Industry seeks clarity from govt on implementation of QR code on API packs
Industry has sought clarity from the Department of Pharmaceuticals (DoP), Central Drugs Standard Control Organisation (CDSCO) and Directorate General of Foreign Trade (DGFT) on implementation of Quick Response (QR) code on Active Pharmaceutical Ingredient (API) packs which has been mired in practical difficulties since last year.
Government had floated the idea for QR coding of medicines to help pass on the benefit of fair pricing to the patient or consumer and to also track counterfeit or spurious drugs.
A draft notification was also issued under Drugs and Cosmetics (D&C) Rules in August 2019 proposing that every API manufactured in India or imported into India will need to carry QR code on its label to facilitate tracking and tracing.
“Though the proposal is for confirming the source of the material, printing of the Code is to be implemented at every level of API pack, for both imported and locally manufactured APIs,” according to an industry official.
This raises the issue of maintaining the QR code even when API is repacked in smaller quantities.
Also the container with the QR Code in which the API is imported or supplied could be misused by an unscrupulous dealer to supply any another material.
DGFT has also been proposing bar-coding and aggregation of all pharma export packs.
In February 2019, DoP had issued an office memorandum (OM) informing that from April 2020, all medicine packs supplied under Public Procurement Policy (PPP) would need to carry QR Code containing information on maximum retail price (MRP) and other details.
CDSCO had also initiated authentication of top 300 brands for domestic market but the process got stalled due to practical difficulties.
Bureau of Pharma PSUs of India (BPPI) procures medicines for Jan Aushadhi and has made Data Matrix essential for tertiary level packing containing information on batch number, name, place of manufacture and date of expiry, without price component.
A QR code is a unique two-dimensional matrix bar-code which is attached to products to obtain information about them and track their origin.
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The DoP has been mulling to create a fair pricing system after the Supreme Court (SC) pulled up the government asking it to devise a mechanism, which will help pass on the benefits of decreased dynamic pricing of drugs to consumers, just in case the MRP printed on the pack is higher at the time of the decrease.
There are close to 60,000 brands and 6,000 formulations, whose data needs to be collated and updated as far as pricing is concerned.
Another challenge in implementing the QR code exercise in the country is in rural areas which are affected due to poor internet connectivity and electricity.