Primacy of Statutory Appeals over Writ Jurisdiction in Drug Licence Suspension: Commentary on Rajpal Kataria v. State of Madhya Pradesh
1. Introduction
This decision of the Madhya Pradesh High Court adds another important application of the well-settled “alternative efficacious remedy” doctrine to the field of drug regulation and public health emergencies. In Rajpal Kataria v. State of Madhya Pradesh, the Division Bench was confronted with a deeply disturbing factual backdrop – the alleged death of around 30 children following consumption of a cold syrup named “Coldrif” – and with drastic regulatory measures against a drug distributor, including sealing of his premises and suspension/cancellation of his drug licence.
The central legal question, however, was not whether those administrative actions were substantively justified, but whether the High Court, in its writ jurisdiction under Article 226 of the Constitution, could or should entertain the challenge when the Drugs and Cosmetics Rules, 1945 provided a specific appellate remedy to the State Government under Rule 66(2).
The Court ultimately affirmed the order of the learned Single Judge who had declined to entertain the writ petition on the ground that the petitioner had an efficacious alternative remedy by way of a statutory appeal. The decision thus reiterates – in a particularly sensitive public health context – that:
- Article 226 relief is discretionary, not absolute, and
- When a specific, efficacious statutory appeal exists, the High Court will ordinarily insist that the aggrieved party exhaust that remedy first, even in cases involving grave allegations and severe consequences.
2. Factual Background
2.1 The public health tragedy
The judgment records that the case arises from what is described as “one of the most shocking case in the medical history,” involving the alleged death of as many as 30 children following consumption of a cold syrup branded as “Coldrif”. The deaths are stated to have occurred over the months of August, September and October (the year is not specified, but clearly close in time to the regulatory action).
The appellant, Rajpal Kataria, is not described as the manufacturer of the medicine, but is admittedly a distributor of Coldrif cold syrup. This distributorship put him directly under the regulatory lens once the causal connection between the medicine and the deaths was suspected.
2.2 Immediate regulatory response
In the wake of the reported deaths, the regulatory authorities initiated proceedings under the Drugs and Cosmetics framework:
- Raid and sealing: A raid was conducted on the appellant’s premises on 02.10.2025, where stock of Coldrif was found. The shop was sealed.
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Show cause notices:
- On 09.10.2025, a show cause notice was issued asking the appellant to explain why action under the Drugs and Cosmetics Rules, 1945 for suspension or cancellation of his drug licence should not be taken.
- On 11.10.2025, another show cause notice was issued, requiring the appellant to respond on the same day.
- Appellant's response: According to the appellant, he submitted a reply on 10.10.2025 seeking further time, arguing that the relevant documents needed for his defence were locked inside the sealed premises.
These steps culminated in the suspension/cancellation of his drug licence and the sealing of his shop, actions that severely impacted his business and reputation.
3. Procedural History
3.1 Writ petition before the Single Judge
Aggrieved by:
- the sealing of his shop, and
- the suspension and cancellation of his drug licence,
the appellant approached the High Court under Article 226 of the Constitution by way of a writ petition. The petition questioned both the legality of the regulatory steps and, implicitly or explicitly, the adequacy of the process, particularly the short notice and the alleged inability to access documents due to the sealing.
By an order dated 31.03.2025, the learned Single Judge dismissed the writ petition. The core reason was procedural rather than substantive: the Judge held that, under Rule 66(2) of the Drugs and Cosmetics Rules, 1945, the appellant had an efficacious alternative remedy of appeal to the State Government against the order cancelling/suspending his licence. On that basis, the writ court declined to exercise its discretionary jurisdiction.
3.2 Writ appeal before the Division Bench
The appellant then preferred a writ appeal (intra-court appeal) under the relevant High Court rules, challenging the Single Judge’s refusal to entertain the writ petition. The Division Bench, presided over by the Chief Justice, considered only whether that refusal was legally sustainable; it did not itself enter into the merits of the regulatory action (sealing or licence suspension/cancellation).
4. Summary of the Judgment
The Division Bench dismissed the writ appeal and affirmed the Single Judge’s order. The principal conclusions can be summarised as follows:
- Existence of statutory appeal under Rule 66(2): The Court noted that Rule 66 of the Drugs and Cosmetics Rules, 1945 provides a right of appeal to the State Government against orders of suspension or cancellation of drug licences.
- Article 226 is a discretionary remedy: The Court reiterated that the writ jurisdiction under Article 226 is not an absolute or automatic remedy but a discretionary one. Where statute provides an efficacious appellate mechanism, the High Court normally refrains from exercising writ jurisdiction.
