Drugs and Cosmetics Rules, 1945

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 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…

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 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 …

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 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 restriction, arguing that…

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 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 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 …

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…