Fake Drugs and Generic Medicines in India: A Growing Concern

Fake Drugs: Pharmaceutical Industry Putting Your Life At Risk

Generic medicines are pharmaceutical products that are equivalent to branded 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 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 it differs from the branded drug

• 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.
• 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 Organization (CDSCO), which ensures that all medicines produced in India, including generic medicines, meet the necessary safety, efficacy, and quality standards. The regulatory process for generic medicines in India involves a rigorous evaluation of the manufacturing process, quality control systems, and clinical data. The CDSCO conducts inspections of manufacturing facilities to ensure that they meet good manufacturing practices (GMP) standards and comply with regulatory requirements.

In addition to regulatory oversight, several voluntary quality certification programs in India provide additional assurance of the quality of generic medicines. For example, the World Health Organization (WHO) has prequalified several Indian generic medicine manufacturers, indicating that their medicines meet international quality standards.

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:

• 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.
• 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.
• 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.
• 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.
• 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.
• Counterfeiting of generic medicines: It is a significant issue in India.WHO report (2017) claims 10.5 per cent of medicines sold in low and middle-income are substandard and falsified which is a serious threat to patient safety with dangerous side effects and may lead to other health problems. The COVID-19 pandemic has fuelled the incidents of sub-standard and falsified drugs and other medical products 

Counterfeit generic medicines 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. Counterfeit medicines can also be ineffective, contain incorrect dosages, or have the wrong active ingredients, which can lead to treatment failure and the development of drug-resistant strains of diseases. 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, unregulated websites filled with misleading information.

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. As per the recent draft notification released by the Ministry of Health & family welfare; from Jan 2023 onwards, QR codes on the packaging of Active Pharmaceutical Ingredients (APIs) will be mandatory. From May 2023, the imposition of a Barcode/QR Code will be mandatory on the packaging of the top 300 pharma brands selling in the domestic market. However, there is still a long way to go to eradicate counterfeit medicines.

What a layperson can do to prevent himself from falling into the trap of counterfeiting

It can be difficult for a layperson to differentiate between branded medicines and generic medicines as they often have similar packaging and labelling.

To protect themselves from counterfeit medicines, consumers can take certain precautions, such as purchasing medicines from licensed and reputable pharmacies, checking the packaging and labelling for signs of tampering or counterfeiting, and reporting suspected counterfeit medicines to the authorities. Awareness and information published by government authorities regarding generic medicines. Several resources are available in India that provides information on generic medicines, including the National List of Essential Medicines (NLEM), the Indian Pharmacopoeia, and the CDSCO database. These resources can help patients and healthcare providers identify and select safe, effective, affordable generic medicines.

The Indian government maintains NLEM, which includes a list of essential medicines that are considered to be the minimum medicine needed for a basic healthcare system. The NLEM is intended to guide the procurement and supply of medicines in the public sector and is updated periodically to reflect changing healthcare needs and disease patterns. The NLEM includes both branded and generic medicines, and the generic names of the medicines are listed. The NLEM is publicly available and can be accessed on the website of the Ministry of Health and Family Welfare. The list is also distributed to healthcare providers, hospitals, and pharmacies, and is used to guide the selection and prescribing of medicines.

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.

Summary- Generic drugs have become an essential part of the healthcare system, providing affordable access to essential medications for millions of people worldwide. Generic drugs are bioequivalent and cheaper pharmaceuticals than branded drugs. 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.

Dr Naman Jain

MD General Medicine, DrNB Clinical Immunology and Rheumatology

Consultant Rheumatologist, Ramakrishna Care hospital Raipur Chhattisgarh