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ISLAMABAD: The Drug Regulatory Authority of Pakistan (DRAP) in collaboration with the Federal Investigating Agency (FIA) has busted an illegal factory in Karachi producing unregistered Boostin (RBST) injections globally banned.

According to a rapid alert issued here by DRAP, RBST (a synthetic recombinant Bovine Somatotropin hormone) injected into animals for enhancing their milk production was banned in the country owing to serious side effects on the health of animals and impact on those consuming milk and meat of such animals.

The product is also banned in Europe, Canada, Australia, and other countries.

During a joint raid by DRAP and FIA, illegal manufacturing of Boostin injections (Synthetic Recombinant Bovine Somatotrop in Hormone) was unearthed at Chandio Village, Clifton, Karachi. A large quantity of raw materials used in the manufacturing of Boostin Plus 2g injections, finished goods, empty cartridges/containers with needles, packing materials/stickers, and packing machinery were seized from the premises as per Form-2 under Section 18(1) of the Drug Act, 1976.

The Regulatory Field Force has been directed to increase the surveillance activities in markets to confiscate the product. All pharmacists and chemists working at distributions and pharmacies should immediately check the stock and stop supplying this product. The stock should be quarantine immediately, and supplier(s) information should be provided to the Regulatory field force in order to ensure the removal of this products. Regulatory action will be taken against the persons involved in manufacturing/ storage /distribution/sale and use of this product.

DRAP requests increased vigilance within the supply chains of institutions/pharmacies/healthcare facilities likely to be affected by this product.

The DRAP has advised the farmers as well milk and meat consumers to not use this product. They shall contact their physician or healthcare provider(s) if the animal experiences any problem that may be related to using this product.

Meanwhile, the DRAP inline with global commitments has announced a series of training on the national pharmacovigilance system for registration holders including manufacturers and importers aimed at ensuring the safety of therapeutic goods. With its endeavour, Pakistan became the 134th full member of the Programme for International Drug Monitoring (WHO-PIDM), Uppsala Monitoring Centre in 2018.

The DRAP notified Pharmacovigilance Rules, 2022, which outline the roles and responsibilities of pharmacovigilance stakeholders, including registration holders of therapeutic goods. The DRAP has also developed Guidelines on Good Pharmacovigilance Practices for registration holders that outline step-by-step guidelines on the establishment of pharmacovigilance systems in pharmaceutical companies. The NPC has dedicated tools in place for the collection of adverse drug reaction reports (ADRs) from pharmaceutical companies (registration holders) such as E2B XML submission through dedicated email, and hard copy submissions via mailing address.

Despite the above efforts of DRAP, very few pharmaceutical companies have established their pharmacovigilance centres and nominated their qualified persons for pharmacovigilance. Implementing pharmacovigilance rules, 2022, and establishing an effective pharmacovigilance system by all stakeholders, including registration holders is a prerequisite for ensuring the safety of medicines in Pakistan. This will reduce the risks associated with medications, thereby ensuring patient safety. This is why DRAP feels that there is a need to enhance the capacity of registration holders in respect to pharmacovigilance.

In this regard, the NPC, Division of Pharmacy Services, DRAP intends to conduct training of pharmaceutical companies (registration holders) on pharmacovigilance rules, guidelines and pharmacovigilance systems including collection and reporting of pharmacovigilance data. Three virtual training sessions will be conducted in the month of July 2024.

Copyright Business Recorder, 2024

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