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 case concerned the classification of "Banphool Oil" under the Central Excise Tariff Act, 1985. The Revenue argued that the product was a perfumed hair oil (Tariff Item 3305.10) or a toilet preparation, while the assessee contended it was an Ayurvedic medicament (Tariff Item 3003.30). The Customs, Excise and Gold (C…

The State of Haryana filed a complaint alleging that two batches of sodium chloride injections purchased by a district inspector were adulterated, as reported by the Government Analyst under the Drugs and Cosmetics Act. The manufacturers, Mis Mittal Pharmaceutical Pvt. Ltd., were served with the analyst's report but fa…

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…

Colfax Laboratories manufactured after‑shave lotions (ASL) under a licence for cosmetics. In 1985 it sought re‑classification of the product as a "medicinal preparation" to obtain a lower excise duty; the Excise Commissioner classified it as medicinal, a decision later challenged. The State issued notices demanding bal…

The petitioners challenged the validity of the Central Government's notification dated 24 February 1983 declaring seeds of food‑crops, fruits and vegetables as essential commodities under the Essential Commodities Act, 1955, and the consequent Seeds (Control) Order, 1983 which required licences for dealing in such seed…

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 appellant (Accused No.2) and his co‑accused were convicted under the Narcotic Drugs and Psychotropic Substances (NDPS) Act, 1985 for unauthorised export of alprazolam, lorazepam and nitrazepam, drugs listed in the Schedule of the Act. The appellant contended that the alleged offence should be dealt with under the D…

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…

Leukoplast (India) Ltd. manufactured plasters, dressings and bandages under a licence from the Drug Controller and paid Central and Goa local sales tax at the rates applicable before certain notifications exempted "drugs and medicines". The company claimed a refund, asserting its products fell within the exemption, but…

The Rajasthan Government, by a 1990 notification, declared medicinal and toilet preparations containing more than 20% proof alcohol to be "liquor" under the Rajasthan Excise Act and its 1989 Rules. Several manufacturers of Ayurvedic medicines challenged the notification and the Rules as beyond the State's legislative c…

Cadila Health Care Ltd. (appellant) and Cadila Pharmaceuticals Ltd. (respondent) are successor companies of the former Cadila Group, each manufacturing drugs for cerebral malaria under the brand names 'Falcigo' and 'Falcitab' respectively. The appellant sought an injunction on the ground that the similarity of the two …

The appellant, a public servant, conducted a raid on a medical shop and seized medicines, later filing an FIR against respondent No.2. In retaliation, respondent No.2 lodged a complaint alleging the appellant had committed offences under IPC sections 161, 167, 465, 466, 469 and 471. The District Magistrate issued a san…

The Drugs Inspector seized samples of Ozomen capsules and Ozomen forte, which were found to contain sildenafil citrate, an allopathic drug, in quantities ranging from 33.9 mg to 46.8 mg per capsule. The respondents, who held licences for Ayurvedic and allopathic medicines but not for manufacturing sildenafil citrate, w…

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…

Cipla Ltd employed cleaning staff through a contractor and routinely terminated them after eleven months to avoid granting permanent status. The Maharashtra General Kamgar Union filed a complaint under Section 28 of the Maharashtra Recognition of Trade Unions & Prevention of Unfair Labour Practices Act, alleging unfair…

The State of Orissa prosecuted Janmejoy Dinda, who ran a nursing home, for stocking medicinal drugs without a valid licence and for failing to disclose the source of those drugs. The trial court convicted him under Sections 27(b)(ii) and 28 of the Drugs and Cosmetics Act, 1940, imposing imprisonment and fines. The High…

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 appellant, Mis. Ponds India Ltd., produced Vaseline white petroleum jelly under a licence granted by the Drugs and Cosmetics Act, 1940. For assessment years 1981‑1989 the Trade Tax Tribunal classified the product as a pharmaceutical preparation (a "drug") under Entry 5 of the Uttar Pradesh Trade Tax Act, 1948, and …

A drug inspector sampled a formulation purchased from a retailer and, after analysis by a Government Analyst, found it to be misbranded, adulterated and spurious. The manufacturer, Amery Pharmaceuticals, sold the drug through a distributor and was charged under Sections 27(b), (c) and (d) of the Drugs and Cosmetics Act…

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…

Alpine Industries manufactured a product called "Lip Salve" and supplied it exclusively to the Defence Department for use by military personnel at high altitude. The company claimed that the product was a medicament and should be classified under Heading 30.03 of the Central Excise Tariff Act, 1985, thereby attracting …

The Supreme Court examined the conviction of Rajasthan Pharmaceutical Laboratory, its partner and its manager for offences under the Drugs and Cosmetics Act, 1940, including sale of unlicensed and sub‑standard drugs, failure to disclose source, and contravention of a prohibitory order. The High Court had imposed fines …

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…

Baidyanath Ayurved Bhawan Ltd. manufactures Dant Manjan Lal, a tooth powder prepared according to Ayurvedic formulas. Earlier it was classified as a medicine and exempt from excise duty, but the Tribunal later held it to be a toilet requisite. After the Central Excise Tariff Act, 1985 introduced Sub‑heading 3003.31 for…

The Drugs Inspector collected a sample of Enalapril Maleate tablets manufactured by M/s. Medicamen Biotech Ltd., divided it into four parts and sent one part to the Government Analyst, whose report declared the drug sub‑standard. The appellant disputed the report, sent two written notices within 28 days expressing inte…

