Health Ministry warns against sale of drugs standardised in India

The Ministry of Health, through the Pharmacy and Poisons Board (PPB), has warned against the importation and sale of unregistered health products in Kenya, particularly those referencing the Indian Pharmacopoeia (IP).

In a statement released on Friday, the board’s Chief Executive Officer, Fred Siyoi, highlighted growing concerns over the influx of such products into the local market.

The Indian Pharmacopoeia, a set of standards used to regulate drugs in India, sets quality, safety, and efficacy requirements for medicines sold within the country.

However, according to the PPB, these standards are not applicable in Kenya.

Siyoi emphasised that products citing the Indian Pharmacopoeia do not meet Kenyan registration requirements and therefore cannot be legally sold, imported, or distributed in the country.

“The Indian Pharmacopoeia 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,” said Siyoi.

He further warned pharmaceutical stakeholders—including manufacturers, distributors, and retailers—to refrain from handling or trading in such unregistered products.

Siyoi’s statement reiterated that all pharmaceutical products sold or distributed in Kenya must be approved by the Pharmacy and Poisons Board in compliance with the Pharmacy and Poisons Act and other relevant regulations.

The board also underscored that failure to adhere to these directives would result in significant penalties, including the seizure of unregistered products, revocation of licenses, and legal prosecution.

“Failure to comply with this directive will attract severe regulatory actions, including but not limited to seizure of products, revocation of licenses, and prosecution as stipulated under the law,” warned Siyoi.

He also urged medical professionals to be cautious and ensure that any pharmaceutical products they handle are properly registered with the PPB.

The board also emphasised that products that are not duly registered by the PPB are strictly prohibited from entering the market.