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Kenya Tightens Rules on Indian Pharmacopoeia-Based Drugs

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NAIROBI, Kenya- The Pharmacy and Poisons Board (PPB) of Kenya is taking a bold step to safeguard public health. 

On Saturday, January 18, the regulatory body announced stringent measures to address the influx of unregistered pharmaceutical products in the Kenyan market.

At the center of this crackdown are drugs referencing the Indian Pharmacopoeia (IP), a widely used drug standardization method in India. 

The Board clarified that IP standards do not align with Kenya’s pharmaceutical registration requirements, marking a major shift in how imported medications are evaluated.

According to the PPB, a rising number of pharmaceutical products entering the Kenyan market fail to meet the country’s regulatory standards. 

These products, often citing IP as their reference for drug quality, have now been deemed non-compliant.

“The Indian Pharmacopoeia is not within the purview of drug registration requirements in Kenya,” the Board emphasized in a statement, adding that such products are prohibited under local laws.

The Board’s mandate includes ensuring public health by regulating pharmaceutical products. 

To enforce compliance, it has issued strict orders to pharmaceutical stakeholders, prohibiting the sale, distribution, importation, or handling of unregistered drugs.

Medical practitioners and stakeholders are now required to ensure that all pharmaceutical products in their possession are registered and approved by the Board

“Failure to comply will attract regulatory actions, including seizure of products, license revocation, and possible prosecution,” warned the Board.

To back these new measures, the PPB has reiterated its commitment to market surveillance and enforcement. 

It has also urged the public to report any suspicious activities related to unregistered drugs through its communication channels.

This move by the PPB is a critical step in strengthening Kenya’s healthcare system and protecting its citizens. 

By cracking down on non-compliant pharmaceutical products, the Board aims to set a higher standard for drug quality and safety in the country.

As Kenya’s pharmaceutical landscape undergoes this shift, the stakes are high for stakeholders and medical practitioners to adapt quickly. 

With these new regulations in place, the PPB is making its intentions crystal clear: only compliant and safe pharmaceutical products will make the cut in Kenya.

George Ndole
George Ndole
George is an experienced IT and multimedia professional with a passion for teaching and problem-solving. George leverages his keen eye for innovation to create practical solutions and share valuable knowledge through writing and collaboration in various projects. Dedicated to excellence and creativity, he continuously makes a positive impact in the tech industry.

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