The Central Drugs Standard Control Organisation (CDSCO) and the Ministry of Health and Family Welfare, in collaboration with state drug regulators, have defined enforcement and regulatory activities to prevent non-standard quality (NSQ), adulterated, and counterfeit pharmaceuticals from reaching patients. Union Minister of State for Health and Family Welfare Anupriya Patel provided an update in a recent written reply to the Rajya Sabha. 

Since the beginning of risk-based inspections in December 2022, authorities have inspected 905 manufacturing and testing units, resulting in 694 regulatory actions ranging from Stop Production Orders (SPO) and Stop Testing Orders (STO) to licence suspensions/cancellations, warning letters, and show-cause notices, depending on the severity of noncompliance. According to the government, the exercise yielded comprehensive understanding of production procedures and resulted in remedial actions that strengthened the regulatory environment. 

The key policy milestones span from 2022-2024. On January 18, 2022, the Drugs Rules of 1945 were updated to require Quick Response (QR) codes on all Active Pharmaceutical Ingredients (APIs) at every packaging level for better tracking and tracing. Another amendment (G.S.R. 823(E)) took effect on August 1, 2023, requiring barcodes/QR codes on primary (or secondary, if space is limited) packets of the top 300 Schedule H2 medicine brands to simplify authentication. On December 28, 2023, the government changed Schedule M under G.S.R. 922(E). Effective June 29, 2024, manufacturers with a turnover of more than ₹250 crore will be subject to increased Good Manufacturing Practices. Those earning under ₹250 crore receive a conditional extension until December 31, 2025, if they have filed an upgrade plan. In February 2024, CDSCO announced standardised, risk-based sampling criteria for pharmaceuticals, cosmetics, and medical devices. 

Measures are in effect throughout the country, in both the federal and state governments. CDSCO has consolidated various public-facing activities on its website, such as gazette notifications, instructions for authenticating packs using barcodes/QR codes, and monthly Drug Alerts that highlight samples that fail quality inspections. State/UT governments have also established special courts to expedite the trial of violations under the Drugs and Cosmetics Act. 

The regulatory strategy is based on four major pillars: enforcement, digitisation, transparency, and capacity building, which work together to create a more robust compliance environment. This technique relies heavily on track and trace technology. Regulators now need machine-readable information, such as product ID, batch number, and expiration date, on all active pharmaceutical ingredients and the top 300 Schedule H2 brands. This solution not only allows authentication at the retail level, but it also provides the groundwork for electronic traceability across the supply chain. 

To complement this, CDSCO has implemented standardised sampling techniques to ensure consistency and rigour among states. The 2024 standards prioritise risk-based selection, ensure broad geographical coverage (including rural outlets), and specify quantities and dates. We have given laboratories a more formal role in this process, which reduces discretion and increases consistency in quality assessments. 

Digitisation supports much of the new workflow. The SUGAM Labs site, which integrates CDSCO testing facility network, has been operational since September 2023. This online system automates end-to-end processes for pharmaceuticals, vaccines, cosmetics, and medical devices, allowing regulators and manufacturers to monitor testing results in real time. Upon identifying gaps, the system offers a transparent, auditable record that can expedite corrective actions. 

When non-standard quality medications are detected, the framework enables rapid regulatory escalation. Manufacturers of failing samples are ordered to promptly recall the products and discontinue further distribution. Depending on the severity, authorities may issue stop-production or stop-testing orders, suspend or cancel licences, or issue warnings and show-cause notices. These actions are based on provisions of the Drugs and Cosmetics Act and Rules, which provide a legal foundation for enforcement. 

The broader regulatory environment is likewise being altered by a Good Manufacturing Practices (GMP) upgrade. The updated Schedule M establishes more stringent regulations for buildings, plants, and equipment. Before a manufacturing licence is issued, establishments must now undergo joint inspections by central and state drug inspectors. Applicants must additionally give bioequivalence data for specific oral dosage forms, stability studies, and evidence of excipient safety, which tightens pre-licensing examination. 

Simultaneously, deterrence has been enhanced through punitive and judicial systems. The 2008 revision to the Drugs and Cosmetics Act increased penalties for counterfeit and contaminated drugs, making some offences cognisable and non-bailable. Dedicated special courts established by states and union territories attempt to expedite the resolution of such cases, establishing a stronger disincentive for malpractice. 

Lastly, investments in people and skills support the system. Over the last decade, the number of sanctioned roles within CDSCO has dramatically increased, and large-scale training programs are still being implemented to develop regulatory capacity. In FY 2023-24 alone, 22,854 workers were trained, followed by another 20,551 in FY 2024-25, with a focus on Good Manufacturing Practices and uniform enforcement across jurisdictions. 

These interconnected initiatives represent a multi-layered effort to resolve regulatory gaps, modernise monitoring, and safeguard patients from the dangers presented by inferior and counterfeit medications. 

By issuing monthly public drug alerts and providing a growing set of compliance tools, like factory inspections and digital tracking, regulators aim to make it simpler to find, discourage, and eliminate low-quality and counterfeit medical products, while also encouraging manufacturers to follow better Good Manufacturing Practices with a clear timeline for compliance.