Recently, a mislabelled batch of pharmaceutical drugs was erroneously distributed in the market, sparking discussions around the necessity for proper Drug Recall Laws in India. These incidents, while regularly addressed in countries like the U.S., are not commonly confronted within the Indian market.
Understanding Drug Recalls
A drug recall denotes the removal of a prescription or over-the-counter medication from the market due to hazardous repercussions or side effects. This procedure is executed when a marketed product infringes laws and regulations concerning the safety, efficacy, or quality of a drug. Common reasons for such recalls include defective products, contamination, mislabelling, or the potential risk to the health and safety of patients. The primary goal of a drug recall is public protection, achieved by removing the problematic product from the market and offering remediation or refunds to consumers who have already purchased the product.
Significance of Instituting Drug Recall Laws in India
The implementation of a national Drug Recall Law in India is paramount to ensure the immediate withdrawal of any drug found to be not of Standard Quality (NSQ), from the market. Currently, no legal provision demands the removal of an entire batch of substandard drugs within India. At best, state regulators can order the withdrawal of a specific batch from their jurisdiction. However, considering India’s interlinked market system, it is feasible that such batches might have been spread across different states, which calls for the role of a central drug regulator for effective national recall execution.
The Underlying Reasons behind India’s Insufficient Regulatory Infrastructure for Substandard Drugs
Various causes contribute to the ineffective handling of drug-related regulatory issues by the government’s Drug Regulation Section. These range from apathy, lack of expertise, to greater interest in boosting the pharmaceutical industry’s growth over securing public health.
Moreover, India has a highly fragmented regulatory structure with each state possessing its own drug regulator. Yet, despite this segmentation, drugs produced in one state can seamlessly be sold in other states across the country.
Furthermore, both the pharmaceutical industry and state drug regulators have shown resistance towards greater centralization of regulatory powers. Consequently, the incompetence of a single state’s regulator could implicate patients in other states, who possess no electoral power to demand accountability from the said regulator.
The Repercussions of Postponement in Establishing Drug Recall Laws
Failure to promptly recall substandard drugs can lead to severe consequences, including consumer illnesses and potential fatalities. Inefficient recall processes result in precarious situations for the public. A delayed or absent response from the government could suggest a lack of accountability and responsibility towards citizens’ health and safety, which could ultimately lead to loss of faith in the healthcare system and the governing body.
Current Drug Regulation in India
The regulation of drugs in India is currently governed by The Drugs and Cosmetics Act, 1940 and Rules 1945, which delineate responsibilities to central and state regulators for overseeing drugs and cosmetics. This act provides guidelines for issuing licenses to produce Ayurvedic, Siddha, and Unani medicines.
Additionally, the Central Drugs Standard Control Organisation (CDSCO) lays down standards and measures to ensure the safety, efficacy, and quality of drugs, cosmetics, diagnostics, and devices. It also controls the market authorization of new drugs and clinical trial standards.
The Drugs Controller General of India (DCGI), an offshoot of the CDSCO and a part of the Government of India, takes charge of approving licences for certain categories of drugs such as blood products, IV fluids, vaccines, and sera in India. The DCGI also sets standards for manufacturing, sales, import, and distribution of drugs in India.
The Way Forward
India’s healthcare activists must acknowledge the existing issues with drug regulation and advocate for systemic reform. There is an evident need to centralize the recall process, with a single authority holding the legal power to mandate companies to recall drugs nationwide, and further, to search and seize batches of non-compliant drugs.
