The fake medicine market has emerged as a threat in India. In 2009, the Central Drugs Standard Control Organisation <a href="https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4355878/#:~:text=In%202009%2C%20CDSCO%20reported%20that,achievement%20by%20the%20drug%20authority.">reported</a> finding 0.16% of the drugs from a sample of 42,354 to be spurious or fake. This might seem like a small percentage, however, numerous lives fall at risk of poor health if this percentage is extrapolated to the national level.

What are spurious or fake drugs?

Spurious or fake drugs are those drug formulations manufactured, concealing the true identity of the product. These drugs are made to resemble another drug, especially some popular brands, to deceive the buyer and cash in on the popularity of the original product. The product may or may not contain the <a href="https://loksabhadocs.nic.in/Refinput/New_Reference_Notes/English/spuriousdrugs.pdf">active ingredient.</a>

The issue has gained increased visibility following a series of high-profile raids across various parts of the nation - fake cancer medicines in New Delhi, chalk powders in antibiotics, and crores worth of painkillers and blood pressure medicines in Ghaziabad and Hyderabad in <a href="https://www.ndtv.com/video/the-fake-medicine-epidemic-decoded-769640">March 2024</a>.

As mentioned, from essential antibiotics, and antidiabetic and antihypertensive medications to high-cost treatments such as anti-cancer drugs, the presence of fake drugs spans the entire pharmaceutical spectrum. They mostly target costlier brands. Apart from the financial burden, the health ramifications these counterfeit drugs impose on consumers are profoundly severe.&nbsp;

Commonly, in the production of these fake medicines, counterfeiters use inert substances like chalk powder as fillers. Alarmingly, there are instances where <a href="https://www.youtube.com/watch?v=rqP_Pa_NgX0">hazardous materials</a>, including paint, and brick dust were being used during the manufacture of such medicines. The frightful harms of these fake drugs lie not just in their failure to treat the medical condition for which they were prescribed but also in the additional health complications caused by their toxic constituents.

Why do these drugs exist in the market?

Central Drugs Standard Control Organisation (<a href="https://cdsco.gov.in/opencms/opencms/en/Home/">CDSCO</a>) is the regulatory authority in India responsible for the approval of new drugs, clinical trials, import and export of drugs, licensing of manufacturing facilities, and monitoring of drug safety and quality in India. There are strict rules like the Drugs and Cosmetics Act (1940), Drugs and Cosmetics Rules (1945), Good Manufacturing Practices, and The Pharmacy Law (1948) which mandates the companies to abide by during the manufacture, storage, transport, and sale of medicinal products, failing which can lead to various consequences.&nbsp;

According to <a href="https://www.indiacode.nic.in/bitstream/123456789/15278/1/drug_cosmeticsa1940-23.pdf">The Drugs and Cosmetics Act,</a> of 1940, if consumption of fake drugs results in death or grievous hurt, the manufacturer may be punished under section 320. The punishment for this offense ranges from 10 years to lifetime imprisonment, along with a fine of up to Rs 10 lakh or three times the value of the drug confiscated, whichever is more. In other scenarios, imprisonment can range from 1 year to 7 years, with a fine not less than Rs 10,000 or three times the amount confiscated. However, despite strict rules on paper, the reality often differs drastically. There have been cases where guilty drug manufacturers were let off with meager fines in the thousands.

The recent amendment of <a href="https://www.hindustantimes.com/india-news/rajya-sabha-passes-jan-vishwas-bill-sparks-debate-on-decriminalising-substandard-medicines-and-dilution-of-punishment-101691002819655.html">The Jan Vishwas Bill 2023</a> proposes the decriminalization of both Section 42 of the Pharmacy Act&nbsp; 1948 (mandating the employment of pharmacy degree holders in the sale of medicines) and Section 27(a) of the Drugs &amp; Cosmetics Act, 1940 (penalties related to fake drugs including imprisonment).&nbsp;

Under the bill, Section 42(2) of the Pharmacy Act was amended on August 2023 to remove the imprisonment clause and instead impose a fine of Rs 1 lakh for the employment of unqualified persons for the sale of medicines. Additionally, Section 27(d) of the Drugs &amp; Cosmetics Act would be made compoundable, allowing offenders to avoid prison by paying a fine of Rs 20,000.&nbsp;

This raises questions about the inconsistency in penalties for the same offense across different laws and the ethical implications of allowing businesses that engage in harmful behaviour towards patients to evade imprisonment.

Should drugs be treated like currency?

Currencies, too, have been subjected to duplication for a long time. To fight the issue of fake drugs that could happen at the manufacture, transport, or storage level, the pharmaceutical industry can draw inspiration from the security measures employed in currency production. Advanced packaging technologies, like using tamper-evident materials and holographic seals, along with the usage of unique identifiers like serial numbers and QR codes. Additionally, the use of chemical taggants, which are unique traceable chemicals that are used to identify the product and blockchain technology, is to have an immutable ledger (or number) that helps to maintain the records for transactions hence a drug product with a blockchain can be tracked to its source, can also be tried. Both these technologies help in monitoring the supply chains&nbsp;

These innovations, combined with collaboration between the pharmaceutical sector and financial counterfeit experts, would strengthen the drug manufacturing process against counterfeits, ensuring patient safety and restoring trust in healthcare products.&nbsp;

What can be done to protect people from fake drugs?

