PPB prohibits sale of unregistered drugs in Kenya

KENYA—The Pharmacy and Poisons Board (PPB) has issued a strict directive prohibiting importing, distributing, selling, or handling pharmaceutical products not officially registered with the Board.

This announcement comes amid growing concerns over the rise of unregistered pharmaceutical products flooding the Kenyan market, especially those referencing the Indian Pharmacopeia (IP).

The Indian government has established the Indian Pharmacopoeia Commission (IPC), an autonomous body tasked with publishing the Indian Pharmacopoeia.

This official book sets the standards for drugs in India, including their identity, purity, and strength.

It is a key reference for regulating drugs within India’s borders, as specified under the Second Schedule of the Drugs and Cosmetics Act of 1940.

However, products adhering to these Indian standards are not automatically compliant with Kenyan regulations, as the Indian Pharmacopeia is not recognized under Kenyan law for drug registration purposes.

Dr. F. W. Siyoi, CEO of the Pharmacy and Poisons Board, emphasized that the Board is statutorily mandated to protect public health by regulating the pharmacy profession and ensuring access to safe, effective, and affordable health products in Kenya.

He clarified that any pharmaceutical products referencing the Indian Pharmacopeia do not comply with local registration requirements, making them illegal for trade or sale in the country.

In response to this issue, Dr. Siyoi has directed all stakeholders in the pharmaceutical industry to cease and desist from trading, importing, or handling unregistered products, including those citing the Indian Pharmacopeia as a standard.

 He further urged stakeholders to ensure that all pharmaceutical products in their possession are duly registered and approved by the Pharmacy and Poisons Board.

To avoid legal repercussions, stakeholders must adhere to the Pharmacy and Poisons Act requirements and any other relevant regulations.

Failure to comply with these directives could result in severe regulatory actions, including the seizure of products, revocation of licenses, and prosecution, as stipulated by Kenyan law.

Dr. Siyoi assured the public that the Pharmacy and Poisons Board will continue to monitor the market closely and take necessary enforcement actions to ensure full compliance with the regulatory framework, thereby safeguarding the health and safety of all Kenyans.

Sign up HERE to receive our email newsletters with the latest news and insights from Africa and around the world, and follow us on our WhatsApp channel for updates.