New Opportunities in the 2017 licensing guidelines
Question 1. Why is NDA so engrossed in issuing annual licensing guidelines?
Answer.The National Drug Authority was established by an Act of Parliament Cap 206 of the Laws of Uganda to ensure the availability at all times of essential, efficacious and cost-effective drugs to the entire population of Uganda as a means of providing satisfactory health care and safeguarding the appropriate use of drugs.
Therefore in order to adequately operationalize the law, the Authority prepares licensing guidelines annually,which are easy to implement because they involve a great extent of public engagement.
Question 2. Most drug shops and pharmacies are based in Kampala, and urban centres, how do these guidelines or NDA facilitate access of drugs to the upcountry or rural population?
Answer.It is true pharmacies are largely located in urban areas while drug shops are predominantly in the rural areas. This is because of the nature of the respective outlet requirements. Drug shops are only allowed to operate in areas that are not sufficiently served by pharmacies and stock only a limited stock of class c drugs. Class C drugs are provided for in the National Drug Policy and Authority Act (CAP 206) under the third schedule.
In a bid to increase access to essential medicines to the rural population, NDA introduced the strategy of equitable distribution of pharmaceutical services which involves, limiting opening pharmacies in areas considered to be sufficiently served, and also charging reduced fees for applicants from upcountry and rural areas. This has resulted into an increase in the number of outlets that have been opened up in the country side.
Question 3. What business opportunities does NDA avail those who wish to establish outlets in upcountry areas or can an individual own one, even when he/she has never attended medical school?
Answer. The current system does not define or restrict ownership of pharmaceutical business. So it is true anyone can own a pharmacy or drug shop even without medical background provided they recruit qualified staff as provided in the Licensing Guidelines, to run the business.
This means only qualified personnel are required to operate pharmaceutical outlets and the premises should also reflect the professional services offered. Therefore the guidelines are issued to help those who operate or intend to operate pharmaceutical businesses understand the requirements.
Question 4. What new changes are you instituting in the 2017 guidelines compared to the current one?
Answer. The Guidelines are reviewed annually and the 2017version does not differ much from the previous guidelines; but definitely some sections were not carried over into the new guidelines while new positions were adopted. The remarkable ones include: restriction on opening of new outlets in Kampala and Municipalities, licensing of herbal outlets, licensing of pharmacies in private hospitals and medical centers and lastly, the introduction of online applications. These are expected to help improve the regulation of drugs in the country, increase access to under served areas and also reduce the time taken to process licenses.
Question 5. What are the requirements for licensing a drug shop or pharmacy?
There is a set of requirements that one has to meet before they are allowed to open a pharmaceutical business. These are listed in the Licensing Guidelines but the critical ones are the distance from existing licensed outlets, minimum acceptable floor area and qualification of the person in-charge.
Question 6. Who are the professional staff that are supposed to manage a drug shop or pharmacy?
Answer. In order to operate a drug outlet there is need for qualified professionals who by law assume the responsibility for all activities particularly those that are regulatory in nature related to that business. Pharmacies whether human or veterinary, are supervised by a registered pharmacist who lives in Uganda. The pharmacy is also required to have other qualified staff including pharmacy technicians, nurses or veterinary surgeons (in case of a veterinary pharmacy), to deputize the pharmacist. Drug shops are required to have professionals with approved medical, pharmaceuticalor veterinary qualification who must be active members of their professional councils.
Question 7. How much does one have to pay to operate a drug shop or pharmacy?
Answer. The fees charged vary depending on the type of business and location. There has not been a change in the fees structure as these are stipulated in the Fees Regulations, 2014. For instance, new drug shop applicants pay between Ug.shs 112,500 to 255,000 depending on the location. New retail pharmacy applicants within Kampala Central Division pay Ug.shs.1,660,000, while for other divisions, NDA charges Ug.shs. 945,000.
Question 8. Where can one access the licensing forms, does one have to travel from wherever to Kampala to collect these forms?
Answer. In order to bring services closer to the people,NDA has seven (7) regional offices: in Kampala for central, Jinja for South Eastern,Tororo for Eastern, Lira, for Northern, Arua, for West Nile, Hoima, for Western and Mbarara for South Western. This is mainly for purposes of licensing and post market surveillance, so depending on your location and service you seek,you may not need to travel to Kampala.
Question 9. You require operators to apply for license renewal at least two months before the expiry of the current licenses, and to close operations if licenses have not been renewed by the 31st Jan 2017. With your current human resource limitations, how do you manage to inspect all the 12,000 outlets in the remaining time? I foresee many pharmacies or drug shops still operating after the statutory deadline.
Answer. Yes, we have over time required operators who intend to continue running existing licensed outlets to apply for renewal before the expiry of their current licenses. This enables us to adequately plan our resources and avoid delays in the licensing period. It is important to note that no facility is issued a licensed before inspection whether new applicant or for renewal purposes. Our clients understand this, and we encourage earlier submissions before deficiencies are noted during inspection. It provides operators enough time to address the deficiencies and have their license processed on time. This is very important especially for those dealing in importation and exportation of drugs, as regulators in other countries may require an operating license or import/export license. The drug inspectorate department understands the enormous effort required when the licensing cycle starts and the best strategies to be employed to have all outlets licensed within the defined timelines.
Question 10. I understand, you have instituted an online application system, what is your expected lead processing time?
Answer. The online application system has been in the pipeline for quite a while and starting December 2016, it will be rolled out.Extensive stakeholder engagements have been made with some still on going to provide an understanding of how the system will work and also address any potential hitches. So when operational, we expect our clients to apply online and then track the progress along the licensing system. We expect this system to drastically reduce the lead-time in licensing to meet the targets indicated in the licensing guidelines.
Question 10.Your Licensing Guidelines provide for herbalists, but it is not clear on requirement specifics, can you elaborate more on that?
Answer. The Licensing Guidelines do not work in isolation and in the 2017 Guidelines, a number of areas were mentioned but only briefly for example medical devices and good manufacturing practice. The area of herbal medicines is a growing area but poorly regulated world over. And those who made the law understood the relevance of this area and included a representative of the herbalists on the NDA Board. In addition, there exists a committee of the Board in charge of herbal medicines. However NDA has involved practitioners in this area to obtain a clear picture of how they operate in order to come up with a document to regulate their activities. NDA has prepared and piloted the guidelines for regulation of traditional/herbal medicines in Uganda on select outlets with mixed results. It was decided that sellers and manufacturers of herbal medicines be issued with certificates of suitability and manufacturing licenses respectively if they meet the requirements.