Regulation of India’s Pharmaceutical Sector

Why in News

The World Health Organization (WHO) has recently expressed concern over India’s drug safety regulations after at least 20 children died due to consuming contaminated cough syrups. The contaminated syrups identified were Coldrif (Sresan Pharmaceuticals), Respifresh (Rednex Pharmaceuticals), and ReLife (Shape Pharma). This tragedy highlighted critical gaps in regulatory enforcement, monitoring of pharmaceutical companies, and the need for a robust drug safety framework to prevent spurious, substandard, and toxic medicines from reaching consumers.

Regulatory Framework in India

India’s pharmaceutical sector is regulated through a multi-layered framework, combining central and state authorities to ensure the safety, quality, and efficacy of medicines. Key components are:

a. Drugs and Cosmetics Act, 1940 & Drugs and Cosmetics Rules, 1945

• Purpose: Governs the import, manufacture, distribution, and sale of drugs and cosmetics in India.

• Objective: Ensures drugs meet the required standards of quality, safety, and efficacy.

• Significance: Provides the legal foundation for regulating the entire pharmaceutical sector in India.

b. State Drug Regulatory Authorities

• Operate at the state level under the Drugs and Cosmetics Act.

• Responsibilities include:

  • Granting manufacturing and retail licenses.

  • Conducting inspections of manufacturing facilities and pharmacies.

  • Monitoring compliance with quality standards and taking action against violations.

• Challenge: Oversight at the state level is often inconsistent, creating gaps in enforcement.

c. Central Drugs Standard Control Organisation (CDSCO)

• Role: National Regulatory Authority under the Ministry of Health & Family Welfare.

• Responsibilities:

  • Approves new drugs and conducts clinical trials.

  • Lays down standards for drug manufacturing.

  • Controls quality of imported drugs.

• Significance: Ensures uniformity of drug regulation nationwide.

d. National Pharmaceutical Pricing Authority (NPPA)

• Enforces provisions of the Drug Price Control Orders (DPCO).

• Ensures medicines are affordable while maintaining quality standards.

e. Good Manufacturing Practices (GMP)

• Prescribed under Schedule M of the Drugs and Cosmetics Rules.

• Align with WHO guidelines.

• Aim to ensure drugs are manufactured in hygienic conditions, with strict quality control to prevent contamination or substandard production.

Challenges Leading to Spurious Drugs

Despite the regulatory framework, several factors contribute to the prevalence of substandard or adulterated drugs in India:

a. Regulatory Gaps

• Oversight by CDSCO and state authorities is fragmented and inconsistent.

• Weak monitoring allows non-compliant pharmaceutical companies to operate with minimal accountability.

b. Toxic Contamination / Substandard Medicines

• Investigations revealed some cough syrups contained diethylene glycol (DEG), a toxic industrial solvent.

• Such contamination arises due to poor quality control, lapses in laboratory testing, and failure to adhere to GMP standards.

c. Supply Chain and Storage Issues

• Improper storage and weak cold chain management degrade medicines, making them unsafe for consumption.

• Poor distribution practices increase the risk of contamination and reduce drug efficacy.

d. Absence of Mandatory Recall Law

• India does not have a binding national law for mandatory recall of substandard or contaminated drugs.

• Though discussed since 1976, no enforceable recall mechanism exists, delaying removal of unsafe medicines from the market.

e. Rise of Online Spurious Drugs

• WHO estimates 1 in 10 medicines in low- and middle-income countries are substandard or falsified.

• Unauthorized online pharmacies have become a major channel for counterfeit drugs, which is difficult to monitor.

Recommendations for Strengthening Regulation

The Standing Committee on Chemicals and Fertilizers (2024-25) and WHO recommend urgent measures to improve regulation and enforcement:

a. Rigorous Enforcement of Laws

• Strict implementation of the Drugs and Cosmetics Act, 1940 and Drugs Rules, 1945 nationwide.

• Focus on eliminating spurious and adulterated drugs.

b. Swift Legal Action and Stronger Penalties

• Prompt prosecution of non-compliant manufacturers.

• Imposition of harsher penalties including fines and closure of facilities.

c. Strengthened Monitoring and Inspections

• Conduct regular inspections, especially in high-risk regions.

• Ensure compliance with GMP, GDP (Good Distribution Practices), and other safety standards.

d. Legally Enforceable GDP Guidelines

• Make CDSCO’s Good Distribution Practices (GDP) mandatory to maintain quality across the supply chain.

• Helps prevent degradation and contamination of medicines during transportation and storage.

e. Enhanced Inter-Agency Coordination

• Strong collaboration between regulatory authorities, law enforcement, and local agencies.

• Aims to dismantle networks producing counterfeit or unsafe medicines.

f. Enforcing Updated Good Manufacturing Practices (GMP)

• Mandatory implementation of updated GMP standards for all pharmaceutical manufacturing units.

• Ensures hygiene, standardized production processes, and quality testing.

g. Public Awareness Campaign

• Launch campaigns targeting consumers and healthcare professionals.

• Educate the public on identifying counterfeit drugs, reporting violations, and promoting safe consumption.

Conclusion

India’s pharmaceutical sector has a robust legal framework, but incidents like contaminated cough syrups reveal critical gaps in enforcement, quality control, and regulatory oversight. Strengthening inspections, implementing legally binding GDP and recall mechanisms, enhancing inter-agency coordination, and increasing public awareness are crucial to prevent such tragedies. A stronger regulatory ecosystem will ensure that medicines available in India are safe, effective, and reliable, safeguarding public health and reinforcing trust in the healthcare system