United Arab Emirates (UAE), the key member of the Gulf Cooperation Council (GCC), is opening up the pharmaceutical market for India by removing the existing GCC restrictions for direct registrations of drugs. With this decision, UAE has done away with the earlier precondition for Indian formulations to have registrations in two European countries or the US market to allow them in the UAE.

The UAE government, relaxing the existing stringent norms and preconditions, has issued a fresh guideline for Indian companies to directly register the products. The UAE formulation market, which is currently estimated at around UAE Dirham 500 million, has been dominated by the multi-national companies due to the European/US registration pre-conditions. However, the new move has been initiated following the recent visit of UAE delegation comprises of the UAE Health Minister and other key Drug control officials to India. The delegation facilitated by B R Shetty, CEO & Managing Director, NMC Group, Abu Dhabi, visited the country in August.

Speaking to Pharmabiz.com, Shetty said that the delegation visited the formulation plants of Ranbaxy and Dr Reddy's. "So far, the UAE authorities despite our prolonged pleas, were not fully convinced about quality standards adopted by Indian drug companies so that they very reluctant to approve the drugs made in India directly," he added. However, after their visit to the drug manufacturing plants in India, they could take a decision.

The Indian industry has however responded overwhelmingly to the new decision of the UAE government. Dinesh Modi, director, JB Chemicals & Pharmaceuticals and chairman, International Business Sub-Committee of IDMA, said that it is definitely a good news for the Indian industry as it can now reach out this very potential market in a big way. Till now, the market was so stringently regulated. Thereby, registering a product in the country was extremely difficult for Indian companies. With the same reason, not many Indian companies keen towards the Middle East market, said G K Singh, chief, International Market Development (Middle East), JBCPL.

Click here to view details of requirements of the Drug Registration in United Arab Emirates