Cipla's Seroflo Rotacaps Under Scanner as Nepal Seizes Suspected Counterfeit Stocks
New Delhi: Nepal's Department of Drug Administration (DDA) has launched a nationwide crackdown on suspected counterfeit asthma medicines, seizing large quantities of Seroflo Rotacaps 250 from wholesalers and retailers across multiple districts after receiving complaints from the product's manufacturer.
According to reports, the DDA, Nepal's national pharmaceutical regulator, confiscated suspected counterfeit Seroflo Rotacaps 250, a salmeterol and fluticasone propionate powder for inhalation manufactured by Cipla Ltd., from wholesale and retail outlets in Kathmandu Valley, Lalitpur, Rupandehi and Kailali. The medicine is widely prescribed by pulmonologists and critical care physicians for the treatment of asthma and other respiratory illnesses and is among the country's most commonly used respiratory medicines.
Acting Director General of the DDA, Shiwani Khadgi, said the department initiated the operation after receiving complaints from representatives of the pharmaceutical company, who submitted evidence indicating that counterfeit versions of the medicine were being sold at several locations across Nepal.
During the inspection, drug inspectors seized counterfeit medicines bearing batch number 5SA2150 from Ares Pharmaceuticals in Chhetrapati. Batch number 5SA0759 was recovered from Success Medicine Distributors, while batch numbers 5SA2150 and 5SA0759 were seized from Damber Medicine Distributor. Inspectors also confiscated batch number 5SA0759 from Height Tygun Medicine Suppliers Pvt. Ltd.
The regulator further seized medicines carrying batch number 5SA0759 from Lalitpur-based Lifeline Pharma and Distributors Pvt. Ltd. In addition, suspected counterfeit medicines with unknown batch numbers were recovered from Sainamaina Health Centre Pvt. Ltd. in Rupandehi and Bishnu Murti Medical Suppliers in Kailali. The raids conducted in Rupandehi were carried out with the assistance of the Nepal Police.
Drug inspectors reported identifying typographical errors in the literature printed on the packaging of the suspected counterfeit medicines, raising concerns regarding their authenticity.
Khadgi said authorities are yet to determine whether the seized products actually contain the active pharmaceutical ingredients present in the genuine medicine or whether they are therapeutically effective. The department has therefore decided to conduct laboratory testing on all seized samples to establish whether the medicines are genuine or counterfeit.The DDA has also directed its officials to intensify inspections of pharmacies across the country and check for the presence of counterfeit medicines.
According to a recent media report published by The Kathmandu Post, the seizure, suspension and recall of substandard and counterfeit medicines form part of the department's routine risk-reduction activities, with numerous substandard medicines being recalled every year. However, officials acknowledged that staffing shortages limit the regulator's ability to ensure all recalled medicines are promptly removed from the market.
Nepal currently has around two dozen drug inspectors responsible for monitoring nearly 25,000 pharmacies, while also inspecting domestic and international pharmaceutical manufacturing facilities supplying medicines to the country. Officials further noted that the National Medicine Laboratory tests only around 500 medicines annually, despite more than 25,000 medicine brands being available in the Nepalese market, often resulting in delays in detecting substandard or counterfeit medicines and increasing the risk of patients receiving ineffective products.
