AdvaMed spurs Indian lawmakers for new import rules on medical devices

India Parliament flag
Stairs

A medical device industry lobby group has renewed a call for India to move more quickly on long-pending legislation that would draw a sharper line between device and pharmaceutical guidelines on imports.

The Drugs & Cosmetics Amendment Bill 2015, which would frame distinct regulations and policies for medical devices, has been tied up in committee work in India's lower house of parliament since last year as issues such as the level of import licenses and taxes keep raising their heads.

But AdvaMed--or the Advanced Medical Technology Association--which represents nearly 300 members across Europe, India, China, Brazil, and Japan, has urged lawmakers to work faster to clear import roadblocks, according to the International Business Times.

Whitepaper

Simplify and Accelerate Drug R&D With the MarkLogic Data Hub Service for Pharma R&D

Researchers are often unable to access the information they need. And, even when data does get consolidated, researchers find it difficult to sift through it all and make sense of it in order to confidently draw the right conclusions and share the right results. Discover how to quickly and easily find, synthesize, and share information—accelerating and improving R&D.

"One of the biggest challenges is the ambiguity faced by the medical device industry because of the 'Pharma' tagging--which means that most medical devices are currently treated at par with pharmaceutical drugs, from a regulatory standpoint," Varun Khanna, chairman of AdvaMed India told the IBT.

Currently, India relies on imports for a majority of its medical device requirements. The industry has therefore sought ease in the process of getting import licenses from the government which can take 9 to 12 months, the IBT said, citing AdvaMed.

The government of Prime Minister Narendra Modi has said that medical devices are a focus for domestic manufacture in the "Make in India" campaign.

But imports dominate regulator actions, with the National Pharmaceutical Pricing Authority in the process of reviewing price levels for some imported orthopedic implants and stents.

According to the IBT, citing a Deloitte India and HealthCare Foundation of India report, the medical device industry in India is expected to reach $8.6 billion by 2020--while industry estimates forecast $50 billion by 2025.

- here's the story from the IBT

Suggested Articles

It’s a familiar scene in the race onto China’s national reimbursement list: Drugmakers cut prices by an average 60.7% to win coverage.

After a longer follow-up of 25 months, Alunbrig cut the risk of disease progression by 51% compared with Xalkori in ALK inhibitor-naïve NSCLC.

Novartis pivots Shanghai R&D from discovery to development. BeiGene nabs FDA nod for BTK inhibitor Brukinsa. FDA clears Shionogi's antibiotic Fetroja.