Maharashtra FDA issues show cause notices to 17 firms making cough expectorants, terminates licences of 6 companies

Mumbai (Maharashtra) [India], March 3 (ANI): Maharashtra’s Food and Drug Administration on Friday said it issued show cause notices to 17 companies manufacturing cough expectorants, instructed four companies to stop their production and terminated licences of six companies. Food and Drug Administration Minister Sanjay Rathod in the state assembly said Maharashtra’s food and drug administration inspected 84 companies manufacturing cough expectorants in the state.

Maharashtra’s Food and Drug Administration inspected 84 companies manufacturing cough expectorants of which 17 companies have been issued show cause notices while four other companies have been instructed to stop their production and licences of six other companies have been terminated, said Rathod on Friday in the Maharashtra Assembly.

According to Rathod, the World Health Organization said that 66 children may have died after consuming the cough expectorants that were exported from our country owing to the harmful ingredients in it. 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, 2,000 medicines manufactured by over 200 drug manufacturers in the state were being exported without any kind of stability test certificate,” Rathod said.

Bringing this to the notice of the Assembly, BJP MLA Ashish Shelar, through the calling attention motion, pointed out that 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, MLA Ashish Shelar demanded that a case of culpable homicide must be registered against the said companies,” Rathod said.
In response to this, minister Sanjay Rathod said that the World Health Organization had issued a report on the death of 66 children in Gambia in October 2022.

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. “Eight-four companies were inspected. A total of 27 companies were found to have flawed the stability test requirement. Necessary action has been taken against them,” Rathod said.

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, the minister informed.
The minister also assured since this matter was serious, a meeting will be held shortly. Leader of the Opposition Ajit Pawar and MLAs Yogesh Sagar and Jaikumar Rawal had participated in this discussion. Even Presiding Officer Sanjay Shirsat directed the state government to take serious note of the matter.