Indian pharma companies have garnered 45 per cent of all new ANDA (abbreviated new drug application) approvals over the past nine months.
Indian pharma companies have avoided any adverse blows, with only one Indian company having to recall Metformin.
India’s pharmaceutical companies are likely to add more feathers to their caps as demand from the largest market — the US — has significantly increased in recent months. Indian pharma companies have garnered 45 per cent of all new ANDA (abbreviated new drug application) approvals over the past nine months, said a report by India Ratings. While the regulatory environment is expected to remain stringent, well-equipped companies will be able to take the advantage of a better pricing outlook emanating from supply shortages and recall, the report added. Indian companies were able to bag approvals in a large number due to significant manufacturing facility clearances, Generic Drug User Fee Amendments, and a strong filing momentum, aided by record investments in R&D.
Indian pharma companies have avoided any adverse blows, with only one Indian company having to recall Metformin. It is to be noted that, altogether, there were 33 drug recalls since August 2020 from the US market. Led by supply chain issues, channel filling, and demand for COVID-19 led preventive products, the demand for drugs have shot up since the onset of the pandemic. Additionally, in the past too, there were drug shortages in the US because of the exit of the large generic players from unviable products. These shortages in the US are leading to moderate-to-stable pricing pressures, India Ratings added.
The Indian government has allocated Rs 900 crore for Mission Covid Suraksha, which is launched to accelerate vaccine development. This grant is to be provided to the Department of Biotechnology for Research & Development of Indian Covid-19 vaccines, and the government will likely ensure that they are fast-tracked in public health systems, subject to all regulatory clearances.
So far, at least five Indian pharmaceutical companies are engaged in vaccine development, and Serum Institute has been chosen for mass production of Covishield vaccine developed by Oxford-AstraZeneca. The government has further initiated a Covid-19 vaccine manufacturing and delivery ecosystem to meet the demand. Meanwhile, Prime Minister Narendra Modi had earlier said that India is playing the role of pharmacy to the world.