Government Mandates QR Codes for Pharmaceutical Transparency

The Indian government has implemented a significant measure to enhance transparency and curb counterfeit medicines by mandating QR codes and barcodes on the top 300 drug brands and all active pharmaceutical ingredients (APIs). This regulatory push is designed to ensure end-to-end tracing and authentication of drugs across the country's pharmaceutical supply chain.

Tackling Drug Pricing and Quality Control

During a recent session in the Rajya Sabha, a question was raised about the discrepancy between production costs and market prices of essential medicines. The discussion also centered on measures to ensure drug affordability and systems to prevent overpricing. In response, the Minister of State for Chemicals and Fertilizers, Anupriya Patel, provided details on the government's drug pricing and quality control strategies.

The foundation of drug price regulation is the National Pharmaceuticals Pricing Policy of 2012, which transitioned from a cost-based to a market-based pricing model. This is enforced through the Drugs Order of 2013. The policy relies on publicly available market data rather than individual manufacturers' costs, allowing the National Pharmaceutical Pricing Authority (NPPA) to set ceiling prices for medicines listed in the National List of Essential Medicines (NLEM).

Manufacturers, marketers, and importers must sell scheduled drugs at or below these ceiling prices, inclusive of local taxes. Retail prices for new formulations created by modifying NLEM drugs are also regulated, ensuring compliance with notified prices. Non-scheduled drugs are not exempt from oversight; their maximum retail price (MRP) cannot rise more than 10% annually.

NPPA's Key Interventions

• As of December 2025, ceiling prices are set for 935 scheduled formulations, resulting in a 17% average price reduction and saving the public around ₹3,802 crore annually.
• Retail prices for over 3,600 new drugs have been notified under the DPCO, 2013.
• In 2014, capping the MRP of 106 non-scheduled anti-diabetic and cardiovascular drugs saved patients about ₹350 crore annually.
• Trade margins for 42 non-scheduled anti-cancer medicines were capped, cutting prices by 50% and saving patients approximately ₹984 crore annually.
• Ceiling prices for coronary stents and knee implants were fixed in 2017, leading to significant savings for consumers.
• In 2021, trade margins for various medical devices were regulated, saving consumers about ₹1,000 crore annually.

Overall, these measures collectively facilitate up to ₹25,000 crore in savings annually, contributing to keeping drug prices in India among the lowest globally.

Enhancing Affordability and Access

To improve drug affordability and access, the government has launched several initiatives:

• The Pradhan Mantri Bhartiya Janaushadhi Pariyojana scheme provides quality generic medicines at substantial discounts through over 17,000 outlets nationwide.
• The Ayushman Bharat Pradhan Mantri Jan Arogya Yojana offers a health insurance cover of ₹5 lakh per family, benefiting over 42 crore people.
• The National Health Mission’s Free Drugs Service Initiative ensures essential medicines are available free of charge in public health facilities.
• The Amrit initiative supplies affordable medicines with significant discounts at AMRIT Pharmacy stores in hospitals and healthcare institutions.
• Financial aid is available for impoverished patients battling severe diseases under schemes like the Rashtriya Arogya Nidhi.

Regulatory Measures to Prevent Overpricing

Under the DPCO, 2013, it is mandatory for drug labels to display the MRP, prohibiting sales above the marked price. The NPPA vigilantly monitors drug pricing and takes action based on inputs from various stakeholders, including state drug controllers and public complaints.

Ensuring Drug Quality Assurance

Quality assurance is a critical focus area. The Central Drugs Standard Control Organisation (CDSCO), in collaboration with State Drugs Controllers, conducts risk-based inspections of manufacturing premises. Since December 2022, over 960 inspections have led to actions like show cause notices and license suspensions.

The Drugs Rules of 1945 were amended in 2023, requiring QR codes on drug packaging for the top 300 drug brands and APIs. This initiative facilitates tracking and tracing using software applications for authentication.

CDSCO also issues monthly drug alerts for products failing quality tests. Manufacturers must recall substandard products immediately, facing actions under the Drugs and Cosmetics Act if they fail to comply.

The Ministry of Health and Family Welfare revised Schedule M to align with WHO standards, effective from mid-2024 for larger manufacturers, with an extended timeline for smaller enterprises. Additionally, new regulatory guidelines for sampling drugs and an online portal named SUGAM are enhancing the monitoring and quality assurance processes.

Central and state regulatory bodies continue to collaborate for consistent enforcement of the Drugs and Cosmetics Act. Ongoing training ensures that officials remain updated on good manufacturing practices. Since April 2023, over 43,000 individuals have received such training.

This comprehensive framework, including the implementation of the QR code generator, aims to safeguard public health by preventing counterfeit drugs, ensuring affordability, and guaranteeing drug quality across India.