How To Start A Pharmaceutical Company In Kenya
How To Start A Pharmaceutical Company In Kenya – Kenya is currently the largest producer of pharmaceutical products in the Common Market for Eastern and Southern Africa (COMESA) region, supplying about 50% of the regions’ market.
The pharmaceutical industry in Kenya is booming. Scientific and technological improvements are the driving force in pharmaceutical innovation. But what does this mean for you? It means there are more opportunities than ever for those looking to break out and start their own pharmaceutical distribution business in Kenya.
The Pharmaceutical Industry in Kenya is growing at a very high rate and there is a huge potential and opportunities for manufacturers, distributers, exporters and importers start a pharmaceutical company in Kenya. The distribution of pharmaceutical products has been increasing over the years.
The Pharmaceutical industry and business is a highly regulated industry which has quite a number of governing Laws and Regulations which include but are not limited to the following:-
- The Pharmacy and Poisons Board of Kenya regulates the trade in medical products and health technologies. We have the Pharmacy and Poisons ACT, CAP 244 laws of Kenya, which makes provision for the control of the Pharmaceutical Profession and the trade in drugs and poisons.
There are 3 major categories to choose from when looking to Start a pharmaceutical company in Kenya. They include;
- Manufacturers;
- Distributors and
- Retailers
The pharmaceuticals industry in Kenya is worth over $500 million and is expected to grow at a compound annual growth rate (CAGR) of 11.8%. Prescription drugs account for around 78% of the market. However, the fastest growth in the coming years is expected in the over-the-counter (OTC) product sales.
Pharmaceutical distribution companies in Kenya can most easily be described as the intermediary between the drug manufacturing company and the retail pharmacy or end user. This industry is recession proof, making it an incredibly advantageous venture for any savvy entrepreneur.
Individuals and Companies Allowed to Start a Pharmaceutical Company in Kenya include;
- A duly registered and licensed pharmacist or a Pharmaceutical Technologist who can own the business.
- A partnership with a person/company for which the superintendent pharmacist must be the majority shareholder and proof of the same attached in the form of an affidavit.
- A registered company in Kenya company that is engaged in the manufacture and or distribution of drugs.
- A representative of a person engaged in the sale and supply of pharmaceuticals subject to being issued with of a permit by the Board
- A duly qualified medical practitioner, dentist or veterinary surgeon who satisfies the Pharmacy and Poisons Board that he is urgently in need of a drug or medicine, which he is unable to obtain in Kenya.
Premises That Can Be Registered To Be Used For Pharmaceutical Operations in Kenya?
- Premises for carrying on the business of a pharmacist.
- Premises for carrying on the business of a pharmacy as either wholesale or retail.
- Premises for carrying on the business of a pharmaceutical technologist.
- Premises for manufacturing pharmaceutical drugs.
Requirements Start A Pharmaceutical Company In Kenya include;
- One should have a fully registered business by either sole proprietorship, partnership or limited company.
- Application in writing for registration of premises and filling of the prescribed forms
- Copies of academic certificates of the superintendent pharmaceutical technologist. A copy of diploma/degree certificate in pharmacy must be included
- A copy of enrolment certificate by Pharmacy & Poisons Board of Kenya for the superintendent pharmaceutical technologist
- Floor plan of the premise
- The recommended equipment’s must be in place
- A copy of the recommended Reference books at the premise
Once all this is done the Pharmacy and Poisons Board shall then review the application forms and documents. In addition, the board may arrange a one on one panel meeting/interview for the applicant by the practice committee of the board.
A pharmaceutical inspector will be sent to assess the suitability of the intended business and conduct an inspection of the proposed premises.
Upon completion of the evaluation, process the Pharmacy and Poisons Board can either issue the annual certificate of registration of premises or advise the applicant in writing in case of unsuccessful application and clearly state the reason the application was unsuccessful.
If the application was unsuccessful, the applicant is given an opportunity to revise and comply and if the applicant is able to revise the application and comply, a license will be issued.
CONCLUSION
The regulations developed by the Government of Kenya aim at ensuring good distribution practices, transportation of pharmaceuticals and also for safe management of pharmaceutical waste.
We are hope that this article will guide you through on how Start A Pharmaceutical Company In Kenya. We wish you all the best as you kick start this exciting journey, feel free to Contact Us for more clarification on the process.
