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]
- AIDS
- Angina Pectoris
- Appendicitis
- Arteriosclerosis
- Blindness
- Blood poisoning
- Bronchial asthma
- Cancer and benign tumour
- Cataract
- Change in colour of hair and growth of new hair
- Change of foetal sex by drugs
- Congenital malformations
- Deafness
- Diabetes
- Diseases and Disorders of the uterus
- Epileptic fits and psychiatric disorders
- Encephalitis
- Fairness of the skin
- Form and structure of the breast
- Gangrene
- Genetic disorders
- Glaucoma
- Goitre
- Hernia
- High/low blood pressure
- Hydrocele
- Insanity
- Increase in brain capacity and improvement of memory
- Improvement in height of children/adults
- Improvement in size and shape of the sexual organ and in duration of sexual performance
- Improvement in the strength of the natural teeth
- Improvement in vision
- Jaundice/Hepatitis/Liver disorders
- Leukaemia
- Leucoderma
- Maintenance or improvement of the capacity of the human being for sexual pleasure
- Mental retardation, subnormalities and growth
- Myocardial infarction
- Obesity
- Paralysis
- Parkinsonism
- Piles and Fistulae
- Power to rejuvenate
- Premature ageing
- Premature greying of hair
- Rheumatic heart diseases
- Sexual impotence, premature ejaculation and spermatorrhoea
- Spondylitis
- Stammering
- Stones in gall-bladder, kidney, bladder
- 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 allowed 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]
References
- "Drugs and Cosmetics Act, 1940" (PDF). Central Drugs Standard Control Organization. Archived from the original (PDF) on 31 October 2005. Retrieved 19 February 2015.
- "HC restrains manufacture, marketing of Immuno-QR". The Hindu. 21 December 2001. Retrieved 21 February 2015.