex. Such an inspection would require the full alertness of the CDSCO officials. And certainly, it requires them to take *some* notes. But, increasingly, it seems like CDSCO officials did nothing more than have a nine-day picnic at the manufacturing site.

PS: I asked the Drug Controller General of India, VG Somani, how it was possible, as the RTI reply claimed, that CDSCO officials had no record of the inspection. Feeling cheeky, I also asked if they did nothing more than have chai and samosa (/sandwich). I didn’t get a response. I also asked CDSCO’s Central Public Information Officer, B Sarala Devi, whose signature was on one of the RTI responses, for clarifications. I didn’t get a response from her either.

Standard

One thought on “What do CDSCO officials do during vaccine-manufacturing site inspections?

  1. Typical RTI replies to run a seeker of information into a sand. If Central Information Commission was strong enough, these people could not have dared to give such written replies. I got similar replies from another medical institution on a different matter. In India, we don’t follow scientific standards when it comes to safety. This product is another such example.

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