Gov't bans importation, sale of drugs citing Indian standards

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

The Indian Pharmacopeia is a set of standards and guidelines for medicines and health products used in India, which specify the quality, safety and efficacy requirements for drugs that are manufactured and sold in India.

“The Board’s attention has been drawn to an increasing influx of unregistered pharmaceutical products in the Kenyan market, particularly those referencing the Indian Pharmacopoeia. Note that 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 said in a public notice on Friday.

According to PPB, while the IP serves an essential role in regulating the pharmaceutical industry within India, it does not hold any regulatory authority in Kenya.

“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," said PPB.

The board subsequently warned local pharmaceutical companies against trading, importing or handling unregistered medicinal products within the country.

“All stakeholders are hereby directed to: Cease and desist from trading, importing, or handling any unregistered products, including those with references to the Indian Pharmacopoeia,” added the statement.

“Ensure that all pharmaceutical products in your possession are duly registered and approved by the Pharmacy and Poisons Board, adhere to the requirements outlined in the Pharmacy and Poisons Act and any other relevant regulations.”

According to PPB, failure to comply with the directive will attract severe regulatory actions, including the seizure of products, revocation of licenses and prosecution as stipulated under 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,” said PPB.  

“For further clarification or to report non-compliance, please contact the Pharmacy and Poisons Board through the provided official channels...”