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.
"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