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Pharma MSMEs urge health ministry to roll back mandatory QR code on APIs from January 2023
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Laxmi Yadav, Mumbai
August 20 , 2022
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Pharma MSMEs have urged the Union health ministry to roll back the Drugs (Amendment) Rules, 2022 mandating Quick Response (QR) code on the label of all active pharmaceutical ingredients (APIs) manufactured or imported in India, at each level packaging from January next year to enable tracking and tracing of the ingredients. They appealed to the ministry to suitably amend it to make QR code mandatory for imported APIs only to prevent the menace of spurious or substandard APIs in the country.
Small and Medium Pharma Manufacturers Association (SMPMA), representing small and medium drug makers across the country on August 18, 2022 wrote to Mansukh Mandaviya, Union minister of health and family welfare and chemicals and fertilizers requesting him to withdraw the notification GSR 20(E) dated January 18, 2022 mandating QR code on label of APIs or suitably amend it for imported APIs only.
“APIs are sold B2B (business-to-business) and not directly to the consumers. Therefore, in B2B if any spurious or substandard APIs are received by formulation units then the same is rejected and returned to the API manufacturer/supplier. There is no way the APIs can directly be consumed by consumers or patients. Therefore, QR coding on APIs does not serve any purpose on curtailing spurious medicines to patients or consumers,” said Nipun Jain, chairman, SMPMA.
“APIs are sold in HDPE bags or drums, affixing barcodes on the same can prove futile because during transportation or rainy season. There are chances that it may get spoiled or torn as these are bulk packing and are thrown in the lorry unlike finished formulations which are packed in cartons and are handled with care,” said Jain.
“We, therefore, suggest that it should be implemented on APIs imported from other countries to curb the menace of spurious, substandard and smuggled APIs into the country. These are many cases where unscrupulous traders are bringing in expired or substandard APIs from other countries, mislabeling them and selling them throughout India,” stated SMPMA chairman.
MSMEs segment of API manufacturers neither have the manpower nor funds to create additional infrastructure for QR coding in their premises, he added.
In light of above facts, we request that notification GSR 20 (E) dated January 18, 2022 may be rolled back and suitably amended for imported APIs only, he opined.
On January 18, 2022 health ministry came out with a notification—GSR 20 (E) amending Labeling Rules of Drugs and Cosmetics Rules, 1945. The ministry inserted a sub-rule (5) after the existing sub-rule (4) under the Rule 96 of the Drugs and Cosmetics Rules, 1945 through the amendment. The amendment Rule is scheduled to come into force from January 1, 2023.
According to the new sub-rule, “Every active pharmaceutical ingredient (bulk drug) manufactured or imported in India shall bear Quick Response code on its label at each level packaging that store-data or information readable with software application to facilitate tracking and tracing”.
The stored data or information shall include the minimum particulars including unique product identification code, name of the API, brand name (if any), name and address of the manufacturer, batch number, batch size, date of manufacturing, date of expiry or retesting, serial shipping container code, manufacturing licence number or import licence number and special storage conditions required (if any).
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