To control the sales of fake drugs, the Ministry of Health has now mandated a compulsory quick response (QR) code. In a notification dated 18th January 2022, the government has made codes on the label mandatory at each level of packaging on Active Pharmaceutical Ingredients (APIs) to facilitate tracking and tracing of the products. The new rule will be effective from 1st January 2023.
Over the years, there have been several reports of counterfeit drugs in the market. According to the World Health Organisation (WHO), in low and middle-income countries about 10 percent of medical products are substandard.
In March last year, the health ministry asked the department of pharmaceuticals (DoP) to shortlist 300 drug brands that can be included in the implementation of mandatory QR codes.
The National Pharmaceutical Pricing Authority (NPPA) had identified the list of 300 drugs, which include widely used medicines, such as painkillers, contraceptives, vitamins, blood-sugar, and hypertension medicines.
“Up to 20% of the pharmaceuticals supplied in India are counterfeit, according to a 2019 annual report on intellectual property rights protection from the US Trade Representative office. In 2018, the Central Drug Standard Control Organization estimated that about 4.5% of all generic drugs in the Indian market were substandard. We as an industry need to be cognizant of the spurious drugs harming patient lives and work closely with the government to keep strong regulations in place which shall prevent the production and circulation of such drugs and put a halt at every juncture from the production right through the supply chain,” Vivek Sehgal, Director General, Organisation of Pharmaceutical Producers of India (OPPI) told Financial Express.com.
According to Authentication Solution Providers’ Association (ASPA), incidents of spurious and substandard drugs from 2020 to 2021 was up by 47 percent. During the COVID-19 peak, incidents of spurious and falsified (SF) medical were observed in 23 out of 29 States and seven Union Territories.
“The pharma industry has year after year emerged as one of the top targets for bad actors in regard with spurious and substandard products. This highlights the great health risks to which our citizens are exposed. This is a huge threat to the overall wellbeing of our citizens as well as a great threat to brand equity earned globally by our country,” Nakul Pasricha, President, ASPA told Financial Express.com.
Impact of Counterfeiting and Illicit Trade in Healthcare & Pharma sector
The presence of a significant number of spurious and substandard drugs in the system has a multifaceted impact – not only do they endanger the lives and well-being of patients, but also damage the trust of people in the healthcare ecosystem.
During Pangea XI, which was carried out in 2018, police, customs and health regulatory authorities from 116 countries targeted the illicit online sale of medicines and medical products, resulting in 859 arrests worldwide and the seizure of USD 14 million worth of potentially dangerous pharmaceuticals.
Reportedly, almost one million packages were inspected during the week of action, with 500 tonnes of illicit pharmaceuticals seized worldwide.
“While counterfeiting is a global issue, it is much more prevalent in low and middle-income countries, where it is estimated that 10 to 30% of medicines are counterfeit, compared to 1% of medicines in high-income countries,” Raheel Shah- Director at BDR Pharma Pvt ltd told Financial Express.com.
How will QR code on drug packaging work?
Under this “track and trace” mechanism, the customers will be allowed to use QR codes to know if the pills they are popping are authentic or not.
Under the first phase of the exercise, QR codes will be printed on the primary packaging labels. Primary packaging labels are the first-level packaging like the bottle, can, jar, tube or strip.
Reportedly, in the first phase, medicines costing over Rs 100 per strip may be included. The Union health ministry had issued a draft gazette notification regarding the same in June last year seeking comments and feedback from the public.
“Its digital aspect makes it an extremely powerful tool that empowers the consumer and other supply chain participants. The application of QR Codes makes it easy to flag potential counterfeits in the system for review by a human analyst,” Paricha added.
Manufacturers of 300 drug formulation products as specified in the Schedule H2 of Rule 96 of the Drugs and Cosmetics Act will be required to print or affix a bar code or quick response code on its primary packaging or secondary package label that store data or information legible with a software application to facilitate authentication.
“We at OPPI believe that the decision to implement QR Code is a positive step to curb the menace of counterfeit medicinal products and thus, improve patient safety. All Active Pharmaceutical Ingredients (APIs) produced or imported into India must have a QR code attached as a step to achieve this. This requirement applies to all API manufacturers who produce or export API to India, and it establishes serialized labelling at an API level well before the formulations are made,” Sehgal told Financial Express.com.
The stored data or information shall include particulars such as unique product identification code, proper and generic name of the drug, brand name, name and address of the manufacturer, batch number, date of manufacturing, and expiry and manufacturing license number.
Around 35 percent of the total market share will be brought under this ambit and by December this year, all drugs may be covered.
The drugs include Allegra, Amlokind, Azithral, Betadine, Calpol, Ceftum, Combiflam, Dolo, Dulcoflex, Ecosprin, Gelusil, Jalra, Lantus, Manforce, Meftal Spaz, Shelcal, Human Mixtard, Pan 40, Otrivin, Pantocid, Rantac, Stamlo, T-bact ointment and unwanted kit and Volini spray.
What will be the impact?
According to Sudarshan Jain, Secretary General, Indian Pharmaceutical Alliance, the Indian pharmaceutical industry is the world’s 3rd largest by volume and 14th largest in terms of value. The sector is vast and fragmented and has large supply chain network to service the patient. Counterfeit drugs have an impact on all stakeholders, he told Financial Express.com.
“The industry is taking preventive measures such as the development of a complex shape of the product, identification marks, and distinct packaging features among others,” Jain told Financial Express.com.
With the implementation, the costs are expected to go up by 3-4 percent for the phone makers, as per media reports.
Along with the QR code, the government may also soon launch a portal where the customers can feed the unique ID of the medicines and check for their authenticity.
Gradually, it may be expanded to other pharma products and handheld devices, experts told Financial Express.com.
Why is this happening?
According to Pasricha, mandating the use of QR Codes on Active Pharmaceutical Ingredients (APIs) used in medicines is a first vital step in the right direction by the government.
Reportedly, 20 percent of the medicines that are manufactured in India are counterfeit. As per a government report, three percent of medicines are of substandard quality.
The Drugs Technical Advisory Board (DTAB), in June 2019, approved the proposal for mandatory QR codes on the APIs in order to combat falsified drugs.
The changes in the rules of the drug were made under the Drugs and Cosmetics Act, 1940, after consultation with the regulator’s subject expert panel— the drugs technical advisory board. The initiative will help easily distinguish between the real and fake drugs.
India’s drug regulatory authority is also in the process of amending the Drugs and Cosmetics (D&C) Rules, 1945. In addition, India had also made it compulsory from 1st April, 2020 that all medicines procured under public procurement will have barcode/QR code at primary level of packaging.