Crucial role of Biobank regulations in advancing Precision medicine in India

• Genomics has become pivotal in revolutionising the diagnosis and treatment of various conditions, including cancers, chronic illnesses and diseases affecting the immune, cardiovascular and liver systems. 
• Other emerging technologies, such as gene-editing and mRNA therapeutics, also contribute to precision medicine.
• Examples: 
• Using gene therapy, researchers were able to restore vision in people who had lost it due to a genetic mutation.
• Researchers in the U.K. reversed an individual’s diabetes by transplanting reengineered stem cells.
• COVID-19 pandemic: Researchers were able to use the mRNA platform to develop new vaccines in record time, winning the technology a Nobel Prize in 2023. 

• Organ-on-chips is a promising precision Medical-Solutions.
• These small microfluidic devices containing human cells can replicate the microenvironment of a tumor or an organ in a laboratory setting.
• Researchers can now test drugs in settings more similar to the drugs’ eventual user.

Advancements in precision medicine in India: 

• The Indian precision medicine market is estimated to be growing at a CAGR of 16% and will be worth more than $5 billion by 2030.
• It contributes 36% of the national bioeconomy. 
• The New ‘BioE3’ ((Biotechnology for Economy, Environment and Employment) policy also includes the development of precision therapeutics.
• The policy aims to harness the power of biotechnology and develop new manufacturing methods that replicate or mimic processes found in natural biological systems. 
• The BioE3 policy emphasizes innovation in research and development (R&D) and entrepreneurship, establishing Biomanufacturing, Bio-AI hubs and bio-foundries to expand India''s skilled biotechnology workforce. 
• This aligns with ''Lifestyle for Environment'' programs, and targets the development of regenerative bioeconomy models.
• In 2023, the Central Drugs Standard Control Organization approved NexCAR19, India’s domestically developed CAR-T cell therapy. 
• The Siemens Healthineers, in collaboration with the Indian Institute of Science, Bengaluru, launched new AI-driven facilities for precision medicine.

The role of Biobanks in advancing Precision medicine: 

• A biobank is a repository of biological samples, such as blood, DNA, cells, tissues, and/or organs, alongside their genetic data.
• These samples are collected from consenting individuals and intended for use in research.
• For precision medicine to succeed, biobanks must be extensive and diverse, ensuring that their research benefits a wide range of individuals rather than just a limited population segment.
• Recently, health researchers created the largest biobank of sarcoma patient-derived organoids. This biobank is used to understand sarcoma and identify potential therapies using high-throughput drug screening.
• Organoids are miniaturized, synthetic versions of organs that can replicate tumors.
• The growth of Biobanks in India: 
• There are 19 registered biobanks in India, hosting many biological specimens, including cancer cell lines and tissues.
• In 2024, the ‘Genome India‘ program finished sequencing 10,000 genomes from 99 ethnic groups to identify treatments for rare genetic diseases. 
• The pan-India ‘Phenome India’ project has collected 10,000 samples to create better prediction models for cardio-metabolic diseases.
• The Paediatric Rare Genetic Disorders (PRaGeD) mission could help identify new genes or variants to develop targeted therapies for genetic diseases that affect children.

Despite potential, stringent regulations around biobanks in India pose a significant challenge to fully harnessing the benefits of precision medicine.

Challenges in regulating Biobanks in India: 

1. Global standards vs. India''s regulatory gaps: 

• The U.K., the U.S., Japan, China, and many European countries have laws or comprehensive regulations addressing several biobanking issues, including informed consent, withdrawal rights, privacy, and data protection.
• India’s regulation of biobanks is inconsistent, with gaps that could undermine public trust and limit the potential of precision medicine.
• There is a lack of regulations to protect the rights of individuals.

2. Inadequacies in ethical guidelines and data practices:

• The Indian Council for Medical Research’s guidelines for biomedical and health research involving human participants, as well as the Department of Biotechnology’s (DBT) practices for data storage and analysis, have many gaps.
• Example: Participants are expected to consent to providing samples without knowing how their data will be used and for how long they will be stored. 
• Genetic information can reveal insights about an individual and their family, potentially leading to discrimination.

