BioAsia to focus on regulatory challenges in pharma

Increasing number of import alerts and warning letters is making it difficult for Indian companies doing business in the West regions.

By Author  |  Business Bureau  |  Published: 12th Feb 2018  7:07 pmUpdated: 12th Feb 2018  7:08 pm
Hyderabad
Source: Twitter

Hyderabad: Telangana’s flagship event BioAsia will deliberate on a range of issues plaguing the Indian Pharma sector including the revenue loss impacting Indian companies and decreasing market capitalisation due to increasing regulatory concerns from the US and European markets. Increasing number of import alerts and warning letters is making it difficult for Indian companies doing business in the West regions.

According to a study conducted by BioAsia along with knowledge partner Deloitte, the financial year 2016-2017 has been among the toughest years for the Indian Pharma companies due to frequent foreign regulatory interventions and major domestic structural policy initiatives. It has been noted that India’s exports in pharmaceuticals has dropped by 0.43 per cent in terms of value, and 6.95 per cent in volume terms during the last fiscal.

Total net sales of top listed domestic pharma companies increased by 4.7 per cent in 2016-17, which was one of the slowest in over a decade. India received 14 drug GMP warning letters in the F/Y- 2017 which is an increase of 40 per cent annually. Also, FDA issued import alerts in six of the 14 warning letters. Impact of these regulatory concerns is evident from the fact that in the past 12 months, the combined market capitalisation of the top 10 domestic pharma companies is down 13 per cent, against a 15.3 per cent rise in the benchmark S&P BSE Sensex during this period.

Commenting on the emerging scenario, Shakthi Nagappan, director-life sciences, Telangana and CEO, BioAsia said, “The global life sciences industry is gradually moving from chemical-based drugs to biologics with the sales contribution of biologics expected to increase from 24 per cent in 2015 to 27 per cent in 2020. Out of this, the global biosimilar segment is expected to increase from the current $2 billion to $12 billion within the next three years and it is imperative for Indian companies to understand the regulatory landscape of Biosimilars.”

Commenting on the important sessions addressing the changing regulatory scenario, Jayesh Ranjan, principal secretary, industries and commerce, Telangana said, “This year’s Summit will witness top brains from the industry and regulatory agencies deliberating on issues that will aid Indian Pharma companies in the years to come.