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