Shut Non-Compliant Firms: Panel Demands Strict Action Against Counterfeit Drugs

The committee, in its Eighth Report on Demands for Grants 2025-26, expressed deep concern over the circulation of substandard and counterfeit drugs, emphasizing that regulatory amendments alone are insufficient unless implementation is uniform, strict, and effectively monitored across all States and Union Territories.

Manufacturing Regulations and Compliance Gaps

The committee noted that drug manufacturing, sale, and distribution in India are governed by the Drugs and Cosmetics Act, 1940, and the Drugs Rules, 1945. The regulatory framework operates through a system of licensing and inspection carried out by the State Licensing Authorities (SLAs) under the respective State Governments.

It pointed out that:

"As per recent amendments to the Drugs Rules, 1945, it is now mandatory for a manufacturing establishment to be inspected jointly by Drugs Inspectors of the Central and State Governments before granting a manufacturing license. Additionally, manufacturing premises must adhere to Good Manufacturing Practices (GMP) as outlined in Schedule 'M' of the Rules. These GMP requirements have recently been revised to further strengthen quality control measures. However, it has been noted that the deadline for compliance with the revised Schedule ‘M’ has been extended until December 31, 2025."

While acknowledging the strengthened GMP requirements, the committee questioned the rationale behind extending the compliance deadline and stressed the need for the pharmaceutical industry to adopt these updated practices at the earliest.

Despite these regulations, the committee remained deeply concerned about the persistence of spurious and adulterated drugs in the market, which pose a serious risk to public health. It strongly emphasized:

"Mere amendments to regulations are not enough unless their implementation is strict, uniform, and effectively monitored across all States and Union Territories. There is an urgent need to ensure full compliance with these regulatory provisions, particularly in high-risk regions where counterfeit drugs are prevalent."

Call for Immediate Strengthening of Regulatory Enforcement

In response to these concerns, the committee has recommended stringent enforcement of the Drugs and Cosmetics Act, 1940, and the Drugs Rules, 1945, across the country. It urged the Department of Pharmaceuticals to work closely with the Ministry of Health and Family Welfare to enhance monitoring and inspections.

The Committee strongly recommends that;

“The Drugs and Cosmetics Act, 1940, and the Drugs Rules, 1945, be enforced rigorously across the country to eliminate the menace of spurious and adulterated drugs. The Department of Pharmaceuticals must work in close coordination with the Ministry of Health and Family Welfare to ensure strict monitoring, timely inspections, and swift punitive action against violators.

The committee further suggested that:

"The guidelines issued by the Central Drugs Standard Control Organization (CDSCO) on Good Distribution Practices (GDP) released on 4th April 2024 be made legally enforceable. This will strengthen the quality standards across the pharmaceutical industry by ensuring proper handling, storage, and tracking of drugs throughout the supply chain."

Additionally, the committee recommended that the Department conduct a comprehensive review of regulatory enforcement, considering the number of inspections conducted, violations detected, actions taken against non-compliant manufacturers, additional measures planned to strengthen enforcement mechanisms.

Alarming Data on Spurious and Substandard Drugs

The committee’s concerns are backed by data revealing widespread violations in drug quality standards. It highlighted that out of 4,57,910 drug samples tested, a shocking 13,735 samples were found not of standard quality, while 1,547 samples were declared spurious or adulterated. The low number of legal actions and arrests relative to these violations was a key point of criticism:

"Further, 2,516 prosecutions were initiated for the manufacture, sale, and distribution of spurious/adulterated drugs, leading to the arrest of 1,228 persons during the period 2019-20 to 2023-24."

The committee expressed deep concern over these figures, stating that they expose the alarming prevalence of substandard drugs. It noted that while the detection of spurious drugs is a serious issue, the low number of prosecutions and arrests is equally troubling.

"The Committee is deeply perturbed by these figures, which expose the alarming prevalence of spurious and substandard drugs in the market. While the detection of non-standard and spurious drugs is a serious concern in itself, the Committee finds it equally disturbing that the number of prosecutions and arrests is disproportionately low compared to the number of substandard and spurious drug samples identified. This indicates weak enforcement, inadequate punitive action, and possible lapses in regulatory oversight, which ultimately compromise public health and safety."

Stronger Legal Action and Industry-Wide Crackdown

The committee has called for urgent legal action against those responsible for the manufacture and sale of counterfeit drugs. It stressed:

“Mere identification of spurious drugs is not enough—strict legal action must follow, including swift prosecutions, stricter penalties, and immediate shutdowns of non-compliant manufacturers. The current level of enforcement is grossly insufficient, and much stronger efforts are needed by the Department of Pharmaceuticals and the Ministry of Health and Family Welfare to eliminate the production and distribution of counterfeit and adulterated drugs.”

Additionally, it recommended the Department of Pharmaceuticals and the Ministry of Health and Family Welfare to take concrete steps to;

1. Enhance surveillance and inspections across all manufacturing units, particularly in high-risk regions. 2. Expedite legal proceedings and ensure maximum penalties for those involved in the production and distribution of spurious drugs. 3. Increase inter-agency coordination, including collaboration with law enforcement agencies, to dismantle networks engaged in counterfeit drug production. 4. Strengthen penalties under the Drugs and Cosmetics Act to serve as a deterrent against the manufacture and sale of substandard drugs. 5. Launch a national awareness campaign to educate consumers and healthcare professionals about identifying counterfeit medicines and reporting violations.

The Committee further demanded,

“To be apprised of the specific measures taken to strengthen enforcement and regulatory oversight in this regard.”