Representational image.
| Photo Credit: Getty Images

Indian Council of Medical Research ((ICMR) is looking at undertaking joint development and commercialisation of typhoid and paratyphoid vaccine and has now invited expression of interest from the eligible organisations, companies and manufacturers.

Giving details about the process the Council noted that under the EoI, the manufacturers/companies who are responsive and fulfilling all the technical need will be shortlisted based on their research and development plan, facilities, and capabilities. After the execution of the agreement such companies/manufacturers shall be responsible to pay the royalty @ 2% on net sales, as applicable, according to the ICMR Guidelines for Technology Development Collaboration.

Read: Editorial – Welcome development: On the ICMR and Controlled Human Infection Studies

Typhoid is a bacterial infection that affects the intestines and sometimes the bloodstream. It’s caused by the Salmonella Typhi bacteria and can be life-threatening if left untreated. The disease is caused due to eating/drinking contaminated food or water, contact with an infected person’s faeces or urine or sexual contact with an infected person. Treatment includes use of antibiotics like chloramphenicol, ampicillin, or ciprofloxacin. Typhoid vaccines available in India include Typbar-TCV, Ty21a, Typhim Vi, and Typherix. Typhoid conjugate vaccines can be given to children over 6 months of age and Vi capsular polysaccharide vaccines can be given to children over 2 years of age. In India, TCVs are currently only available in the private sector. 

According to recent studies, typhoid fever is considered a significant public health issue in India, with estimates suggesting that the country bears a large burden of typhoid cases globally, with millions of cases reported annually, particularly concentrated in urban areas, making it a major menace in the region. A study found a national incidence of around 360 cases per 100,000 people, translating to approximately 4.5 million cases annually. 

Meanwhile, the ICMR-National Institute for Research in Bacterial Infections (NIRBI) has developed a technology entitled “Enteric fever vaccine based on outer membrane vesicles from two different strains of Typhoidal Salmonelle species”.

The objective of ICMR now is to validate the technology “broad specificity Typhoid and Paratyphoid vaccine against Salmonella Typhi, Salmonella Paratyphi ” developed at ICMR-NIRBI, Kolkata. This will be followed by proper regulatory compliances, commercialization and marketing, explained the Council.

Under the agreement the Company would be granted rights to undertake scientific/technical validation of the Technology as a Phase-I, only after signing of a non-disclosure agreement (NDA) further development, manufacture, sale, and commercialize the technology/product vaccine (Typhoid & Paratyphoid Vaccine ) or undertake further R&D and commercialize the end product(s) /technology.

Under the agreement ICMR-NIRBI Institute will provide expert guidance and technical support for the production of Typhoid & Paratyphoid vaccine in all phases. 

“Such technical oversight by ICMR-NIRBI Institute would accelerate the development of the Product and its commercialisation. The support will be provided through its team of experienced scientists in study planning, product development, development of study protocol, results/data analysis, outcome assessment, safety and efficacy assessment, product improvement, etc., if deemed fit upon the mutual understanding between ICMR and collaborative company,’’ noted the Council.

This microscope photo provided by the Centers for Disease Control and Prevention shows crescent-shaped red blood cells from a sickle cell disease patient.
| Photo Credit: AP

India is getting closer to developing a gene therapy for sickle cell disease, a genetic blood disorder with a high prevalence rate among the Scheduled Tribes, officials of the Union Tribal Affairs Ministry said on June 19.

Vibhu Nayyar, Secretary, of the Tribal Affairs Ministry, said the government was expecting to hear “good news” by January 2025 on the laboratory tests that are being run. M. Srinivas, Director of the All India Institute of Medical Sciences (AIIMS), said researchers were working to develop a gene therapy using CRISPR-Cas9, a gene-editing tool.

“We want that in the next six months to one year, we will be able to go forward with using this method for treating SCD — making India one of the first countries to do so,” Mr. Srinivas said.

He was speaking at the National Conclave on Generating Awareness on Sickle Cell Disease, organised by the Tribal Affairs Ministry in collaboration with the Birsa Munda Centre at the AIIMS.

Union Tribal Affairs Minister Jual Oram, addressing the opening of the conclave, lauded the efforts but said it was important to involve and coordinate with ground-level healthcare workers such as ASHAs and Anganwadi workers for these plans to be implemented properly.

“They will be the ones doing the heavy lifting on the ground,” Mr. Oram said.

Officials of the Tribal Affairs Ministry told The Hindu that the “good news” Mr. Nayyar was referring to was related to the tests that are currently being run by the Council of Scientific and Industrial Research–Institute of Genomics and Integrative Biology (CSIR-IGIB).

“Following this, the tests will proceed to the next phase and eventually move on to being tested on patients,” a senior official said.

This comes months after the U.S. Food and Drug Administration approved the CRISPR-Cas9 technology for a cell-based gene therapy to treat sickle cell disease in December 2023.

Officials of the Tribal Affairs Ministry said one of the main challenges for India was to find a way to make this therapy cost-effective.

Developing a gene therapy using CRISPR has been part of India’s mission to eradicate sickle cell disease by 2047. A government dossier on the mission, which was launched by Prime Minister Narendra Modi in July 2023, said the technology had “the potential to be a single dose cure for blood disorders like sickle cell anaemia”.

Part of this mission is to also conduct over seven crore screenings among vulnerable tribal populations across 17 States and Union Territories, of which three crore screenings have been achieved so far, Ministry officials said.

The CRISPR-Cas9 system consists of an enzyme that behaves like molecular scissors which can be directed to cut a piece of DNA at a precise location. This will then allow a guide RNA to insert a changed genetic code at the sites of the incision. While there are a few ways to effect such changes, the CRISPR system is believed to be fast and the most versatile of all.

Addressing the gathering of doctors, experts, and healthcare professionals, Mr. Oram said the Union government was committed to working on the sickle cell disease eradication mission and called for officials from across Ministries and departments to ensure that grassroots workers were roped in for the implementation process and that they should themselves engage with them.

Following the addresses by senior officials and the Minister, a series of technical panel discussions were also held on recognising and screening for sickle cell disease, managing the disease, and other issues. Officials said district centres at nearly 350 districts across the country were taking part in the conclave virtually.

Apart from the gene therapy being developed by India, the sickle cell disease eradication mission also includes developing two coded formulations — AYUSH-RP and AYUSH-SC3 — for managing the disease through a systemic drug development process, for which continued testing will be undertaken by the Central Council for Research in Ayurvedic Sciences in collaboration with the Indian Council of Medical Research.