| Chapter 3: Rationality of Drugs | ||
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(vi) Mucoviscidosis is an uncommon condition in India. (vii) These are unnecessary and costly preparations. Essential drug list of WHO (1992) has not mentioned any of these preparations. Recommendations: All these formulations of oral digestive enzymes should be banned immediately with the following exception: only enteric coated preparations of pancreatic enzymes may be allowed for restricted use in properly diagnosed cases of pancreatis and mucoviscidosis under expert supervision. 6) Local Antiseptics Various Preparations of Povidone Iodine, i.e., solutions, mouth washes, scrubs, skin ointments/creams, vaginal pessaries, etc. Brand Name Examples: Alphadine (Nicholas) mouth wash solution, vaginal pessaries, ointment; Betadine (Win-Medicare) mouth wash solution, pessaries, ointment, scrub; Wokadine (Wockhardt) solution, pessaries, ointment, powder, gargle, scrub; Piodin (Croydon) solution, cream, mouth wash; Povidax (Unique) solution, mouth wash; Torvidone (Torrent) solution, cream; and several such others. Comments: (i) Povidone-iodine is an iodophore, a loose complex of iodine with poly-vinyl-pyrrolidone. A 10 percent solution is a stable one and when diluted 10 to 100 times with water, it sets iodine in free form which is effective as a germicidal. After such dilution, activity of povidone-iodine increases 10 fold (which is still only 1/15th of the activity of 2 percent tincture of iodine.) [Goodman-Gillman, 1985, 7th edition]. (ii) Considering
the above facts:
Recommendations: (i) Ban preparations like creams, ointments, pessaries. (ii) Allow the formulations like scrubs and solutions in appropriate strength, that is, 10 percent, with clear cut instructions on its use, that is dilute with water by 10 to 100 times before use. In addition to the above, the following categories of drugs also need to be banned/rationalised: 7) FDCs of Antiasthmatic Drugs 8) FDCs of
Antacids 10) Topical Anticoagulants 11) Oral/Injectable Haemostatics except Vitamin K 12) Cerebral Activators such as Pyritinol and Piractecam (Torrent) 13) Cerebral Vasodilators 14) Placentrex (Albert David) and products based on human/animal placenta 15) Ginseng and other such so-called sexual rejuvenators 16) Presence of Alcohol not required as solvents 17) Entire categories of products under the so-called label of Nutritional Supplements. 18) Drugs (of non-modern medical systems) approved by the FDA purporting to cure snake bites, increase semen, increase the risk of abortion, increase fertility, etc. Source: Additional Affidavit of LOCOST in Supreme Court Writ Petition No.698/93, Drug Action Forum and ors versus UOI and ors
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