Mumbai News: FDA Brings Out Track And Trace Rule To Curb Spurious Drug Flow

Mumbai News: FDA Brings Out Track And Trace Rule To Curb Spurious Drug Flow

The FDA has asked pharmacists to create a separate email ID to maintain daily records that must be shared with the authorities. The details must include billing to the amount of stock procured from other states.

Swapnil MishraUpdated: Sunday, October 22, 2023, 09:57 AM IST
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FDA Brings Out Track And Trace Rule To Curb Spurious Drug Flow | representative pic/Pixabay

Mumbai: All pharmacists (retailers and wholesalers) have been directed by the Food and Drug Administration (FDA) to keep a daily record of drugs owing to spurious drugs making way from other states into Maharashtra. A senior FDA official told the Free Press Journal that they have confirmed news on large scale procurement of spurious drugs by wholesalers and retailers. He said this can pose a serious threat to people’s health.

The FDA has asked pharmacists to create a separate email ID to maintain daily records that must be shared with the authorities. The details must include billing to the amount of stock procured from other states.

The official said if any irregularities are found, appropriate action would be taken, including cancellation of licenses. Another official on condition of anonymity said that about 80% of spurious drug activity takes place in the northern states of Uttar Pradesh, Madhya Pradesh, Bihar, Delhi, Rajasthan and Gujarat.

FDA's Action Follow Past Incidents Of Health Hazards Due To Spurious Drugs

In the past, a series of incidents have been reported wherein spurious cough syrups and eye drops from Indian pharmaceutical companies allegedly caused health complications in patients abroad. In May, the Centre had cancelled the manufacturing licenses of 18 pharmaceutical companies and scrapped product permissions of three.

The official said, “Taking lessons from past incidents, we had to increase our surveillance. We have found that the problem of spurious and substandard drugs in the market has become acute, with many posing a threat to public health, especially drugs sold online. The FDA does not have details of online sales or control over them.”

Experts said that joint inspections are a part of heightened pharma surveillance that the government is undertaking after a few incidents were reported globally over the last six months.

Medical Alert By WHO Over Indian Cough Syrups

A medical alert was issued by WHO on October 5 last year, over four cough syrups; Promethazine oral solution, Kofexmalin baby cough syrup, Makoff baby cough syrup, and Magrip ’n cold syrup, manufactured and exported by Maiden Pharmaceuticals that could have possibly linked to 70 deaths of children in Gambia.

In February this year, the Tamil Nadu-based Global Pharma Healthcare recalled its entire lot of eye drops allegedly linked to vision loss in the US. On March 22, the Uttar Pradesh Drugs Controlling and Licensing Authority cancelled the manufacturing license of Noida-based pharmaceutical company, Marion Biotech, whose cough syrup was allegedly linked to the death of 18 children in Uzbekistan in December last year.

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