Generic drugs have become an essential part of the healthcare system, providing affordable access to essential medications for millions of people worldwide. This article explains how generic medicines differ from branded drugs and what are counterfeit generic medicines. 

Generic medicines

Generic medicines are pharmaceutical products that are equivalent to brand-name drugs in terms of safety, efficacy, and quality. They contain the same active ingredient, dosage form, strength, and route of administration as their brand-name counterparts. They can be used to treat the same medical conditions and can provide the same relief and outcomes.

Branded drugs

Branded drugs are medications that are developed and marketed by pharmaceutical companies under a specific brand name. These drugs are protected by patents. Branded drugs may also have certain advantages over generic drugs, such as better quality control and consistency, more rigorous testing and clinical trials, and unique delivery systems or formulations.

How generic medicines differ from the branded drug

1. Generic drugs are typically less expensive than their brand-name equivalents because they are marketed after the expiration of the patent protection of the original drug.
2. Generic medicines may have different inactive ingredients than branded medicine, such as preservatives, flavourings, or dyes, as long as they are not harmful to the body. But they provide the same therapeutic benefit.

Generic medicines have a significant presence and importance in India. These are often the first choice because they are more affordable than brand-name drugs. The government of India has implemented several policies and initiatives to promote the use of generic medicines. It includes price control and the requirement for doctors to prescribe medicines by their generic names rather than brand names. Also, India has a robust pharmaceutical industry that produces a wide range of generic medicines, and the country is also a major exporter of generic medicines to other countries.

However, despite the availability and affordability of generic medicines in India, there are still challenges related to access and quality. Many people in rural and remote areas may need access to quality generic medicines, and there have been reports of substandard and counterfeit generic medication in circulation.

How does generic medicine get approval for use on the market?

For the marketing of generic drugs, the manufacturer must demonstrate bioequivalence to the branded drug. In India, the approval of generic medicines is subject to strict regulatory norms. The regulatory framework for generic drugs in India is overseen by the Central Drugs Standard Control Organisation (CDSCO), which ensures that all medicines produced in India, including generic medicines, meet the necessary safety, efficacy, and quality standards.

1. The regulatory process for generic medicines in India involves a rigorous evaluation of the manufacturing process, quality control systems, and clinical data.
2. The CDSCO conducts inspections of manufacturing facilities to ensure that they meet good manufacturing practices (GMP) standards and comply with regulatory requirements.

Despite the regulatory framework and quality control measures in place, there have been instances of substandard and counterfeit medicines in circulation in India. Following are a few of the several issues related to generic medicines that can affect their availability, affordability, and quality;

1. Lack of regulatory capacity: Many developing countries have weak regulatory frameworks and limited capacity to regulate and oversee the production and distribution of generic medicines. This can lead to a proliferation of substandard and counterfeit medicines in the market, which can be harmful to patients.
2. Limited access to essential medicines: In many developing countries, there is limited access to essential medicines, including generic medicines. This is often due to a lack of infrastructure, inadequate healthcare financing, and insufficient supply chains.
3. Intellectual property rights: The issue of intellectual property rights can affect the availability and affordability of generic medicines in developing countries. Patents and other forms of intellectual property protection can limit the production and distribution of generic medicines, leading to higher prices and limited access for patients.
4. Pricing and affordability: While generic medicines are generally more affordable than brand-name medicines, they can still be expensive in developing countries, where healthcare financing is limited. The pricing of generic medicines can be affected by a range of factors, including supply and demand, production costs, and intellectual property protection.  
5. Quality control: Ensuring the quality of generic medicines can be a challenge in developing countries, where regulatory frameworks and quality control systems may be weak.
6. Counterfeiting of generic medicines: It is a significant issue in India.

Counterfeit generic medicines

These are fake medicines that are manufactured and sold illegally. These drugs may contain harmful substances, such as toxins, heavy metals, and other contaminants, that can cause serious health problems, including death.

India has a large market for generic medicines, and this market is vulnerable to counterfeiting due to a lack of effective regulation, inadequate quality control, and weak enforcement mechanisms. Counterfeit medicines are often sold through unlicensed and unregulated channels, such as street vendors, online pharmacies, and informal drug markets.

Addressing these issues requires a multifaceted approach that involves strengthening regulatory capacity, improving healthcare infrastructure and financing, addressing intellectual property concerns, ensuring fair pricing and affordability, and improving quality control systems. The Indian government has taken several steps to combat the counterfeiting of generic medicines, including the implementation of new laws, the creation of specialised law enforcement agencies, increasing public awareness and the use of technology to track and monitor the supply chain. However, there is still a long way to go to eradicate counterfeit medicines.

How to prevent from falling into the trap of counterfeiting?

The Indian Pharmacopoeia Commission (IPC) publishes the Indian Pharmacopoeia, which is a comprehensive reference book that provides standards for the quality of medicines and lists the generic names of medicines. The IPC also maintains a database of all medicines approved by the CDSCO, which the public can access.

Disclaimer- The views and opinions expressed in this article are those of the author and do not necessarily reflect the official policy or position of M3 India.

About the author of this article: Dr Naman Jain is a practising rheumatologist from Chattisgarh.