India corners ANDA filings; to benefit from improving demand in US market

Adding more feathers to their cap in recent months, Indian drug majors have garnered 45% of all new Abbreviated New Drug Application (ANDA) approvals over the past nine months.

Led by significant manufacturing facility clearances, GDUFA-II (Generic Drug User Fee Amendments), and a strong filing momentum aided by historical investments in R&D, research firm India Ratings said in a report that Indian companies have received a higher share of new ANDA approvals since April 2020.

The agency adds that while the regulatory environment is expected to remain stringent, well-equipped Indian companies will be able to take the advantage of a better pricing outlook in the USA emanating from supply shortages and recalls.

It may be recalled that, in April, four of India’s leading drugmakers had their manufacturing facilities cleared in the span of 10 days by the US Food and Drug Administration. The decision was taken when supply-chain disruptions were huge due to the Covid-19 pandemic, causing drug shortages across the world.

As companies continue their horizontal and/or vertical integration in order to become more aggressive suppliers to the USA, the Indian drug industry is bound to rise to the occasion once again in the post-Covid era.

First India-developed pneumococcal vaccine launched in India

In India, Serum Institute of India, the largest vaccine manufacturer in the world by doses, has already shown the way. On December 28, the company announced the launch of India's first indigenously developed pneumococcal vaccine, Pneumosil, in the presence of Union Health Minister Harsh Vardhan.

Pneumosil has been developed through collaboration spanning over a decade among the Serum Institute, PATH and the Bill and Melinda Gates Foundation.

The vaccine is to protect children against pneumococcal diseases. India's drug regulator in July granted market approval for the pneumococcal polysaccharide conjugate vaccine, which is to be much more affordable than existing ones manufactured by Pfizer (NYSE: PFE) and GlaxoSmithKline (LSE: GSK).

The vaccine makes the Serum Institute the world's third supplier of pneumococcal conjugate vaccines (PCV) under the pneumococcal Advance Market Commitment, and the first developing country vaccine manufacturer to access the global PCV market.