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Table 2 Assessment of secondary labels of medicines against the criteria mandated by the National Medicines Regulatory Authority, Sri Lanka

From: Regulatory requirements and labeling of commercially available prescription (oral) medicines in Sri Lanka: there is room for improvement

Criteria to be displayed on the label Yes No NA
General labeling requirements
 The official/generic name in the recommended format (e.g., metformin tablets B.P. 500 mg) 142 (66%) 74 (34%) 0
 The registration number issued by the authority 6 (3%) 210 (97%) 0
 Pack size: the number of doses, weight, or volume contained in the pack 212 (98%) 4 (2%) 0
 The dosage form 216 (100%) 0 0
 Storage temperature 211 (98%) 5 (2%) 0
 The date of manufacture in clear terms (month/year) 216 (100%) 0 0
 The date of expiry in clear terms (month/year) 216 (100%) 0 0
 The batch or lot number 216 (100%) 0 0
 The name of the manufacturer and address of the manufacturing site 214 (99%) 2 (1%) 0
 The name and address of the local agent 85 (39%) 131 (61%) 0
 A special warning to store the product out of reach of children 187 (87%) 29 (13%) 0
General criteria restricted on secondary labels
 The availability of attractive pictures 4 (2%) 212 (98%) 0
 Web addresses 12 (6%) 204 (94%) 0
 Use of over stickers 74 (34%) 142 (66%) 0
Active pharmaceutical ingredient related labeling criteria
 The active ingredient is given by its International Nonproprietary Names (INN) 205 (95%) 11 (5%) 0
 The quantity of each active ingredient expressed in terms of weight, volume, capacity, or units of activity 209 (97%) 7 (3%) 0
 The active substances present as salts are indicated 119 (55%) 52 (24%) 45 (21%)
Product-specific labeling criteria
 Conform with Pharmacopeial labeling requirements 35 (16%) 8 (4%) 181 (80%)
 Any other special warnings and precautions that may be necessary for the medicinal product 1 (0.46%) 3 (1.39%) 215 (98%)
 Specific instructions if the product needs to be reconstituted, diluted, or prepared by any other means prior to its use 4 (2%) 0 212 (98%)
 The period for which the medicine can be used after opening of the container or after reconstitution of the product 4 (2%) 0 212 (98%)
  1. Yes—the claim is relevant to the product and present in the label under evaluation, No—the claim is relevant to the product under evaluation, but it was absent on the label, Not applicable/NA—the claim is not relevant to the product under evaluation