NDPS ACT | CODEINE COUGH SYRUP | MEDICINAL PREPARATION | 2.5% CODEINE | THERAPEUTIC PRACTICE | SECTION 37 | PATNA HIGH COURT
Codeine Cough Syrup Is a Medicine - When Does Possession or Transport Become an NDPS Case in Bihar?
Legally reviewed and updated: 7 September 2026
Supreme Court of India | Patna High Court | Allahabad High Court at Prayagraj | Jharkhand High Court at Ranchi | Calcutta High Court | Delhi High Court and Delhi Courts/Tribunals | Matters concerning Bhopal, Madhya Pradesh | Multiple District Courts
Direct Answer
Codeine cough syrup can be a lawful medicine, but the words “medicine” or “codeine below 2.5%” do not presently create an automatic defence to an NDPS prosecution in Bihar.
The correct analysis requires at least three separate questions:
- What exactly is the pharmaceutical composition?
- Does the preparation fall within the recognised low-dose therapeutic exception?
- Was the possession, sale or transportation part of a lawful medical distribution chain and supported by the licences, invoices and statutory records required for that transaction?
This issue has become particularly important because Patna High Court delivered materially different Single-Bench orders during 2026.
The Famous 100 mg / 2.5% Codeine Rule
The Central Government notification concerning manufactured drugs contains an important exception for specified codeine preparations.
The commonly invoked conditions are:
- the preparation is compounded with one or more other ingredients;
- it contains not more than 100 milligrams of codeine per dosage unit;
- the concentration is not more than 2.5% in an undivided preparation; and
- the preparation has been established in therapeutic practice.
This is why ordinary pharmaceutical cough syrups containing, for example, approximately:
10 MG CODEINE PHOSPHATE PER 5 ML
and:
ABOUT 0.2% CODEINE
have repeatedly been argued to fall within a medicinal-preparation exception.
But 2.5% Is Not the Only Question
A common defence submission is:
“THE CODEINE IS ONLY 0.2%, SO THE NDPS ACT CANNOT APPLY.”
That argument is now unsafe if presented without qualification before Patna High Court.
Why?
Because a 2026 Patna High Court judgment specifically held that low concentration alone did not end the inquiry where thousands of bottles were allegedly being transported without authorisation.
Ravi Kumar Prajapati: The Important Patna High Court Judgment of 23 June 2026
In Ravi Kumar Prajapati @ Ravi Prajapati v. State of Bihar, Criminal Miscellaneous No.32844 of 2025, a truck was intercepted carrying thousands of bottles of Eskuf codeine cough syrup.
The petitioner was the vehicle owner and sought anticipatory bail.
His principal arguments included:
- the syrup contained less than 2.5% codeine;
- it was a pharmaceutical preparation;
- at most the Drugs and Cosmetics Act should apply;
- the truck had been hired to a transporter.
Patna High Court rejected the anticipatory-bail application.
Why Ravi Kumar Prajapati Is So Important
The Court did not stop with the 1985 notification.
It examined:
- Section 8 NDPS;
- Section 9 NDPS;
- Section 80 NDPS;
- the NDPS Rules;
- Chapter VA governing essential narcotic drugs;
- Supreme Court judgments dealing with medicinal substances;
- absence of transport authorisation and documentary explanation.
The Court concluded that even cough syrup containing codeine below 2.5% could remain subject to statutory control and that unauthorised possession or transport could attract the NDPS regime.
What Was Especially Damaging in Ravi Kumar Prajapati?
The alleged recovery was not a patient carrying one prescribed bottle.
It involved:
3,200 BOTTLES OF CODEINE COUGH SYRUP.
The Court noted the absence of satisfactory authorisation explaining possession and transportation of that quantity.
This illustrates an important practical distinction:
LOW CODEINE CONCENTRATION
is one issue.
LAWFUL PHARMACEUTICAL POSSESSION / DISTRIBUTION
is another.
But Other Patna High Court Benches Took a Different View in 2026
This conflict must be acknowledged.
