INDORE: The proposed process of authentication and the Trace and Track mechanism of drugs to curb counterfeit and spurious medicines is going to be applicable on 300 brands as an experiment before implementing it on all products, according to recent media reports.
Medical Dialogues had earlier reported that the Drugs Technical Advisory Board (DTAB) had granted the approval to a proposal of the Drug Controller General India (DCGI) to spot fake medicines.
The DCGI proposal plans to introduce a unique code on drug packs whether it is a bottle, strip or vial to ensure the authenticity of the medicine.
DTAB in its meeting held on 16th may 2018 deliberated on the matter and agreed for the introduction of trace and track mechanism for major 300 pharmaceuticals brands as a test trial on a voluntary basis.
A 14-digit number will be printed on the labels of the top 300 pharmaceutical brands and these numbers will be unique to each strip and bottle sold in the market along with a mobile number provided by the company marketing the brand.
Consumers can message this code to the designated contact number and they get a prompt response giving details about drug manufacturers’ name, batch number, manufacturing date, the expiry date of the medicine.
On 25th June 2018, the DCGI had invited manufacturers for a meeting on the introduction of trace and track for the top pharmaceuticals brands.
The national drug regulatory body had identified the top 300 brands, which would be included in the initiative, on the basis of moving annual total (MAT) data provided by AIOCD AWACS and had a meeting with manufacturers’ representatives on June 25 to discuss modalities for implementing the initiative.
Rajeev Mujumdar, DGM-HR of one of India’s leading pharmaceutical manufacturer told TOI, “This system will be a good initiate to check counterfeit drugs but there are chances that prices will escalate. Percentage of customers using the system to check the authenticity of the manufacturer will be very less due to lack of awareness.”
The mechanism has started on pilot mode and gradually will be implemented on all drugs.
Small Sellers raise concern
Skepticism has been shown by many drug manufacturers as well as small-scale sellers who have raised worries about cost escalation and loss of business. According to these persons, the alpha-numerical authentication system will lift the cost of packing, system, and employees.
Speaking with TOI, MP Small Scale Drug Manufacturers Association president Himanshu Shah said, “Most local drug manufacturers of the region are into the job work for multinational companies. The new system will require the additional cost of operation and trained workers. Meeting the requirement will be very difficult.”
TOI reports that that the cost of implementation for authentication system will be at least around Rs30lakh per unit.
A leading drug manufacturer from Indore told TOI, “Such system will significantly raise the cost of medicines in the country. The authentication of drug manufacturers is required, where counterfeit drugs are abundant. In India, it is just 0.02 percent.”