The top 300 pharmaceutical brands in India with the biggest
sales have barcodes or QR codes applied to them as a requirement by the
government. Beginning on August 1, these special codes will offer essential
details, enabling customers to confirm their transactions.
Combating fake and inferior medications is the goal of the
"Track and Trace" system. People can obtain vital information by
scanning the QR code, such as the batch number, manufacturing date, expiration
date, and manufacturing license number, confirming the quality and authenticity
of the medications they are taking.
In the first stage, QR codes would be attached to widely
distributed medications in the pharmaceutical retail industry, which is
estimated to be worth about 50,000 crores. This list covers necessary
medications such as antibiotics, heart meds, painkillers, anti-diabetic, and
allergy drugs. A significant portion of the initial batch, accounting for more
than 2 lakh crores in the domestic retail market, includes well-known
medications such as Mixtard and Glucomet-GP for diabetes, Augmentin and Monosef
for infections, and Pan for gastrointestinal problems.
The Drugs Controller General of India (DCGI) has given
pharmaceutical businesses stringent instructions to comply with this new
regulation and has threatened penalties for noncompliance. Additionally,
pharmaceutical organizations have been instructed to make sure that their
member firms follow the new rules.
Although the idea to use QR codes on medications was
conceived ten years ago, it was not implemented until recently because of
concerns with local pharmaceutical sector readiness and a lack of the required
software and technology systems.No of the manufacturing location, all
manufactured and defined medication formulations starting on or after August 1,
2023, must contain either a barcode or QR code, according to a statement sent
by the Central Drugs Standard Control Organization (CDSCO) in November 2022.
As of today (August 1), 300 medication products must have QR
codes or Quick Response (QR) tags to make it simple to identify names, brands,
and expiration dates. The purpose of this action is to make it easier for
consumers to determine whether or not the exact drug they bought from one of
these 300 brands is authentic. Additionally, they can look up the manufacturing
and expiration dates.
The DCGI has given pharmaceutical companies stringent
directions to follow the guidelines. Additionally, well-known pharmaceutical
companies including Allegra, Shelcal, Calpol, Dolo, and Meftal are required to
include a barcode or QR code on their products. The DCGI has made it plain that
businesses that disobey these regulations would be subject to severe fines.
The notification states that a barcode or QR code will be
printed or applied to the secondary packaging label along with a software
program that gathers data or information for authentication purposes if the
primary packaging label or primary pack label of a drug in Schedule H2 does not
have enough room.
The nation's central government has taken action to halt and
restrict the sale of phony medications, and to carry out this plan, it has
revised the 1940 Drugs and Cosmetics Act. The government has mandated that
pharmaceutical businesses include a barcode or QR code on the labels of their
medications as a result of this change.
The notification states that regardless of the location of
manufacture, every batch of a designated medication formulation produced on or
after August 1, 2023, must contain a barcode or QR code on its label. The
addition of a QR code will be necessary for about 300 brands of medicinal
formulations. However, a manufacturer is permitted to add a barcode or QR code
for any other brand if they choose to do so willingly.
All domestic and international producers of medication
formulations for domestic sale are subject to this regulation.The regulating
body for drugs has stated that items should only be imported with barcodes or
QR codes printed on them after acquiring the required licensing authorization
under the 1945 Drugs Rules.
There is a lack of consistency in the use of QR codes, which
have been used freely by several pharmaceutical brands in the absence of laws.
The execution of this step will contribute to maintaining the quality of
medications and enhancing patient safety and health.The Indian Drug
Manufacturers' Association (IDMA) has issued instructions to its member
businesses requiring them to follow the new regulations.
Customers will be able to scan the QR code as part of the
"Track and Trace" system to determine if the pills they are taking
are authentic or not. QR codes will be printed on principal packaging labels
during the initial implementation phase. First-level packaging, such as
bottles, cans, jars, tubes, or strips, is referred to by primary package
labels.
By December of this year, all medications might be covered
by the legislation, which is anticipated to cover about 35% of the entire
market share.Numerous well-known medications are listed, including Allegra,
Amlocard, Azithral, Betadine, Calpol, Ceftram, Combiflam, Dolonex, Dulcoflex,
Ecosprin, Gelusil, Jalaara, Lantus, Manforce, Metform Spas, Shelcal, Human
Mixtard, Pan 40, Otrivin, Pantosec, RainTake, and Volini Spray.
It is anticipated that the deployment of QR codes will
result in a 3-4% cost rise for phone manufacturers. The government may also
provide a portal where users may enter a drug's unique ID and confirm its
legitimacy.
A significant move made by the government to combat the
problem of fake medicines is the requirement that QR codes be placed on active
pharmaceutical ingredients (APIs) used in medications. Approximately 20% of the
pharmaceuticals made in India are thought to be phony, while 3% are thought to
be of subpar quality.
In June 2019, the Drug Technical Advisory Board (DTAB)
approved the proposal to make the use of QR codes on APIs necessary to combat
fake medications.
The Drugs and Cosmetics Rules, 1945 are also being amended
by the Indian Pharmaceutical Regulatory Authority. Additionally, starting on
April 1, 2020, all medications purchased through public procurement must
include a barcode or QR code on the principal container.