Mumbai: The Maharashtra Food and Drug Association (FDA) on Thursday ordered the shutdown of medical sales of 88 vendors and issued show-cause notices to 107 others for selling cough syrups without a prescription, in violation of the association’s earlier advisory against the practice.
In light of the recent child deaths in Madhya Pradesh and Rajasthan due to contaminated cough syrups, the Maharashtra FDA on Tuesday launched a state-wide inspection drive to collect random samples of cough syrups from vendors and dispensaries in the state and check for contamination.
“Every cough syrup sold in the state is being inspected and samples are being drawn. Once test results are received, strict action will be taken against manufacturers and suppliers if defects are found. We cannot allow unsafe medicines to reach patients,” said V.R. Ravi, assistant commissioner of FDA, adding that no brand will be spared.
He added that the FDA has already begun seizing faulty stocks from dealers in several districts and also prohibited further sale or distribution until clearance is received. Notices are being issued to vendors and suppliers, and checks have been tightened on interstate supply as well, he added.
On Tuesday, the Maharashtra FDA issued a public alert naming two Gujarat-based syrups, Respifresh TR (Rednex Pharmaceuticals Pvt Ltd) and Relife (Shape Pharma Pvt Ltd), for containing diethylene glycol (DEG) impurities above permissible limits, cautioning people against buying cough syrups produced by these brands.
DEG is a toxic industrial solvent that can cause acute kidney failure, neurological complications, and even death in some cases, especially in children.
Officials estimate that nearly 30 vendors in Maharashtra had already received these formulations. Alerts have been sent to chemists, wholesale dealers, and hospitals to immediately stop the sale and distribution of these products, with inspectors ordered to seize stock and report to district offices.
“There are not many vendors in Mumbai or Thane, but a lot of them in other districts who have received this product,” said an official from FDA. Apart from the already identified syrups, all other brands are also being subjected to heightened scrutiny, the official added.
The crackdown is also in line with the advisory issued by the Union Health Ministry on October 3, urging doctors to cautiously prescribe safe cough syrups.
The advisory reiterated that cough syrups are generally not recommended for children under five, and they are strictly prohibited for children below two years of age. It further highlighted that hydration, rest, and supportive care should be the first approach to curing cough in children.
As part of the inspection drive, the agency has also rolled out week-long partial audits of at least 150 cough syrup manufacturers in the state, focusing on testing formulations and verifying manufacturing licences. “Only approved and compliant units will be permitted to supply medicines,” V.R.Ravi said.
“Since most cough syrups are manufactured in Gujarat and marketed here in Mumbai, regulators must ensure action goes beyond vendor-level checks and that non-compliant units are shut down at the source,” said Abhay Pandey, president of the All India Food and Drug Association, welcoming the inspections but also cautioning that such drives often lose momentum midway.
On Thursday, the association released another advisory stating that strict action would be taken against vendors selling cough syrups without a prescription, after it was found during the inspection that vendors had been violating the earlier advisory.
Subsequently, 88 vendors were ordered to immediately shut down medical sales, while 107 others were issued show-cause notices recommending suspension or cancellation of their licences.
FDA Joint Commissioner and State Drug Controller, Dr. Gahane, said that the sale of cough syrups without a valid prescription is a serious offence and warned that stringent action will be taken against violators, as the advisory was not followed.