QR code to monitor spurious pharma ingredients delayed
Ambika Sharma
Solan, October 27
The delay in the implementation of the quick response (QR) code for tracking and tracing active pharmaceutical ingredients (API) for a year after its notification by the Central Government has defeated its purpose.
The system was introduced to ensure quality of drugs manufactured in the country, as APIs, sold in the market, were at times found contaminated with toxic contents. The need to introduce this system also gains significance after cases of a spurious cough syrup led to the death of 12 children in Udhampur in February 2021 and 66 children in Gambia.
Investigations proved that the use of solvent propylene glycol, for preparing the cough syrup was found laced with a toxic contaminant diethylene glycol and ethylene glycol in unaccepted proportions though it should not be present.
To ensure that no such cases came to the fore again, the QR tracking and tracing system should be implemented at the earliest, say pharma manufacturers.
Several manufacturers, including the Himachal Drug Manufacturers Association (HDMA), Laghu Udyog Bharti, etc, had taken up the issue with the ministry after the cases of availability of substandard APIs had led to spurious drug manufacturing.
The Central Drugs Standard Control Organisation had prepared a draft and sent it to the Drug Technical Advisory Committee, which had recommended the QR code tracing and tracking system in 2019. It was finally notified in January this year and will be implemented from January 2023.
Its implementation will ensure genuineness of products. The code can be scanned to obtain the details of a product. Manufacturers have been raising the issue due to the lack of quality API availability, as traders were re-labelling and re-packing the original product after its import. The industry is heavily dependent on China, which supplies 65 per cent of APIs to the domestic industry.
Rajesh Gupta, all-India head of the pharma committee of the Laghu Udyog Bharti, says that the implementation of the code for APIs will help in tracing the original product. It will also put an end to substandard API availabile in the market.
