Friday, April 25, 2014

FDA keeps close watch on pharmacies

AURANGABAD: Following restrictions implemented by the Food and Drug Administration from March 1, 2014 for the sale of 46 drugs off-the-counter (OTC), FDA inspectors from the Aurangabad division had launched a weeklong inspection drive on March 27.

The inspectors had monitored around 150 medical stores over the week and found that pharmacies have started maintaining a register of supply and sale of these 46 drugs under the notification.

"Around 80% of medical stores sell medicines under this schedule in the city. Hence the department had taken up the inspection drive to check whether they were maintaining proper records," said Viraj Paunikar, the Aurangabad division joint commissioner, drugs. "The inspectors are also making sure that these medicines will be dispensed by a pharmacist only on the prescription of a registered medical practitioner as defined under the Drugs and Cosmetics Act," he said.

"Chemists will have to keep a record, with the name and address of the prescriber, the name of the patient, the name and the quantity of the drugs supplied that have been brought under the newly-inserted Schedule H1 in the Drugs and Cosmetic Rules," Paunikar said.

"Such records shall be maintained for three years and be open for inspection by the Drug and Controller General of India (DCGI). Violation can result in cancellation or suspension of licence and even prosecution. The state drug inspectors or FDA inspectors are authorized to conduct surprise inspection at any retail medicine shop and check the register," he said.

Paunikar said some of the retail pharmacists - there are 8,000 total in the Aurangabad division - equipped with logistics like computers are maintaining the records online, while others are keeping separate registers with columns marked with the patient's name and address, the doctor's name and address, invoice number, date, the drug and the quantity supplied.

"The notification aims to regulate the sale of the antibiotics that are being presently sold over-the-counter (OTC) without any check and mandatory prescriptions from doctors," the official said.

If a specific medicine contains a drug substance specified in Schedule H1, the drug formulation shall be labelled with the symbol Rx in red and conspicuously displayed on the left top corner of the label, the notification states.

Posted by: Indian Biological Sciences and Research Institute, NOIDA

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