FDA Issues Track & Trace Rule To Curb Illicit Drug Flow

The Food & Drug Administration (FDA) directed all the pharmacists (retailers and wholesalers) to keep a record of drugs. FDA asked this owing to spurious drugs making their way from other states into Maharashtra.

Speaking with media persons, a senior FDA official stated they had verified reports of wholesalers and merchants buying fake medications on a massive scale. He claimed that doing this might seriously endanger people's health.

Pharmacists are required by the FDA to set up a separate email account for daily data that must be shared with the authorities. The specifics must mention billing for the quantity of products purchased from other states.

The representative indicated that if any inconsistencies are discovered, appropriate action, including license cancellation, will be taken. According to another officer who spoke on the record on the condition of anonymity, Uttar Pradesh, Madhya Pradesh, Bihar, Delhi, Rajasthan, and Gujarat in the north account for around 80% of all fake drug activities.

A series of incidents have been reported, wherein spurious cough syrups and eye drops caused health issues in patients abroad. Those eye drops and cough syrups were manufactured by Indian pharmaceutical companies. The central government in May canceled the licenses of 18 pharmaceutical companies and scrapped the product permits of three companies.

According to the official, they needed to step up surveillance by learning from prior mistakes. They discovered that the issue of fake and substandard drugs on the market has gotten worse, with many of them posing a risk to public health, especially those sold online. According to the official, the FDA has no information about or control over internet sales.

Experts said the joint inspections are part of the government's increased pharma surveillance following a few instances reported abroad in the last six months.

World Health Organisation (WHO) Issued A Medical Alert Against Cough Syrups Made By An Indian Pharmaceutical Company

On October 5 last year, a medical alert was issued by the WHO Over the following cough syrups:

Promethazine oral solution,

Kofexmalin baby cough syrup,

Makoff baby cough syrup,

Magrip ’n cold syrup,

All the above-mentioned cough syrups were manufactured and exported by Maiden Pharmaceuticals which could have possibly linked to the deaths of 70 children in Gambia.

The state FDA ordered four cough syrup manufacturers, including three from the Mumbai Metropolitan Region, to halt production in March this year due to their failure to conduct mandatory purity tests on raw materials. The action was taken as a result of their failure to test raw materials for lethal adulterants such as diethylene glycol (DEG) and ethylene glycol (EG), both of which have been found in Indian-made cough syrups linked to fatalities in other countries.

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