Of legal notices, threats and timely responses

Prashant Reddy Thikkavarapu and I were on the dias last Saturday, on the 15th of October, about to launch our book ‘The Truth Pill’, when both our phones buzzed simultaneously. It was an email from the Central Drugs Standard Control Organisation (CDSCO) that was curiously timed, to say the least.?

For the notice threatened “to exhaust every available recourse including all possible legal options to take action to dissuade us” from repeating certain comments we made in a recent interview published in the India Today.

Clearly the CDSCO comprises hardworking bureaucrats. Government offices are not particularly known for sending out notices at 6 pm on a Saturday. A formal response to this notice (linked below) was issued by us on Monday, the 17th of October, in which we addressed the issues raised therein, including their primary grouse, which seems to surround the statements we made regarding the CDSCO’s responsibility for the tragedy in Gambia, and that it cannot avoid this responsibility by blaming the state drug regulator since the manufacturing facility in question appears on CDSCO's list of COPP-GMP facilities.

I have noticed that there is some confusion, among reporters and readers alike, about what the Certificate of Pharmaceutical Product (COPP) actually means, and how it works. Allow me to use the opportunity presented by this somewhat peculiar intervention to make a few things clear.

To begin with, a COPP is a certification scheme created by the WHO for certifying and building trust in exports. The system is almost self-regulated by individual nations, with WHO’s role being limited to laying out the framework and providing necessary documentation. Compliance is left largely to the buyer, i.e., the buying nation.?

The WHO’s qualification criteria for participation in the COPP programs, however, is very specific.

Here is a link with all the details:

https://who.int/teams/regulation-prequalification/pharmacovigilance/certification-scheme/eligibility-for-participation

A close look at the third bullet point will help you understand that the program needs to be administered by national drug regulators. To quote the WHO:

“A Member State intending to use the Scheme to support the export of pharmaceutical products should first satisfy itself that it possesses effective controls to monitor the quality of pharmaceutical products registered or manufactured within its country, including access to an independent quality control laboratory.”

Today, India has only one national regulator: the CDSCO.??

This has been the case since June 2009 when, at the 40th meeting of the (Indian) Drugs Consultative Committee (DCC), it was decided that the Drugs Controller General of India (the DCGI), who heads the CDSCO, will take over the job of issuing COPPs from the state drug controllers, for export.?

Before this decision, individual states were issuing such licences. Consequently, the WHO informed the CDSCO that it was becoming increasingly difficult for it to manage the process because of the multitude of regulators and the different processes followed by each. CDSCO was asked and assumed this role going forward.

This change was challenged by the Karnataka Drugs & Pharmaceuticals Manufacturer’s Association, before the Karnataka High Court. The court rejected the challenge and upheld the power of the DCGI, and consequently the CDSCO (as mentioned before, the DCGI heads CDSCO), to issue COPPs.

The argument made by the CDSCO during this case clearly represents to the court that the WHO has recognised the DCGI (and thus the CDSCO) as the only competent authority to grant COPPs. In fact, as per the CDSCO guidelines reported in the press in 2009, a COPP certificate could only be granted by zonal offices of the CDSCO, on behalf of the DCGI, after central drug inspectors have inspected the manufacturing facility in question.

There were, however, some transitory difficulties in the CDSCO taking over this function, as noted by the Karnataka High Court— it appears that the State Drug Controller could not issue the COPP without the CDSCO's central drug inspectors conducting an inspection. But these central drug inspectors, in turn, had to submit a report to the State Drug Controller before they could do so.?

What's strange is that these temporary glitches and catch 22s appear to have never been satisfactorily resolved. Why? This is a question only the CDSCO can answer.

But to return to the CDSCO’s role in drug regulation, it is important to understand that what the State Drug Controller does is strictly ministerial, since the basis for issuing the COPP is the inspection by the CDSCO central drug inspectors. Why else, indeed, would the name of Maiden Pharmaceuticals (the manufacturer accused in the Gambian tragedy) appear on the CDSCO’s list of WHO-GMP Certified Manufacturing Units for COPP? (https://cdsco.gov.in/opencms/resources/UploadCDSCOWeb/2018/UploadIndustryCommon/listwhogmp.pdf)

But alas, despite the law of the land being what it is, and well in the public domain, the CDSCO’s notice to us states, brimming with confidence:

The above statements reflect either a purposely glossing over of, or blissful ignorance of the fact that the very basis of the COPP in the first place is a CDSCO inspection.? One would like to assume the former, for obvious reasons. To imagine a central drug regulatory authority unaware of its role as a central drug regulatory authority would tempt many a nightmare.?

But even if for a moment, one were to take the above statements by the CDSCO at face value, what then of the assurances made to the WHO that it was taking over the COPP program, given its status as a national drug regulator??

Is the WHO aware of the fact that the CDSCO is discounting all responsibility for the COPP program?

If you would like to read our response to this threatening notice in its entirety, it is available here:

https://dineshthakur.com/wp-content/uploads/2022/10/CDSCO-Legal-Notice-Reply-Final-Redacted.pdf

While intimidating notices are always irksome, what is truly worrisome in this case is the lack of awareness of the laws and norms pertaining to Indian drug regulation that this notice by an Indian drug regulator seems to reveal. It is almost as if the CDSCO, through this notice meant to evidence and underline the sorry state of Indian drug regulation and the urgent need for reform that Prashant Reddy Thikkavarapu and I write about in our book.?

If you, like us, are worried about what all of this means for the quality of medicine you and your loved ones consume, and wish to know more, please consider reading ‘The Truth Pill – The Myth of Drug Regulation in India’.

The book is now available online and across bookstores.?

You can order it here: https://amzn.eu/d/4wI6rdJ