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 Case Digest

Drugs and Cosmetics Act, 1940
Section 26-A—Ban order
Section 26-A—Ban order
Notification issued by the Union of India, Ministry of Health and Family Welfare, imposing a ban on the manufacture, sale and distribution of a drug by name “Gatifloxacin”—in challenge - The Central Government claims to have been satisfied that the use of the drug in question was likely to involve certain risks to human beings and that in view of the availability of safer alternatives, the Government thought it necessary and expedient to ban the drug in public interest—the power of the Central Government under Section 26A is legislative in nature—held that where there is scientific uncertainty as to the existence or extent of risks to human health, Community institutions may, by reason of the precautionary principle, take protective measures without having to wait until the reality and seriousness of those risks become fully apparent, therefore, the decision taken by the Sub-committee comprising of 10 experts, is sufficient to satisfy the precautionary principle—impugned order of the Central Government not interfered—writ petition dismissed.
Macleods Pharmaceuticals Limited and another vs. Union of India and another, Madras High Court, 2013 (1) Drugs Cases (DC) 1


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