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Drugs and Cosmetics Rules, 1945

21 judgments · newest first · showing 1–21

Mumbai Travel Retail LimitedversusUnion Of India,Through the Secretary

DISPOSED OFF

The petitioners, operators of duty‑free shops at Mumbai International Airport, were selling nicotine‑pouch products (brand “ZYN” and “FOX”) without a Drugs and Cosmetics Act import licence or registration certificate. The Union of India and various drug‑control and customs officials issued notices …

Flemingo Dutyfree Shop Private LimitedversusUnion Of India

DISPOSED OFF

The petitioners, operators of duty‑free shops at Mumbai International Airport, were selling nicotine‑pouch products (brand “ZYN” and “FOX”) without a Drugs and Cosmetics Act import licence or registration certificate. The Union of India and various drug‑control and customs officials issued notices …

M/s ASK PharmaversusThe State of Bihar

DISPOSED

M/s ASK Pharma filed a writ petition challenging an order of the State Drug Controller and related authorities. The petitioner sought permission to withdraw the petition and to appeal the order. The Patna High Court allowed the withdrawal and directed the petitioner to file an appeal under Rule …

M/s Sukhi EnterprisesversusThe State of Bihar

DISPOSED

M/s Sukhi Enterprises, represented by Vijay Kumar, filed a writ petition challenging an order of the State Drug Controller-cum-Chief Licensing Authority. The petitioner sought permission to withdraw the writ application and instead file an appeal under Rule 66(2) of the Drugs and Cosmetics Rules, …

M/S Ravi Pharma Proprietor Surendra KumarversusThe State of Bihar

DISPOSED

The petitioner, M/s Ravi Pharma, sought permission to withdraw its writ petition and to file an appeal against an order of the licensing authority. The court allowed the withdrawal and directed the petitioner to file an appeal under Rule 66(2) of the Drugs and Cosmetics Rules, 1945. A stay of the …

S. ATHILAKSHMIversusTHE STATE REP. BY THE DRUGS INSPECTOR

2023 INSC 237Appeal(s) allowed

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 …

HASMUKHLAL D. VORA & ANR.versusTHE STATE OF TAMIL NADU

2022 INSC 1294Appeal(s) allowed

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 …

G H M/S GENENTECH INC. & ORS.versusDRUGS CONTROLLER GENERAL OF INDIA & ORS.

2019 INSC 1391Appeal(s) allowed

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, …

UNION OF INDIA AND ANR.versusPFIZER LIMITED AND ORS.

2017 INSC 1248Disposed off

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 …

COMMISSIONER OF CENTRAL EXCISE, GOAversusM/S. COSME FARMA LABORATORIES LTD.

2015 INSC 287Dismissed

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 …

INDIAN SOAPS & TOILETRIES MAKERS ASSOCIATIONversusOZAIR HUSAIN AND OTHERS

2013 INSC 141Appeal(s) allowed

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 …

M/S. PONDS INDIA LTD. (MERGED WITH H.L. LTD.)versusCOMMISSIONER OF TRADE TAX, LUCKNOW

2008 INSC 719Appeal(s) allowed

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 …

SUBHASHIS BAKSHI AND ANR.versusWEST BENGAL MEDICAL COUNCIL AND ORS.

2003 INSC 86Appeal(s) allowed

The appellants, diploma holders in Community Medical Service, were authorized by a 1980 notification to treat common diseases in rural West Bengal. The State later barred them from issuing prescriptions and medical certificates, requiring counter‑signatures. The diploma holders challenged this …

DR. MUKHTIAR CHAND AND ORS. ETC.versusTHE STATE OF PUNJAB AND ORS.

1998 INSC 385Disposed off

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 …

COMMON CAUSEversusUNION OF INDIA AND ORS.

1996 INSC 20Disposed off

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, …