Anti cancer medicines now under Schedule H2 of Drugs Rules, Here is what it means
New Delhi: In order to track the movement of anti-cancer drugs and prevent counterfeiting, the Drug Technical Advisory Board (DTAB) has agreed to include all anti cancer medicines under Schedule H2 of Drugs Rules, 1945. With this, all manufacturers of anti cancer medicines will now be required to print or affix a barcode or QR code on the labels of their products.
This decision comes in response to reports of unscrupulous criminals refilling empty vials of expensive anti-cancer drugs with counterfeit medications. These fake drugs were then mixed with genuine stocks and sold to unsuspecting cancer patients and putting their life at risk.
What is Schedule H2?
The Ministry of Health and Family Welfare had notified the Drugs (Eight Amendment) Rules, 2022 (“Amendment Rules”) on November 17, 2022, which amended the Drugs and Cosmetics Rules, 1945 to insert a new labelling requirement for drug formulation products specified under Schedule H2 of the DnC Rules. The Amendment Rules came into force on August 01, 2023.
Schedule H2 contains a list of 300 drugs which are required to be in compliance with the Amendment Rules.
The manufacturers of drug formulation products as specified in Schedule H2 have to print or affix Bar Code or Quick Response Code on its primary packaging label or, in case of inadequate space in primary package label, on the secondary package label that store data or information legible with software application to facilitate authentication.
This enables storage of data or information regarding the product, readable with software application to facilitate tracking and tracing of the product. The stored data associated with the QR code include certain minimum particulars prescribed, which include proper and generic name of the drugs, unique product identification code, brand name, batch number, date of manufacturing, date of expiry, name and address of the manufacturer, etc.
Read Also: Union Health Ministry notifies 300 drug brands under Schedule H2, Details
Earlier this year, Medical Dialogues team had reported that the crime branch of Delhi Police had busted a counterfeit cancer drug racket, arresting seven individuals for producing and selling fake cancer and chemotherapy medicines. Among the counterfeit drugs were Keytruda and Opdyta, typically used to treat cancer. These fake medicines were sold at high prices to unsuspecting patients. Police recovered fake drugs worth Rs 4 crore, along with packaging materials and empty vials, during raids.
Also Read: Delhi Police cracks down on fake cancer drug racket
In view of such events, the Drug Technical Advisory Board (DTAB) in its 91st meeting on August 14, 2024, considered and approved the proposal for track and trace mechanism for oncology products by providing quick response and bar code.
"These anti-cancer drugs must be issued under strict directives to implement mandatory QR codes and rigorous track and trace mechanisms on every vial and strip of medication that are marketed in India."
Accordingly, Schedule H2 of Drugs Rules, 1945 will be now amended to include all Anticancer medicines to have mandatory provision to print or affix Bar Code or Quick Response Code in its labels.
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