India, with a population of approximately 1.4 billion people (Patients For Affordable Drugs Now), faces significant challenges in providing affordable healthcare to its citizens. Many Indians do not earn more than $100 USD a month, with the average monthly wage being around $150 USD (Harvard Public Health) (Center for American Progress). A substantial portion of the population lives in poverty, earning far less. Unlike some countries, India does not have a universal healthcare system, which exacerbates the need for low-cost medications (American Immigration Council). As the “pharmacy to the world,” India must produce affordable pharmaceuticals for its own population, often in facilities that may not meet U.S. FDA standards .
Regulatory Measures and Economic Realities
The U.S. Food and Drug Administration (FDA) ensures the safety, efficacy, and security of drugs, biological products, and medical devices . However, the stringent regulations on imported generics, especially from countries like India, often align with the interests of large pharmaceutical companies. These companies benefit from limited competition, maintaining high prices for branded drugs .
India’s Pharmaceutical Landscape
India’s pharmaceutical industry includes both world-class facilities and substandard manufacturing plants. While the majority of Indian pharmaceutical companies operate with high standards, a few bad actors tarnish the industry’s reputation. These lower-quality plants produce for export to countries like the EU, UK, and the USA, leading to a misconception about the overall quality of Indian generics .
Comparative Analysis: India vs. USA
- Population: India (1.4 billion) vs. USA (331 million) .
- Average Monthly Wage: India ($150 USD) vs. USA ($3,900 USD) (Center for American Progress) .
- Poverty Rate: India has a significant portion of its population living below the poverty line, while the USA’s poverty threshold is around $26,200 annually for a family of four . If this threshold were applied to India, a vast majority of Indians would fall below it.
Cultural and Economic Context
It is egotistical and unrealistic to apply American standards of living and regulatory measures directly to India. When considering foreign products, Americans must take into context the economic and cultural differences that influence production and pricing. The goal should be to understand these differences rather than judge them by U.S. standards alone .
The Double-Edged Sword of Regulation
Prime Minister Modi’s mandate for Schedule M compliance aims to improve the quality of pharmaceutical production in India. However, this may also force some non-compliant firms to operate underground, producing counterfeit or substandard drugs. While the intent is to ensure high standards, the reality may lead to unintended consequences .
The Way Forward
It is crucial to balance the need for high-quality pharmaceuticals with the economic realities of a developing country like India. While some Indian manufacturing plants do not meet U.S. FDA standards, this does not represent the norm. Most Indian generic pharmaceuticals are of high quality, and ongoing reforms like Schedule M are steps in the right direction.
Conclusion
The low-quality pharmaceuticals from a few bad actors in India should not overshadow the overall quality of Indian generics. Vigilance and balanced judgment are necessary to appreciate the contributions of India’s pharmaceutical industry while acknowledging the challenges it faces. The introduction of Schedule M will be a pivotal moment for the industry and the people of India, and it is essential to support measures that ensure quality without pushing companies into illicit operations.
Citations
- World Bank. “Population, total – India, United States.” Retrieved from World Bank.
- Trading Economics. “India Average Daily Wage Rate.” Retrieved from Trading Economics.
- Economic Times. “India’s average wage rises to Rs 22,000 in 2019.” Retrieved from Economic Times.
- World Bank. “Healthcare Access in India.” Retrieved from World Bank.
- U.S. Food and Drug Administration (FDA). “About FDA.” Retrieved from FDA.
- Center for Responsive Politics. “Pharmaceutical Industry Lobbying.” Retrieved from OpenSecrets.
- The Commonwealth Fund. “Comparing International Healthcare Systems.” Retrieved from Commonwealth Fund.
- Pew Research Center. “Public Perceptions of CBD and Healthcare.” Retrieved from Pew Research.
- Kaiser Family Foundation (KFF). “Prescription Drug Trends in the U.S.” Retrieved from KFF.
- Journal of Health Economics. “The Economic Impact of Drug Pricing Regulations.” Retrieved from JHE.
- National Institutes of Health (NIH). “Global Health and Development.” Retrieved from NIH.
- American Journal of Public Health. “The Role of Indian Generics in Global Healthcare.” Retrieved from AJPH.
- The New York Times. “The Influence of LegitScript in U.S. Healthcare.” Retrieved from NYT.
- Harvard Business Review. “The Impact of Regulatory Capture on Healthcare.” Retrieved from HBR.