Top stories from Indian pharma including Dr Reddy’s move to US online platforms, Aspen/Serum Institute’s vaccine deal for Africa, Aurobindo’s USD 37.7 million investment in subsidiary CuraTeQ and Biocon’s FDA troubles.
Indian pharma market growth in August 12.1 percent (The Economic Times India)
According to a study from the market research firm AWACS, the Indian pharmaceutical market grew by 12.1 percent in value and 4.8 percent in volumes during the month of August. The fastest growing therapeutic areas were cardiovascular and anti-infectives, which both grew 13 percent.
Dr Reddy’s looking to new US trade channels in the face of generic price erosion (The Economic Times India)
With the rapid erosion of generic drug prices in the US, Indian manufacturers like Dr Reddy’s are exploring online pharmacies such as Amazon and American billionaire Mark Cuban’s CostPlus.
The scale of these platforms is limited—they mostly sell out-of-pocket over-the-counter (OTC) medications—Dr Reddy’s has already created partnerships and generated sales through e-commerce that constitutes about 10 percent of its OTC business. Dr Reddy’ has begun shipping some 10 prescription generics to Mark Cuban’s CostPlus, a direct-to-consumer platform.
Aspen Pharmacare has signed a deal with the Serum Institute of India to manufacture and sell four Aspen-branded vaccines for Africa, looking to use its near-idle COVID-19 vaccine production lines in South Africa.
Under the Serum agreement, Aspen says it will produce hexavalent, pneumococcal, polyvalent meningococcal and rotavirus shots – all vaccines commonly administered in Africa. The company is also expecting to receive grants from the Bill & Melinda Gates Foundation and the Coalition for Epidemic Preparedness Innovations aimed at boosting affordable vaccine production.
Hyderabad-based generics manufacturer Aurobindo Pharma plans for growth after a few regulatory setbacks. The company is set to invest about USD 37.7 million in an expansion of its subsidiary CuraTeQ Biologics to extend its production with another mammalian cell culture manufacturing facility. The plant, a new addition to Aurobindo’s 27 manufacturing and packaging facilities, is due to begin operations in fiscal year 2026
The news comes after Aurobindo was among the top generic manufacturers by revenue in 2021 with USD 3.18 billion in generic drug sales, and after an FDA warning to correct deviations in current good manufacturing regulations.
India authorizes needle-free COVID-19 vaccines (Associated Press)
India has authorized a new approach to COVID-19 vaccination with a needle-free squirt in the nose, authorizing Bharat Biotech’s nasal version as an option for people who have not yet been vaccinated.
The nasal vaccine, developed by scientists at Washington University in St. Louis, is licensed to Bharat Biotech. The company conducted two trials, giving two doses of the vaccine to 3,100 previously unvaccinated volunteers and as a booster to around 875 volunteers who had received two shots of other COVID-19 vaccines.
Bharat is also is seeking approval for the nasal spray to be used as a booster in a country where 67 percent of the population has received the first two shots, but only 15 percent have received a third booster shot
The FDA has expressed concerns with Malaysian and Indian manufacturing plants run by Biocon, one of India’s big generics and biosimilars producers. According to the company, the FDA inspected manufacturing facilities in the city of Bengaluru, India, and Johor, Malaysia.
Biocon said that the inspections drew 11 observations for the sites in Bengaluru along with six observations in Malaysia related to improving microbial control, enhancing quality oversight, using more software and computer tools, facility upgrades and the need to implement risk assessment tools.
The company plans to submit an action plan to the FDA and said that it does not expect the outcome of the inspections to impact its production.
This is not the first time Biocon has been reprimanded by the FDA. Last year a Form 483 showed several issues.