Schedule J

The Schedule J of the Drugs and Cosmetics Rules, 1945 of India contains a list of diseases and ailments which a drug may not claim to prevent or cure. Under Rule 106 of the Drugs and Cosmetics Act, 1940, a drug cannot make claims to treat or prevent any of the diseases or reform the conditions listed.[1]

List

According to the last changes introduced in 1996 by the Government of India by the Notification No. G.S.R. 21(E), the list as follows:[1]

  1. AIDS
  2. Angina Pectoris
  3. Appendicitis
  4. Arteriosclerosis
  5. Blindness
  6. Blood poisoning
  7. Bronchial asthma
  8. Cancer and benign tumour
  9. Cataract
  10. Change in colour of hair and growth of new hair
  11. Change of foetal sex by drugs
  12. Congenital malformations
  13. Deafness
  14. Diabetes
  15. Diseases and Disorders of the uterus
  16. Epileptic fits and psychiatric disorders
  17. Encephalitis
  18. Fairness of the skin
  19. Form and structure of the breast
  20. Gangrene
  21. Genetic disorders
  22. Glaucoma
  23. Goitre
  24. Hernia
  25. High/low blood pressure
  26. Hydrocele
  27. Insanity
  28. Increase in brain capacity and improvement of memory
  29. Improvement in height of children/adults
  30. Improvement in size and shape of the sexual organ and in duration of sexual performance
  31. Improvement in the strength of the natural teeth
  32. Improvement in vision
  33. Jaundice/Hepatitis/Liver disorders
  34. Leukaemia
  35. Leucoderma
  36. Maintenance or improvement of the capacity of the human being for sexual pleasure
  37. Mental retardation, subnormalities and growth
  38. Myocardial infarction
  39. Obesity
  40. Paralysis
  41. Parkinsonism
  42. Piles and Fistulae
  43. Power to rejuvenate
  44. Premature ageing
  45. Premature greying of hair
  46. Rheumatic heart diseases
  47. Sexual impotence, premature ejaculation and spermatorrhoea
  48. Spondylitis
  49. Stammering
  50. Stones in gall-bladder, kidney, bladder
  51. Vericose vein

Notable verdicts

The Kerala High Court in December 2001 responding to a Public Interest Litigation restrained one T. A. Majeed, proprietor of the Kochi-based Fair Pharma, from manufacturing and marketing a drug called Immuno-QR, which he claimed to cure HIV/AIDS, or any drug under Schedule J. The manufacturer held a patent for a drug for treating general weakness and fatigue, but not AIDS. The petitioners, People's Union for Civil Liberties, had asked the court the manufacturers should be allow to sell the Ayurvedic drug only after it has undergone clinical trials, under the supervision of National Institute for Communicable Diseases and the Centre for Advanced Research in Virology.[2]

See also

References

  1. 1.0 1.1 "Drugs and Cosmetics Act, 1940" (PDF). Central Drugs Standard Control Organization. Retrieved 19 February 2015.
  2. "HC restrains manufacture, marketing of Immuno-QR". The Hindu. 21 December 2001. Retrieved 21 February 2015.