The government plans to bring barcode/quick response (QR) codes with an aim to ensure a traceability mechanism to track the genuineness of pharma products’ in the domestic market. To understand the challenges associated with the implementation of these technologies, the Ministry of Health and Family Welfare (MoHFW) has called for an inter-departmental committee meeting along with pharma stakeholders.
This video conference, convened by Dr Mandeep K Bhandari, Joint Secretary-Regulations, was attended by representatives from the CDSCO, Department of Pharmaceuticals, Ministry of Health and CDAC along with the pharma stakeholders. The government highlighted the benefits of adopting these technologies while industry representatives expressed concerns with regards to the implementation of barcoding on pharma products for domestic use.
The government has been aiming to implement QR code since 2011 and make it mandatory for the pharma industry. And, several times the industry has raised their concerns expressing challenges associated with implementation.
Reportedly, the industry has asked the government to minimise multiple level directions for track and trace and unify them with a single QR code. The objective is to track the movement of drugs and minimise the possibility of spurious or fake drug entries into the supply chain.
Sharing insights from the recently held meeting, Dr Viranchi Shah, National Vice President, IDMA informed, “It was an exploratory meeting with all stakeholders. Although, during the meeting, IDMA expressed its willingness to be a part of the government’s efforts to weed out spurious drugs from the market through the use of technology. However, we highlighted the limitations of available technology, CAPEX and OPEX issues and impact on the cost of drugs, need for validation of technology through small trials and the time window for implementation. The government and regulators were very positive and receptive of our opinion and we thank them for that. IDMA is aligned with the government’s initiative, but we also feel the need to do it pragmatically.”
Highlighting the objectives and key highlights of the meeting, Harish Jain, Regulatory Advisor, FOPE commented, “The objective of today’s inter-department meeting with the industry stakeholders was to understand the industry’s preparedness as well as a willingness in implementing the barcode/QR code technologies. During the meeting, it was realised that there is a need to carry out a study focusing on the cost implied in the implementation of QR codes/barcodes. Besides, the industry also raised other concerns such whether NPPA will allow the industry to increase the price of finished formulations considering the intensive capital cost involved in the implementation of such technologies as well as affixing the bar codes at all levels of packaging.”
He further added, “When we affix barcodes on the strip or blister, it gets smudged wherever there are knurlings. This leads to improper or no recognition by the barcode scanner at the user end and then the whole purpose of barcodes get defeated. Therefore, we seek suggestions from the authorities in dealing with such crucial issues.”
Nipun Jain, Chairman, Small and Medium Pharma Manufacturers Association (SMPMA) pointed out, “In today’s meeting, the need of QR code for active pharmaceutical ingredients (API) was discussed. On behalf of our association members, I feel that though the intent of the government is very good but the implementation of QR code on APIs is not going to serve any purpose. First of all, nowhere in the world are there QR codes on APIs. Secondly, APIs as such is not consumed by the end-user directly. Thirdly, there is a process which each formulation manufacturer needs to adhere to, given the regulatory requirements. It also requires manufacturers to carry out a quality test for APIs before initiating the finished formulation process. So, if at all the quality of the API is spurious then the finished formulation manufacturer will not start the manufacturing process.”
Rajesh Gupta, All India Head Laghu Udyog Bharati – Pharma Wing and President of Himachal Drug Manufacturers Association, suggested, “We have appealed to the government authorities that considering the pandemic situation across the country which has impacted the industry significantly, the government should give some time to the industry for making the huge investment in implementing these technologies. Considering the capital cost involved, which would not be feasible, particularly for MSME units, the government should consider implementing them in a phased manner. It would be better if the implementation takes place post the COVID-19 pandemic because by then the industry will gain momentum in the business and could be in a position to make investments in implementing the QR code technologies.”
The industry also expressed that considering the objective of barcode implementation, which is to trace the movement of drugs and minimise the possibility of spurious or fake drugs’ entry into the supply chain, authorities also need to pay attention to the possibility of the QR code getting copied.