Indian Pharma Moves Ahead with QR Code Regulation

Now that the Indian government has introduced mandatory QR codes on drugs, the country’s pharmaceutical companies are moving forward with implementing these codes.

Starting 1 August, around 300 essential drugs, spanning categories from antipyretics like Dolo to antibiotics like Azithromycin, must feature QR codes on their packaging labels.

The codes must carry the following information:

• Proper and generic name of drug

• Brand name

• Name and address of manufacturer

• Batch number

• Date of manufacturing

• Date of expiry and manufacturing licence number.

The move follows significant amendments made by the Ministry of Health and Family Welfare to the Drugs and Cosmetics Rules of 1945, to include measures to ensure drug authentication and accurate labelling.

While the code is mandatory for the top 300 brands, other manufacturers can voluntarily incorporate this system. The regulation applies to both local and foreign manufacturers of the top brands for the Indian market. It also recommends that imported products already bear the QR code upon arrival, although it also permits affixing these codes in India post-import.

The Indian Drugs Manufacturing Association has also urged its member companies to follow the new guidelines. Implementing this directive is expected to significantly enhance the traceability and authentication of drugs, effectively curbing the spread of spurious medicines.

Habit-forming drugs also to carry QR code

In addition to the top 300 brands, the health ministry may also introduce mandatory QR code-based traceability for 11 habit-forming drugs and their formulations, to stop their misuse and illicit trade. These 11 medicines are codeine-based cough syrup, fentanyl and its analogues, buprenorphine injections, tramadol, alprazolam, nitrazepam, diazepam, lorazepam, clonazepam, zolpidem, and ketamine – drugs that are commonly used for sleeping, pain relief and anxiety.

The move can be seen as a precautionary step by the government to control the misuse of these drugs, as well as prevent the trafficking of semi-finished versions or raw materials for these drugs to the chemical industry.

According to a 2019 report by the Ministry of Social Justice and Empowerment and the National Drug Dependence Treatment Centre, around 2.5 million people are users of pharmaceutical habit-forming drugs in India.

India’s fight with fakes

According to the latest report by the Authentication Solution Providers’ Association and Indian research company CRISIL, counterfeit products constitute 25-30% of the market in India. While India follows strict regulations on medicine exports, the domestic industry is one of the top targets for counterfeiting and falsified products. Even unprecedented crises like the COVID-19 pandemic were exploited by criminals in order to sell vast volumes of fake, spurious, and substandard drugs.

In the first week of August, India's drug regulator recovered counterfeit medicines worth more than INR 20 million ($242,000) during a raid in the eastern city of Kolkata. The raid, carried out by the Central Drugs Standard Control Organisation (CDSCO), found counterfeit copies of products belonging to the country’s leading pharma companies, including Sun Pharma, Alkem, Cipla, Glenmark, GSK, Abbott, Novartis, Dr Reddy’s, and Aristo.

The raid was a follow-up of one conducted in April, when a team of drug inspectors from CDSCO seized spurious drugs worth INR 1 million in another state. According to the officials, counterfeiters are supplying fake medicines to different states in the country, and they urged pharma companies to warn their marketing teams about counterfeit medicines in circulation.

S Swaminathan, CEO of GS1 India, said, ‘with consumers becoming more digitally savvy, access to a product’s detailed and trusted information is all the more essential. QR codes are the next-generation way to identify and authenticate products.’ Other experts say the Indian pharmaceutical industry requires a comprehensive, proactive, holistic counter approach that goes beyond the QR code. They say the pharma industry needs to make a significant change in increasing awareness, implementing authentication solutions, supporting these with robust track and trace infrastructure and securing the supply chain against criminals.

For a detailed story on ‘Pharma Traceability and Authentication in India’, click here.