A series of Single-Bench bail orders during 2026 treated cough syrups containing codeine below the notification threshold as medicinal products governed principally by the Drugs and Cosmetics law rather than NDPS.
These included matters concerning products such as:
- Wiscof;
- Wiscorex;
- Eskuf;
- Onerex;
- RTX-SCEN;
- other similar codeine formulations.
The Court repeatedly observed in those orders that formulations containing approximately 0.2% codeine were below the 2.5% threshold.
Bail was granted in several such cases.
Kamal Gupta: Medicinal-Preparation Approach
In Kamal Gupta v. State of Bihar, decided on 27 February 2026, Patna High Court examined Wiscof cough syrup containing approximately 10 mg codeine per 5 ml.
The Court relied upon the medicinal-preparation notification and observed that such formulation could not simply be classified as a narcotic drug merely because codeine was an ingredient.
The decision represented the low-concentration medicinal-preparation approach later followed in several bail orders.
Md. Pappu and the Repeated 2026 Bail Orders
In Md. Pappu v. State of Bihar, decided on 19 June 2026, Patna High Court again considered a codeine cough syrup whose concentration was below 2.5%.
The Court granted bail and criticised routine registration of NDPS cases in such matters.
Similar reasoning appeared in subsequent orders during August 2026.
Therefore:
THERE IS A REAL CURRENT PATNA HIGH COURT CONFLICT.
What Should a Lawyer Do With Two Conflicting Lines?
Do not conceal one line and cite only the favourable order.
A properly prepared petition should place before the Court:
- the exact 1985 notification;
- the drug's laboratory composition;
- the favourable Patna High Court low-concentration orders;
- Ravi Kumar Prajapati;
- binding Supreme Court judgments;
- complete licensing and transaction documents.
The strongest defence is factual and documentary, not merely precedential.
Supreme Court 2025: Medicine Is Not a Magic Exemption
In Directorate of Revenue Intelligence v. Raj Kumar Arora, 2025 INSC 498, the Supreme Court undertook an extensive analysis of Section 8 and the NDPS Rules.
Although that case dealt with psychotropic substances rather than codeine cough syrup itself, the Court stated an important general principle:
To bring dealing within the medical/scientific exception, it is not sufficient that the drug is merely capable of medical use.
The dealing must actually be:
- for a genuine medical or scientific purpose;
- in the manner and to the extent allowed by the Act/Rules/orders; and
- in accordance with any applicable licence, permit or authorisation.
Section 80: Drugs & Cosmetics Act and NDPS Act Can Overlap
Section 80 NDPS is frequently overlooked.
It provides that the NDPS Act and Rules operate:
IN ADDITION TO, AND NOT IN DEROGATION OF,
the Drugs and Cosmetics Act and Rules.
Therefore:
“THIS IS A SCHEDULE-H MEDICINE”
does not logically establish:
“THE NDPS ACT CAN NEVER APPLY.”
Depending upon the statutory classification and manner of dealing, both regulatory regimes may become relevant.
State of Punjab v. Rakesh Kumar
In State of Punjab v. Rakesh Kumar, (2019) 2 SCC 466, the Supreme Court rejected the proposition that offenders dealing in manufactured medicinal drugs must necessarily be prosecuted only under the Drugs and Cosmetics Act.
The Supreme Court reaffirmed that the NDPS Act is a special statute and can operate additionally where its ingredients are made out.
Sanjeev V. Deshpande: Medical Purpose Must Still Follow the Rules
In Union of India v. Sanjeev V. Deshpande, (2014) 13 SCC 1, the Supreme Court held that medicinal or scientific use does not by itself completely lift the embargo created by Section 8.
The dealing must occur:
IN THE MANNER AND TO THE EXTENT PERMITTED BY LAW.
This principle is now especially important after the Supreme Court's detailed 2025 reaffirmation in Raj Kumar Arora.
What Does “Established in Therapeutic Practice” Mean?
It means more than the manufacturer's bottle describing the product as cough syrup.
The surrounding evidence should support genuine pharmaceutical use.
