India’s pharmaceutical industry faces renewed scrutiny as the Drug Controller General of India (DCGI) flagged numerous substandard drugs in September 2024. At the same time, an October 02, 2024, Business Standard report highlights an ongoing crackdown on such drugs by regulators. This article explores these contrasting developments, beginning with the September findings.

On September 22, 2024, multiple reports revealed that the DCGI, through the Central Drugs Standard Control Organization (CDSCO), identified 195 instances of substandard drugs, devices, and vaccines over three months. Popular brands like Shelcal 500, NICIP MR, and Pantocid were among the flagged drugs, affecting treatments for common ailments like hypertension and acid reflux. Major companies like Alkem, Sun Pharma, and Hetero Labs were implicated. The DCGI ordered the withdrawal of these drugs and called for stricter vigilance, highlighting ongoing issues despite regulatory frameworks being in place, which is known to all drug manufacturers, but still happening all over the county.

Industry Response: 

After the DCGI’s September 2024 report on substandard drugs, responses from pharmaceutical companies were mixed. Many large firms cooperated, taking corrective steps to comply with Good Manufacturing Practices (GMP) and tightening quality control. Some acknowledged the need for stricter oversight and preventive measures.

As happens mostly, there has been notable pushback from a portion of the industry, particularly smaller and mid-sized manufacturers. These companies argue that the stringent audits and frequent shutdowns due to non-compliance are creating significant financial and operational pressures.

Interestingly, some large manufacturers claimed that the faulty products were counterfeit or spurious. This makes the scenario even more complex. Although, both endanger patient lives.

Decades of regulatory failures persist, but at what cost? 

Back in June 2015, I highlighted that “Fake Drugs Kill More People Each Year Than Terrorism Over the Last 40 Years.” Shockingly, little has improved since then.

The problem is deeply rooted in nations with weak enforcement - India being a prime example. Alarmingly, the Ministry of Health has long downplayed this threat, as it appears now.

For example, even prior to that, in 2009, their “Report on Countrywide Survey for Spurious Drugs” grossly underestimated the issue, claiming only 0.046% of spurious and 0.1% substandard branded drugs. This underreporting reflects a dangerous “Ostrich Syndrome” among regulators, who continue ignoring this life-threatening crisis, leaving millions at risk.

The question I raised in this blog on October 12, 2015 2015 still haunts me today: “Does India produce ‘world-class’ medicines for all?” Effective checks and accountability are crucial to address this crisis.

To tackle counterfeit drugs, India needs a comprehensive strategy, such as:

1. Strengthen Regulation: Stricter inspections, penalties, and GMP adherence.
2. Leverage Technology: Implement digital tracking systems.
3. Improve Coordination: Better agency collaboration and audits.
4. Foster Industry Self-Regulation: Internal audits and regulatory partnerships.
5. Raise Public Awareness: Educate consumers, protect whistleblowers.
6. Adopt Global Standards: Align with international benchmarks.

Only with strong accountability can India safeguard drug safety.

While there have been reports of some progress, concerns remain:  

A Business Standard report from October 02, 2024, highlights a regulatory crackdown on substandard drugs. However, this raises critical questions about the true effectiveness of these efforts. Upon closer inspection, the report reveals limitations that warrant deeper scrutiny. These include gaps in data coverage, inconsistent inspections, and doubts about the sustainability of the actions taken, which cast doubt on how far-reaching and impactful this so-called crackdown really is.

Some of the notable flaws that I find in the report include:

1. Lack of Comprehensive Data: The report focuses on inspected units, which represents only a small fraction of India’s vast pharmaceutical manufacturing sector, especially considering that 80% of India’s pharma units are micro, small, and medium enterprises that often escape the regulatory radar.
2. Limited sample size could misrepresent the true scale of substandard drug production.
3. Inconsistent Inspection Coverage: While the CDSCO has ramped up its audits, the inspection coverage appears uneven. Many smaller manufacturers, particularly those operating in less regulated states, may not face the same scrutiny as larger companies. This could skew the perception of improvement.
4. Global Discrepancies: Despite claims of reduced international complaints, the report doesn’t fully address concerns like the recent ban on Indian-made antibiotics by Nepal, signaling that quality issues persist in exports.. This suggests a gap between domestic inspections and international quality standards. 
5. Sustainability Questioned: The report emphasizes short-term regulatory actions, but long-term sustainability is unclear. Temporary shutdowns and corrective actions might not be enough to ensure lasting quality improvements, especially in an industry facing systemic issues like weak documentation and quality control in smaller firms 

In summary, while the report provides some optimistic updates, its credibility is limited by incomplete data, uneven enforcement, and questions about long-term impact. 

Is entity-centric accountability grossly missing in this area? 

Absolutely. The accountability of both regulators and pharmaceutical companies regarding substandard and counterfeit drugs in India has been alarmingly deficient for years. Despite recurring reports of poor drug quality, weak enforcement, and ineffective oversight persist. 

Regulatory bodies have failed to consistently hold companies accountable, allowing dangerous drugs to flood the market and endanger public health. This systemic neglect, coupled with inconsistent audits and lax penalties, has led to a crisis that remains unresolved even today. Thus, the following two areas, I reckon, need to attract greater focus:

• Regulatory Gaps: The Central Drugs Standard Control Organization (CDSCO) has faced criticism for being reactive rather than proactive, with irregular inspections and delays in addressing violations. The weak enforcement of Good Manufacturing Practices (GMP) and insufficient penalties for violators have allowed substandard drugs to continue circulating.  

• Pharma Companies’ Compliance: Many pharmaceutical companies have either ignored or downplayed the issue, sometimes blaming counterfeiters rather than addressing quality control lapses. While larger companies might cooperate after being caught, the lack of strict and consistent regulatory pressure has allowed many manufacturers to evade full accountability.

This lax accountability, both in the regulatory framework and among drug companies, has created an environment where the production and distribution of substandard and fake drugs continue to pose serious risks to public health in India. The need for stricter enforcement and transparent accountability is crucial for restoring trust in the system.

Conclusion:

Despite years of scrutiny, regulatory lapses in India’s drug industry continue to jeopardize patient safety. Weak oversight and inconsistent enforcement allow substandard and counterfeit drugs to flood the market, with deadly consequences.  

Regulatory bodies have failed to take firm action, and pharmaceutical companies are often not held accountable. As a result, millions remain at risk, and trust in the healthcare system is eroding. The cost of these failures is measured in lives, and without immediate reforms, the crisis will only deepen.

This underscores the point that the time for complacency has passed – India’s healthcare system and public trust demand swift, decisive action against counterfeit and low-quality drugs, with clear accountability and stringent punitive measures for violators.

By: Tapan J. Ray

Disclaimer: The views/opinions expressed in this article are entirely my own, written in my individual and personal capacity. I do not represent any other person or organization for this opinion.