The appellants, manufacturers and dealers of Ayurvedic and Unani medicines, challenged the validity of the Tamil Nadu Spirituous Preparations (Control) Rules, 1984, which require licences for the sale of any medicinal preparation containing alcohol or intoxicating drugs. They argued that the rules imposed unreasonable …

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 Union of India challenged a Delhi High Court decision that had upheld Ranbaxy Laboratories' claim of exemption from the Drugs (Price Control) Order, 1995 for its bulk drug Pentazocine. The exemption was granted by a government notification dated 29 August 1995 and was said to expire on 31 October 1999. The issue wa…

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…

The appellant, a manufacturer of Ayurvedic toothpaste containing 4% tobacco, challenged a 1992 government notification that prohibited the manufacture and sale of any Ayurvedic drugs licensed as tooth‑pastes or tooth‑powders containing tobacco. The notification was issued under Section 33(E) of the Drugs and Cosmetics …

The State of Karnataka prosecuted three respondents – two partners and their firm – for allegedly providing a fictitious address of the supplier of a drug, violating sections 18(a)(ii), 18(c) and 18A of the Drugs and Cosmetics Act, 1940. The prosecution relied on an inspector’s report that the address was fictitious, b…

The State of Bihar enacted notifications licensing the use, possession and sale of Ayurvedic medicinal preparations containing alcohol, after amending the Bihar Excise Act, 1915 to include such preparations within the definition of "intoxicant". Manufacturers challenged the constitutional validity of the amendment and …

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…

Dr. (Miss) Alette Grace Bell, the Medical Superintendent of Duncan Hospital in Bihar, was served a notice by the Drug Controller requiring a licence to manufacture and distribute an IV solution for patients, invoking Section 18(c) of the Drugs and Cosmetics Act, 1940. The High Court held that the hospital needed such a…

The Supreme Court examined whether Rule 2(ee)(iii) of the Drugs and Cosmetics Rules, 1945, which defines "registered medical practitioner", exceeded the legislative competence of the Central Government under the Indian Drugs and Cosmetics Act, 1940, and whether state notifications declaring Vaids/Hakims as practitioner…

The Revenue challenged the Customs, Excise and Gold (Control) Appellate Tribunal’s finding that 22 products of Ishan Research Lab were Ayurvedic medicines under Chapter 30 of the Central Excise Tariff, liable to 10% duty, rather than cosmetics under Chapter 33 at 40% duty. The Court examined whether the products should…

Mis. Puma Ayurvedic Herbal (P) Ltd., a licensed manufacturer of Ayurvedic medicines, challenged the classification of its products as cosmetics by the CEGAT, which attracted a higher excise duty. The Supreme Court applied the well‑settled "twin test"—the common‑parlance test and the Ayurvedic‑text‑book ingredients test…

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…

Mentha & Allied Products Ltd manufactured menthol under a licence granted under the Drugs and Cosmetics Act and claimed exemption from central excise duty under Notification No. 31188‑CE, which exempts "bulk drugs" as defined in the Drugs (Prices Control) Order, 1987. The Central Excise Collector held that the menthol …

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…

A complaint under Sections 18(c) and 27(b)(ii) of the Drugs and Cosmetics Act, 1940 alleged that the accused were manufacturing, selling and storing drugs defined under Section 3(b) without a licence. The accused contended that the seized items were Ayurvedic drugs, governed by Section 3(a), and therefore the complaint…

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…

B.P.L. Pharmaceuticals Ltd. manufactured a Selenium Sulfide Lotion (branded Selsun) containing 2.5% selenium sulfide, used for treating seborrhoeic dermatitis and tinea versicolor. The product was certified as a drug by the FDA, labelled with warnings, and marketed through chemists on prescription. While earlier excise…

The Supreme Court entertained a public‑interest writ under Article 32 filed by Common Cause seeking remedial measures for the serious deficiencies in India’s blood‑banking system. A 1990 consultancy report highlighted widespread unlicensed banks, reliance on professional donors, inadequate testing, poor equipment and h…

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…

Vincent Panikurlangara, an advocate and General Secretary of a public‑interest law service society, filed a writ petition under Article 32 seeking a total ban on the import, manufacture, sale and distribution of certain drugs that had been recommended for prohibition by the Drugs Consultative Committee, along with canc…

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…

The State of Rajasthan filed a complaint under sections 27(d) and 27(b)(i) of the Drugs and Cosmetics Act, 1940 alleging that sub‑standard drugs were being sold. Samples were collected on 29‑Feb‑1988, but the Government Analyst’s report confirming the drugs were not of standard quality was received on 2‑July‑1988. The …

The petitioners, manufacturers of Ayurvedic, Siddha and Unani drugs, challenged the amendment to Section 3(h) of the Drugs and Cosmetics Act, 1940, arguing that it arbitrarily prohibited the manufacture of drugs administered by the parenteral route and violated Articles 14 and 19(1)(g) of the Constitution. The Court ex…

Pratap Pharma Pvt. Ltd. and others filed writ petitions under Article 32 challenging the amendment of Section 3(h) of the Drugs and Cosmetics Act, 1940 (as amended by Act 68 of 1982), alleging it was arbitrary and violative of Articles 14 and 19(1)(g) of the Constitution. The petitioners contended that the amendment ex…