FOPE seeks reconsideration of proposed automatic suspension of drug manufacturing licences on NSQ reports

The Federation of Pharma Entrepreneurs (FOPE) has taken note of the Ministry of Health and Family Welfare’s draft notification G.S.R. 956(E), proposing amendments to the Drugs Rules, 1945, to provide for immediate suspension of manufacturing licences when drugs are declared Not of Standard Quality (NSQ). FOPE has stated its support for the Government’s commitment to patient safety and ensuring the availability of safe, effective and quality medicines. The organisation said the pharmaceutical industry recognises that quality compliance and patient safety are paramount and that regulatory authorities must have the powers to take action against manufacturers wherever quality failures or violations are established. However, FOPE believes that the existing provisions of the Drugs and Cosmetics Act, 1940 and the Drugs Rules, 1945 already provide a regulatory framework that empowers authorities to investigate quality failures, take enforcement action and suspend or cancel manufacturing licences wherever warranted. In this context, FOPE has called for reconsideration of the need for an additional provision mandating automatic suspension of manufacturing licences upon receipt of an NSQ report, without addressing procedural safeguards. FOPE’s principal concern is that regulatory enforcement must be consistent with the principles of natural justice, fairness and proportionality. The organisation stated that an NSQ test report should trigger regulatory examination and investigation. However, the consequences of such a report should be determined after considering the nature and severity of the failure, its potential impact on patient safety, the circumstances leading to the deviation, and the manufacturer’s explanation and supporting evidence. FOPE has identified five concerns regarding the proposed automatic suspension mechanism. These include the absence of an express provision allowing manufacturers to present their explanation before suspension, the lack of specific provisions for appellate confirmatory testing where analytical results are disputed, and the absence of a distinction between critical quality failures and other technical or analytical deviations. The organisation has also raised concerns about the operational and financial consequences of suspension and the absence of prescribed timelines for regulatory assessment of corrective and preventive action (CAPA), verification and restoration of manufacturing permissions. FOPE has emphasised that the principles of natural justice, including the opportunity to be heard, should form part of regulatory decision-making. It stated that where an urgent situation involving an immediate threat to patient safety requires interim action, post-decisional hearings and time-bound review mechanisms should be provided. The proposed amendments should also distinguish between suspension of permission for the affected product and suspension of the entire manufacturing licence, according to FOPE. Regulatory action should be proportionate and product-specific unless wider systemic GMP failures are established. In its statement, FOPE said: “Patient safety is non-negotiable, and the pharmaceutical industry fully supports strong and effective regulatory oversight. However, strong regulation must also be fair, scientifically justified and consistent with established legal principles. We believe that the existing legal framework already empowers regulatory authorities to take appropriate action against quality failures and protect public health. Introducing an additional automatic suspension mechanism without adequate safeguards may create unintended consequences without necessarily improving the effectiveness of quality enforcement. An NSQ observation must lead to prompt investigation, identification of root causes and effective corrective and preventive action. At the same time, manufacturers must have a reasonable opportunity to present their case, seek appellate confirmatory testing wherever warranted and receive a reasoned regulatory decision in accordance with the principles of natural justice. Our concern is particularly significant for manufacturers, where suspension of a product or manufacturing permission can have substantial operational and financial implications. Regulatory action must be proportionate to the nature of the failure and the actual risk to patients. FOPE will submit a detailed representation to the Ministry of Health and Family Welfare and engage constructively with CDSCO and other regulatory authorities. We will seek reconsideration of the proposed automatic suspension provisions and advocate a balanced approach that strengthens patient safety while preserving fairness, transparency and due process. We believe that patient safety, regulatory effectiveness and the sustainability of responsible pharmaceutical manufacturing are complementary objectives and must move forward together.” FOPE stated that it will submit a representation to the Ministry of Health and Family Welfare and engage with CDSCO and other regulatory authorities to seek reconsideration of the proposed automatic suspension provisions. The Federation of Pharma Entrepreneurs reiterated its commitment to working with the Government and regulatory authorities to strengthen India’s pharmaceutical quality ecosystem and sustain the country’s position as a global pharmaceutical manufacturing destination. The post FOPE seeks reconsideration of proposed automatic suspension of drug manufacturing licences on NSQ reports appeared first on Express Pharma.