Central govt in talks with UAE to recognise Indian Pharmacopoeia

Mumbai, June 29, 2022:

The Central government is in talks with the United Arab Emirates (UAE) to include Indian Pharmacopoeia (IP) in the standards of pharmaceuticals authorized in UAE with an aim to boost export of Indian drugs to the Emirates.

Confirming this, S V Veeramani, vice-chairman of Pharmaceuticals Export Promotion Council of India (Pharmexcil) said, “Our delegation called on concerned authorities in UAE before the trade pact between India and the Emirates was signed and deliberated a slew of issues including reduction of approval timelines for Indian drugs, recognition of Indian Pharmacopoeia etc. The approval process for any dossier filed by India drug companies in UAE – to sell their medicines in their market – takes almost two years. We have appealed to the UAE to reduce the timeline for registration of Indian drugs manufactured in plants approved by regulated markets including US FDA, European Medical Agency, UK’s MHRA, TGA-Australia and Health Canada etc.”
 
India and UAE on February 18, 2022 inked the Comprehensive Economic Partnership Agreement (CEPA) to enhance bilateral merchandise trade to USD100 billion by 2030. The CEPA which is touted to be the first trade pact India has signed with a major trading partner in over a decade, softens the conditions of drug approvals in the UAE.
 
With this, the timeline for approval of Indian drugs manufactured in facilities approved by eight drug regulators, including those of the US FDA, European Medical Agency, UK’s MHRA, TGA-Australia and Health Canada in UAE, will be reduced to 90 days from two years earlier. It is likely to increase exports of Indian medicines to Middle Eastern countries.

According to 2020 data, the UAE drug market was estimated at USD 3.5 billion. The 68 per cent of the total pharma market was dominated by patented drugs followed by 18 per cent generic drugs and 14 per cent OTC drugs.

The UAE is called a gateway to the Gulf Cooperation Council (GCC), Iran, Iraq and Africa. It means that the UAE first imports and then exports drugs to other countries. Hence, the UAE market penetration will give access to several countries, said Veeramani.

So far Indian Pharmacopoeia has been recognised by four countries—Afghanistan, Ghana, Nepal, Mauritius, he said.
 
As per the Second Schedule of the Drugs and Cosmetics Act 1940, Indian Pharmacopoeia is designated as the official book of standards for drugs imported and/or manufactured for sale, stock or exhibition for sale or distribution in India. In order to ensure the quality of medicinal products, the legal and scientific standards of IP are published at regular intervals by the Indian Pharmacopoeia Commission (IPC). Standards prescribed in the IP are authoritative in nature and are enforced by the regulatory authorities for quality control of medicines in India. PharmaBiz