FDA to Doctors, Hospitals: Report adverse drug reactions

The plan was conceptualized and implemented under the Pharmacovigilance Programme of India (PPI).

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Food and Drugs Administration FDA Maharashtra
FDA Maharashtra

Last Updated on January 20, 2024 by The Health Master

Nagpur: The Food and Drug Administration (FDA), Nagpur, Maharashtra, has issued a letter to the government, semi-government, and private doctors, hospitals, and health departments to report cases of adverse drug reactions (ADR) observed in any patient to enable early sampling, testing, and corrective measures.

The drug regulatory authority has urged stakeholders to report ADR either to them or directly upload details on the website of the Indian Pharmacopoeia Commission (IPC) (IPC.gov.in).

The IPC has undertaken a special initiative as a part of the second National Pharmacovigilance Week (September 17 and 23) to raise awareness about ADR.

It had urged drug regulatory authorities across the states to alert the stakeholders regarding the need to report ADR for corrective, preventive, and analytical measures.

The plan was conceptualized and implemented under the Pharmacovigilance Programme of India (PPI).

Jt commissioner, drugs, FDA Viraj Paunikar said that senior officials like civil surgeons, district health officers, and so on have been approached to ensure the health infrastructure, facilities, and professionals working under them are sensitive about reporting ADR.

“We have taken meeting of stakeholders to create alertness regarding ADR and significance of reporting,” said Paunikar adding that citizens must contact their doctors about drug reactions and seek guidance.

The objective of the exercise, according to the official, is to ensure that studies and research are carried out to ensure that the medications and medical services are improved.

“Early reporting would help in quick sampling and other analysis,” said Paunikar.

According to Dr. Anup Marar, convenor of the Vidarbha Hospitals Association (VHA), earlier ADR reporting may have gone unnoticed.

“Reporting ADR is a technically good move for bettering health services and curtailing adverse outcomes,” he said.

He claimed that because of frequent interactions, it had been possible to report one such case from various hospitals during C-19.

Hetal Thakkar, secretary, Nagpur Druggist, and Chemist Association, said retailers have been alert about drug reactions.

Retailers generally alerted the pharmaceutical company’s dealers and distributors. We will also create awareness now among our members and share information with them,” said Thakkar.

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