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Single Judge’s approach upheld: The Division Bench agreed with the Single Judge that:
- this was not a fit case to invoke Article 226 directly, and
- the appellant should first avail himself of the appellate remedy before the State Government.
- No infirmity in the impugned order: The Bench held that there was no infirmity in the Single Judge’s decision and no merit in the appeal; consequently, the writ appeal was dismissed.
- Scope of appellate authority: The Court clarified that if an appeal is filed, the State Government would be entitled to examine “all the facts and circumstances” of the case and decide the appeal.
Importantly, the Division Bench did not adjudicate on the substantive validity of the sealing, or on the merits of the licence suspension/cancellation; it confined itself to the propriety of declining writ relief in light of the alternative remedy.
5. Analysis
5.1 Precedents cited in the Judgment
The judgment, as reproduced, does not explicitly cite any prior judicial precedents by name or citation. Instead, it relies directly on:
- the text of Rule 66 of the Drugs and Cosmetics Rules, 1945, and
- the well-established doctrinal understanding that Article 226 relief is discretionary and ordinarily deferred when an efficacious alternative statutory remedy exists.
However, the reasoning of the High Court closely tracks long-settled Supreme Court jurisprudence on the alternative remedy rule, most notably:
- Whirlpool Corporation v. Registrar of Trade Marks, (1998) 8 SCC 1;
- Harbanslal Sahnia v. Indian Oil Corporation Ltd., (2003) 2 SCC 107;
- Union of India v. Satyawati Tondon, (2010) 8 SCC 110; and
- Authorized Officer, State Bank of Travancore v. Mathew K.C., (2018) 3 SCC 85.
While these cases are not mentioned in the text, they provide the doctrinal backbone for what the Division Bench has done here. The decision in Rajpal Kataria should therefore be understood as an application – not a departure – from this settled line of authority.
5.2 The alternative remedy doctrine and Article 226
Article 226 of the Constitution empowers High Courts to issue writs for enforcement of fundamental rights and “for any other purpose.” Yet, from early on, the Supreme Court has held that:
- The existence of an effective alternative remedy is not a complete bar to writ jurisdiction.
- However, it is a self-imposed rule of prudence that High Courts will ordinarily not entertain a writ when such a remedy exists.
Classic formulations include:
- State of U.P. v. Mohd. Nooh, AIR 1958 SC 86: The alternative remedy doctrine is a rule of policy, convenience and discretion, rather than a jurisdictional bar.
- Thansingh Nathmal v. Superintendent of Taxes, (1964) 6 SCR 654, and Titaghur Paper Mills v. State of Orissa, (1983) 2 SCC 433: Tax cases emphasising that when a statute provides a complete mechanism including appeals, parties must ordinarily use that route.
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Whirlpool and Harbanslal Sahnia: Clarifying the exceptions to the alternative remedy rule, namely:
- where the writ is filed for enforcement of fundamental rights,
- where there is a complete lack of jurisdiction or a patent jurisdictional error,
- where there is a clear violation of principles of natural justice, or
- where the impugned order is wholly without jurisdiction or suffers from a clear constitutional/legislative challenge.
- Satyawati Tondon: Strongly emphasising that High Courts must be circumspect in interfering under Article 226 when specialised statutes provide effective remedial mechanisms.
The Division Bench in Rajpal Kataria is plainly proceeding on this accepted understanding: in absence of a clearly pleaded and made-out exception, the High Court will honour the legislative choice of a statutory appeal.
5.3 Rule 66 of the Drugs and Cosmetics Rules, 1945
The Court’s reasoning hinges on Rule 66, which falls under Part VI of the Drugs and Cosmetics Rules, 1945 (sale of drugs other than homoeopathic medicines). In substance, Rule 66 provides that:
- The licensing authority may suspend or cancel a drug licence if there is contravention of the Act or Rules, after giving the licensee an opportunity to show cause and for reasons recorded in writing.
- The aggrieved licensee is entitled to appeal to the State Government (within a prescribed time, typically three months).
- The State Government may confirm, reverse or modify the licensing authority’s order.
Thus, the statutory scheme itself contemplates:
- an administrative/quasi-judicial decision at the level of the licensing authority, and
- a higher-level review by the State Government as an appellate body – a built-in supervisory safeguard.
By emphasising Rule 66(2), the High Court is effectively stating that:
“Where the rule-making authority has fashioned a complete, hierarchical remedy for resolving disputes about suspension or cancellation of drug licences, the writ court should, in ordinary course, respect that framework and avoid being the first forum of challenge.”
5.4 The Court’s legal reasoning
The reasoning proceeds in a concise but clear chain:
- Identification of statutory remedy: The Single Judge and Division Bench both recognise, and the appellant does not appear to dispute, that Rule 66(2) vests a right of appeal to the State Government against suspension/cancellation of a drug licence.
