India to implement new track-and-trace codes for APIs of drugs from August 2023

INDIA – The Government of India has postponed the implementation of a new track and trace system for exports of drug formulations for another four months to August 1^st, 2023.

The upcoming pharmaceutical regulations will affect three areas of manufacturing: labeling active pharmaceutical ingredients (APIs), reporting, and product labeling for top brands in India.

In an official note, the Directorate General of Foreign Trade (DGFT) cited that the regulatory decision is applicable for both non-SSI (Small Scale Industry) and SSI-manufactured drugs.

The recent change of the date of the new system launch, with the main focus being maintaining the parent-child relationship in packaging levels, applies to SSI and non-SSI manufactured drugs.

Moreover, this window will be open for uploading exported active pharmaceutical ingredients on the official portal of the Central Government.

“The manufacturer or the exporter of drug formulations would have to print the barcode as per global standard at different packaging levels — primary, secondary, and tertiary,” stated the DGFT.

According to the Directorate General of Foreign Trade, all imported and domestically manufactured APIs must be labeled with quick response (QR) codes at different levels of packaging.

“Mandatory QR codes will help in tracking and tracing the origin of drugs, which minimises the chances of genuine medicines being considered spurious, sub-standard or counterfeit,” asserted the DGFT.

This news follows the revocation of the manufacturing licence of India’s Marion Biotech after investigations found that samples of its drugs were “adulterated” and “not of standard quality”.

Marion Biotech has lost its licenses to both manufacture and sell its cough syrup, Dok-1 MAX, which is suspected to have led to the death of 18 children who consumed it in Uzbekistan.

In an unexpected twist, the Indian government pushed back allegations that cough syrups made by another Indian company, Maiden Pharmaceuticals, led to tragic fatalities.

In the wake of these allegations, Indian authorities have cancelled or suspended licences of some domestic drug companies for selling adulterated or fake products.

This comes as Indian pharma exports witnessed a growth of 103% since 2013-14, from Rs. 90, 415 Crores (nearly US$6.8 billion) in 2013-14 to Rs. 1,83,422 Crores (approx. US$13.7 billion) in 2021-22.

The new track and tracing system will facilitate uploading of the primary, tertiary, and secondary level barcoding data for authentication of drug packages exported from India.

This strategic move builds on India’s ongoing efforts to enhance control over all medicines circulating in the country as well as to reduce the number of substandard drugs in the supply chain.

In 2015, the Indian Government launched a comprehensive traceability system called Drug Authentication & Verification Application (DAVA) for both export and domestic markets.

India officially replaced its Drugs Authentication and Verification Application (DAVA) with the Integrated Validation of Exports of Drugs from India and its Authentication (iVEDA) in 2020.

The implementation of compulsory QR codes for APIs of drugs is expected to complement the existing iVEDA system and help combat falsified drugs.

The track and trace system had been scheduled to become fully operational on 1^st January 2023, according to the latest publicly available data from the Central Government.

Similarly, the United Arab Emirates launched a national drug tracking system christened ‘Tatmeen’ in February 2023.

This is the UAE region’s first platform to track and trace pharmaceutical products, marking a significant step towards ensuring the immunity and security of its medical supply chains.

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