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Here is a detailed regulatory guide / framework (with legal references, rules, and recent events) focused on cough syrups under CDSCO / DCGI / Drugs & Cosmetics regime in India. You can use this as a reference (or checklist) if you are a company, regulator, consultant, or legal advisor in the pharma sector.
Regulatory & Legal Framework: Key Statutes, Rules, and Guidelines
Below is a breakdown of the legal basis governing cough syrups (i.e. pharmaceutical formulations), especially those that are combinations or intended for children.
Legal Provision / Rule | Applicability / Relevance | Key Requirements | Notes / Interpretations |
Drugs & Cosmetics Act, 1940 | Primary statute for drugs & cosmetics in India | Provides for control over import, manufacture, sale, distribution of drugs. | All pharmaceutical products (including cough syrups) are “drugs” under the Act if they make therapeutic claims. |
Drugs & Cosmetics Rules, 1945 | Operationalizes the Act | Licensing, standards, tests, inspections, rules for “new drugs,” fixed dose combinations, record keeping, labeling, etc. | Many critical requirements relevant to cough syrups are in these Rules (e.g. Rules on licensing, testing each batch, etc.). |
Schedule U (of the Drugs & Cosmetics Rules) | For licensing conditions | It mandates that the licensee shall test each batch or lot of raw materials and each batch of final product, and maintain records/registers as specified. | This is a core requirement. (Scribd) |
Rule 122B (Drugs & Cosmetics Rules) | For “new drug” approval | If a cough syrup or its formulation is considered “new drug” (or new combination, new ratio, new claims), an application must be made under this rule with supporting data, clinical trials, etc. | |
Rule 122-E | Definition of “new drug / new FDC” | A fixed dose combination (FDC) of two or more drugs (or a change in ratio, dosage, route, etc.) is to be treated as a “new drug.” (CliniExperts) | |
Rules / Provisions for Fixed Dose Combinations (FDCs) | For combinations used in cough syrups (e.g. dextromethorphan + other ingredients) | Prior central approval (CLA/DCGI) is required for FDCs (unless exempted) under Rule 122E / related FDC rules. (CDSCO) | |
Section 26A of the Drugs & Cosmetics Act | Power to prohibit drugs | The Centre can prohibit manufacture, sale, or distribution of drugs (e.g. FDCs) by a Gazette notification, especially those deemed “irrational” or unsafe. (The Hindu) | |
Rule 78 (or rules for license conditions) | Conditions of licence | The licence (manufacturing) may be suspended or cancelled if conditions are violated; one condition is batch-wise testing and record keeping. |
What Makes Cough Syrups Special / Risky: Why Extra Scrutiny
Because cough syrups often:
- are pediatric (for use in children) or for vulnerable populations
- include multiple active and inactive ingredients
- use solvents, preservatives, flavorings, etc., which may be vulnerable to contamination
- may involve fixed dose combinations (FDCs)
Regulators treat them with extra caution. Some specific risks:
- Contaminants / impurities: e.g. diethylene glycol (DEG), ethylene glycol (EG), or other toxic solvents that may get mixed (intentionally or accidentally) into the formulation, especially via substandard excipients.
- Microbial contamination (especially in syrups)
- Inappropriate combinations / irrational FDCs
- Dosage errors (especially for infants / children)
- Lack of clinical data / rationality of combinations
Thus both rules and regulatory vigilance are high for cough syrups.
Recent Events / Enforcement — What is Happening in 2025 (and late 2024)
These are not theoretical risks — they are real, ongoing regulatory actions and controversies that every company or stakeholder must monitor and consider.
