India is the third largest country in the world to produce drugs in the largest quantities. Along with the growth of this business, counterfeit and poor quality drugs are also increasing in the markets.
By: Satyawan Saurabh
According to a new WHO study, around 1 in 10 medical products in low- and middle-income countries are either substandard or inaccurate. This means that people take drugs that fail to cure or prevent disease, which not only wastes money for individuals and health systems, but substandard or counterfeit medical products cause serious illness or even death. Substandard and counterfeit medicines particularly affect the most vulnerable communities.
The World Health Organization has received 1500 case reports of substandard or counterfeit products. Of these, antimalarials and antibiotics are the most frequently reported. Most reports (42%) come from the Africa region, 21% from the Americas and 21% from the Europe region. This is a small part of the problem and many cases go unreported. Many of these products, like antibiotics, are important to people’s survival and well-being. Substandard or counterfeit medicines not only have a tragic impact on patients and their families, but also pose a threat to antimicrobial resistance. For this reason, the treatment power of drugs is decreasing in the worrying trend.
One of the biggest concerns about counterfeiting issues today is counterfeit pharmaceuticals that are spreading around the world, directly affecting people’s health and sometimes even causing death. These counterfeit drugs not only pose a serious health hazard, but also waste consumers’ income by paying for substandard drugs, which have no therapeutic value. Plus, it displaces sales from legitimate pharmaceutical companies. Reports indicate that the global counterfeit drug market is worth approximately $200 billion and the economic loss in the United States is $9 billion in lost federal and state tax revenue. is responsible for
India is the third largest country in the world to produce drugs in the largest quantities. Along with the fastest growing trade in the country, reaching $55 billion, the illegal trade in counterfeit and substandard drugs is also increasing and hence the threat to people’s lives is eminent. Last year, Assocham revealed in its report that 25% of the total drugs manufactured in the country are fake and of poor quality, or 35% of the global total of counterfeit drugs. These drugs have been a major problem in the world since the 1980s, with a huge impact on people’s health and the country’s economy.
In view of the serious concerns, the Government of India has introduced the New Drugs, Medical Devices and Cosmetics Bill 2022 and this bill seeks to replace the Drugs and Cosmetics Act 1940 with more regulations stringent to keep up with changing needs and technology. Directions are given. Currently, about 80% of medical equipment sold in the country is imported, especially high-end equipment. The main objective of this bill is to ensure that medical products sold in any country are safe, effective and meet prescribed quality standards.
He proposed the creation of a statutory technical advisory committee on medical devices composed of experts in the fields of nuclear energy, science and technology, electronics and related fields such as biomedical technology. to guide the safe and effective sale of medical products. They gave a separate definition of medical devices to include diagnostic devices, their software, implants, assistive devices for disabled people, life support devices, devices used for disinfection and any reagents or kits. The bill proposes medical device testing centers modeled on drug laboratories at the national and central levels.
The new bill proposes mandatory authorization from the Central Licensing Authority for clinical trials or clinical investigations of drugs and medical devices. Compensation is provided for the legal heirs of the participant, in the event of death and injury to persons injured during participation in clinical trials. The bill specifically states that the central government should come up with rules to regulate the online sale of drugs and for online pharmacies to operate “under license or authorization issued”.
The bill sets out provisions providing for prison sentences or fines for “adulterated” or “counterfeit” medical devices. Counterfeit medicines can pose a major health and safety risk to consumers who fall victim to poor quality counterfeit products unable to identify unauthorized medicines. Moreover, these consumers are not even aware of the risks that this can represent for them. Substandard and counterfeit pharmaceuticals can affect many people in different ways. A modern regulatory system should be designed to guarantee the right of citizens to participate in decision-making. There is a need to create legal avenues such as public hearings or citizen petitions to enable citizen participation in the regulatory process and to register their objections.
Modern purchasing models such as online pharmacies can easily circumvent regulatory oversight. These are particularly popular today, but further research is needed to determine the proportion and impact of sales of substandard or counterfeit medical products. Globalization makes it more difficult to regulate medical products. Many counterfeiters manufacture and print packaging in different countries, shipping the components to a final destination where they are assembled and distributed. Sometimes foreign companies and bank accounts have been used to facilitate the sale of counterfeit drugs.
This is a global problem, so all countries need to assess the magnitude of this problem and cooperate regionally and globally to stop the trafficking of these products and improve identification and treatment. The government has introduced provisions to punish those who sell and manufacture fake drugs, but experts say the business is thriving due to a lack of government oversight and investigation. The institutions that monitor them do not always check the quality of drugs and do not deal with counterfeit drugs.
The author is a researcher, poet, freelance journalist and columnist.
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