Serum institute sets up Rs 3,000-cr vaccine manufacturing facility in Pune

The manufacturing plant, spread across two million square feet, is set to commence production from November this year. It has been built in compliance with American and European vaccine manufacturing regulations.

Adar Poonawalla, CEO of SII, who is also the chairman of the Indian Vaccine Manufacturers Association, told The Indian Express that they were currently developing new vaccines against HPV, dengue, pneumonia and malaria.

“One purpose is to make these products and the second is that for the first time in the country have design and investment of a facility that complies with US and Europe norms. There are many pharma companies that make products for US and Europe, but, so far, there is no vaccine manufacturing company that has been able to sell its products and life-saving biologicals in US or Europe. Our dream is to capture those markets, which we have not been able to do so far,” Poonawalla said.

Currently, SII manufactures 1.5 billion vaccine doses per year thus saving lives of more than 20 million children worldwide.

While SII authorities said that there were limitations with the old facility, the new plant will maximise the production of vaccines such as HPV and TdaP (Tetanus, diphtheria, and pertussis) in addition to monoclonal antibody.

“According to the process, we will apply for the Indian licensure, after which permission will be sought for exports. In the next two years we are hoping to enter the US and European market. By then, the clinical trials of these products will also be over,” Poonawalla said.

IVMA to raise issues on regulatory reforms, online permissions

Poonawalla said as the president of the IVMA, he would take up the issues about change in procedures and rules of import with policy makers, finance ministry, NITI Aayog and the health ministry.

“I hope to have some of the barriers removed so that Indian companies can sell freely to foreign markets. We are not anti-foreigners and also want them to invest in India, make in India and create jobs as today there is a dire need for investment and jobs. But what is the sense if today the product is made say in the US and China and then dumped in India. We are not able to sell there whereas they can sell their products here without making an investment or creating jobs,” the IVMA president said.

He pointed out that the Association will raise these issues related to regulatory reforms, online permissions and timely response towards a better ease of doing business.

Dengue vaccine likely in 4 yrs, monoclonal antibody soon

Poonawalla said while the SII is likely to be ready with a dengue vaccine in four years, the plant, with state-of-the-art equipment and facilities,will soon be ready with HPV and TDaP vaccines along with some monoclonal antibody.

“There is a dengue vaccine that will take four years to come, but more exciting is the dengue monoclonal antibody for which we have acquired technology and strains from the US. Currently, clinical trials are underway in Australia and as soon as we get the results we can export to other countries. In India, after a bridge study, we can launch it in two to three years…,” he said.

Referring to the dengue monoclonal, he added that it will work as a hospital IV drip and can cure a person in two to three days.

“This is a ready-made human anti-body that goes in the system and eliminates the virus,” Poonawalla said.

He added that such fast-track procedures were the need of the hour. He also admitted that there was more lethargy than fear among people about taking vaccines.

Flu and dengue is not something that people take as a preventive vaccines. However we are planning to increase awareness on these issues.