By: Satyawan Saurabh
According to new WHO research, an estimated 1 in 10 medical products in low- and middle-income countries are either substandard or inaccurate. This means that people are taking medicines that fail to cure or prevent the disease amounting to not only a waste of money for the individuals and the healthcare systems, but substandard or counterfeit medical products cause serious illness or even death. Substandard and counterfeit medicines particularly affect the most vulnerable communities.
World Health Organization has received 1500 reports of cases of substandard or counterfeit products. Among these, the antimalarials and antibiotics are the most commonly reported. Most of the reports (42%) come from the African region, 21% from the Americas and 21% from the European region. This is a small part of the problem and many cases go unreported. Many of these products, such as antibiotics, are important to people’s survival and well-being. Substandard or counterfeit drugs not only have a tragic impact on individual patients and their families but also pose a threat to antimicrobial resistance. Due to this, the treatment power of the drugs decreases in the worrisome tendency.
One of the biggest concerns in counterfeiting problems today is counterfeit pharmaceutical products that are spreading globally, directly affecting people’s health and sometimes even causing death. These counterfeit medicines not only pose a serious health hazard but also waste consumers’ income by paying for substandard medicinal products, which have no therapeutic value. In addition, 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 nine billion dollars in lost federal and state tax revenue. is responsible for
India is the third largest country in the world in producing medicines in the highest quantity. Along with the fastest growing business in the country reaching 55 billion dollars, the illegal business of counterfeit and low-grade drugs is also increasing and the threat to people’s lives is therefore eminent. Last year Assocham revealed in its report that 25 percent of the total drugs manufactured in the country are fake and of poor quality, which is 35 percent of the world’s total counterfeit drugs. Such drugs have been a major problem worldwide since the 1980s, with a huge impact on people’s health and the country’s economy.
Given 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 of 1940 with stricter regulations to keep pace with changing needs and technology. Directions are given. Currently, about 80% of the medical equipment sold in the country is imported, especially high-end equipment. The primary objective of this bill is to ensure that medical products sold in any country are safe, effective, and conform to prescribed quality standards.
It proposed the establishment of a Statutory Medical Device Technical Advisory Board with 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 have given a separate definition of medical devices to include diagnostic devices, their software, implants, devices for assisting the disabled, life support, devices used for disinfection, and any reagents or kits. The bill proposes medical device testing centers on the lines of drug laboratories at the state and central levels.
The new bill proposes mandatory permission from the Central Licensing Authority for clinical trials or clinical investigation of drugs and medical devices. Provision is made for compensation to the legal heirs of the participant, in case of death and injury to persons injured while participating in clinical trials. The bill specifically states that the central government should come up with rules to regulate the online sale of medicines and for online pharmacies to operate “under license or permission issued”.
The draft bill defines provisions for imprisonment or fines for “adulterated” or “counterfeit” medical devices. Counterfeit medicines can pose a major health risk and safety hazard to consumers who fall victim to low-quality counterfeit products, unable to spot unauthorized medicines. Moreover, these consumers are not even aware of the risks that may pose to them. Poor quality and fake pharmaceutical products can affect many people in different ways. A modern regulatory system should be designed to guarantee citizens’ right 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 shopping models such as online pharmacies can easily circumvent regulatory oversight. These are particularly popular today, but more research is needed to determine the proportion and impact of sales of substandard or counterfeit medical products. Globalization is making it harder to regulate medical products. Many counterfeiters manufacture and print packaging in different countries, shipping 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 extent of this problem and cooperate at the regional and global levels to stop the traffic of these products and improve identification and processing. The government introduced provisions to punish those who sell and manufacture fake drugs, but experts say the business is flourishing due to a lack of government monitoring and investigation. Institutions monitoring these are not always checking the quality of drugs and dealing with counterfeit drugs.
The writer is Research Scholar, Poet, Freelance Journalist and Columnist .
