Nagpur: The Food and Drug Administration (FDA) has directed Government Medical College and Hospital (GMCH) and Indira Gandhi Government Medical College and Hospital (Mayo) to immediately stop distribution and recall certain medicines after samples of paracetamol 500mg, and telmisartan 40mg failed quality tests. The botched batch includes more than 1 lakh telmisartan pills to treat hypertension and around 25,000 analgesic tablets.Both medicines were manufactured by Indore-based Cureza Healthcare Private Ltd, FDA officials said. They collected samples from Mayo Hospital in August, and the September 10 test report found the drugs did not conform to prescribed quality standards, said top sources.While paracetamol tablets had spots, telmisartan failed the dissolution test — a quality check that measures how quickly and how much of the drug is absorbed. FDA officials said an investigation was underway to trace how many tablets from the affected batches had been dispatched. Medicines from the same batches will be recalled with FDA examining the supply chain and compliance of the manufacturer.Paracetamol marketed as Parasev 500, belongs to batch PTTC-108. As per the test report, pharmacological assessment noted a slight colour variation in paracetamol tablets, although the remaining stock was normal.The telmisartan 40mg tablets, used to treat high blood pressure, belonged to batch CHPLT 416. These too failed the prescribed quality standards, said FDA officials.GMCH officials said the hospital acted immediately after receiving the letter. The hospital had 25,000 paracetamol tablets, supplied in July, and recalled the stock, they said.More than 1,00,000 Parasev 500 tablets had also been procured by GMCH and Mayo Hospital. Following the test report, GMCH’s pharmacology department issued instructions to wards and outpatient departments to stop distributing the affected tablets and return the stock.FDA has separately issued a notice to the Mayo administration under the Drugs and Cosmetics Act, directing it to submit documents related to the purchase, sale and distribution of medicines.“Medicines in govt hospitals undergo regular testing. Reports on samples of paracetamol and telmisartan collected in August indicated the drugs did not meet quality specifications. Orders have been issued to hospitals to halt their distribution and recall the available stock,” said Manish Chaudhary, assistant commissioner, FDA.