3. Lack of Central regulation and penalties:

• Without a single authority to regulate biobanks and no penalty for misconduct, there is a considerable risk of inconsistencies arising from sample mishandling and ethical violations like data sharing for non-consenting purposes.

4. Risks of unregulated access to biological samples:

• Many pharmaceutical companies, including those abroad, will have access to samples from India,  as many research projects often require researchers and pharmaceutical companies to collaborate with biobanks during drug discovery and development.

5. Impact of regulatory gaps on Data ownership and profits:

• Indians could be deprived of the ownership of biological samples, the data and the profits from the resulting research findings.

Seizing the opportunity for leadership in Biobanking: 

1. Enhancing public trust through strong protections: 

• Vital data, privacy protections and regulatory oversight by an expert committee will encourage more people to share samples and participate without worry.
• It will also allow research to happen on the right foundations. 

2. India''s pharmaceutical diplomacy and global aspirations: 

• India is a part of international groups like the Quad and BRICS, with pharmaceuticals as a critical component of its soft diplomatic initiatives.
• It is a major supplier of generic drugs and a hub of vaccine manufacturing, and it plans to expand its leadership to include next-generation therapeutics.
• For this, India will have to align its biobanking laws with global standards, which will encourage public participation and trust.

Fostering greater public confidence in biobanking practices will encourage participation in precision medicine research, which in turn will enhance healthcare outcomes for India’s population and solidify its role in the global biopharmaceutical landscape. 

The Problem with Free Food

• The world has made tremendous progress in increasing food production by large-scale adoption of better seeds, more irrigation, and higher doses of fertilisers and pesticides. Farm machinery has become more efficient. 
• All this could not have been done without increasing incentives to farmers — input subsidies, higher prices for their produce, or a mix of some of the two. 

Government Initiatives

• National Food Security Act (NFSA), 2013: It was to cover roughly two-thirds of the Indian population in providing rice, wheat or coarse grains (5kg/person/month) at Rs 3/kg, Rs 2/kg, and Rs 1/kg, respectively.
• These prices could be revised upwards after three years of the Act, keeping in view the ballooning magnitude of food subsidy on account of this Act, and the overall finances of the government.
• Targeted PDS: Under that scheme, the antyodaya (most vulnerable) people got free food, while those above that had to pay at least half the minimum support price (MSP) being paid to the farmer, and those above the poverty line had to pay 90% of MSP. 

Challenges with Food Security Schemes

• Fiscal Burden: Huge beneficiary base as the scheme covers roughly 66% of the population, whereas the Rangarajan Committee estimated the headcount poverty ratio at about 29%. This wide coverage puts a huge fiscal burden on the government. As a result, food subsidy is the largest subsidy in the Union budget.
• Reduces Fiscal Space for Capital Investments: Along with fertiliser subsidy, it cuts down much more rational and productive investments in agri-food space, such as in agri-R&D, precision agriculture, micro-nutrients, women’s education and sanitation. These investments are almost 10 times more effective in ensuring the food and nutritional security of our people than free food and highly subsidised fertilisers and power.
• Incentivises Corruption: Subsidies, when they are abundant and almost open-ended, become an instrument of corruption. ICRIER research shows that a substantial part (almost 25-30%) of these two subsidies, food and fertilisers, never reaches the intended beneficiaries. If one looks at the inefficiency in the use of these two subsidies, and adds that to the leakages, the overall loss easily goes to 40-50% of the total amount of resources being spent on them.

Wayanad’s new X-band radar

How do radars work?

• Radar is short for ‘radio detection and ranging’. The device uses radio waves to determine the distance, velocity, and physical characteristics of objects around the device. A transmitter emits a signal aimed at an object whose characteristics are to be ascertained (in meteorology, this could be a cloud). A part of the emitted signal is echoed by the object back to the device, where a receiver tracks and analyses it.
• One of the important kinds of radars is Weather radar or a Doppler radar. 
• The Doppler effect is the change in frequency of sound waves as their source moves towards and away from a listener. 
• In meteorology, Doppler radars can reveal how fast a cloud is moving and in which direction based on how the cloud’s relative motion changes the frequency of the radiation striking it. 
• Modern Doppler radars can monitor weather conditions and anticipate new wind patterns, the formation of storms, etc.

