Drugs and Cosmetics Act, 1940

The respondent, Manimaran, operated a medical shop without a valid drug licence and was charged under Sections 18(c), 27(b)(ii) and 28 of the Drugs and Cosmetics Act, 1940. The trial court and the first appellate court convicted him, imposing a one‑year rigorous imprisonment and a fine of Rs.5,000, but the Madras High …

The State of Andhra Pradesh alleged that INOX Air Products Ltd. (now INOX Air Products Private Ltd.) sold Nitrous Oxide I.P. to a third‑party firm that allegedly lacked a Form 20B licence, thereby violating s.18(a)(vi) of the Drugs and Cosmetics Act, 1940 and attracting punishment under s.27(d). The High Court dismisse…

The appellants, M/s JM Laboratories and its partners, were summoned by a Judicial Magistrate in Kurnool to appear in a case filed under the Drugs and Cosmetics Act alleging manufacture of sub‑standard drugs. They filed a petition under Section 482 of the CrPC seeking to quash the criminal proceedings, which the High Co…

The Bank of Baroda issued a possession notice under the SARFAESI Act to recover defaulted loans, but a clerical error inflated the outstanding amount, leading the borrower Phoenix India to allege defamation and file a criminal complaint under Sections 499, 500 and 501 IPC against the Bank's senior officers. The magistr…

The Union of India challenged a High Court order that quashed an FIR registered under the Code of Criminal Procedure (CrPC) for the alleged sale of unlicensed drugs, holding that prosecution for offences under Chapter IV of the Drugs and Cosmetics Act, 1940 must be initiated only by persons named in Section 32 of the A…

The Drug Inspector seized a sample of Betnesol tablets manufactured by Glaxo Smith Kline Pharmaceuticals and sent it to the Government Analyst, who certified on 27 August 1997 that the sample was not of "standard quality". A show‑cause notice was issued on 29 September 1997, to which the company replied on 3 November 1…

The petitioners challenged the constitutional validity of the amendments to the Customs Act, 1962 and the arrest provisions in the Central Goods and Services Tax Act, 2017, arguing that offences under these statutes remain non‑cognizable and that authorized officers must obtain a magistrate's warrant, relying on the Om…

Thana Singh, an undertrial accused of an offence under the NDPS Act, had been detained for over twelve years without trial despite repeated bail refusals. The Supreme Court examined whether such prolonged detention violated the right to speedy trial under Article 21 of the Constitution. Relying on earlier decisions tha…

The Supreme Court examined the validity of a 27 April 2018 notification issued under Section 26A of the Drugs and Cosmetics Act that restricted the domestic manufacture of oxytocin to public‑sector undertakings, excluding private manufacturers, while allowing export by both sectors. The petitioners (Union of India) arg…

The State of Madhya Pradesh challenged the imposition of entry tax on Marico Industries' products Mediker and Revive instant starch. The issue was whether Mediker, marketed as an anti‑lice treatment, should be classified as a shampoo under Schedule II Entry 32 of the Madhya Pradesh Entry Tax Act, 1976, or as a drug/med…

The case concerned whether pure coconut oil sold in small retail packs (5 ml‑2 L) should be classified as ‘edible oil’ under Heading 1513 of Chapter 15 or as ‘hair oil’ under Heading 3305 of Chapter 33 in the First Schedule to the Central Excise Tariff Act, 1985. The respondents marketed the oil as edible oil, while th…

Genentech Inc., Roche Products (India) and F. Hoffmann‑La Roche filed a suit in the Delhi High Court seeking to restrain Reliance Life Sciences from launching its biosimilar product ‘TrastuRel’, alleging improper use of data and passing off. The Single Judge of the High Court, on 25 April 2016, allowed Reliance to mark…

The Directorate of Revenue Intelligence investigated the illegal possession, manufacture and sale of Buprenorphine Hydrochloride, a psychotropic substance listed in the Schedule to the NDPS Act but not in Schedule I of the NDPS Rules, leading to charges under Sections 8(c), 22 and 29 of the NDPS Act against several res…

