Regulatory considerations for Over-the-Counter Drugs in India and USA: A critical study

1. REGULATORY CONSIDERATIONS FOR OVER-THE-COUNTER DRUGS IN INDIA & USA: A CRITICAL STUDY Supervised by: Prof. (Dr.) Arun Nanda Head, Department Of Pharmaceutical Sciences & Dean, Faculty of Pharmaceutical sciences, Maharshi Dayanand University, Rohtak (Haryana) Submitted by: Vibha Sharma M. Pharmacy, Pharmaceutics (Drug Regulatory Affairs) Regn. No. 04-GPS-53

2. introduction

3. Over-the-counter drugs

4. Patients’ behavior in illness

6. Examples: Omeprazole 20mg, Bisacodyl 5mg, etc.No legal recognition Defined by negative implication Drugs that are not included in the list of Prescription drugs i.e. Schedule H, G and X, are considered as OTC drugs Examples: Bisacodyl, Hyoscine, Paracetamol etc.

7. Difference between Rx & otc drugs

8. Characteristics of otc drugs

9. Criteria to classify drugs as otc drugs: usa

13. Reasons for interest in otc drugs

14. Otc drugs list

16. There is no official list of Therapeutic categories of OTC drugs

18. Otc drugs list in usa (monograph category list)

20. all the drugs that are not included in the list of ‘prescription only drugs’ are considered as non-prescription drugs (or OTC drugs)

21. According to Drug & Cosmetic Act, 1940 and Drug and Cosmetics Rules,1945, prescription drugs are enlisted in-

22. Schedule H- Prescription Drugs

23. Schedule X- Narcotic Drugs

25. Otc drugs list in india

26. Regulations for otc drugs

27. Marketing authorization of otc drugs in india

28. Documents needed to be submitted for the approval of a New Drug in India 1. INTRODUCTION A brief description of the drug and the therapeutic class to which it belongs. 2. CHEMICAL AND PHARMACEUTICAL INFORMATION. 2.1 Chemical name, code name or number, if any, non-proprietary or generic name, if any, structure, physio-chemical proportion. 2.2 Dosage form and its composition. 2.3 Specifications of active and inactive ingredients. 2.4 Tests for identification of the active ingredient and method of its assay. 2.5 Outline of the method of manufacture of the active ingredient. 2.6 Stability data 3. ANIMAL PHARMACOLOGY 3.1. Summary 3.2. Specific pharmacological actions. 3.3 General pharmacological actions. 3.4. Pharmacokinetics, absorption, distribution, metabolism, excretion. 4. ANIMAL TOXICOLOGY 4.1. Summary 4.2 Acute Toxicity 4.3. Long Term Toxicity 4.4 Reproduction Studies. 4.5 Local Toxicity 4.6. Mutagenicity and Carcinogenicity.

29. 5. HUMAN/CLINICAL PHARMACOLOGY (PHASE I). 5.1. Summary 5.2 Specific Pharmacological effects. 5.3 General Pharmacological effects. 5.4. Pharmacokinetics, absorption, distribution, metabolism, excretion. 6. EXPLANATORY CLINICAL TRIALS (PHASE II). 6.1 Summary 6.2 Investigator wise reports. 7. CONFIRMATORY CLINICAL TRIALS (PHASE III) 7.1 Summary 7.2 Investigator wise reports 8. SPECIAL STUDIES 8.1 Summary 8.2 Bioavailability and dissolution studies. 8.3 Investigator wise reports. 9. REGULATORY STATUS IN OTHER COUNTRIES. 9.1 Countries where – (a) Marketed (b) Approved. (c) Under trial, with phase. (d) Withdrawn, if any, with reasons. 9.2 Restrictions on use, if any, in countries where marketed/approved. 9.3 Free sale certificate from country of origin. 10. MARKETING INFORMATION. 10.1 Proposed product monograph 10.2 Drafts of labels and cartons. 10.3 Sample of pure drug substance, with testing protocol.

30. Regulations concerning Advertisements of otc drugs in india

31. Price control of otc products

33. Otc drug review process

34. Otc drug review process OTC Drug Review Process consists of 3 phases:

35. OTC DRUG REVIEW PROCESS

38. Nda vs. Otc drug monograph process NDA OTC Monograph

40. dosage strength

41. dosage form

42. Labeling requirements

43. indications

45. Labeling of otc drugs

46. Importance of a label

47. Labeling regulations for otc drugs in india

49. A correct statement about the net content in terms of weight, measure, volume, no. of units of activity, no. of units of content, etc.

50. The content of active ingredient(s).

51. The name and address of the premises of manufacturer.

52. Batch or lot no. preceded by the words “Batch No.” or “B No.” or “Lot No.” or “Batch” or “Lot”

53. Manufacturing License Number preceded by the words “Mfg.Lic.No.” or “M.L.”

54. Manufacturing Date and Expiry Date

56. Content of an otc label Purpose General pharmacological category(ies)or the principal intended action(s) of the drug.

