November 27, 2023

Current Affairs

Decentralised Autonomous Organisations

Context: The idea behind Decentralised Autonomous Organisations (DAO) is to create self-sustaining, community-driven entities governed by smart contracts on blockchain networks. However, the legality and regulatory framework surrounding DAOs remain a topic of debate.

Decentralised Autonomous Organisation:

DAOs are digital entities that operate without centralised control and are governed by smart contracts and the consensus of their members, often utilising cryptocurrencies as a means of decision-making and resource allocation.

Unique features:

DAO are governed by smart contracts on blockchain networks. The rules are encoded as a computer program that is transparent, controlled by the respective organisation members, without the need for intermediaries and not influenced by a government.
They enable global, borderless cooperation. Participants, referred to as token holders, can propose and vote on decisions related to the organisation’s goals and resources (decentralised decision-making process). This fosters innovation and cooperation as ideas flow freely, unencumbered by hierarchical structures.

Various use cases:

Decentralised finance: Platforms like Compound and MakerDAO have introduced lending and borrowing services, enabling users to participate in the global financial ecosystem without relying on traditional banks.
Digital Art: Artists can tokenize their creations and utilise DAOs to manage royalties and maintain control over their intellectual property.
Supply chain management: DAO offers transparency and traceability in global supply chains, ensuring the authenticity and quality of products.

Challenges:

Susceptible to cyber attacks: The infamous DAO hack in 2016 exposed vulnerabilities in the code, leading to a contentious hard fork in the Ethereum blockchain (a hard fork refers to a change in a network’s protocol that makes previously invalid blocks and transactions valid, or vice-versa). This highlights the need for rigorous security audits and raises questions about the immutability of blockchain systems.
Accountability: Issues like smart contract vulnerabilities and security breaches introduce questions of legal recourse and liability. Legal liability within DAOs remains elusive, with decentralised decision-making and automated smart contracts making it difficult to assign responsibility for actions taken.
Dispute resolution: Taxation of transactions within DAOs, identity verification, and compliance with Anti-Money Laundering (AML) and Know Your Customer (KYC) regulations further add layers of complexity to the legal framework. Dispute resolution, often relying on code-based solutions, present a unique challenge in the absence of traditional legal mechanisms.

Generic Medicines approved for Rare Diseases

Context: Health Ministry has made available generic drugs to support the care and treatment of four ailments: Tyrosinemia-Type 1, Gaucher’s Disease, Wilson’s Disease, and the Dravet-Lennox Gastaut Syndrome.

About Rare Diseases:

It is a debilitating lifelong disease or disorder that occurs infrequently in the human population.
WHO defines rare disease with a prevalence of 1 or less, per 1000 population.
There is no universally accepted definition of rare diseases India accept that a disease prevalence of less than 100 patients per 100,000 people is categorized as a rare disease.
A rare disease, also referred to as an orphan disease, is a health condition that affects a small number of people compared to the general population.
These diseases can be genetic or acquired.
Some examples of rare diseases include Huntington's disease, cystic fibrosis, amyotrophic lateral sclerosis (ALS), Haemophilia, Thalassemia, Sickle-cell Anaemia, Cystic Fibrosis, auto-immune diseases and others types of muscular dystrophy.
Due to the limited number of affected individuals, research and development for treatments may be insufficient, and patients may face difficulties in obtaining a timely and accurate diagnosis. The rarity of these diseases often makes it challenging to conduct clinical trials, gather data, and develop effective treatments.

Tyrosinemia-Type 1: It is a rare autosomal recessive genetic metabolic disorder characterized by lack of the enzyme fumarylacetoacetate hydrolase (FAH) which is needed for the final break down of the amino acid tyrosine.

Failure to properly break down tyrosine leads to abnormal accumulation of tyrosine and its metabolites in the liver, potentially resulting in severe liver disease.
Tyrosine may also accumulate in the kidneys and central nervous system.

Gaucher’s Disease: Characterized by the accumulation of a fatty substance called glucocerebroside in various organs, particularly the spleen, liver, and bone marrow. This accumulation occurs due to a deficiency of an enzyme called.

This causes these organs to enlarge and can affect their function. The fatty substances also can build up in bone tissue, weakening the bone and increasing the risk of fractures.

Wilson’s Disease: Also known as hepatolenticular degeneration, is a rare genetic disorder characterized by the accumulation of copper in various organs of the body, particularly the liver, brain, and cornea.

Dravet-Lennox Gastaut Syndrome: These are two distinct types of epileptic syndromes.

Dravet syndrome, also known as severe myoclonic epilepsy of infancy (SMEI), is a rare and severe form of epilepsy that typically begins in the first year of life.
Lennox-Gastaut syndrome is a severe form of childhood-onset epilepsy characterized by multiple types of seizures and cognitive impairment.

Rare diseases in India

As per National Consortium for Research and Development on Therapeutic for Rare Diseases, approximately 450 rare diseases have been identified and reported in India however, 80% of all rare disease patients are affected by approximately 350 rare diseases.
With an estimated burden of about 80 to 96 million cases reported annually in India.
Moreover, 70-80% of rare diseases are of genetic nature, and thus are asymptomatic, but will appear in the person’s lifetime.
In India, there are between 7000 - 8000 rare diseases, but less than 5% have therapies available to treat them.

