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The Issue of Substandard and Fake Drugs in India
Context:
A case was registered recently against a group supplying fake drugs, including antibiotics, to government hospitals in Maharashtra, Chhattisgarh, Uttar Pradesh, and Jharkhand.
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- These fake drugs were primarily composed of talcum powder and starch, with no active pharmaceutical ingredients.
- Simultaneously, the Central Drugs Standard Control Organisation (CDSCO) conducted a survey that revealed 50 commonly used medications, including antibiotics, antacids, antipyretics, and antihypertensives, were substandard.
- Some of these drugs were manufactured by prominent companies like Hindustan Antibiotics, Alkem, and Torrent.
State-Level Drug Sampling and Consistent Issues
- Drug officers in India perform random sampling of medications in the market every month.
- The CDSCO has consistently found numerous substandard drugs in these samples, with many reports highlighting this ongoing issue.
- According to the World Health Organisation (WHO), 1 in 10 medical products in low- and middle-income countries is substandard or falsified, with India falling into the lower middle-income category.
Drug Regulation in India
Drug regulation in India is primarily governed by the Drugs and Cosmetics Act, 1940, which establishes the framework for the approval, manufacture, distribution, and sale of drugs and cosmetics. The Central Drugs Standard Control Organisation (CDSCO), headed by the Drug Controller General of India (DCGI), is the principal regulatory authority responsible for ensuring drug safety and efficacy in the country.
Key Regulatory Bodies
- CDSCO: Oversees drug approval processes, clinical trials, and quality control. It operates under the Ministry of Health and Family Welfare and has multiple zonal offices across India.
- National Pharmaceutical Pricing Authority (NPPA): Responsible for regulating drug prices to ensure affordability, particularly for essential medicines.
- State Drug Control Authorities: Manage local enforcement of drug regulations and quality standards.
Economic Impact of Substandard Drugs
- Substandard and fake drugs negatively affect India’s economy by prolonging illnesses, increasing healthcare costs, and causing job losses and higher personal debt due to healthcare expenses.
- In a country where many are just one hospitalisation away from poverty, this issue contributes to pushing more people below the poverty line.
- Ineffective drugs lead to higher mortality rates, particularly among infants and the elderly, and may contribute to long-term dangers like antimicrobial resistance.
Challenges Unique to India
- Population: India’s massive population exacerbates the impact of substandard drugs. As the world’s most populous country, the scale of the issue is far greater.
- Economic Growth: The problem poses a significant threat to India’s economic growth, especially at a time when the country should be capitalising on its demographic dividend.
- Global Reputation: India has earned a reputation as the “pharmacy to the world” due to its generics and low-cost vaccines. However, the increasing prevalence of substandard and falsified medicines could damage this reputation and allow competitors to capture the global market for affordable pharmaceuticals.
- Lack of Regulations: Despite the discovery of substandard drugs, manufacturers face little to no serious consequences.
- Penalties are often small fines that do not deter wrongdoing, and there is minimal effort to recall defective drug batches.
- Weak Regulatory Capacity: The CDSCO heavily relies on state-level officials for testing and regulation, but most states lack the capacity, expertise, and infrastructure to ensure strict quality control and enforcement.
- Quality Control Issues: Much of India’s pharmaceutical production is outsourced to small-scale manufacturers that have lax quality control practices.
- These manufacturers often lack the resources to invest in proper instruments for testing and quality assurance.
- Low Priority: Indian policymakers have historically placed low priority on healthcare, both in terms of developing state capacity and enforcing laws against substandard drug manufacturers.
- For India to escape the middle-income trap and achieve high-income status in the coming decades, policymakers need to address this issue with greater urgency. Strengthening regulatory frameworks and enforcing stricter penalties for violations are key steps that need to be taken.
