KARACHI, Pakistan – The drug regulator in Pakistan is putting its foot down to enforce its planned barcoding system to address the issues of counterfeit and overpriced drugs.
"It's time to use technologies to confront the counterfeited medicines by introducing a barcode system in the pharma industry of Pakistan," said Muhammad Aslam, CEO of the Drug Regulatory Authority of Pakistan (DRAP), at a recent press conference.
On April 13, the country's federal government and the Prime Minister's cabinet approved the barcoding system. In turn, DRAP issued the notice to implement the system this month.
The labeling system will not only aim to crack down on a growing problem with fake drugs but also seek to put more genuine products in the hands of customers, while stopping the flow of overpriced medicines that has benefited pharmaceutical manufacturers and may create false demand and supply problems, Aslam added. The DRAP team has been working on this new labeling system for almost two years in order to eradicate sale of spurious drugs and overpricing.
Aslam further elaborated that the barcode system would be implemented in two phases and on different levels.
The primary level is that all pharma manufacturers have to print barcodes on tablets and syrups boxes. Eventually, they will be required to put the codes on individual package such as strips and syrup bottles as well.
"It will be optional for the initial three months and after that all the pharmaceutical companies would have to have the bar codes on the packets of the medicines. Medicines sold in the country will henceforth bear barcodes on their package for consumers to distinguish them from spurious drugs," he said.
The Secretary of the Ministry of National Health Services Regulation and Coordination (MNHSRC), Muhammad Ayub Sheikh, said the barcoding system is the only way to stop the sale of illegal and spurious drugs.
"The sale of unregistered drugs has become a matter of concern for the DRAP as a number of pharmaceutical companies continue to manufacture and sell medicines even after their registration is canceled," said Sheikh.
There have been many cases where drug sales continue after DRAP issues a suspension order. That is especially true in small towns in Pakistan.
This year, DRAP discovered that some local manufacturers in Sahiwal, a neighboring area of Lahore Punjab Province, are still making and selling a tablet that lost its registration approval in 2013 because of quality issues.
The barcode system will make it possible to track the movement of pharmaceuticals in the supply chain, recall products after complaints such as those related to unwanted chemicals being mixed in the drug or drugs being contaminated by fungus, Aslam explained.
There will be machines in department stores in the country for customers to check the barcodes of the products as well as smartphone applications to scan the two-dimensional codes on the package. Customers will only need a few minutes or even seconds to get the information they need, including the name of the medicine, its manufacturer, batch number, expiry date and its price.
The software will help both the buyer and seller to make sure the drug is genuine, as it would not identify bar code of any spurious medicine.
The government also wants to ensure that staff at drug dispensaries show and scan the barcode for customers who don't know how to use it due to the low literacy rate on the use of technology – like smartphones – in rural areas. It is also looking to start advocacy campaigns to raise awareness.
"Citizens who do not have smartphones can get the help from the owner of the pharmacies or any other person to verify the medicine information," Sheikh added.
Saira Afzal Tarar, minister of the MNHSRC, noted that "the new system will also help the government hospitals, who are the major customers of bulk drugs, to monitor the expiry dates and availability of the medicines in their inventory."
Tarar further added that DRAP has already held several meetings with the Pakistan Pharmaceutical Manufacturers Association (PPMA), the Pharma Bureau and other stakeholders in that regard and they are willing to introduce the barcode since it is in their own interest as well.
A spokesman of the PPMA said the association has been demanding the implementation of this scheme for three years but government has now decided to give the manufacturers only six months to destroy the already-printed packets and to get the printing equipment for the new codes.
When asked about the concerns of the PPMA, Sheikh told BioWorld that "the ministry is giving maximum space to fulfill the PPMA's requirements, but we have to do it before December 2017, and it is mandatory to all the pharmaceutical manufacturers; otherwise, legal action would be taken."
The side effect of the implantation of the barcode system could be higher drug prices caused by higher manufacturing cost, including buying new printing machines.
PPMA member and managing director of Indus Pharma, Zahid Saeed, said that "before implementing the barcode laws, government should waive the duty on imported labeling machines."
With the seventh largest population in the world, Pakistan has more than 600 pharmaceutical manufacturing units, including more than 550 national or Pakistani-owned manufacturing units and 25 licensed international subsidiaries of well-known MNCs.