QR Codes Mandatory on Drugs says CDSCO

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Dated: 14.08.2025

QR Codes Mandatory on Drugs says CDSCO

Ensuring the safety and efficacy of drugs is a critical responsibility of any government. In India, the Ministry of Health and Family Welfare, along with the Central Drugs Standard Control Organization (CDSCO), has implemented a series of robust measures to prevent the sale of adulterated, spurious, and substandard drugs. These initiatives aim to enhance drug quality, improve regulatory compliance, and protect public health. Below, we outline the key steps taken by the government to address this pressing issue.

1. Risk-Based Inspections and Enforcement Actions 

Since December 2022, the CDSCO, in collaboration with state regulators, has conducted risk-based inspections of drug manufacturing and testing facilities. As of now, 905 units have been inspected, leading to 694 enforcement actions, including Stop Production Orders, license cancellations, and warning letters. These inspections have provided valuable insights into manufacturing practices and have driven significant improvements in regulatory compliance.

2. Implementation of QR/Barcodes for Drug Authentication 

To enhance drug traceability and authenticity:

Top 300 Drug Brands: From August 1, 2023, manufacturers of the top 300 drug brands are required to print or affix QR codes or barcodes on their packaging. These codes store critical information such as batch numbers, manufacturing dates, and expiry dates.
Active Pharmaceutical Ingredients (APIs): Since January 2022, all APIs manufactured or imported in India must bear QR codes at every level of packaging to facilitate tracking and tracing.

These measures empower consumers and regulators to verify drug authenticity using software applications.

3. Enhanced Drug Quality Monitoring 

The government has introduced several initiatives to ensure consistent drug quality monitoring:

Monthly Drug Alerts: CDSCO publishes details of drugs failing quality checks on its website, making this information publicly accessible.
Immediate Recall of NSQ Drugs: Drugs declared as Not of Standard Quality (NSQ) are immediately recalled, and further distribution is halted.
SUGAM Labs Portal: Launched in September 2023, this online platform integrates drug testing labs, automating workflows and ensuring transparency in the testing process.

4. Revised Good Manufacturing Practices (GMP) 

The government has revised Schedule M of the Drugs Rules, 1945, to strengthen GMP requirements. These revisions became effective on June 29, 2024, for manufacturers with a turnover exceeding ₹250 crores. Smaller manufacturers have been granted a conditional extension until December 31, 2025, provided they submit an upgradation plan.

5. Structured Drug Sampling Guidelines 

In February 2024, CDSCO introduced regulatory guidelines for drug sampling. These guidelines ensure a uniform and risk-based approach to sampling, covering diverse locations, including rural areas. This structured methodology enhances the quality and efficacy of products available in the market.

6. Stringent Penalties and Legal Framework 

The Drugs and Cosmetics Act, 1940, was amended to impose stringent penalties for the manufacture of spurious and adulterated drugs. Certain offenses have been made cognizable and non-bailable. Additionally, special courts have been established in states and union territories for the speedy trial of such offenses.

7. Capacity Building and Training

To strengthen regulatory enforcement, the government has significantly increased the number of sanctioned posts in CDSCO over the last decade. Regular training programs and workshops on Good Manufacturing Practices (GMP) are conducted for officials of CDSCO and state drug regulatory authorities. In the financial years 2023-24 and 2024-25, over 43,000 personnel were trained.

8. Collaborative Efforts for Uniform Administration 

The central regulator coordinates with state drug control organizations through the Drugs Consultative Committee (DCC) to ensure uniform administration of the Drugs and Cosmetics Act. Joint inspections by central and state drug inspectors are now mandatory before granting manufacturing licenses.

9. Public Awareness Campaigns 

The CDSCO has made guidelines for identifying and verifying spurious drugs available on its website. Public awareness campaigns are being conducted to educate consumers about using QR codes and barcodes to verify drug authenticity.

Conclusion

The Indian government’s multi-faceted approach to preventing the sale of adulterated drugs reflects its commitment to safeguarding public health. From implementing advanced technologies like QR codes to revising regulatory frameworks and enhancing enforcement actions, these measures collectively strengthen the drug quality ecosystem in the country. By fostering transparency, accountability, and collaboration, India is setting a benchmark in ensuring the safety and efficacy of pharmaceutical products.

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Source: Ministry of Health and Family Welfare

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