India’s Pharmaceutical Regulation and Drug Safety Crisis

India recently witnessed a tragic loss of over 20 children in Madhya Pradesh and Rajasthan due to consumption of a cough syrup contaminated with diethylene glycol (DEG). This deadly industrial chemical causes kidney failure. Similar deaths occurred in 2022 in The Gambia, Uzbekistan, and Cameroon linked to Indian-made cough syrups. These incidents show critical gaps in India’s pharmaceutical regulation despite its global leadership in drug production.

India’s Role in Global Pharmaceutical Supply

India produces about 20% of the world’s medicines and dominates the generic drugs market. The pharmaceutical sector contributes nearly 6% to India’s export earnings. It supplies essential medicines domestically and internationally. However, ensuring drug safety remains a challenge due to counterfeit and contaminated medicines.

Causes of Drug Contamination and Substandard Medicines

Drugs fail mainly due to two reasons – counterfeit products with no active ingredients and contamination from poor manufacturing. In the recent case, industrial-grade chemicals tainted with DEG were likely used instead of pharmaceutical-grade inputs. Surveys show around 3% of Indian drugs are substandard, but episodic manufacturing failures often go undetected. Deaths linked to defective drugs are rarely connected across regions, masking the true scale of the problem.

Regulatory Framework and Its Limitations

India’s drug regulation is governed by the Drugs and Cosmetics Act of 1940 and its 1945 Rules. The Central Drugs Standard Control Organisation (CDSCO) manages approvals and enforcement coordination, while State Drug Controllers license and inspect manufacturers locally. This shared authority creates regulatory gaps, as states compete for investment by relaxing oversight, risking national drug safety.

Manufacturing Capacity and Quality Compliance

India has about 10,500 pharmaceutical manufacturing units, but only 1,300 comply with WHO’s Good Manufacturing Practices (GMP). Gujarat alone has nearly 5,800 licensed manufacturers. Vaccine production is more tightly controlled with fewer facilities and stringent batch testing, resulting in fewer quality lapses. Larger, centralised facilities adhering to global standards reduce risks of failures.

Challenges in Enforcement and Industry Self-Regulation

The pharmaceutical industry has relied on limited government interference and market-driven self-regulation. However, recent tragedies reveal this approach’s weaknesses. Corruption and profit motives lead some firms to cut corners. Arrests and factory closures come too late to prevent harm. Stronger, centralised enforcement is needed to restore trust.

Proposed Legal Reforms and the New Drugs Bill

The New Drugs, Medical Devices and Cosmetics Bill, 2023, aims to modernise India’s drug laws. It proposes risk-based drug classification, central licensing for high-risk products, online approvals, pharmacovigilance networks, and stricter penalties. The Bill balances federal and central powers but faces opposition from online pharmacy debates, small manufacturers, and some states losing licensing revenue. Swift passage and enforcement are critical.

Need for a National Quality Standard

India requires a binding, industry-wide commitment to GMP enforced centrally. The current state-by-state licensing system is outdated and ineffective. A unified national framework can prevent future tragedies and uphold India’s responsibility as the world’s pharmacy.

Questions for UPSC:

1. Critically analyse the impact of federal versus central regulatory control in India’s pharmaceutical sector with suitable examples.
2. Comment on the challenges of ensuring drug safety in developing countries and suggest measures to improve regulatory oversight.
3. What are the causes and consequences of counterfeit and substandard medicines in global health? How can international cooperation mitigate these risks?
4. Explain the role of Good Manufacturing Practices (GMP) in pharmaceuticals and discuss the difficulties in enforcing GMP standards in India’s diverse manufacturing landscape.

Answer Hints:

1. Critically analyse the impact of federal versus central regulatory control in India’s pharmaceutical sector with suitable examples.

1. Drug regulation is shared between CDSCO (central) and State Drug Controllers, causing fragmented oversight.
2. States compete for investment by relaxing inspections, risking national drug safety (e.g., lax oversight in Gujarat with 5,800 manufacturers).
3. Central control enables uniform standards and rapid response, but states resist losing licensing revenue and autonomy.
4. Cold-rif tragedy shows failure of decentralized system to prevent contaminated drugs spreading nationwide.
5. New Drugs Bill 2023 proposes central licensing for high-risk drugs, balancing federalism with national interests.
6. Centralized enforcement can reduce corruption, improve quality compliance, and protect public health more effectively.

2. Comment on the challenges of ensuring drug safety in developing countries and suggest measures to improve regulatory oversight.

1. Limited resources and infrastructure hamper effective inspections and quality control.
2. Prevalence of counterfeit and contaminated medicines due to weak enforcement and corruption.
3. Inadequate data and surveillance obscure the true scale of substandard drug-related harm.
4. Measures – implement risk-based regulation, strengthen pharmacovigilance, and improve testing labs.
5. Centralize and modernize licensing and approvals, e.g., online systems and unified standards.
6. Capacity building for regulators and industry-wide mandatory adherence to GMP with strict penalties.

3. What are the causes and consequences of counterfeit and substandard medicines in global health? How can international cooperation mitigate these risks?

1. Causes – poor manufacturing practices, use of industrial-grade raw materials, profit-driven corner-cutting.
2. Consequences – treatment failure, drug resistance, increased morbidity and mortality (e.g., children deaths from DEG-tainted syrups).
3. Substandard medicines undermine trust in health systems and burden economies with avoidable healthcare costs.
4. International cooperation aids harmonizing standards, sharing intelligence on counterfeit networks, and joint enforcement.
5. WHO prequalification and GMP certifications promote global compliance and safer supply chains.
6. Cross-border regulatory alignment and capacity building reduce loopholes exploited by counterfeiters.

4. Explain the role of Good Manufacturing Practices (GMP) in pharmaceuticals and discuss the difficulties in enforcing GMP standards in India’s diverse manufacturing landscape.

1. GMP ensures drugs are consistently produced and controlled to quality standards, safeguarding patient safety.
2. Only ~1,300 of 10,500 Indian pharma units comply with WHO GMP, indicating widespread gaps.
3. Large number of small manufacturers spread across states complicates uniform enforcement and inspections.
4. State-level licensing leads to variable oversight; some states relax standards to attract business.
5. Corruption and resource constraints among regulators hinder effective enforcement.
6. Solution – centralize GMP enforcement, consolidate manufacturing in fewer large compliant units, and mandate industry-wide quality commitments.