The FDA will begin collecting data on antigen home test kits set to publish advisories

PUNE, January 14, 2022:

The Food and Drug Administration (FDA) has requested registered pharmacists to update sales, purchase, and inventory records of antigen home testing skills against the backdrop of state governments expressing concerns about district and civil administration. did. Unregulated use and unreported cases impair community communication.

As on Thursday, the FDA learned that about 51,385 antigen home test kits have been sold in the past few months. Due to the lack of specific data and records, FDA officials and other citizens and district authorities have not reported how many of these tests are in writing by users of the Indian Medical Research Council (ICMR) portal. I don’t know if it has been updated properly. Instructions on the product.

According to data accessed by TOI, one of the private institutions sold about 11,700 antigen home test kits throughout December last year, but sales by January 12 this year have already exceeded 11,186. Since June last year, the agency has sold 38,800 home test kits, but there is no official data on whether the results have been updated on the ICMR portal.

Waiting for state guidelines, the FDA is set up to issue recommendations to registered pharmacists to retain data and keep records of antigen do-it-yourself kits separate from purchaser details. The FDA will also ask pharmacists to advise customers on proper use, disposal, and renewal of test results on the ICMR portal.

“These home test kits are approved by a central drug regulatory body, so it’s not yet clear how to regulate sales, but we’re aware of proper usage. We can warn our customers about the standards. We are updating the expected pharmacists, “said PM Ballal, FDA Assistant Commissioner, whose team under co-commissioner Viraj Paunikar is responsible for pharmacists and issues.

Last week, with the intervention of department commissioner Prajakta Lavangare Verma, the FDA began investigating the sale and use of home-use test kits. TOI also reported that this issue occurred at a Covid review meeting attended by Minister of Protection Nitin Raut.

Dr. Ravindra Sarnaik, a member of the Covid Task Force, said unregulated use of home test kits could lead to a parallel exponential increase in the number of cases that could explode without breaking official records. I said there is.

Hetal Thakkar, secretary of the Association of Chemists and Pharmacists in the Nagpur area, said pharmacists could help expand support for the FDA and spread awareness, as unreported cases can lead to havoc. Stated. ETHealthWorld