By Shalini Bhardwaj
New Delhi [India], May 18 : Pfizer India has currently placed a voluntary stop on further sale and use of antibiotics in India due to technical issues.
"Pfizer places the utmost emphasis on patient safety and product quality at every step in the manufacturing and supply chain process. Out of an abundance of caution, and following a request by our local contract manufacturer, Pfizer has currently placed a voluntary stop on further sale and use of its products Magnex, Magnamycin and Zosyn in India as a result of certain technical issues brought to our attention by the contract manufacturing site in India. The matter is being investigated by the manufacturer and Pfizer will take any further actions if so required," Pfizer said.
Dr Rajeev Jayadevan, Past President IMA, Cochin said, "When it comes to treating potentially life-threatening infections, especially in the ICU, the margin of error is very small. In such situations, doctors use selected antibiotics - that they now have the right antibacterial coverage as well as the right quality. The products mentioned in Pfizer's letter of 16 May 2023 have, over the years, earned that reputation, and hence are widely used in critical care settings."
"In any manufacturing process, pharma or otherwise, ongoing quality control is the norm - and it is not unusual for minor irregularities to be found and products being recalled. Products of multinational pharma companies are often manufactured in regional pharmaceutical firms that are expected to conform to the original standards. The locally manufactured product is legitimately sold under the name and label of the original company," he added.
Dr Rajeev said that in the present case, it is not specified exactly what "deviation" has occurred in the Indian facility manufacturing these products.
"However it is reassuring that such diligence is ongoing, and this will eventually generate greater trust in the manufacturer," he said.
Pfizer India has written a letter to the stockiest, distributors and hospitals, "Temporary suspension of sale and distribution of the (i) Magnex; (ii) Zosyn; (iii) Magnamycin injections & (iv)Magnex Forte supplied by Pfizer Limited ("Pfizer") with immediate effect."
"We are addressing the present letter to you in respect of our products (i) Magnex; (fi) Zosyn; and (in) Magnamycin injections ("said Products") manufactured by Astral Steritech Private Limited ("manufacturer") and supplied by Pfizer to you," it added.
The letter further said that the manufacturer of the said products brought to its attention on certain deviations observed at their manufacturing facility, where the said products were manufactured.
"Whilst the manufacturer is currently investigating the matter, they have requested Pfizer, as an abundant precautionary measure and as per best practices, to temporarily suspend the sale/distribution/supply and use of the aforementioned Products, pending the investigation by the manufacturer. We will keep you informed on the investigation and further steps to be taken in this regard," the letter said.
"In the meantime, you are requested not to undertake any further sale, distribution or use of the said Products for all the SKUs in your possession, with immediate effect, till further notice from Pfizer," it said.
Pfizer has assured taking all reasonable efforts to resolve the matter at the earliest.
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