With the introduction of a stringent regulatory environment binding to all the Gulf Co-operation Council (GCC) countries, many of the Indian companies without US FDA approved plants are finding it difficult to market their products in the Middle East countries.

According to informed sources, the new GCC norms for product registration in GCC countries are almost similar to the standards of US FDA and EU. Many of the Indian manufacturers, who were so far selling pharmaceuticals without much regulatory stumbles, are now finding it difficult to even get their products registered in the Gulf countries. Almost all countries in the Gulf were semi-regulated, helping small and medium Indian companies to look at Gulf for exports. United Arab Emeritus (UAE) countries had a common regulatory environment, which was also liberal and favorable to the interests of even small and mid-cap Indian companies. The new norms insist on drugs manufactured in US FDA standard plants, which deny entry for most of the Indian manufacturers. The new norms are favorable to the local manufacturers and MNCs, sources said.

They said out of the half a dozen companies in UAE, almost all have US FDA plants and the new norms have not affected the local manufacturers like Global Pharma, Pharmacar, Julphar, Neopharma etc. which have world class manufacturing facilities to comply with the GCC standards. Major Indian players in the Middle East include Himalaya, Ranbaxy, Cipla, Cadila, Glenmark etc., having a considerable share in the middle east markets.

Further, the Indian companies now have to undergo the process of stringent scrutiny and a lot of procedural work in getting their products registered in GCC nations. Most of the manufacturers rely on local partners to enter the Middle East markets and this has become a preferred choice for many Indian manufacturers operating in the Gulf region. Indian companies, which were planning to set up manufacturing base in the Middle East, are now rethinking their plans. A leading South Indian manufacturer which had almost finalized its plans of setting up a US FDA standard production facility in Gulf in association with a major local manufacturer, is now planning to set up the plant at its home city in South.