Kenya bans pharmaceutical products referenced to Indian Pharmacopeia

KENYA – The Pharmacy and Poisons Board (PPB), Kenya’s statutory drug regulatory authority, has officially banned the trade, importation, distribution, and sale of pharmaceutical products referenced to the Indian Pharmacopeia (IP).

The IP, a statutory body under India’s Ministry of Health and Family Welfare, is responsible for standardizing pharmaceutical products within India.

However, the PPB emphasized that the IP has no regulatory authority in Kenya and that its standards do not meet the country’s legal requirements for drug registration and compliance.

In an advisory issued on January 18, the PPB highlighted concerns over the rising influx of pharmaceutical products citing the IP standard into the Kenyan market without proper regulatory oversight.

The board stated unequivocally that such products fail to comply with Kenyan regulations.

“Note that the Indian Pharmacopeia is not within the purview of drug registration requirements in the country, and as such, products citing this standard are not compliant with Kenyan regulations. Any pharmaceutical product that is not duly registered by the Pharmacy and Poisons Board is strictly prohibited for importation, distribution, sale, or handling in Kenya,” the PPB announced.

The board further warned local pharmaceutical stakeholders against trading or handling unregistered products, including those referencing the Indian Pharmacopeia.

It directed all stakeholders to immediately cease such activities and ensure that all pharmaceutical products in their possession are registered and approved by the PPB in line with the Pharmacy and Poisons Act and other relevant regulations.

Failure to comply with these directives, the board cautioned, would result in strict regulatory actions.

These include the seizure of unregistered products, revocation of licenses, and legal prosecution as stipulated by the law.

“The Pharmacy and Poisons Board will continue to monitor the market and take necessary enforcement actions to ensure compliance with the applicable regulatory framework,” the advisory added.

The PPB serves as Kenya’s principal regulatory body for pharmaceutical activities, mandated by the Pharmacy and Poisons Act, Chapter 244 of the Laws of Kenya.

Its responsibilities include regulating the manufacture, importation, and sale of medical products, as well as ensuring public health safety through strict oversight of pharmaceutical practices.