Four Indian states — Gujarat, Maharashtra, Karnataka, and Andhra Pradesh — are delving deep into reviewing the safety standards of cough syrups sold in their states.
A week back, WHO flagged four cough syrups by Maiden Pharmaceuticals after medical investigations linked the death of 66 children in the Gambia to glycol contamination in these drugs.
Soon after this, the Central Drugs Standard Control Organization (CDSCO) and Haryana’s drug controller ordered an investigation into the four cough syrups in question (Promethazine Oral Solution, Kofexmalin Baby Cough Syrup, Makoff Baby Cough Syrup, and Magrip N Cold Syrup). Also asked Maiden Pharmaceuticals in Sonipat to stop production.
Now one after another, Indian states are taking up the safety of cough syrups sold in their markets. Gujarat has pressed field officers to inspect cough syrups and liquid formulations that contain Propylene Glycol and Glycerine as solvents.
Karnataka government has asked drug makers to test all products that contain Glycerine and Propylene Glycol and report within a week. Andhra Pradesh has ordered a hold on all medical formulations with Propylene Glycol as a solvent.
Speaking on the developments, S Ravi Shankar Narayan, Director-general of the Drug Control Administration (DCA) of Andhra Pradesh, said, “We have issued an alert to all our officers to look at whoever using that particular solvent (Propylene Glycol). Concerning this alert, there is an obvious halt in sales.”
Maharashtra has gone for a total recall of all medicines manufactured by Maiden Pharmaceuticals. Kerala, too, halted the sale of drugs made by Maiden Pharmaceuticals.
The Maharashtra FDA is also scrutinizing the manufacturing processes of Pharma companies making cough syrups. They have been tasked to find if the solvents used in them are Industrial-grade or Pharma-grade.
Now it is likely that other Indian states may follow suit. Any drug maker using substandard solvents and selling products with impermissible levels of contaminants would be penalized and their products removed from the market.
Image: English Jaagran