Anil Kumar was first convicted under Section 22 of the NDPS Act and sentenced to ten years' rigorous imprisonment with a fine of Rs.1 lakh and a default two‑year term. He was later convicted under Sections 27(b)(ii) and 28 of the Drugs and Cosmetics Act and sentenced to one year' rigorous imprisonment with a fine of Rs…

The appellants, owners of a chemical trading company, were accused of contravening the Drugs and Cosmetics Act by purchasing and allegedly repackaging pyridoxal‑5‑phosphate, a bulk food substance, for sale to drug manufacturers. The complaint was filed more than four years after the initial inspection, and the investig…

The Supreme Court examined whether the Central Government must obtain prior advice from the Drugs Technical Advisory Board (DTAB) before invoking the power under Section 26A of the Drugs and Cosmetics Act, 1940 to prohibit, restrict or regulate a drug or cosmetic in public interest. The Court held that Section 26A is a…

Dr. S. Athilakshmi, a registered medical practitioner and associate professor of dermatology, was inspected by a Drugs Inspector who seized a small quantity of lotions and ointments from her private practice premises. The Inspector alleged that she had "stocked" and sold the drugs without a valid licence, invoking Sect…

The case concerned the classification of Ketoconazole (Nizral) Shampoo for central excise purposes. The assessee argued that the product, containing 2% ketoconazole and marketed for the treatment of dandruff, should be classified under CHS 3003.10 as a pharmaceutical product, attracting 16% duty, whereas the revenue co…

The Supreme Court examined whether "physician samples" of patented and proprietary medicines, which are distributed free of cost to doctors and prohibited from sale under the Drugs and Cosmetics Act, are liable to central excise duty. It held that excise duty is a tax on manufacture, not on sale, and therefore the stat…

The State of Andhra Pradesh assessed tax on M/s Linde India Ltd for its sale of Medical Oxygen IP and Nitrous Oxide IP, treating them as unclassified goods under Schedule V of the Andhra Pradesh Value Added Tax Act, 2005, which would attract a 12.5%/14.5% rate. Linde argued that the products are drugs/medicines covered…

The Supreme Court examined whether Section 8 of the Narcotic Drugs and Psychotropic Substances (NDPS) Act, 1985 applies to psychotropic substances that are listed in the Act’s Schedule but not in Schedule‑I of the NDPS Rules. It held that the prohibition in Section 8 is absolute and covers all such substances, and that…

The appellants, directors of Cachet Pharmaceuticals Pvt. Ltd., were charged under the Drugs and Cosmetics Act, 1940 for manufacturing a sub‑standard drug (Hemfer syrup) and were summoned as accused under sections 16, 18 and 34. They challenged the summons, a criminal revision and a writ petition, arguing that mere dire…

The Uttar Pradesh Krishi Utpadan Mandi Samiti (appellant) issued notices to Mis. Baidyanath Ayurved Bhandan Ltd. (respondent) demanding a licence under Section 9 of the Uttar Pradesh Krishi Utpadan Mandi Adhiniyam, 1964, because the company bought agricultural produce such as gur, amla and ghee in bulk and used them as…

The State of Gujarat appealed a High Court judgment that the product Kadiprol, sold in 100‑gram sachets and mixed with poultry feed, should be classified as "poultry feed" under Entry 25 of Schedule I of the Gujarat Sales Tax Act, 1969, rather than as a "drug and medicine" under Entry 26(1) of Schedule II Part A. The D…

Reckitt Benckiser (India) Ltd. appealed against the Kerala Commercial Taxes Department’s classification of several of its products under the Kerala VAT Act. The appellant claimed that mosquito mats, coils, vaporizers and Mortein insect killers were insecticides (Entry 44(5), HSN 3808) taxable at 4%, that Harpic and Liz…

The State of Himachal Pradesh appealed against the Himachal High Court’s order that replaced the trial court’s imprisonment sentences for Nirmala Devi with a fine of Rs.30,000. The trial court had convicted her under IPC sections 307 (attempt to murder), 328 (causing hurt by poison) and 392 (robbery) and sentenced her …

