Inspire Positivity

A Stricter Regulation and Price Control: The Primary Requirement of India’s Medical System

Introduction

During my childhood and student years, private hospitals were scarce, and most healthcare services were provided by government-run dispensaries and hospitals. People generally relied on these institutions for treatment and recovery. While some serious patients did not survive, the dedication of healthcare providers was unquestionable, and spurious medicines were unheard of.

In 1973, after joining the Central Water Commission as a Class I officer, I frequently struggled with viral fever and throat infections. Frustrated by the lack of improvement despite regular visits to the CGHS dispensary, I consulted my family doctor, Dr. Choudhury. To my surprise, he prescribed the same medicines issued by the dispensary but advised me to purchase them from a specific chemist. Skeptical yet desperate, I followed his advice, and to my astonishment, the medicines worked. This was my first encounter with the issue of substandard medicines—an issue that has since grown into a widespread menace.

A few days ago, I came across an unverified news alert on my mobile phone about 29 generic medicines issued by CGHS being found below the requisite quality standards. This is deeply concerning for me, my wife, and many other senior citizens who are constantly battling health issues and cannot afford the high cost of treatment outside this system.

This experience prompted me to reflect on the pressing need for stricter regulation and effective price control in India’s healthcare system. Despite significant advancements, the system faces critical challenges such as affordability, accessibility, and quality of care. Substandard drugs, vast price disparities—especially in imported medicines—and the high cost of treatments continue to undermine equitable healthcare access, leaving millions vulnerable to inadequate care and financial distress.

The Current State of India’s Medical System

Despite being one of the largest producers of generic medicines globally, India’s healthcare system is marred by inefficiencies and inequalities. On one end, there are high-quality private hospitals with exorbitant costs, while on the other, overcrowded and overburdened public healthcare institutions struggle to meet even basic needs.

A critical aspect of this disparity lies in the pharmaceutical sector, where issues like spurious drugs and vast price variations in the same medicines, especially imported ones, highlight the need for stricter oversight.

The Issue of Substandard and Spurious Drugs

Substandard and spurious drugs have long plagued India’s healthcare landscape. These counterfeit or poor-quality medicines fail to meet established safety and efficacy standards, posing severe risks to patient health. According to reports, nearly 10-15% of medicines in the Indian market may fall into this category.

The impact of spurious drugs is devastating:

  1. Ineffective Treatment: Patients unknowingly consume drugs that lack potency, leading to prolonged illnesses or complications.
  2. Antibiotic Resistance: Substandard antibiotics contribute to the growing threat of antimicrobial resistance, a global health crisis.
  3. Erosion of Trust: The prevalence of fake drugs undermines confidence in India’s pharmaceutical industry, both domestically and globally.

The government’s initiatives, such as the introduction of the Drugs and Cosmetics Act and the use of technology for drug authentication, are steps in the right direction. However, the inconsistent enforcement of these measures highlights the need for stronger regulatory mechanisms, stricter penalties, and, most importantly, addressing the general laxity in the legal system. This laxity fosters a perception among offenders that “one can get away with anything in India.” By the time a decision is reached, public interest often fades, and a host of new issues emerge.

Examples of Delays in Medicolegal Cases

Delays in India’s legal and judicial system have often led to public interest in medico-legal cases diminishing over time. Here are a few notable examples:

  1. Kunal Saha vs. AMRI Hospital (1998 – 2013):
    • Case Details: Dr. Kunal Saha, a U.S.-based physician, filed a case against AMRI Hospital and three doctors in Kolkata, alleging medical negligence leading to his wife Anuradha Saha’s death in 1998.
    • Delays: The legal battle spanned 15 years, with the Supreme Court of India awarding a record compensation of ₹11 crore in 2013. The prolonged litigation process caused significant distress to the aggrieved party and led to public interest waning over time (Pub Med Central PMCID: PMC5109756).
  2. Medical Negligence Cases in Kerala:
    • Case Details: Victims of medical negligence in Kerala face prolonged legal battles, with cases dragging on for years without resolution.
    • Delays: The slow judicial process often leads to victims abandoning their pursuit of justice, resulting in diminished public interest and trust in the medical and legal systems (The News Minute, 8th September 2024).
  3. Bengaluru Medical Negligence FIRs (2015 – Present):
    • Case Details: Between 2015 and 2019, 25 FIRs were registered in Bengaluru alleging medical negligence.
    • Delays: As of the latest reports, not a single conviction has been secured, with at least 10 cases dismissed. The lack of timely justice has led to public disillusionment and decreased interest in pursuing such cases (Deccan Herald, 8th July 2024).

