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.