What is an X-band radar?

• Doppler radar relies on Rayleigh scattering, when the scatterer is much smaller than the wavelength of the radiation. A radar trying to ‘see’ smaller particles like rain droplets or fog will need to use radiation of lower wavelengths, like in the X-band. 
• An X-band radar is radar that emits radiation in the X-band of the electromagnetic spectrum: 8-12 GHz, corresponding to wavelengths of around 2-4 cm (this is in the microwave part of the spectrum.)
• Due to operating at a smaller wavelength, X-band radars are more sensitive and can detect smaller particles compared to other radar bands. The smaller wavelengths allow the radar to produce images of higher resolution.
• However, the greater the frequency of any radiation, the faster it will be attenuated. So, X-band radars have a relatively shorter range. 
• X-band radars are typically used for studies about cloud development and light precipitation due to their abilities to detect tiny water particles and snow.
• Significance: In Wayanad, the new radar is expected to be able to monitor the movements of particles, such as soil, to inform landslide warnings. The device will also perform high temporal sampling, i.e., rapidly sample its environs, allowing it to spot particle movements happening in shorter spans of time.

S-band radars vs. X-band radars: 

There are two types of radars that are frequently used: S-band and X-band. 

1. S-band radar:

• Operating frequency: 2-4 GHz.
• Speciality: Long-range detection.
• Benefits: Capable of operating accurately even in severe weather conditions (heavy precipitation and cloud cover), making it useful for civilian and military aircraft navigation. 
• Applications:
• Used for maritime surveillance as it provides long-range coverage. E.g., Used by naval warships for precise tracking of threats, both aerial and surface, at greater distances.
• Used in weather forecasting due to their ability to operate in adverse weather. 

2. X-band Radar:

• Operating frequency: 8-12 GHz.
• Speciality:
• Higher-resolution short-range imaging for target identification.
• Detection of smaller objects because X-band radars (operating on smaller wavelengths) have high sensitivity. 
• Benefits: They have compact size and thus can be installed on mobile platforms.  
• Limitations:
• More susceptible to be impacted by weather conditions due to their smaller wavelengths. (atmospheric conditions like rain can reduce their range)
• Have relatively shorter range than S-radars.  
• Applications:
• Used in short-range weather forecasting and for monitoring localised weather phenomenon, like, heavy rainfall, thunderstorms, weather patterns, cyclones etc. 
• X-band technology is also used for civil, military, and government settings for tasks such as:
• Weather Monitoring (localised weather phenomenon)
• Air Traffic Control (high resolution imaging helps in the identification/distinguishing and tracking of aircrafts)
• Maritime Vessel Traffic Control 
• Vehicle Speed Detection for Law Enforcement
• Missile guidance systems (can track small, fast-moving targets with precision).

How many radars does India have?

• The India Meteorological Department (IMD) started using radar for weather applications in the early 1950s. The first indigenously designed and manufactured X-band storm detection radar was installed in 1970 in New Delhi. In 1996, IMD replaced 10 outdated X-band radars with digital X-band radars. In its X-band radar network, India has both wind-finding and storm-detecting radars, and some with dual capabilities. 
• The country also uses S-band radars (2-4 GHz) for long-range detection. The first S-band cyclone detection radar was installed in Visakhapatnam in 1970 and the first locally made variant was commissioned in Mumbai in 1980.
• In September 2024, the Ministry of Earth Sciences said India is set to have 56 additional Doppler radars in a few years. On September 11, the Union Cabinet cleared the ₹2,000-crore ‘Mission Mausam’ to upgrade meteorological infrastructure in the country. This includes installing up to 60 meteorological radars until 2026 under the Mission’s first phase.
• The government has started the process to procure and install 10 X-band Doppler radars to improve weather forecasting in the northeast States and in Himachal Pradesh’s Lahaul and Spiti district.