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  • Last Updated on March 25, 2024 by Neelam Singh Quick Take According to a well-circulated X post, there are concerns about the quality of medicines produced and authorised in India. After conducting a fact-check, we found that the claim is False. The Claim A widely shared social media post shares a newspaper story where the claimant makes a suggestive statement, giving rise to the conspiracy theory that “medicines in India are of bad quality because of incidents like electoral bond purchases, where money flows from pharmaceutical companies to political parties in power.” We have been meticulously promoting evidence-based information on medicines. These include the ones that should be taken on an empty stomach, those that should be taken with or after meals, and their significance in the management of endometriosis and lung cancer. Fact Check Does the news article cast doubt on the efficacy of Indian medicines? It should be made clear that the newspaper article does not refer to the quality of medications manufactured in India. Conversely, the report indicates that several pharmaceutical corporations have purchased numerous electoral bonds. Nonetheless, a portion of these bonds were purchased during periods when the Enforcement Directorate (ED) was conducting regulatory oversight of the enterprises. This could imply that the corporations avoided the regulatory probe by using the bond purchase as a means of influencing key government figures. Nevertheless, this remains unsubstantiated and is merely an allegation at this point. Is the quality of Indian medicines regulated by electoral bonds? No, not really. This is primarily due to the fact that electoral bonds are a means of streamlining political financing in India. These bonds aim to promote transparency in the political party funding process by enabling both individuals and organisations to do so. These electoral bonds provide a history of political donations that may be traced. This process enhances transparency and accountability for political funding. Additionally, this establishes a legal framework that provides a regulated avenue for political donations. Ultimately, this ensures political parties are accountable for the funds they receive. However, the article points out that several Indian pharmaceutical companies have contributed significantly to political parties through electoral bonds, yet these payments have not had an impact on specific industries such as healthcare or pharmaceuticals. This may be explained by the fact that governing bodies like the Central Drugs Standard Control Organization (CDSCO) are in charge of regulating drug quality in India. This authority is in charge of licencing, overseeing compliance with quality standards, and inspecting facilities that manufacture pharmaceuticals. Among the most critical pieces of legislation is the Drugs and Cosmetics Act, 1940 , which regulates the importation, distribution, and manufacturing of pharmaceuticals in India. A 2020 observational study found that the pharmaceutical and health product industries made significant financial contributions to political campaigns and lobbying between 1999 and 2018. These activities might have an impact on legislative outcomes such as on US health policy. This implies that there are financial transactions between government officials and the pharmaceutical industry that are not confined to India. Therefore, although they could indirectly intersect with the pharmaceutical industry, electoral bonds do not directly regulate or affect the quality of medications in India. How are medicines licenced in India? India exports its pharmaceuticals to several nations. This may be related to India’s strict licencing procedures. This process ensures regulatory standards are met while safeguarding public health interests. In India, a number of significant bodies are in charge of granting medical licences. Their primary goal is to ensure that the standards for efficacy, safety, and quality are adhered to before a product is introduced. The Central Drugs Standard Control Organisation (CDSCO) is the primary regulatory authority responsible for providing drug licences. The Drugs Controller General of India (DCGI) is the ultimate regulatory authority under CDSCO and has a major role to play in approving clinical trials. Pharmaceutical businesses are required to acquire authorization from these agencies. The CDSCO also monitors the Drugs Consultative Committee, the Drugs Technical Advisory Board (DTAB), and the Central Licencing Approving Authority to ensure compliance with medical device legislation. The licencing procedure necessitates the filing of comprehensive applications. The application must include all relevant information on the medication, its manufacturing process, and the quality control measures employed. Additional criteria influencing licencing include the assessment of clinical trial results and the inspection of manufacturing facilities. These licences may be subject to state regulations in addition to federal law, making them location-specific. Any facility that stores or sells medications must, therefore, submit distinct applications. Once a drug or medical equipment is approved and licenced, it is continuously monitored by the authorities. This ensures continued compliance with safety and quality standards. Furthermore, India is a member of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). As a result, this collaboration ensures that drug-regulatory standards comply with international standards and guidelines.
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