Lopsided Solution: Restricting OTC Cough Syrups

Subject: Science & Technology

The Union Government has mandated that syrup-based medicines, including cough syrups, can only be sold on a doctor’s prescription through licensed pharmacies.

Regulatory Change

• The amendment was made by removing the term “syrup” from Schedule K of the Drugs Rules, 1945.
• As a result, cough syrups and similar formulations no longer enjoy Over-the-Counter (OTC) exemption.
• The decision aims to restore confidence in India’s pharmaceutical supply chain following a series of deaths linked to contaminated India-manufactured cough syrups.

Background: Cough Syrup Contamination Crisis

Since 2022, contaminated cough syrups containing Ethylene Glycol (EG) and Diethylene Glycol (DEG) have been linked to the deaths of more than 300 children across several countries.

WHO Alerts

• The World Health Organization (WHO) issued alerts in 2022 and 2023 regarding contaminated Indian cough syrups.
• The incidents raised serious concerns about:
  • Drug quality assurance.
  • Manufacturing standards.
  • Export quality control mechanisms in India.

Concerns Regarding OTC Cough Syrups

Many OTC cough syrups contain combinations of:

• Bronchodilators
• Antihistamines
• Decongestants

Potential Adverse Effects

These medicines may cause:

• Tremors
• Heart palpitations
• Excessive sedation
• Blood pressure fluctuations
• Paradoxical agitation in infants

Risks for Children

The American Academy of Pediatrics has stated that cough suppressants are:

• Largely ineffective in children below six years.
• Potentially unsafe for young children.

Diagnostic Concerns

Improper use of cough syrups may:

• Mask serious illnesses such as pneumonia and asthma.
• Delay accurate diagnosis and timely treatment.

Ground Reality

In many rural and semi-urban regions:

• Pharmacists often function as de facto primary healthcare providers.
• OTC medicines remain an easily accessible source of treatment.

Therefore, restricting access may affect healthcare accessibility without addressing the root cause of contamination.

Structural Issues in India’s Pharmaceutical Sector

The contamination incidents were primarily caused by:

Manufacturing Failures

• Weak quality control systems.
• Inadequate testing of raw materials.
• Poor manufacturing practices.

Regulatory Weaknesses

• Insufficient regulatory oversight.
• Limited inspection and monitoring capacity.
• Inadequate enforcement mechanisms.

Key Concern

Restricting consumer access to cough syrups alone does not prevent contaminated medicines from entering the supply chain.

The fundamental problem lies in manufacturing and regulatory failures rather than consumer misuse.

Industry Concerns

Sections of the pharmaceutical industry have opposed stricter quality requirements, arguing that:

• Enhanced testing protocols increase production costs.
• Smaller manufacturers may face financial difficulties in complying with stringent standards.

However, public health experts argue that quality assurance cannot be compromised for cost considerations.

Corrective Measures Taken

Following the contamination incidents:

Updated Testing Standards

Both the:

• Indian Pharmacopoeia (IP)
• International Pharmacopoeia (Pharmacopoeia Internationalis)

have updated analytical methods to improve detection of:

• Ethylene Glycol (EG)
• Diethylene Glycol (DEG)

contamination in pharmaceutical products.

Regulatory Challenges in India

India has approximately:

• Three dozen State Drug Controllers.

Persistent Limitations

Regulatory agencies continue to face:

• Chronic understaffing.
• Shortage of qualified inspectors.
• Limited laboratory infrastructure.
• Inadequate surveillance and enforcement capacity.

These weaknesses undermine effective drug quality monitoring.

Way Forward

As the “Pharmacy of the World,” India must strengthen confidence in its pharmaceutical products through:

Strengthening Quality Assurance

• Mandatory testing of raw materials and finished products.
• Strict batch-wise quality verification.

Enhancing Regulatory Capacity

• Expanding inspectorates.
• Increasing staffing of drug regulatory authorities.
• Strengthening laboratory infrastructure.

Improving Surveillance

• Better post-market monitoring.
• Real-time reporting and recall mechanisms.
• Robust pharmacovigilance systems.

Ensuring Global Compliance

• Harmonisation with international quality standards.
• Adoption of best practices in manufacturing and testing.

Pharmacopoeia Internationalis (International Pharmacopoeia)

About

The International Pharmacopoeia (Pharmacopoeia Internationalis) is a collection of internationally accepted standards and specifications for medicines and pharmaceutical products.

Publisher

• Published and periodically updated by the World Health Organization.

History

• First published in 1951.
• Developed to promote harmonised global standards for medicine quality.

Objectives

The International Pharmacopoeia aims to:

• Establish global quality standards for medicines.
• Ensure safety, efficacy, and quality of pharmaceutical products.
• Provide standardised methods for:
  • Drug identification.
  • Assay of active ingredients.
  • Purity testing.
  • Detection of contaminants and impurities.
  • Storage and packaging requirements.
• Assist countries that lack their own national pharmacopoeias.

Key Features

Contains Monographs For

• Active Pharmaceutical Ingredients (APIs)
• Excipients
• Finished pharmaceutical products
• Herbal medicines
• Vaccines and biological products

Provides

• Analytical methods
• Reference standards
• Chemical tests
• Chromatographic techniques
• Guidelines for quality control laboratories

Legal Nature

• The standards are non-binding.
• Nevertheless, they are widely adopted by countries and pharmaceutical manufacturers worldwide.

Relevance to India

India maintains its own official drug standards publication known as the Indian Pharmacopoeia (IP).

Indian Pharmacopoeia Commission (IPC)

• Functions under the Ministry of Health and Family Welfare.
• Responsible for publishing and periodically updating the Indian Pharmacopoeia.

Harmonisation of Standards

India frequently aligns its standards with:

• WHO International Pharmacopoeia
• British Pharmacopoeia (BP)
• United States Pharmacopeia (USP)
• European Pharmacopoeia (Ph. Eur.)

Conclusion

While restricting OTC sale of cough syrups may reduce inappropriate self-medication, it does not address the core issue behind recent tragedies—weak manufacturing practices and inadequate regulatory oversight. Sustainable reform requires stronger quality control systems, enhanced regulatory capacity, rigorous testing standards, and effective surveillance mechanisms to safeguard public health and preserve India’s reputation as a reliable global pharmaceutical supplier.