Regulatory Aspects of Pharmaceuticals’ Exports in Gulf Cooperation Council Countries

The Gulf cooperation council (GCC) region is considered as “Emerging market” for pharmaceutical export and bilateral trade. The understanding of the regulatory requirements of this region can be beneficial for pharmaceutical export. Some incidents of the year 2008-09, like recession or economic slowdown in highly well-off and regulated market of the EU and US, raised the demand for alternate destinations for business. The regulations of Gulf countries are encouraging the import of quality generic products, which can be good news to the Indian drug manufacturers.


Indian Pharmaceutical export: present scenario
The Indian pharmaceutical industry, which is one of the major manufacturers of multi-source generic drugs, has a broad spectrum of export of pharmaceuticals all over the world. The exports of drugs, pharmaceuticals, and fine chemicals for the year 2008-09 stood at US $ 8.6 billion, At the same time the other destinations of export are not only yielding the same ratio of profit but are also increasing at an appreciable rate. Many new windows for trade are opening for India. For example, export to African countries has increased from 10-15% in the year 2007-08. [5] Therefore, it is time to look at other segments of the market which is by and large called 'emerging market' and can increase our export rate including our traditional customers.

GULF COOPERATION COUNCIL [6]
Export opportunities for India: [7] Based on responses from 215 representatives of leading pharmaceutical manufacturers in India and those registered in the six GCC countries, the FICCI study found an overwhelming keenness to tap the GCC market.
According to a FICCI survey report "There is a  1. The executive office of GCC-DR assumes the receipt of registration files after ensuring the fulfillment of registration requirements and upon duly filling the following forms: • The drug companies' registration form.
• A pharmaceutical chemical entity/ preparation registration form. 2. Eight complete files for each chemical entity and 17 samples have to be submitted to the executive office and two samples shall be dispatched to each country along with registration file. 3. Every country shall study the registration files forwarded to it and then return those files with its recommendation to the committee. The procedure is shown in Figure 2. 4. The company needs to provide the laboratory for the analysis of standard materials, methods etc. 5. The executive office dispatches the samples of chemical entity to reference-accredited laboratory for the analysis.  • Largest trading partner after US -6.8 USD billion business annually [7] • Annual increase of population is more than one million -Great potential for healthcare sector • Economic development boards (EDB), joint ventures and economic liberalization by GCC countries-Opportunities for Indian investors [19,20] • Less custom duty on pharmaceuticals-duty-free (Saudi Arabia & UAE) and 4-5% by all the remaining GCC members. [18] 6. After approving the registration of company andor chemical entity centrally, the remaining authentication and documentation, fees are finalized on country basis, as per their prescribed and established policies. The fees for centralized procedure is shown in Table 3. 7. The executive office issues the registration certificate. 8. The companies reserve their rights to lodge their grievances to the executive office within a period of two months effective from the date of notification about the registration by GCC-DR.

Fees
The validity of the central registration a. The central Gulf committee's resolutions for drug registration are binding for the consolidated purchasing. b. All countries must sanction and approve the export price, which has been approved by the committee upon completion of the registration procedures in the country.

Issue of Centralization of registration of drugs
It is not mandatory to centralize the registration of drugs in GCC, as of now. But for special classes of drugs, registration through the centralized process is necessary. These are as follows: 1. Generic drugs for which bioequivalence studies cannot be done, e.g. inhalable medicines and some nasal inhalers.

Drugs supported by biotechnology for which
bioequivalence studies cannot be done and which require clinical or pharmacodynamic studies. 3. Drugs with narrow therapeutic spectrum, which are administered orally.
B. The Decentralized registration procedure: [8] Registration regulations in major countries of GCC Although there is a centralized and quite harmonized process for drug registration in GCC countries, the regulatory requirements of a few big countries like Saudi Arabia and UAE are separate. These countries have their well-established regulatory system and its enforcement.
In this study, we will discuss briefly the registration requirements of multi-source generic products of the following GCC countries: The applicant is needed to make an appointment with the SFDA office to hand over the application. The earliest appointment can be scheduled 1 to 12 weeks in advance. The applicant can reschedule a week before the  appointment. An automatic reminder will be sent 3 days before the appointment. Target performance timeline for SFDA is shown in Table 4.  [12] SFDA recommends the GCC guidelines for stability study data preparation. GCC countries come under climatic Zone III and IVa (Hot and dry and hot and humid). Three primary batches are recommended by the GCC guidelines. For generic drug product long-term stability study supporting the complete proposed shelf-life should be submitted.

KINGDOM OF BAHRAIN-DRUG REGISTRATION REQUIREMENTS [13]
The regulations for pharmaceutical registration in Bahrain are almost similar to the other GCC countries. All types of necessary information is required by the Ministry of Health, Bahrain but as compared to the other GCC countries, they also focus on the details of the company profile and several types of business activities like current business merger by the company, etc. The following table provides the basic information required for the registration of a drug in the Kingdom of Bahrain and other GCC countries.

KUWAIT: DRUG REGISTRATION REQUIREMENTS
Medicines in Kuwait are regulated for quality, safety and efficacy standards, price control, and patent protection. Kuwait has 40 years of experience of a regulatory system and plays a prominent role in the GCC. The Kuwait food and drug authority (KuFDA) is the head regulatory agency, which follows the ministerial decree 302/80 to register pharmaceutical products.
According to Dr. Reem Al-Essa, Head of the Licensing Division of the Kuwait Drug and Food Control, "Kuwait is facing an overwhelming regulatory challenge reflecting the rapid advancement of the regulatory services with limited resources possibly influencing patients' timely access to medicines." [14] The Pharmaceutical manufacturing environment is not very competitive in Kuwait because of the very small population and the lack of the proper expertise to establish a good base of manufacturing practices for the pharmaceutical products within the country. There is only one manufacturing company (Kuwait-Saudi Pharmaceutical Industry Co-KSPICO) in Kuwait. This company produces generic medicines.
Enclosures required for drug registration in GCC countries [8,9] The documents required to be submitted to fulfill different regulatory requirements for drug registration in GCC countries are summarized and compared in Table 5 and 6.  Five countries have been taken for the comparison. They are Saudi Arabia, UAE, Oman, Bahrain, and Kuwait.

CONCLUSION
The GCC market is very lucrative in terms of benefits offered to the Indian pharmaceutical industry. With large pharmaceutical markets like the US, Europe and Japan getting saturated, it is the need of the hour that the Indian pharmaceutical industry in general and pharmaceutical companies in particular tap the opportunity of this "emerging" GCC market.  CTD format for dossier submission R [9] NR NR NR NR 22 eCTD or NeeS (non eCTD electronic submission) R [9] NR NR NR NR R: Recommended by regulatory authority, NR: Generally, not recommended by regulatory authority