- Mass failure in cough syrup quality tests (2024 report)
- In a CDSCO report, of 7,087 cough syrup batches tested, 353 were “Not of Standard Quality (NSQ)” for reasons including presence of DEG / EG, assay failures, microbial contamination, pH / volume issues. (The Hindu)
- Some of these contaminated batches had levels of DEG (toxic solvent) higher than permissible limits. (The Hindu)
- Crackdown on unapproved FDCs
- In April 2025, CDSCO directed all state drug controllers to stop manufacture, sale, and distribution of 35 unapproved FDCs across categories including cough syrups, analgesics, etc. (Moneylife)
- The regulator emphasized that even if a state licensing authority (SLA) had permitted such FDCs earlier, those would not suffice: central approval must be there. (Moneylife)
- Child deaths and toxic cough syrup scandal (2025)
- In Madhya Pradesh and Rajasthan, multiple child fatalities are reported in connection with a cough syrup brand Coldrif, allegedly containing 48.6% diethylene glycol in one batch (vs permissible limit ~0.1%). (ETPharma.com)
- CDSCO has launched risk-based inspections across six states (Tamil Nadu, MP, Maharashtra, Gujarat, Uttarakhand, Himachal Pradesh) covering 19 drugs including cough syrups, antibiotics, etc. (The Week)
- The regulator has directed states to intensify inspections and ensure that manufacturers perform per-batch raw material testing, maintain vendor qualification systems, and draft stronger control procedures. (ETPharma.com)
- Some state governments (Tamil Nadu, Kerala, MP, Haryana) have suspended sale or banned that brand, and sought recalls. (mint)
- Regulatory actions under “most serious offences” have been floated. (India Today)
- Some of the initial CDSCO / central test results reportedly did not detect contamination in the tested samples, while Tamil Nadu state lab tests found contamination in the same batch. There is some discrepancy and debate in reporting. (India Today)
- CDSCO’s advisory / directives following the scandal
- CDSCO issued directives to state drug controllers to increase inspections, ensure testing protocols, vendor qualification, raw material testing etc. (ETPharma.com)
- The regulator warned manufacturers not to dispatch the same batch of cough syrup to multiple test labs for sample testing (to avoid duplicate / manipulated results). (Legality Simplified)
- The agency issued an urgent alert to all states/UTs to adhere to drug-testing compliance protocols. (The Times of India)
These events strongly illustrate that the regulatory environment for cough syrups is under heightened scrutiny and noncompliance can lead to severe consequences (recalls, license cancellation, criminal liability, reputational damage).
What a Company / Manufacturer Must Do — Compliance Guide for Cough Syrups
Below is a (rough) checklist / guidance of what a responsible manufacturer or stakeholder should do to ensure compliance and minimize risk.
1. Product classification & regulatory status
- Determine whether your cough syrup (or formulation) is a “new drug / new combination / new formulation / new ratio / new route of administration under Rule 122E / NDCT rules. If yes, then you must obtain central approval (DCGI) with requisite clinical, safety, efficacy data.
- For FDCs (fixed dose combinations), ensure they are approved centrally — do not rely solely on state licenses.
- Check whether any part of your formulation is on the list of prohibited drugs / prohibited FDCs (drugs banned under Section 26A).
- If the product was already on the market, check whether “grandfathered” or “deemed approval” status is claimed — but these are under high regulatory scrutiny nowadays.
2. Licensing & registration
- Hold a valid manufacturing license under the Drugs & Cosmetics Rules (Form 25, Form 28, etc.).
- Ensure your facility is licensed with the appropriate category (liquid formulations, sterile / aseptic conditions if needed).
- For changes in formulation / process / intermediates, follow the change control rules and apply for modified licenses if required.
3. Good Manufacturing Practices (GMP) & facility / process controls
- Comply with Schedule M or relevant GMP standards (especially clean areas, containment, HVAC, process validation, documentation).
- Maintain standard operating procedures (SOPs) for all stages—raw materials, weighing, mixing, filtration, filling, in-process controls, packaging, etc.
- Validate all critical steps (e.g. mixing, homogenization, sterilization, filtration, preservative efficacy).
- Implement stringent vendor qualification / audit programs for suppliers of APIs, excipients, solvents, flavorants, preservatives, etc.
- Stress testing, stability studies, and continuous monitoring of environmental parameters (e.g. microbial load, humidity, temperature).
4. Testing & quality control (QC) / quality assurance (QA)
- Batch-wise testing of raw materials / excipients and finished product is mandatory under Schedule U and license condition rules.
- Tests may include: assay of actives, impurity profiling, solvent residuals (especially toxic solvents such as DEG / EG), pH, microbial limits, preservative efficacy, viscosity, uniformity, stability tests, preservative / antioxidant content, particulate contamination, etc.
- For excipients and solvents, ensure Certificates of Analysis (CoA), supplier audits, and periodic requalification.
- Conduct stability studies (accelerated and long-term) and shelf-life validation.
- Maintain full records and registers as required by law; retention as per rule (years) is required. (Scribd)
- Avoid sending the same batch of syrup to multiple labs (to circumvent duplication) — CDSCO has warned against that. (Legality Simplified)
- In case of any nonconformity (NSQ / out-of-specification), have a deviation / investigation / CAPA (corrective & preventive action) procedure.
5. Labeling, packaging, and documentation
- Ensure labels comply with Drugs & Cosmetics Rules labeling requirements (e.g. name, strength, batch, manufacturing / expiry dates, storage conditions, warnings, prescribing information).
- For pediatric / child formulations, include specific usage warnings, contraindications, dosage instructions (especially caution in children