“Each party, however, has a right to conduct its own inspection of the manufacturing facilities approved by the regulatory authorities… The party’s own inspection shall be an exception from the normal practice…,” the document said. Both countries will also be able to exchange any information necessary for mutual recognition of inspections.
India has exported pharmaceutical products worth Rs 1,197.5 crore to the UAE so far in the ongoing fiscal compared with Rs 1,774.3 crore a year ago. The country has imported pharmaceutical products worth Rs 21.2 crore from the U.A.E. so far in 2021-22.
“India has largely been an exporter of pharmaceutical products and this facilitation will help from a trade perspective as well. Indian pharma companies have made GCC (Gulf Corporation Countries) an important area and this will further boost growth,” said Sujay Shetty, global health industries advisory leader at PwC.
The trade pact also mentioned that both countries establish “fast-track” procedures for approval of pharmaceutical products from at least one of the regulatory authorities of Australia, Canada, EU, Japan, the U.S., or the U.K.
On test results from accredited laboratories, the document said, “The regulatory authority of the importing party shall accept tests conducted by the testing laboratories accredited by the exporting country’s national accreditation body and approved by the regulatory authority of the importing party.” The importing country, it said, may conduct an additional test, if necessary, in line with its domestic regulations.