CDSCO: role & context in India’s pharmaceutical regulation.

• The Central Drugs Standard Control Organisation (CDSCO) is the national regulatory authority in India under the Ministry of Health & Family Welfare.
• Under the Drugs & Cosmetics Act, 1940 and Rules 1945, CDSCO is responsible for approving new drugs, regulating imports, laying down standards, coordinating with state regulators, and overseeing certain classes of drugs and manufacturing authorization.
• The states’ drug control organizations handle much of the licensing, inspection, distribution control, etc., but the CDSCO provides central oversight, technical guidance, setting standards, and coordination.

Thus, regulation of cough syrups (like any drug formulation) is jointly governed: manufacturers must comply with central rules (for product approval, safety, standards) as well as state-level enforcement.

Regulatory issues & recent controversies around cough syrups in India

In recent times, especially in 2025, there have been serious controversies relating to substandard or contaminated cough syrups causing fatalities in children, which have brought regulatory scrutiny to the fore. Key points:

1. Failures in quality tests / non-standard quality (NSQ) batches
   • A CDSCO report (from 2024) showed that out of ~7,087 batches of cough syrups tested, 353 were classified as “Not of Standard Quality (NSQ)” due to issues like presence of diethylene glycol (DEG) / ethylene glycol (EG), incorrect assay, microbial contamination, pH deviation, or volume issues. (The Hindu)
   • Some batches were especially alarming because they contained toxic solvents (DEG/EG) beyond permissible limits. (The Hindu)
2. Recent child deaths linked to toxic cough syrups
   • In 2025, multiple child fatalities in Madhya Pradesh and Rajasthan have been allegedly connected to consumption of a cough syrup “Coldrif,” produced by Sresan Pharma, with extremely high levels of diethylene glycol (much above permissible limits) being detected in samples. (ETPharma.com)
   • As a reaction, CDSCO initiated risk-based inspections across manufacturing units in six states to trace gaps in compliance, production practices, and quality assurance. (ETPharma.com)
   • Some samples collected from Tamil Nadu were found to contain DEG above safe levels. (ETPharma.com)
3. Crackdown on unapproved fixed-dose combinations (FDCs)
   • The CDSCO has directed all manufacturers to cease production or sale of 35 unapproved FDCs (fixed-dose combinations) including those used in cough syrups, analgesics, antibiotics. (Moneylife)
   • For example, FDCs combining dextromethorphan + phenylephrine, chlorpheniramine + codeine + sodium citrate, or ambroxol + dextromethorphan + chlorpheniramine have been flagged. (Moneylife)
   • The rule is that no FDC should be manufactured or marketed without prior approval from the central licensing authority (CLA) as required by Rule 81 under the New Drugs & Clinical Trials Rules, 2019. (Moneylife)
4. Requirements for raw material / excipient testing / batch testing
   • CDSCO has emphasized that manufacturers should test every batch of active pharmaceutical ingredients (APIs), excipients, and finished product, and maintain records, especially for sensitive formulations (pediatric syrups) that may be vulnerable to solvent contamination. (ETPharma.com)
   • In investigations of NSQ batches, it was observed that many manufacturers had not conducted the prescribed tests or had weak vendor qualification systems. (ETPharma.com)
   • Under Schedule U of the Drugs & Cosmetics Rules, drugmakers are mandated to test each lot of raw materials/excipients and maintain documentation. (ETPharma.com)
5. State-level responses, bans, and prescription rules
   • Some states have banned sale of certain cough syrups (e.g. Coldrif in Tamil Nadu) and have ordered re-testing of stocks. (The Week)
   • Authorities have issued directives to state drug controllers to intensify inspections. (ETPharma.com)
   • There are calls and moves to enforce prescription-only sale of cough syrups, particularly for children under 2 years of age. (The Times of India)
   • Some medical bodies caution against unsupervised use of cough syrups, especially in young children. (The Times of India)
6. Market impact & reputational risks
   • India’s pharmaceutical sector is one of the world’s major suppliers of generics and formulations. Contamination or quality failures affecting export products can severely damage trust and trade links, especially in regulated foreign markets.
   • There is increased regulatory scrutiny both domestically and internationally, which may raise compliance costs, risk of license cancellations, or stricter enforcement.

Challenges & gaps in regulation / compliance

• Weak compliance by smaller manufacturers: Smaller or less capitalized firms may struggle to fully comply with rigorous testing, vendor qualification, or maintaining quality systems.
• Enforcement capacity: State drug regulatory authorities may lack resources (laboratories, inspectors, funding) to effectively monitor all units.
• Complex supply chain / excipient sourcing: The contamination often originates from poor quality excipients or solvents (e.g. diethylene glycol as a cheaper substitute), making tracing and control difficult.
• Overlap of regulatory jurisdictions: Coordination between central and state bodies may be a challenge, especially in executing bans, recalls, or inspection orders.
• Legacy approval / unapproved combinations: Many older formulations (FDCs) may have been marketed on the basis of “deemed approvals” or interpretations before stricter norms came, creating ambiguity and legal challenges.
• Timely detection & recall: Detecting NSQ batches early, recalling them before harm occurs, and tracking their distribution is logistically difficult.
• Liability, accountability, compensation: When adverse events or fatalities occur, determining accountability (manufacturer, regulator, distributor) and ensuring compensation is legally complex.

Implications & recommendations for the pharma sector (especially for companies dealing with cough syrups)

1. Strengthen quality systems and GMP compliance
   • Invest in better in-house laboratories or tie-ups with reliable labs.
   • Ensure rigorous vendor qualification and auditing of raw material/excipient suppliers.
   • Test every batch per regulatory norms, including for impurities (e.g. DEG, EG), microbial limits, pH, stability, etc.
   • Maintain full documentation and transparency to withstand audit/inspection.
2. Rational formulation / avoid unapproved FDCs
   • Companies should review their product portfolio and ensure any FDC is properly approved under new drug rules and not part of banned/unapproved lists.
   • Where possible, prefer simpler formulations with clear mechanistic rationale rather than multiple combinations that may raise safety or regulatory concerns.
3. Proactive regulatory engagement & compliance culture
   • Engage proactively with CDSCO or subject expert committees to verify approvals.
   • Be prompt in responding to inspection observations or corrective actions.
   • Institute internal audits, compliance teams, risk assessment for formulations, especially pediatric ones.
4. Recall readiness & traceability
   • Maintain robust batch traceability (from raw material to customers).
   • Have an established system for swift recall, public advisories, and coordination with regulators.
5. Safety over cost-cutting in excipients / solvents
   • Avoid using cheaper substitute excipients or solvents of dubious quality even if cost pressures exist.
   • Use only those excipients from reputable, audited vendors, and verify their certificate of analysis, impurity profiles.
6. Monitoring and post-marketing surveillance
   • Monitor adverse event reports, track any complaints, and be willing to voluntarily withdraw or test suspect batches.
   • Work with regulatory authorities in sample testing and investigations.
7. Reputation protection & risk mitigation
   • In the event of controversies or news, communicate transparently with regulators, markets, stakeholders.
   • Ensure liability insurance or legal readiness for potential issues.