Rapid Alert
Unregistered and Falsified Cosmetic Cream Containing Unauthorized Pharmaceutical Ingredient(s)
| DRAP Alert No | No I/S/01-26-128 |
| Action Date | 14 January , 2026 |
| Target Audience | 1. Regulatory Field Force of DRAP and Provincial Drug Control departments. 2. Healthcare Professionals 3. Pharmacies and medical stores |
| Problem Statement | Central Drugs Laboratory (CDL) Karachi informed that Laboratory analysis of Below mentioned Cream, marketed for skin fairness and treatment of skin darkness (cosmetic products) & a Gel marketed for pain relief, confirmed the presence of steroids (prescription-only corticosteroid). These products were being marketed as a cosmetic without declaring this pharmaceutical ingredient and without registration or authorization from the Drug Regulatory Authority of Pakistan (DRAP). The presence of a potent medicinal substance in a cosmetic product constitutes misrepresentation of identity, composition, and regulatory status, rendering the product an Unregistered and Falsified Drug Product under the Drugs Act, 1976. |
The product identification d
| S# | Product Name | Batch No. | Manufacturer | Remarks |
| 1. | Eventone-C Cream | 12706 | M/s Pharma Health Pakistan Pvt. Ltd. | The sample has been declared “Un-registered/falsified” under the Drugs Act 1976 because Hydrocortisone has been identified as suspected by Federal Inspector of Drugs. |
| 2 | LUFA Advanced Pain Relief Gel | 25C372 | M/s ASR Global Traders | The sample has been declared “Un-registered/falsified” under the Drugs Act 1976 because Betamethasone has been identified as suspected by Federal Inspector of Drugs. |
etails are as under: –
| Risk Statement | The identification of hydrocortisone in Eventone-C Cream and betamethasone in LUFA Advanced Pain Relief Gel, both of which are prescription-only corticosteroids, in products being marketed without registration or authorization poses a serious public health risk. Use of these substances without medical supervision may result in skin thinning, steroid-induced acne, pigmentation disorders, delayed wound healing, suppression of local immunity, masking of infections, and worsening of underlying skin diseases. As these products are falsely presented as ordinary cosmetic and topical preparations, users are unknowingly exposed to potent pharmaceutical agents, increasing the risk of prolonged misuse, dependency, and irreversible skin damage, particularly in women, children, and long-term users. |
| Action Initiated | The Regulatory Field Force has been directed to conduct surveillance activities to confiscate the abovementioned falsified product. All Pharmacists, chemists, and other healthcare professionals working at distributions, pharmacies, healthcare facilities, and other aspects of the supply chain system should immediately check the stock, and information related to the suppliers of such products should be provided to the Regulatory field force (DRAP, Provincial Drug Control Departments) to ensure the removal of these product from the circulation. |
| Advice for Healthcare Professionals | DRAP requests healthcare professionals to have increased vigilance within the supply chains of institutions/pharmacies/healthcare facilities likely to be affected by above mentioned product. Any adverse events or quality problems experienced with the use of these products should be reported to National or Provincial pharmacovigilance centers using Adverse Event Reporting Form or online through this link. Further information on reporting problems to DRAP is available on this link. |
| Advice for Consumers | Parents, caregivers, pharmacies, retailers, and online sellers are strongly advised to immediately check product names and batch numbers, stop use and sale of affected batches, and remove them from circulation. Consumers who have already used these products and observe any adverse symptoms in infants should seek immediate medical attention and report the case to the relevant health authority. This alert is issued in the interest of public health and infant safety, and dissemination through healthcare facilities, pharmacies, online platforms, and social media is strongly recommended. |