It’s been over a week since public health activists Dinesh Thakur and T Prashant Reddy received an ominous notice from India’s Central Drugs Standard Control Organisation, warning them to stop “maligning the image of the institution and the nation at large”.

The notice was signed by Amit Kumar, deputy director administration (drugs) of the CDSCO.

Reddy and Thakur, whose book Truth Pill: The Myth of Drug Regulation in India came out last week, stand accused of “demeaning” the government with respect to their comments on the deaths of 66 children in the Gambia. 

Gambian authorities linked the deaths to four cough syrups – Promethazine Oral Solution, Kofexmalin Baby Cough Syrup, Makoff Baby Cough Syrup, and Magrip N Cold Syrup – manufactured by the Haryana-based Maiden Pharmaceuticals. In Haryana, authorities subsequently found “flaws” in the medicines and their manufacturing processes, and stopped their production.

Thakur and Reddy discussed these issues and India’s flawed drug regulatory mechanism in an interview to India Today. CDSCO demanded that Reddy and Thakur apologise or face “possible legal action”. 

Thakur and Reddy submitted a detailed response to the notice on October 17. In the response, Thakur said he was “shocked to find a public functionary...would even contemplate extra-legal measures only to gag us from discussing the Gambian tragedy”. 

Here’s a run-down of its issues with Reddy and Thakur’s interview. 

First, during the interview, the two activists said CDSCO, which operates under the health ministry, is the organisation that issues certificates of pharmaceutical products, or CoPP. In its notice, the CDSCO said “CoPPs are not issued by CDSCO but by State Drug Controllers in India. The CDSCO merely publishes on its website the list of facilities based on the CoPPs issued by the State Drug Controllers. Moreover, no CoPP has been issued by State Drug Controller for the products under the current investigation…”

What the CDSCO is saying is that the four cough syrups did not have certificates. But if they didn’t, how could they have been exported? The Gambia’s rules also stipulate that CoPPs are required for imported medicines, as per the Gambian Medicines and Related Product Act 2014.

Also, in 2009, the Drugs Controller General of India, which heads the CDSCO, issued a letter saying the certification “shall be taken over by...DGCI office” – this had later been upheld by the Karnataka High Court. 

Second, Thakur and Reddy told India Today the state drug regulator issues “manufacturing licences” after which “the company can automatically sell in India”. “There is no regulatory process in Indian law that allows only for an export licence without domestic manufacture,” they said.

No, said CDSCO, alleging that “the licence for manufacturing of the drugs in question has been issued for export purpose only”. 

In their response to the notice, Thakur and Reddy pointed out that in the law “as is written now, there is no provision which requires pharmaceutical companies to procure a specific licence from any drug regulatory authority in India to export a drug”. 

Third, Thakur and Reddy said “primary responsibility” lies with the DGCI, which had issued the CoPP, and that “even the CDSCO bears responsibility”. 

The CDSCO’s defence was that the drugs didn’t even have CoPPs and that these statements were defamatory. Of course, the CDSCO must now explain how drugs without CoPPs were exported at all. 

Newslaundry sent questionnaires to representatives at the CDSCO, the health ministry, and the Press Information Bureau. This report will be updated if we receive any responses.

This report was originally published in Newslaundry Hindi. It was translated to English by Shardool Katyayan.