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India is pressing for preferential market access for drugs and pharmaceutical products during the bilateral-free trade agreement talks with Australia and an interim deal is expected to be finalized within a few weeks, said two government officials seeking anonymity. India is negotiating a mutual recognition agreement (MRA) for pharmaceutical products as part of the pact, they added.

At the latest round of discussions in Canberra last week, New Delhi had sought faster and easier approvals for India’s generic pharmaceutical products, that have already been approved by developed countries such as the US, the UK, and European Union.

Australia accounts for 1.63% of India’s outbound pharma shipments, with exports worth $316 million in 2020-21, up 25% year-on-year.

“The negotiations are at an advanced stage and an interim agreement is expected to be finalized soon," said one of the two officials.

India is the largest exporter of generic drugs globally. The annual report 2020-21 issued by the department of pharmaceuticals, under the ministry of chemical and fertilizers, said the pharmaceutical industry is the world’s third largest by volumes and 14th in terms of value. “Australia has a market size $12 billion, of which only 13% is generic, i.e., $1.5 billion. This means they have more than 80% of branded pharmaceutical products. When the medicine is branded, the treatment cost is expensive. Our objective is to promote the use of more generic drugs with a high quality, but affordable," said the second official.

On 10 February, commerce and industry minister Piyush Goyal said India and Australia will be finalizing an interim trade deal within 30 days.

Besides, the MRA, the deal is likely to cover other sectors such as textiles, health, education, renewables, wines, gems and jewellery, and tourism.

“According to the discussions, Australian authorities can pursue table inspections, or desktop inspection to expedite the approval process for India’s generic pharma products if they are already approved by reference regulatory authorities such as USFDA (Food and Drug Administration), UK MHRA (Medicines and Healthcare products Regulatory Agency), EMA (European Medicines Agency), Health Canada and Japan PMDA (Pharmaceuticals and Medical Devices Agency)," he added.

“Furthermore, the regulatory authority of the importing country will accept tests conducted by laboratories accredited by the exporting party’s national accreditation body and approved by the regulator of the importing party. The importer may conduct an additional test, if necessary, in line with its domestic regulations," the official said.

This discussions are in sync with India’s FTA strategy for the pharma sector. Under the recently inked comprehensive economic partnership agreement with UAE, Indian pharmaceutical and medical products, which are approved by developed nations, including Australia, will get regulatory approval within 90 days. India is seeking approval for its pharmaceutical products from the Therapeutic Goods Administration, Australia, without major checks and fast approval for products approved by the five developed nations.

Queries emailed to spokespersons of the Australian High Commission and commerce and industry ministry did not elicit a response till press time.

Ajay Sahai, director-general and chief executive, Federation of Indian Export Organizations, said getting certification from countries including Australia is time consuming. “Generally, they depute their heath officer for a plant visit. In covid times these visits weren’t happening. For most countries it was taking one-two years in getting an approval. It is good that the process might be fast-tracked through MRA, like in the case of UAE," said Sahai.

Officials from Central Drugs Control Department, ministry of commerce and industry, Pharmaceuticals Export Promotion of Council of India, India Pharmaceutical Alliance, ABLE Pharma and Confederation of Indian Beverage Companies are negotiating the terms of the bilateral deal.


Priyanka Sharma

Priyanka Shamra is a health and pharma journalist with nearly nine years of field reporting experience. She is a special correspondent with Mint. Her beat includes covering the Ministry of Health and Department of Pharmaceuticals. She also covers the Ministry of Women and Child Development and the Department of Biotechnology.
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