Government Interventions

National Policy for Rare Diseases, 2021 aims at lowering the incidence and prevalence of rare diseases based on an integrated and comprehensive preventive strategy encompassing awareness generation, premarital, post-marital, pre-conception and post-conception screening and counselling programs.
Production Linked Incentive Scheme 2.0 for Pharmaceuticals, with an outlay of INR 15000 Crore providing financial stimulus to orphan drugs development under Category 1 of pharmaceutical goods in the Production Linked Incentive (PLI) Scheme.
The Central Drugs Standard Control Organisation(CDSCO) has made provisions for fast-track processing of applications for rare diseases drugs for drug trials and experimental therapies and have exempted the application fee of potential drug candidates.
Genomics for Understanding Rare Diseases: India Alliance Network (GUaRDIAN), a non-profit clinical genomics research network, has established a network of clinicians and scientists for largest clinical genomics research networks in India.
Council of Scientific & Industrial Research (CSIR), established an Indian Genetic Disease Database (IGDD) for keeps track of mutations in the causal genes for genetic diseases common in India and provides valuable insights to physicians and researchers.

What is the Piezoelectric effect?

Piezoelectric effect is the ability of a material to generate an electric charge in response to an applied mechanical stress or pressure.

The phenomenon can be observed in some materials – including quartz, topaz, tourmaline, ceramics such as lead zirconate titanate (PZT), and even certain biological substances like bone and the tendons.
Inverse piezoelectric effect: Some materials also display an inverse piezoelectric effect, where the application of an electric current induces a mechanical strain or deformation.

Mechanism:
- Normally, the charges in a piezoelectric crystal are exactly balanced. The forces (electric dipole moments) of the charges exactly cancel out, leaving no net charge on the crystal faces.
- When the crystal is stretched or compressed due to mechanical stress, this pushes the charges out of balance.
- Now the dipole moments no longer cancel one another out and net positive and negative charges appear on opposite crystal faces. This gives rise to a small electric current.
Applications: Used in pressure sensors, accelerometers, acoustic devices, high voltage generators, electronic frequency generators, microbalances, inkjet printers, electronic stethoscopes.

SC calls for collaborative efforts to bring children into the adoption pool

Context: The Supreme Court has recently given various directions to facilitate and expedite the legal adoption of parentless and abandoned children in childcare institutions across India. This marks an important step in providing a family environment to vulnerable children.

Adoption Regulations in India

The legal framework governing adoptions in India includes Acts like Juvenile Justice (Care and Protection of Children) Act, 2015, that uphold child rights.

It provides a framework for in-country and inter-country adoption, covering aspects like eligibility norms, procedural safeguards, agencies involved, etc.

Adoption Process in India

Readiness Assessment: Prospective parents wishing to adopt are counselled and evaluated based on eligibility criteria spanning income, parenting capacity, motivation, etc.
Matching via Referral: Caseworkers facilitate compatibility assessment between waiting families and adoption referral profiles of children needing homes, considering individual care needs.
Fostering Period: Following referral acceptance, prospective families undergo a fostering period typically spanning a few meetings, building rapport with the child while observing indications of bonding, acceptance, etc.
Legal Formalisation: Based on successful adaptation progress during fostering, legal formalities around custody transfer, birth certificate, etc. are completed, often requiring court ratification before the child is officially welcomed into the adoptive family.
Post-adoption Support: Follow-up support continues to span integration monitoring and counselling access to ensure the child's holistic development within a caring, stable family environment.

Central Adoption Resource Authority (CARA)

CARA serves as a central body that streamlines and monitors care standards across adoptions as per mandate in the JJ Act.
CARA regulations stipulate guidelines on eligibility criteria, referral, matching, and post-adoption protocols.
It primarily facilitates adoptions of orphaned, abandoned, or surrendered children through recognised agencies.

Domestic vs Inter-Country Adoptions

Indian families are preferred for placements, and NRI, OCI, and PIO cardholders also get priority compared to foreign nationals during referrals.
Inter-country adoptions require additional clearances from a central authority and immigration formalities for Child visas, etc. Both adoption types follow the same screening and counselling protocols.

Institutional Framework

Specialised Adoption Agencies (SAAs) facilitate legal adoptions with CARA oversight and adherence to regulations and timeframes while protecting child rights. Various SAA models exist-

Government agencies like State Adoption Resource Agencies
Voluntary or private institutions recognised by CARA
Public sector agencies like the Central Social Welfare Board

District Child Protection Units serve as local implementing bodies for welfare schemes and drive the creation of vital village-level child protection structures like Foster Care Committees.

Recent Supreme Court directions

Bi-Monthly Drives: The court has ordered bi-monthly drives starting December 2023 for District Child Protection Units to trace orphaned, abandoned, and surrendered children across all childcare institutions.

A special focus will be on children with unfit parents or uncertain legal status.

Identifying Children with Unfit Guardians: The court defines an “unfit guardian.” This term applies to several types of people.

