DoP seeks industry to submit details of vaccine and biopharma raw material production capabilities

New Delhi, July 29, 2022:

In an effort to enhance the country’s capabilities in terms of vaccine manufacturing and assess the availability of raw materials, especially in the backdrop of Covid-19 pandemic, the Department of Pharmaceuticals (DoP) is in the process of collating the details of domestic raw material manufacturers of vaccines and biopharmaceuticals.

The DoP has said that it is in the process of collating the details of domestic manufacturers of various input materials required for manufacturing of vaccines and biopharmaceuticals. The major vaccine manufacturers have provided a list of critical raw or input materials for the manufacturing of vaccines, that can be grouped as micro-reactor bags of various kinds; cell culture media; and filters, cassettes, cartridges, chromatography resins etc, for filtration process.

In order to explore this further, the department is looking at the requests received from the industry for possible government support for manufacturing of these raw materials. Also recognising the fact that the manufacturers of the critical raw materials of vaccines may be spread across the country, the Department has sought certain information from the existing, interested domestic manufacturers of various input materials required for manufacture of the vaccines and bio-pharmaceuticals in specific formats.

The format requires the manufacturers to submit the name and other details of the domestic manufacturer, name of the input materials and description of the items they manufacture, an indication on which group of input material they manufacture (out of the three groups listed by the DoP), whether any licensing approval is required and if so, the details of approvals obtained, whether the manufacturer possess the required technology to manufacture or yet to obtain, among others.

The existing or interested manufacturers are requested to send the requisite information to the concerned official latest by August 10, 2022, said a public notice issued by the DoP.

Identifying and developing raw material suppliers for vaccines in India is critical for the country, for the growth it aspires to become a global leader in the sector. Besides, the supply chain constraints and the challenges in getting the raw materials for Covid-19 vaccine in the year 2021, for the vaccine manufacturing companies, especially from suppliers like US, also highlights the need for self sustainability in raw materials for vaccines in the country.

According to India Bio-economy Report 2022, prepared for Biotechnology Industry Research Assistance Council (BIRAC) by Association of Biotechnology Led Enterprises (ABLE) earlier this month, the vaccine industry excluding Covid-19 vaccines in the country was valued at $8.7 billion, while the therapeutics segment in biopharma valued at $10.3 billion and diagnostics sector at $20.4 billion.

“Covid-19 has changed the dynamics of the vaccine industry both in terms of managing production capacities and global trade,” said the study.

Before the pandemic, the leading producers of vaccines were the European Union (EU), the US and India. The production capacities of EU companies catered to vaccine supplies to developed and rich countries, while the US production capacity was mainly met for its own requirement. Vaccine companies from India mostly supplied to the developing countries, while China, another large producer, focused on local consumption.

The scenario reversed with Covid-19 vaccines. China became the leading supplier of Covid-19 vaccines to developed countries, while India used its Covid-19 production capabilities for its people.

Before the pandemic, India was the second largest vaccine exporter by volume according to various research studies. Studies suggest that India accounted for nearly a quarter of the total global exports by volume, but in value terms, the share of exports was under two per cent. This is mainly because India companies focused on producing vaccines at affordable prices and mostly supplied to the developing countries or low-income markets, said the BIRAC report.

According to Brussels based economic think tank, Bruegel, India is the second largest producer of vaccines behind the EU. Bruegel estimates the annual production capacity of the EU to be around 15.5 million kgs of vaccines, while India’s production capacity is at 14.5 million kgs. China is third with a production capacity of 8-12 million kgs, it said. PhamaBiz