- Character of Article 226: The Division Bench underlines that Article 226 is not an “absolute remedy” but a discretionary one. This is critical: even if a petitioner can demonstrate some illegality, the Court may still choose to decline to exercise its writ jurisdiction on prudential grounds.
- Efficaciousness of the statutory remedy: The Court treats the appellate remedy as “efficacious.” It notes that the State Government, as the appellate authority, would be entitled to examine all facts and circumstances and is fully competent to grant appropriate relief.
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Non-invocation of exceptions: Although the appellant complained, inter alia, that:
- documents necessary to defend himself were sealed inside the locked premises, and
- a second show cause notice gave him time to respond on the same day,
- Deference to Single Judge’s discretion: Given that writ jurisdiction is discretionary, the Division Bench examines only whether the Single Judge misapplied that discretion. It finds that the Single Judge’s approach – refusing to exercise writ jurisdiction in light of the alternative remedy – accords with settled law, and hence no appellate interference is warranted.
Implicitly, the Court is affirming the proposition that even serious allegations of violation of procedure or natural justice in the licensing process are not, by themselves, a reason to skip the statutory appeal. They are better tested and remedied within the appeal itself, unless the case is extraordinary in the sense contemplated in Whirlpool and other precedents.
5.5 Public health tragedy vs. procedural fairness – the Court’s balance
A notable feature of the judgment is its acknowledgment that the case arises from “one of the most shocking” medical incidents, involving the alleged death of 30 children. Yet, the Court uses this as an argument reinforcing the need to:
- allow the specialised statutory machinery to fully function, and
- permit the State Government to conduct a comprehensive factual and regulatory review.
The Court does not treat the magnitude of the tragedy as a reason to bypass statutory procedure by granting immediate judicial relief. Instead, it treats the seriousness of the situation as a reason to:
- respect the regulator’s primary role, and
- avoid transforming the High Court into the first forum for fact-finding in a technically complex and socially sensitive matter.
From a rule-of-law perspective, this reflects a clear preference for:
- structured, hierarchical decision-making within the administrative system, followed by
- judicial review at the appropriate stage, if necessary (for instance, after exhaustion of the statutory appeal).
5.6 Could this case have fit within an exception to the alternative remedy rule?
The facts mention:
- a very short time given to respond to the second show cause notice (effectively one day), and
- a plea that essential documents needed to prepare an effective defence were locked inside the sealed premises.
Such features potentially suggest a procedural fairness/natural justice concern. In some earlier cases, the Supreme Court has allowed writ petitions notwithstanding alternative remedies when:
- the order is passed in flagrant breach of natural justice, or
- the action is alleged to be malafide or patently arbitrary.
However, the High Court here evidently took the view that:
- these contentions can be adequately addressed by the State Government in the appeal; and
- they are not of such an extraordinary or jurisdictional nature as to justify immediate writ intervention.
In essence, the Court implicitly categorises the complaints as matters:
- going to the correctness of the decision-making process, rather than
- constituting a total lack of jurisdiction or a situation where the entire process is a nullity.
Thus, it reinforces a relatively strict approach to the exceptions: unless the case clearly falls into the recognised exception categories, the High Court will, as a matter of discipline, require parties to first exhaust statutory appeals.
5.7 Impact on future cases and on the relevant area of law
5.7.1 For drug licence holders and distributors
The judgment sends a clear signal to those engaged in the distribution and sale of drugs:
- If your licence is suspended or cancelled under the Drugs and Cosmetics Rules, 1945, your primary recourse is the appeal to the State Government under Rule 66(2).
- Directly approaching the High Court under Article 226 – even in high-stakes or reputationally devastating situations – is unlikely to succeed, unless:
- you can demonstrate a complete lack of jurisdiction,
- a serious constitutional or vires challenge, or
- a rare and patent violation of natural justice beyond what the appellate authority can reasonably correct.
It also underlines the need for:
- collecting and marshalling all factual and legal grounds comprehensively at the appellate stage, since that is where the main battle will now be fought,
- rather than treating the writ court as the immediate forum of first resort.
5.7.2 For regulatory and licensing authorities
For drug regulators and licensing authorities, the judgment:
- strengthens confidence that their decisions will not be easily interrupted or pre-empted by writ proceedings where an appellate structure exists;
- encourages rigorous, reasoned orders at the initial and appellate stages, knowing that courts will, in the first instance, require parties to work through that framework;
- still leaves open the possibility of eventual judicial review (for instance, through a subsequent writ petition or other appropriate proceedings) after the appellate process is complete.