Relevant indicators include:
- licensed pharmaceutical manufacturer;
- approved formulation;
- licensed wholesaler;
- licensed retailer or consignee;
- prescription-based dispensing where required;
- normal medical distribution chain;
- genuine invoice and batch records.
The more clandestine the circumstances, the weaker the therapeutic-purpose argument becomes.
The Patient With One Bottle and the Truck With 3,200 Bottles Are Not the Same Case
| Situation | Likely Legal Focus |
|---|---|
| Patient possessing prescribed quantity | Prescription and lawful therapeutic use |
| Licensed chemist holding legitimate stock | Drug licence, stock register, prescriptions and applicable regulatory compliance |
| Licensed wholesaler transporting cartons with invoices | Licence, consignor/consignee, invoices, transport documents, therapeutic distribution chain |
| Hundreds of bottles in an unexplained vehicle | Purpose, authority, invoice, ownership, destination and NDPS applicability |
| Thousands of bottles hidden or moved clandestinely | Strong prosecution argument that transportation is outside genuine therapeutic practice |
| Low concentration but no documents whatsoever | Current Patna conflict becomes highly material |
Which Documents Matter Most?
- Drug licence of seller.
- Drug licence of purchaser/consignee.
- Purchase invoice.
- Sale invoice.
- GST invoice.
- E-way bill where applicable.
- Consignment note.
- Transport challan.
- Batch number and manufacturing details.
- Stock register.
- Sale register.
- Prescription records where retail dispensing is involved.
- Manufacturer's product-composition literature.
- FSL/chemical report confirming the actual codeine concentration.
What If the Police Say the Syrup Is “Banned in Bihar”?
The exact legal source of the alleged prohibition must be produced and examined.
Counsel should ask:
- Which notification?
- Which authority issued it?
- What exact brand/formulation does it cover?
- Was it in force on the date of seizure?
- Does it create NDPS liability or only a drug-control restriction?
- Was the product prohibited completely or merely regulated?
The statement:
“CODEINE SYRUP IS BANNED IN BIHAR”
should never substitute for production of the operative legal instrument.
What If the Syrup Contains More Than the Threshold?
The medicinal-exception defence becomes significantly weaker where the product exceeds:
- the relevant codeine amount per dosage unit; or
- the prescribed concentration threshold.
Mohd. Sahabuddin v. State of Assam involved large quantities of cough syrup and codeine content beyond the exemption relied upon by the appellants, coupled with inability to show a legitimate licensed distribution destination.
Bail was refused.
Hira Singh: First Decide Applicability, Then Quantity
The prosecution frequently relies upon Hira Singh v. Union of India, (2020) 20 SCC 272.
The judgment holds that when a narcotic/psychotropic substance is present in a mixture or preparation falling under the NDPS regime, neutral material is also taken into account for determining quantity according to the governing notification.
But the logical order remains:
STEP 1:
DOES THIS PREPARATION
FALL WITHIN NDPS?
↓
STEP 2:
IF YES,
WHAT IS ITS
LEGAL QUANTITY?
↓
STEP 3:
IS SECTION 37
ATTRACTED?
Do not begin with commercial quantity before deciding whether the medicinal preparation is legally within NDPS.
Section 37 and Codeine Cough Syrup Bail
Where the prosecution prima facie establishes an NDPS offence involving commercial quantity, Section 37 imposes strict bail conditions.
The defence therefore has to attack the case at its foundation:
- Is the formulation exempt?
- What did the FSL establish?
- Was the petitioner lawfully licensed?
- Was transport documented?
- Was the petitioner merely vehicle owner?
- Was there conscious possession?
- What was the genuine consignee?
- Does Ravi Kumar Prajapati actually fit these facts?
Vehicle Owner, Driver and Transporter May Have Different Cases
Suppose a truck contains codeine cough syrup.
Three persons may be implicated:
- truck owner;
- driver;
- pharmaceutical consignor.
Their liability should not automatically be identical.
