India's Bitter Pill: Tackling Fake Medicines and Resisting Pharma Dumping

India’s Bitter Pill

 

India stands tall as the "Pharmacy of the World," a leading manufacturer and exporter of generic medicines globally. Yet, this success story is shadowed by a persistent and dangerous problem: the proliferation of fake, spurious, and substandard drugs within its own vast domestic market. Compounding this internal threat are growing concerns that India, with its price-sensitive consumers and complex regulatory landscape, is sometimes treated as a dumping ground for pharmaceutical products from abroad that may not meet the stringent standards of their origin countries. Both issues pose significant risks to public health and undermine trust in the healthcare system.  

 

The Menace Within: Fake and Substandard Drugs

 

Counterfeit, spurious, or substandard medicines – drugs that may contain no active ingredient, the wrong ingredient, incorrect dosages, harmful contaminants, or are deliberately mislabelled – are a critical public health challenge in India.  

 

Scale of the Problem: Quantifying the exact scale is difficult, with estimates varying dramatically. While official government surveys (like those by CDSCO in 2009 and 2015) reported relatively low percentages of spurious drugs (around 0.046%) and substandard drugs (around 3-5%), industry bodies and some independent reports suggest much higher figures, potentially reaching 15-20% or even more, particularly in certain regions or drug categories. The All India Organisation of Chemists and Druggists (AIOCD) reported a concerning surge of nearly 50% in counterfeit medicines post-COVID-19, estimating they might now constitute nearly 15% of the retail market.

 

Why it Persists: Several factors contribute to this menace:

 

Regulatory Gaps: Historically fragmented regulation between the central authority (CDSCO) and state bodies leads to inconsistencies in enforcement and licensing.

 

Enforcement Challenges: Understaffing, inadequate testing infrastructure, and lack of resources hamper effective monitoring and prosecution. Penalties, though increased by amendments in 2008, are often seen as insufficiently deterrent or inconsistently applied.

 

Complex Supply Chain: Long and fragmented supply chains offer multiple points where spurious products can enter.

 

Price Sensitivity: Consumers and sometimes even retailers are lured by hefty discounts offered on potentially fake drugs.

 

Ease of Movement: Uniform tax structures (like GST) have reportedly made inter-state movement of goods, including illicit ones, easier.  

 

Devastating Impact: The consequences are severe, ranging from treatment failure and prolonged illness to increased antimicrobial resistance and death, as tragically highlighted by incidents involving contaminated Indian-made cough syrups exported to other countries.  

 

The External Concern: A 'Dumping Ground' for Foreign Pharma?

 

Alongside the issue of domestically produced fakes, there's a perception, and some evidence, that India is vulnerable to becoming a recipient of pharmaceutical products that might not pass muster in more stringently regulated markets. This can include:

 

Drugs Banned Elsewhere: Products withdrawn or banned in their country of origin potentially finding a market in India due to differing regulatory standards or approval timelines. The Indian government itself acknowledged this possibility in court in 2016 regarding certain combination drugs.

 

Substandard or Near-Expiry Goods: Importing products with lower efficacy, questionable quality, or those nearing their expiration date.

 

Refurbished Medical Devices: Concerns have been explicitly raised by industry bodies about the unregulated import of used or refurbished high-end medical equipment (like CT/MRI scanners), potentially posing patient safety risks and undermining domestic manufacturing initiatives under 'Make in India'.  

 

Why India Might Be Vulnerable:

 

Regulatory Arbitrage: Differences in national regulations and approval processes can be exploited.

 

Market Dynamics: The large, diverse, and price-sensitive Indian market creates opportunities for lower-cost, potentially lower-quality products.

 

Enforcement Issues: Weaknesses in monitoring the domestic market can inadvertently make it easier for substandard imports to slip through or circulate undetected, despite existing import regulations managed by CDSCO that require registration of drugs and manufacturing sites.

 

Strengthening the Defences: Regulatory Efforts and the Path Forward

 

India's regulatory bodies are aware of these challenges and have initiated several measures:

 

Enhanced GMP: Revised Good Manufacturing Practices (Schedule M) are being implemented, becoming effective for larger companies from mid-2024 and with a deadline extension for smaller firms.  

 

Track and Trace: QR codes have become mandatory (since August 1, 2023) on the packaging of the top 300 pharmaceutical brands and on Active Pharmaceutical Ingredients (APIs) to enable authentication and tracking. However, concerns have been raised about the implementation, potential vulnerabilities of static codes, and the need for robust backend systems and security. Extending this mandate, particularly to vaccines, is under consideration.  

 

Increased Oversight: Risk-based inspections of manufacturing units have been intensified, leading to actions like production stoppages and license suspensions/cancellations.

 

Stricter Penalties: The Drugs and Cosmetics Act was amended in 2008 to impose harsher penalties for spurious drug manufacturing, though consistent enforcement remains key.  

 

However, significant challenges persist, including the need for better Centre-State coordination (with some advocating for greater centralisation of regulation), more testing labs, trained personnel, and robust mechanisms to tackle online pharmacy loopholes.

 

Cautionary Steps

 

Ensuring access to safe and effective medicines is fundamental to public health. India faces a dual challenge: eradicating the menace of domestically produced fake and substandard drugs while simultaneously guarding against becoming a destination for potentially unsafe or low-quality pharmaceutical products from abroad. Addressing this requires a multi-pronged strategy: strengthening regulatory capacity and enforcement at all levels, leveraging technology like robust track-and-trace systems effectively, ensuring strict compliance with quality standards for both domestic production and imports, and fostering greater public awareness. Only through concerted and sustained efforts can India protect its citizens and truly solidify its reputation as a reliable global pharmacy.