GlaxoSmithKline Pharmaceuticals Ltd challenged notices issued by the Drug Inspector after a price‑fixation notification under the Drugs (Prices Control) Order, 1995. The issue was whether the notified ceiling price became operative for all sales immediately, or whether manufacturers could continue to sell pre‑notificat…

The Supreme Court examined whether a drug‑manufacturing loan licencee, Cosme Pharma Laboratories Ltd, which contracts job workers to produce its medicaments, should be treated as a "manufacturer" under the Central Excise Act, 1944 and thus liable for excise duty. The Commissioner of Central Excise had issued notices tr…

The Delhi High Court, in a public‑interest writ, ordered manufacturers of drugs and cosmetics (other than life‑saving drugs) to display symbols indicating whether the product contained vegetarian or non‑vegetarian ingredients. The petitioners challenged this order, arguing that the Drugs and Cosmetics Act and Rules do …

Vetindia Pharmaceuticals Ltd., a licensed drug manufacturer, challenged an order of blacklisting issued by the State of Uttar Pradesh on 8 September 2009, alleging that it had never supplied the disputed veterinary injection under the tender and that the show‑cause notice did not specifically propose blacklisting. The …

A criminal complaint was filed against a medicine‑manufacturing company and its directors alleging that the drug was defective due to fungal growth, constituting a breach of the Drugs and Cosmetics Act. The company and its directors sought to quash the complaint under Section 482 of the Criminal Procedure Code. The Guj…

Rekha, the wife of a man accused of selling expired drugs with tampered labels, challenged his preventive detention order under the Tamil Nadu Prevention of Dangerous Activities Act, 1982. The High Court dismissed her habeas corpus petition, but the Supreme Court allowed the appeal, holding that the detention order was…

The Supreme Court examined a detention order issued under the Andhra Pradesh Prevention of Dangerous Activities Act, 1986 against Munagala Anjaiah, who was alleged to be a bootlegger violating the Andhra Pradesh Prohibition Act, 1995. The appellant's wife challenged the order, and the High Court upheld it, reasoning th…

The Union of India challenged the Delhi High Court's order setting aside price‑fixation notifications for Doxofylline formulations, arguing that Doxofylline is a derivative of the scheduled bulk drug Theophylline. The respondents contended that Doxofylline is a new chemical entity not listed in the First Schedule of th…

Heinz India Ltd. challenged the classification of its product, Nycil Prickly Heat Powder, under state sales tax statutes. The Kerala High Court and the Madras High Court had held the product to be a "medicated talcum powder" and thus a cosmetic, subject to a lower tax rate, rejecting the revenue's view that it was a me…

The accused were apprehended with bulk quantities of manufactured narcotic drugs and were convicted under Sections 21 and 22 of the Narcotic Drugs and Psychotropic Substances (NDPS) Act. The High Court, however, suspended their sentences under Section 389 of the Code of Criminal Procedure, holding that the matter shoul…

The case concerned the applicability of the Pharmacy Act, 1948 to the newly created State of Jharkhand after the Bihar Reorganisation Act, 2000. The petitioners challenged a Jharkhand Government notification that sought fresh registration of pharmacists under Section 31 of the Act, arguing that the First Register prepa…

The case concerned the classification of Aswini Homeo Arnica Hair Oil (AHAHO) under the Central Excise Tariff Act, 1985 – whether it should be taxed as a medicament (Chapter 30) or as a cosmetic/toilet preparation (Chapter 33). The Revenue, relying on the 2012 amendment of the tariff schedule, sought a re‑examination o…

The petitioners, invoking Article 32, sought a court order to stop private hospitals from forcing patients to purchase medicines and consumables exclusively from the hospitals' own pharmacies at inflated prices, alleging exploitation and violation of the right to life under Article 21. They highlighted personal experie…

The Supreme Court examined a public‑interest writ petition challenging COVID‑19 vaccine mandates, the disclosure of segregated clinical trial data, the emergency approvals of COVISHIELD and COVAXIN, the adequacy of the adverse‑event‑following‑immunisation (AEFI) system, and the policy of vaccinating children. It held t…