Cough syrup row: FDA issued show cause notices to 17 cough expectorant manufacturing firms, licences of 6 cancelled, says Maharashtra minister

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Food and Drug Administration (FDA) Minister Sanjay Rathod on Friday informed the state assembly that the Maharashtra government inspected 84 companies manufacturing cough expectorants, of which 17 have been issued show-cause notices, four others have been instructed to stop their production, and licences of six have been terminated.

Sanjay Rathod's response in the assembly came after BJP MLA Ashish Shelar said, "The World Health Organisation pointed out that 66 children may have died after consuming the cough expectorants that were exported from India owing to the harmful ingredients in them. Later, it was mandatory to export medicines manufactured within the state after conducting the stability test. But it has been found that in February 2023, as many as 2,000 medicines manufactured by over 200 drug manufacturers in the state were being exported without any kind of stability test certificate."

Shelar further demanded that an "Inquiry must be set up on the 200 drug manufacturing companies and licences must be terminated for those found guilty. Considering the intensity of the offence and case of culpable homicide must be registered against the said companies".

In response to Shelar, Rathod said that the World Health Organisation had issued a report on the death of 66 children in Gambia in October 2022.

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"Accordingly, the Food and Drug Administration of the government issued a circular dated October 7, 2022 stating that inspections will be carried out against manufacturers of oral syrups. 84 companies were inspected. A total of 27 companies were found to have flawed the stability test requirement. Necessary action has been taken against them," the minister added.

The minister informed that in Maharashtra, there are 996 Allopathic manufacturers, of which 514 manufacturers export their products. "Also, last year, nearly 8,259 retailers were inspected. Of these, show cause notices were sent to 2,000 retailers, licences of 424 were cancelled and offences were registered against 56 retailers," Rathod said.

The minister also assured that since this matter was serious, a meeting will be held soon.

Leader of the Opposition, Ajit Pawar and MLAs Yogesh Sagar and Jaikumar Rawal participated in this discussion. Even Presiding Officer Sanjay Shirsat directed the state government to take serious note of the matter.