58. The title, headings, and subheadings shall be left justified.

59. Minimum type size

60. For Title: a type size larger than the largest type size

61. For Headings: at least 8 point or 2 points larger than text

62. For Text and Subheadings: at least 6 point

64. When there is more than one statement, each individual statement listed under the headings and a solid square or solid circle bullet of 5-point type size shall precede subheadings. Bullets shall be presented in the same shape and color throughout the labeling.

65. Graphical images and information shall not appear in or in any way interrupt the required title, headings, subheadings, and information of this section. Hyphens shall not be used except to punctuate compound words.

66. The information shall be set off in a box or similar enclosure by the use of a bar line. A distinctive horizontal bar line extending to each end of the "Drug Facts" box or similar enclosure shall provide separation between each of the headings.

68. Prescription-to-otc switch

69. Prescription-to-otc switch (usa)

70. Rx-to-otc switches are motivated mainly by three factors:

72. The drug should have favourable adverse-event and drug-interaction profiles, relatively low toxicity and a low potential for abuse. This information is derived from clinical trial results and post-marketing safety surveillance data, and it is submitted to the FDA by the manufacturer of the product.

74. Before that time, the decision was left up to drug manufacturers, who often had different ideas about the same drug formulation, leading to confusion within the medical community.

75. Today, a drug making the Rx-to-OTC switch goes through a careful review process to predict its safety for a person’s self-diagnosis and self-treatment.

76. There are 3 methods of switching a Rx drug to OTC drug, which are following:

77. A petition.

78. OTC Drug Review.

80. Otc drug review process

82. the FDA determines whether the drug has been shown to be safe and effective for OTC use.

84. Rx-to-otc list

86. lower health care costs.

87. newly FDA-approved use can extend their patents on the drugs and provide periods of market exclusivity. A drug company can get a 3 year period of market exclusivity, in which no generic applications may be approved, if the company pioneers a new drug through an NDA or supplemental NDA.

89. Disadvantages- india

90. Branded versus generic otc drug product

91. Branded & generic product- usa

92. Branded & generic product- india

94. The use of generic drugs can add up to marked savings for everyone in general but particularly for the elderly who generally take more medications than the young and have less available income for such items.

95. Generic drugs do not have unfavourable effects more than their branded counter parts on an individual.

96. It is safe and as effective as the name brand medication.

97. The chemical makeup, dosage and the method in which the medication should be taken is the same as the brand name medication.

98. It can lower the cost of healthcare overall with the same results.

100. All medications are not available in generic formulation.

101. Not suitable for drugs with narrow therapeutic window.

104. Status of Bisacodyl as OTC in India & USA

105. Evaluation tests- indian Pharmacopoeial monograph Weight variation test (Branded Product- Dulcolax)

106. Weight variation test (Generic Product- Bisomer 5)

107. Uniformity of content Test (Branded Product- Dulcolax)

108. Uniformity of Content Test (Generic Product- Bisomer 5)

109. Assay Standard Calibration Curve Concentration (mcg/ml)

111. Dulcolax (Branded product)

112. 0.1M hydrochloric acid = do not disintegrate for 2 hrs

113. 1.5%w/v Sodium bicarbonate = disintegrate in 45 min

114. Bisomer 5 (Generic product)

115. 0.1 M hydrochloric acid = do not disintegrate for 2 hrs

117. Conclusions and recommendations

119. USA INDIA

120. USA INDIA

121. Potential rx-to-otc switches in usa

122. Generic VS. Branded OTC drugs

124. Government should take care that any OTC drug in India does not have a blanket OTC cover, instead, use of any drug as OTC be specifically restricted to only specified or recommended doses, indications, therapeutic categories, etc.

125. The label of an OTC drug must contain essential information on the lines of US FDA guidelines for OTC drugs. In particular, patient help line or drug information centre numbers must be included on the label of OTC drug in India.

126. It is highly recommended that the concept of OTC drugs in India, should be modified to OPC drugs i.e., Over-the-Pharmacist’s Counter.

127. An OTC drug should have a distinct mark on its label, for identification as OTC drug.

128. Government should fix up guidelines and criteria for Rx-to-OTC switch and may provide some benefits in this regard on the lines of USFDA guidelines.

129. Government should promote the distribution of OTC drugs through non-licensed drug stores.

130. Government should take steps to make strict regulations for manufacturing, marketing and promotion of generic OTC drugs. Like Jan Aushadhalaya - the generics pharma shop by government of India, opened in government hospitals in various cities, generic medicines are available to patients at cheaper affordable prices than market prices. These generic drugs counter are open for 24×7 under the supervision of a registered medical practitioner.