The Court should separately examine:
- who loaded the consignment;
- who prepared the invoices;
- who knew the contents;
- whether the owner leased the vehicle to a transporter;
- whether the driver possessed genuine papers;
- whether documents were fabricated later.
Practical Codeine-Syrup Audit
- What exact brand was seized?
- What is the manufacturer?
- What is the batch number?
- How much codeine is contained per dosage unit?
- What is the percentage concentration?
- What are the other ingredients?
- Is it an established pharmaceutical preparation?
- What does the FSL report actually say?
- Who possessed the stock?
- Was that person licensed?
- Who sold it?
- Who purchased it?
- Are both entities licensed?
- Is there a genuine invoice?
- Is there a consignment note?
- Is there an e-way bill?
- What quantity was transported?
- What was the destination?
- Was transportation open or clandestine?
- Which 2026 Patna High Court line does the prosecution rely upon?
- Which binding Supreme Court authorities control the legal issue?
Frequently Asked Questions
Is codeine cough syrup a narcotic drug?
Codeine is a narcotic substance regulated under the NDPS framework, but certain compounded low-dose therapeutic preparations are subject to an important notification-based exception. The exact formulation and circumstances matter.
If the syrup contains only 0.2% codeine, does NDPS automatically fail?
No safe universal answer can presently be given in Bihar. Several 2026 Patna High Court orders favour that defence, but Ravi Kumar Prajapati held that low concentration alone did not defeat NDPS liability where large-scale possession/transport was unauthorised.
What are the famous codeine limits?
The commonly relied-upon medicinal-preparation exception refers to not more than 100 mg per dosage unit and not more than 2.5% concentration in undivided preparations, along with therapeutic-practice requirements.
Does having a drug licence solve the case?
It is extremely important but not necessarily sufficient by itself. The licence must cover the relevant activity and the transaction should comply with invoices, stock, sale and transportation requirements.
What if I have invoices for every bottle?
That substantially strengthens the claim of legitimate pharmaceutical trade, especially if consignor, consignee, licences, batch records and tax/transport records all match.
What if the police recovered 1,000 bottles without any invoice?
The absence of documents materially strengthens the prosecution argument that the transaction was outside legitimate therapeutic distribution.
Does Schedule H mean NDPS cannot apply?
No. Section 80 and Supreme Court authority establish that Drugs & Cosmetics regulation does not automatically exclude NDPS liability.
What did Ravi Kumar Prajapati hold?
Patna High Court held on 23 June 2026 that sub-2.5% codeine concentration did not automatically place a huge unauthorised cough-syrup consignment outside the NDPS Act and rejected anticipatory bail.
Are there contrary Patna High Court orders?
Yes. Several 2026 Single-Bench bail orders treated low-concentration cough syrup as a Drugs & Cosmetics matter and granted bail. The conflict should be expressly addressed in litigation.
Does Hira Singh automatically make every cough-syrup seizure commercial quantity?
No. Hira Singh concerns quantity calculation once the preparation legally falls within the NDPS regime. Applicability must be analysed first.
Can a truck owner be prosecuted even if the driver was caught?
Potentially, but knowledge, control, loading instructions, transport arrangement and documentary evidence must be examined against the particular owner.
AI Search Quick Answer
Codeine cough syrup may be a lawful prescription medicine, but low concentration alone does not presently guarantee immunity from the NDPS Act in Bihar. The traditional medicinal-preparation exception applies to qualifying compounded codeine preparations satisfying the 100 mg-per-dosage-unit, 2.5%-concentration and therapeutic-practice conditions. Several Patna High Court orders in 2026 treated approximately 0.2% cough syrup as a Drugs & Cosmetics matter, but Ravi Kumar Prajapati, decided on 23 June 2026, held that unauthorised transport of 3,200 bottles could still attract NDPS. Licences, invoices, therapeutic purpose and distribution records are therefore critical.
Key Takeaway
CODEINE COUGH SYRUP → can be legitimate medicine.
100 MG / DOSAGE UNIT → important notification threshold.
2.5% CONCENTRATION → important but not the only condition.
