Chapter IV Offences Under Drugs and Cosmetics Law Triable by Sessions Court

Source: Supreme Court 

Why in News? 

The bench of Justice Prashant Kumar Mishra and Justice Vipul M. Pancholi in the case of M/S SBS Biotech & Others v. State of Himachal Pradesh (2026) held that offences punishable under Chapter IV of the Drugs and Cosmetics Act, 1940 cannot be tried by a Magistrate and must be tried by a Court not inferior to a Sessions Court. 

What was the Background of M/S SBS Biotech & Others v. State of Himachal Pradesh (2026) Case? 

• A Drug Inspector conducted an inspection on July 22, 2014 at the manufacturing premises of M/s SBS Biotech at Kala Amb, District Sirmaur, Himachal Pradesh. 
• The firm was alleged to have not maintained records in the manner required under Schedule M (good manufacturing practices and documentation) and Schedule U (particulars to be shown in manufacturing records) of the Drugs and Cosmetics Rules, 1945, particularly in relation to the drug Pseudoephedrine. 
• A re-inspection was carried out on August 5, 2014, revealing discrepancies in the manufacturing, testing, and distribution records. 
• Sanction for prosecution was granted on September 15, 2016, and a complaint was filed on February 27, 2017 alleging contravention of Section 18(a)(vi) read with Rule 74, Section 22(1)(cca), and Section 18-B, punishable under Section 27(d) and Section 28-A of the Act. 
• The Judicial Magistrate First Class (JMFC) took cognizance on April 6, 2017 and later committed the case to the Special Judge on October 5, 2017, holding the offence to be exclusively triable by the Sessions Court. 
• The appellant's quashing petition before the High Court was dismissed, prompting the present appeal before the Supreme Court. 

What were the Court's Observations?  

• The Court observed that Section 32(2) of the Drugs and Cosmetics Act specifically mandates that no Court inferior to a Court of Session shall try offences punishable under Chapter IV, making the Sessions Court the minimum forum for such trials. 
• The Court held that when the complaint disclosed an offence under Section 18(a)(vi) — relating to prohibition of manufacture and sale of drugs in contravention of Chapter IV — the punishment under Section 27(d) would apply, which prescribes imprisonment of not less than one year and up to two years. 
• On the question of limitation, the Court held that since Section 27(d) prescribes a minimum of one year's imprisonment, the applicable limitation period under Section 468 of the CrPC is three years. As the complaint was filed within two years and six months of the inspection, it was not barred by limitation. 
• The Court rejected the argument that Section 36-A — which provides for summary trial by a JMFC for offences punishable with imprisonment not exceeding three years — could vest jurisdiction in a Magistrate. It noted that Section 36-A itself excludes offences triable by a Special Court under Section 36-AB or by a Sessions Court, and that Section 32(2) specifically bars any court inferior to a Sessions Court from trying Chapter IV offences. 
• The Court found no error in the Magistrate's decision to commit the case to the Sessions Court and dismissed the appeal. 

What is the Drugs and Cosmetics Act, 1940? 

Background & Purpose: 

• Enacted to regulate the import, manufacture, distribution, and sale of drugs and cosmetics in India. 
• Replaced the earlier Dangerous Drugs Act and aimed to ensure the safety, efficacy, and quality of drugs available to the public. 
• Administered jointly by the Central Government and State Governments. 

Structure: 

• Divided into multiple Chapters dealing with drugs, cosmetics, and Ayurvedic, Siddha, and Unani medicines separately. 
• Supported by the Drugs and Cosmetics Rules, 1945, which provide detailed procedural and technical requirements. 

Key Definitions: 

• "Drug" includes medicines for internal or external use, substances used for diagnosis, and articles intended to affect body structure or function. 
• "Cosmetic" means any article intended for use on the human body for cleansing, beautifying, or altering appearance. 
• "Manufacture" includes any process involved in making, altering, ornamenting, finishing, or otherwise treating a drug. 

Regulatory Authorities: 

• Central Drugs Standard Control Organisation (CDSCO) is the national regulatory body headed by the Drugs Controller General of India (DCGI). 
• State Drug Authorities handle licensing and enforcement at the state level. 
• Drug Inspectors are empowered to inspect, sample, and seize drugs. 

Chapter IV – Manufacture, Sale & Distribution: 

• Prohibits manufacture, sale, or distribution of drugs that are misbranded, adulterated, or spurious. 
• Section 18(a)(vi) prohibits manufacture or sale in contravention of Chapter IV or Rules made thereunder. 
• Manufacturers must comply with Schedule M (Good Manufacturing Practices) and Schedule U (manufacturing record requirements). 
• Licenses are mandatory for manufacture and sale of drugs. 

Scheduled Substances & Records: 

• Schedule M lays down standards for premises, equipment, and documentation for drug manufacturing. 
• Schedule U prescribes the particulars to be shown in manufacturing, testing, and distribution records. 
• Habit-forming substances like Pseudoephedrine are subject to stricter record-keeping and oversight. 

Offences & Punishments: 

• Section 27 prescribes punishments for various offences including manufacture of spurious or adulterated drugs, with imprisonment ranging from one year to life, depending on the nature of the offence. 
• Section 27(d) punishes contravention of Chapter IV or Rules with imprisonment of not less than one year and up to two years. 
• Section 28-A prescribes imprisonment of up to one year for failure to maintain records or furnish information under Section 18-B. 
• Section 32(2) mandates that no Court inferior to a Court of Session shall try offences under Chapter IV. 

Cognizance & Trial: 

• Offences under Chapter IV are exclusively triable by a Sessions Court and cannot be tried by a Magistrate. 
• Section 36-A, which allows summary trial by a JMFC for lesser offences, does not apply to Chapter IV offences due to the overriding mandate of Section 32(2). 
• Special Courts under Section 36-AB may also be constituted for speedy trial of drug offences. 

Inspection & Enforcement Powers 

• Drug Inspectors have wide powers to enter and inspect premises, take samples, seize stocks, and examine records 
• Section 22(1)(cca) empowers inspectors to check compliance with record-keeping requirements 
• Refusal to produce records or furnishing false information is itself an offence under the Act 

Significance 

• The Act serves as the backbone of drug regulation in India, ensuring that only safe and effective medicines reach consumers 
• It has been periodically amended to address emerging challenges such as counterfeit drugs, online pharmacies, and new drug categories 
• Compliance with the Act is essential for all pharmaceutical manufacturers, importers, and distributors operating in India