While paying attention to details such as medicine labels, package quality, medicine uniformity, checking batch numbers, avoiding purchasing loose tablets, and buying from reputed stores are important steps to avoid fake medicines, more vigilant measures are needed from the regulatory side. There needs to be more than these steps to ensure complete safety. Increasing the authenticity of the medicines purchased at the store is crucial.

Additionally, it is vital to educate consumers about counterfeit medicines. Sensitizing the public on how to protect themselves from fake drugs can significantly reduce risks. This can be achieved through educational campaigns utilizing print and digital media. Providing clear information and guidance on what to look for when purchasing medicines&mdash;such as recognizing official seals, understanding packaging quality, and verifying batch numbers&mdash;can empower consumers to make safer choices.&nbsp;

By combining vigilant regulatory measures with comprehensive consumer education, we can create a robust defense against counterfeit medicines, ensuring that the medicines people rely on for their health are safe and effective.

Some regulatory bodies have already adopted new-age technologies to monitor supply chains and maintain transparency. A few examples include the FDA&#39;s Drug Supply Chain Security Act (<a href="https://www.fda.gov/drugs/drug-supply-chain-integrity/drug-supply-chain-security-act-dscsa">DSCSA</a>)<a href="https://www.fda.gov/drugs/drug-supply-chain-integrity/drug-supply-chain-security-act-dscsa">)</a>, the European Medicines Verification System (<a href="https://emvo-medicines.eu/mission/emvs/">EMVS</a>)<a href="https://emvo-medicines.eu/mission/emvs/">)</a>, and the WHO&rsquo;s <a href="https://www.who.int/who-global-surveillance-and-monitoring-system#:~:text=The%20system%20is%20designed%20for,French%2C%20Spanish%20and%20Portuguese%20languages.">Global Surveillance and Monitoring System</a>. These are functioning organizations that collect and keep track of medicinal products from the source to the consumer.

India, though still in the planning stages, is set to join the list with its own digital initiative, the &ldquo;Digital Drug Regulatory System&rdquo; (DDRS). In November 2023, the Central Drugs Standard Control Organization (CDSCO) issued a call for software companies to <a href="https://cdsco.gov.in/opencms/export/sites/CDSCO_WEB/Pdf-documents/EoI_DDRS_CDSCO_2ndnov23.pdf">bid</a> for its digital initiatives. These initiatives aim to build trust and confidence in the quality of drugs, medical devices, and cosmetics in both domestic and global markets.&nbsp;

They also seek to enhance transparency and accountability in the regulation of quality, ensure effective enforcement of quality, safety, and efficacy at the field level, and ensure compliance with Indian pharmacopeia and standards. Once operational, the <a href="https://www.expresspharma.in/gs1-india-has-been-actively-providing-technical-guidance-and-implementation-support-for-the-dava-portal/">DDRS</a> is set to replace all existing portals with a single-window, single-sign-in system. The Indian government&rsquo;s National Informatics Centre (NIC) designed the Drug Authentication and Verification Application (<a href="https://gs1india.org/media/dava-case-study.pdf">DAVA</a>) based on GS1 standards. GS1 standards make it possible to uniquely identify, capture, and share important information on these pharmaceuticals with regulators and patients.

Tackling the issue of counterfeit drugs requires efforts from multiple stakeholders, including pharmaceutical companies, regulatory agencies, healthcare professionals, the media, and consumers. Though stringent laws exist to control the manufacture, distribution, and sale of counterfeit medicines, the efforts have not been fruitful due to leniency in executing the punishments. By paying attention to packaging details, verifying batch numbers, and buying from trusted sources, consumers can protect themselves. Regulatory agencies must adopt newer technologies like tamper-evident materials, holograms, blockchain, and chemical taggants to track medicines from the manufacturing facility to the consumer. Through strict regulation and public education, we can ensure that the medicines people take are safe and reliable.

Edited by Parth Sharma.

Image by Deekshith Vodela.

Fake drugs have been caught in India and are a threat to people's health.

The Threat of Fake Medicines: Is it Time to Treat Medicines Like Currency

The Threat of Fake Medicines: Is it Time to Treat Medicines Like Currency?

Dr Balakumar is a Post-Graduate resident in the Department of Pharmacology, at Maulana Azad Medical College. He is interested in the pharmaceutical industry and regulatory affairs.

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Dr Balakumar is a Post-Graduate resident in the Department of Pharmacology, at Maulana Azad Medical College. He is interested in the pharmaceutical industry and regulatory affairs.

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Balakumar

Balakumar

The Threat of Fake Medicines: Is it Time to Treat Medicines Like Currency?

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