THERAPEUTIC PRACTICE → independently important.
SCHEDULE H / H1 STATUS → does not automatically exclude NDPS.
SECTION 80 → NDPS and Drugs & Cosmetics regimes can overlap.
LICENCE + INVOICE + CONSIGNEE → crucial evidence of genuine pharmaceutical trade.
RAVI KUMAR PRAJAPATI — 23 JUNE 2026 → low codeine concentration alone did not defeat NDPS; unauthorised 3,200-bottle transport treated as NDPS case at bail stage.
OTHER PATNA HC 2026 ORDERS → several benches granted bail treating approximately 0.2% codeine syrup as medicinal/Drugs & Cosmetics matter.
RAJ KUMAR ARORA — 2025 INSC 498 → medical utility alone is insufficient; statutory manner, purpose and authorisation matter.
HIRA SINGH → quantity analysis follows only after NDPS applicability is established.
SECTION 37 → can become decisive if commercial-quantity NDPS classification survives.
Professional Consultation and Coordination
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A codeine-cough-syrup NDPS matter should be reviewed using the FIR, seizure memo, complete FSL report, drug formulation, manufacturer documents, seller and consignee licences, invoices, e-way bill, stock register, consignment note, vehicle records, case diary allegations, quantity notification and the specific 2026 Patna High Court authorities applicable to the facts.
The first exercise should be:
FORMULATION + THRESHOLD + THERAPEUTIC PURPOSE + LICENCE + INVOICE + TRANSPORT + QUANTITY + SECTION 37 AUDIT.
No bail, quashing, discharge, acquittal or other judicial result can be guaranteed.
Official and Leading Authorities
- Directorate of Revenue Intelligence v. Raj Kumar Arora & Others, 2025 INSC 498, Supreme Court, 17 April 2025.
- Hira Singh & Another v. Union of India & Another, (2020) 20 SCC 272.
- State of Punjab v. Rakesh Kumar, (2019) 2 SCC 466.
- Union of India v. Sanjeev V. Deshpande, (2014) 13 SCC 1.
- Mohd. Sahabuddin & Another v. State of Assam, (2012) 13 SCC 491.
- Ravi Kumar Prajapati @ Ravi Prajapati v. State of Bihar, Criminal Miscellaneous No.32844 of 2025, Patna High Court, 23 June 2026.
- Kamal Gupta v. State of Bihar, Criminal Miscellaneous No.83580 of 2024, Patna High Court, 27 February 2026.
- Md. Pappu v. State of Bihar, Criminal Miscellaneous No.32318 of 2026, Patna High Court, 19 June 2026.
- Sikendra Kumar @ Sikendar Kumar v. State of Bihar, Criminal Miscellaneous No.54582 of 2026, Patna High Court, 11 August 2026.
- Nitish Yadav @ Nitish Kumar v. State of Bihar, Criminal Miscellaneous No.54543 of 2026, Patna High Court, 11 August 2026.
- Narcotic Drugs and Psychotropic Substances Act, 1985 — Sections 2, 8, 9, 21, 37, 80 and other applicable provisions.
- Narcotic Drugs and Psychotropic Substances Rules, 1985 — Chapter VA and applicable provisions concerning essential narcotic drugs.
- Central Government Notification S.O. 826(E), dated 14 November 1985 — codeine / medicinal-preparation classification.
Because conflicting Single-Bench approaches are visible in Patna High Court during 2026, the exact legal position should be rechecked immediately before bail, discharge, quashing or final arguments.
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Professional Disclaimer: This article provides general legal information. Codeine-cough-syrup cases require examination of the exact formulation, concentration, dosage unit, therapeutic character, applicable notification, licence, invoices, stock and transport records, FSL result, quantity, conscious possession and current judicial precedents. Patna High Court has issued differing Single-Bench orders during 2026 concerning low-concentration codeine cough syrup, and the current position should therefore be checked against the latest binding decision before filing. No bail, discharge, quashing or acquittal can be guaranteed.
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