In contexts involving mass casualties or public health emergencies, it thereby supports:
- decisive initial regulatory action, and
- subsequent structured reconsideration within the executive hierarchy,
before judicial oversight is invited.
5.7.3 For High Courts and writ practice
From a systemic perspective, the judgment aligns with a broader trend in Supreme Court and High Court practice:
- to reduce premature resort to writ jurisdiction where comprehensive statutory remedies are available; and
- to reinforce the principle that the High Court is not intended to be an alternative appellate forum bypassing specialised mechanisms.
In doing so, it reinforces:
- judicial economy, and
- respect for legislative design, particularly in technically complex regulatory domains like drug safety and public health.
6. Complex Concepts Simplified
6.1 Writ petition under Article 226
A “writ petition” under Article 226 is a special kind of proceeding by which a person asks a High Court to:
- protect their fundamental rights, or
- correct serious legal wrongs by public authorities (including administrative authorities, tribunals, etc.).
Key points:
- It is not an appeal; it’s a supervisory and corrective jurisdiction.
- The High Court has wide powers but may choose not to exercise them in a given case (discretionary jurisdiction).
6.2 Writ appeal
A “writ appeal” is an intra-court appeal permitted by certain High Courts’ rules against orders of a Single Judge passed in writ jurisdiction. A Division Bench (usually two judges) re-examines the Single Judge’s order, but:
- usually does not convert itself into a court of first instance on facts, and
- largely examines whether the Single Judge applied legal principles correctly and exercised discretion properly.
6.3 “Discretionary” nature of Article 226
When the Court says Article 226 is “discretionary,” it means:
- a petitioner has a right to approach the Court, but
- no guaranteed right to relief – the Court can decline to issue a writ even if some illegality is shown, based on broader prudential considerations (like the existence of other remedies, complex fact issues, delay, etc.).
6.4 “Alternative efficacious remedy”
An “alternative efficacious remedy” refers to:
- a remedy provided by law (like an appeal, revision, review) which is:
- accessible to the aggrieved party,
- capable of granting appropriate relief (e.g., setting aside a wrongful order), and
- designed to deal specifically with that kind of grievance.
If such a remedy exists and is reasonably adequate, the High Court will usually insist that it be used before invoking Article 226.
6.5 Suspension and cancellation of drug licence
Under the Drugs and Cosmetics Act, 1940 and its Rules, any person dealing in drugs (such as manufacturers, stockists, distributors, retailers) must hold a valid licence. The licensing authority can:
- suspend a licence – temporarily halting operations, or
- cancel a licence – effectively terminating the legal ability to continue in that business,
if there are contraventions of the Act or Rules, or in the interest of public health. Rule 66 sets out the process, including:
- notice and opportunity to show cause, and
- a right of appeal to the State Government.
6.6 Sealing of premises
“Sealing” a shop or premises means physically locking and restricting access, usually by an authority under statutory power. It prevents:
- physical access to stock, records, and documents on the premises,
- further sale or distribution of the goods stored there.
Sealing is often used where the continued operation poses serious danger (for example, suspected supply of contaminated or harmful products).
7. Conclusion
Rajpal Kataria v. State of Madhya Pradesh is not a detailed merits adjudication on regulatory action taken in response to a grave public health tragedy. Instead, it is a tightly focused reaffirmation of a key procedural principle:
Where a statute – here, the Drugs and Cosmetics Rules, 1945 – provides a specific, efficacious appellate remedy (Rule 66(2)) against suspension or cancellation of a drug licence, the High Court will ordinarily decline to entertain a writ petition under Article 226 at the first instance, even in cases involving severe consequences and highly emotive public interest issues.
The judgment underscores that:
- Article 226 is a discretionary and supervisory jurisdiction, not a substitute appellate forum;
- litigants must, as a matter of rule, first exhaust statutory appellate remedies unless their case falls within recognised narrow exceptions (lack of jurisdiction, clear violation of fundamental rights or natural justice, constitutional challenge, etc.);
- serious allegations of procedural unfairness in the licensing process are, in the first instance, to be addressed by the appellate authority designated by the statute (the State Government), which can examine “all facts and circumstances of the case.”
In the broader legal context, the case contributes to a consistent line of authority that seeks to:
- reinforce respect for legislative choice in creating hierarchical regulatory and appellate schemes,
- preserve High Courts from becoming first-instance fact-finding bodies in complex technical matters, and
- maintain procedural discipline in the use of extraordinary writ jurisdiction.
For practitioners and regulated entities in the pharmaceutical and healthcare sectors, the key message is practical and clear: in disputes over suspension or cancellation of drug licences, start with the statutory appeal to the State Government under Rule 66(2); writ jurisdiction will typically be available, if at all, only as a subsequent, exceptional recourse.
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