The spectacular growth of the Indian pharmaceutical sector is driven by both improved access to modern healthcare and a surge in demand for
prescribed medicines. The rising demand for medicine comes with the challenge of the circulation of adulterated and spurious drugs in the market posing serious health risks to patients. The detection of spurious and adulterated drugs being a technical issue, people are fully dependent on government measures for its prevention. The Parliamentary Standing Committee on Chemicals and Fertilisers flagged the persistent issue of spurious and adulterated drugs circulating in the market, posing a serious threat to public health and safety despite regulatory provisions. The committee has rightly emphasized in its report that 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, it recommended. Official data presented to the parliamentary profile shows the gravity of the situation. Out of 4,57,910 drug samples tested, as many as 13,735 samples were found not of standard quality, and 1,547 samples were declared spurious or adulterated. 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. What the Committee finds “equally disturbing” is that while the detection of non-standard and spurious drugs is a serious concern in itself, the number of prosecutions and arrests is disproportionately low compared to the number of substandard and spurious drug samples identified. This is a serious gap in quality control which needs to be addressed urgently before it widens further and jeopardises public health safety. The report highlights that the manufacturing, sale, and distribution of drugs in India are regulated under 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. 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 licence. Additionally, manufacturing premises must adhere to Good Manufacturing Practices (GMP) as outlined in the rules, it adds. This implies that there are regulatory measures to ensure quality control, but the circulation of spurious and adulterated medicine is a pointer to failure to enforce those effectively. Two key recommendations made by the committee are that 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, and the guidelines issued by the Central Drugs Standard Control Organisation (CDSCO) on Good Distribution Practices (GDP) released last year be made legally enforceable. The parliamentary panel expressed the view that this will strengthen the quality standards across the pharmaceutical industry by ensuring proper handling, storage, and tracking of drugs throughout the supply chain. The Department of Chemicals and Fertilisers conducting a detailed review of the situation, as recommended by the panel, to ascertain the number of inspections conducted, violations detected, actions taken against non-compliant manufacturers, and additional measures planned to strengthen enforcement mechanisms will be critical to curb the menace. The report also highlights the committee’s firm opinion that 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 committee’s findings that the current level of enforcement is grossly insufficient and the recommendation that 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 have set the guideline for the government to draw the action plan to remove the gaps. The committee has also underscored the importance of launching a national awareness campaign to educate consumers and healthcare professionals about identifying counterfeit medicines and reporting violations. However, a vast majority of consumers belong poor and underprivileged categories; empowering them to play a proactive role in this regard is quite challenging. The Guidance for Identification and Verification of Spurious Drugs issued by CDSCO prescribes checking the primary/secondary label of the drug for a barcode/quick response code and scanning it with a mobile phone to read the information for product authenticity/genuineness. While healthcare professionals will be able to draw the informed opinion about the authenticity/genuineness of the drug, even a tech-savvy consumer without adequate technical guidance will not be able to derive any conclusion after reading the information displayed on the mobile screen. Under such a prevailing situation, strengthening inspection and regulatory regimes is a more pragmatic option to prevent the circulation of spurious and adulterated medicines across the country.