Price Disparities in Medicines: A Case for Regulation

The price disparities in medicines—especially between generic and branded versions or imported and domestic drugs—pose another significant challenge. In many cases, patients pay exorbitant amounts for imported drugs, even when affordable domestic alternatives of equal quality are available.

Key Issues in Price Variations:

  1. Imported Medicines: Many imported drugs, especially those used for critical illnesses like cancer, diabetes, or rare diseases, are sold at significantly higher prices due to markups, import duties, and lack of local manufacturing capabilities.
  2. Branded vs. Generic Drugs: Branded medicines are often sold at 5-10 times the cost of their generic counterparts, even though both have the same active ingredients and efficacy. This is largely due to aggressive marketing by pharmaceutical companies.
  3. Medical Devices: The cost of medical devices like stents, pacemakers, and implants often varies drastically, with imported versions being priced much higher despite negligible differences in performance.

Examples of Price Disparities:

  • Cancer drugs like Herceptin (used for breast cancer treatment) can cost lakhs of rupees when imported, while similar biosimilar versions manufactured in India are available at a fraction of the price.
  • Insulin pens and diabetes medications from multinational companies are priced several times higher than locally-produced equivalents.

The Need for Stricter Regulation and Price Control

To address these pressing issues, the Indian healthcare system must adopt stringent regulations and enforce robust price control measures:

  1. Combating Spurious Drugs:
    • Strengthen enforcement of the Drugs and Cosmetics Act by increasing inspections and imposing stricter penalties on offenders. Impose strict penalties on corrupt health officials/workers, including imprisonment and acquisition of their properties. All corruption cases, including those involving politicians, should be decided within a reasonable timeframe of one year. Representatives of people engaged in corrupt practices should face heavier penalties as their conduct is required to be exemplary.
    • Introduce mandatory track-and-trace systems using QR codes or blockchain to authenticate drugs at every stage of the supply chain.
    • Enhance public awareness about recognizing genuine medicines and reporting counterfeit ones. Outlets engaged in such practices must be heavily penalized, with their properties confiscated.
  2. Regulating Medicine Prices:
    • Expand the National List of Essential Medicines (NLEM) to include more life-saving drugs under price control.
    • Cap the prices of imported medicines and encourage domestic production of essential drugs to reduce dependency on imports. Control the maximum retail price of all medicines, including imported ones, through government negotiations with pharmaceutical companies.
    • Promote generic medicines by increasing awareness among doctors and patients and ensuring their availability in public healthcare facilities.
  3. Price Standardization for Medical Devices:
    • Extend the National Pharmaceutical Pricing Authority (NPPA)’s pricing authority to include more medical devices, ensuring affordability without compromising quality.
    • Encourage innovation and local manufacturing to reduce reliance on costly imports.
  4. Encouraging Transparency:
    • Mandate hospitals and pharmacies to disclose the pricing of medicines, devices, and treatments, preventing unjustified markups. Establish an upper limit for each component of treatment, including consultation, diagnostic testing, surgical implants, surgical procedures, and medicines.
    • Set up price comparison portals for patients to make informed choices.
  5. Strengthening Public Healthcare:
    • Invest in public healthcare to reduce dependency on private providers, which often charge exorbitant fees. Mandate a portion of the GDP to be invested in public healthcare.
    • Offer subsidized or free medicines and diagnostics for low-income families through government schemes.

Conclusion

India’s healthcare system stands at a critical juncture, where the need for reforms has never been more urgent. Stricter regulation and price control are essential not just for curbing the exploitation of patients but also for restoring faith in the system. Addressing the issues of spurious drugs and price disparities in medicines, especially imported ones, must be a top priority.

Healthcare is a fundamental right, not a privilege. It is time for policymakers, healthcare providers, and regulatory authorities to collaborate and create a system where quality healthcare is accessible and affordable for every Indian. The future of India’s health depends on the actions we take today.