They may neglect or refuse to care for a child.
Some may use drugs or alcohol.
Others might have abused or neglected the child, including those with criminal records.
It covers people who need care for themselves.
Finally, it includes those with mental health issues.

Reporting to Authorities: It has mandated collating adoption data and forwarding it to the Central Adoption Resource Authority (CARA) under the WCD ministry by January 2024.

CARA shall facilitate suitable family placement for these children. The court also emphasised teamwork between districts and departments.

These directions translate into binding obligations across states to locate adoptable children, determine eligibility, maintain updated records and ensure CARA linkage under the oversight of dedicated cadres like child protection officers, special juvenile police units, etc.

Challenges

Despite robust frameworks, adoption processes encounter multiple challenges:

Tedious Legal Formalities: Exhaustive paperwork and court procedures often lead to attrition of prospective parents in the adoption process pipeline. Streamlining legal aspects is vital.
Shortage of babies/young children: A high demand-supply skew exists for healthy infants/toddlers amid prevalent societal prejudices.
- Most adoptable children tend to be older and have moderate special needs. Addressing mindset issues is crucial.
Infrastructure Constraints: Resource limitations and staff shortcomings affect monitoring capacity for post-adoption follow-ups by agencies as existing personnel juggle varied work portfolios.
Lack of Awareness: Limited adoption literacy among the public, including myths linking infertility or sociocultural barriers, affects uptake. Sensitisation outreach must be boosted.

Way-forward

Address Legal Complexities: Simplify procedures, digitise records to expedite processing while retaining safeguards, and make court processes child-friendly avoiding intimidating environments. Set time-bound frameworks at each step.
Expand System Capacities: Build state/district level formal networks of foster families and kinship caregivers through sensitization to accommodate younger or special needs children until permanent families are identified. Set up more Specialised Adoption Agencies.
Enhance Monitoring: Quality enhancement mechanisms for Child Care Institutions, including mandatory licensing and annual grading on indicators like resource availability and child protection norms compliance, are critical.
- Robust post-adoption tracking systems are also needed.
Awareness Drives: Grassroots campaigns involving local leaders, prominent adoptive parents, etc. can accentuate community awareness of adoption opportunities and address stigma barriers currently deterring prospects.

Draft National Pharmacy Commission Bill

Context: The Union Ministry of Health welcomed public and stakeholder input regarding the National Pharmacy Commission Bill 2023. The ministry put up the draft bill on its website on November 14 seeking comments from the public.

About National Pharmacy Commission Bill 2023

Salient Provisions of the National Pharmacy Commission Bill 2023

New Body: It seeks to establish the National Pharmacy Commission by replacing the Pharmacy Act, 1948, and the Pharmacy Council of India (PCI). PCI will be regulating both the profession and practise of pharmacy.
Accessibility of pharma professionals: It seeks to ensure the availability of quality pharmacists across the country. For this, the focus is on increasing access to high-quality, reasonably priced pharmacy education.
National Pharmacy Commission: The bill aims to establish the National Pharmacy Commission (HQ-New Delhi). The Commission will have 14 part-time members, 13 ex-officio members, and a chairperson.
New boards: The central government will establish three boards which will function under the Commission. These are the Pharmacy Education Board, the Pharmacy Assessment and Rating Board, and the Pharmacy Ethics and Registration Board.
New pharmacy institution: The bill prohibits the creation of new pharmacy schools or programmes without first obtaining approval from the Pharmacy Assessment and Rating Board.
- The board will review and assess pharmacy schools and post evaluation reports on its website.
- Minimum standard violations could lead to fines ranging from warnings to revocation of recognition.
National Pharmacy Register: To ensure openness, a National Pharmacy Register will be maintained under the Pharmacy Ethics and Registration Board with information on pharmacy professionals.
Implementation: States are required to create a state pharmacy chapter within a year of the passage of the Act.
- This will facilitate the exercise of any authority and the performance of any obligations outlined in the Act.
Periodic and open evaluation: The bill also calls for transparent and periodic evaluation of pharmacy schools.
Additional provisions: The Bill also pushes professionals to maintain high ethical standards, participate in research, and incorporate the most recent findings into their work.
- It is an efficient grievance redressal procedure.
- The draft bill aims to establish an efficient grievance redressal system and suggests flexibility to adjust to changing needs.

Concerns Associated with the Bill

The threat of bureaucratisation: It is feared by Pharma bodies and organisations that the move will bureaucratise pharmaceutical regulation.
Decline in Standard of Regulation: Pharma bodies allege that the new National Pharmacy Commission will take away the control of pharmacists over the Pharma body thereby impacting the technical guidance provided by the PCI.

Way-Forward

Proper Consultation: Since the bill is still in the draft stage, a proper consultation among key stakeholders is necessary, and the bill intends to bring about a significant change in the pharma sector of India, which is still largely governed by the 1948 Act.
Expansion of Scope: Since the draft bill seeks to replace an archaic law of 1948, it should include emerging challenges in the sector, especially the rise of unethical practices such as a gift culture between a doctor and an MR.
Integration with NEP: Changes in pharma education must not be limited to the curriculum alone; they should be integrated with the innovative pedagogy of the New Education Policy.