Month: August 2023

Categories
Science & Tech

Schoolchildren’s Use of Smartphones

  • The report, titled “State of Elementary Education in Rural India,” was just published.
  • It focuses on the current digital landscape in rural regions for education.

India’s Elementary Education Situation

  • It is a detailed survey of 6,229 parents of rural schoolchildren aged 6 to 16 from 21 Indian states.
  • It is made public by the Development Intelligence Unit (DIU).
  • It discovered an interesting trend: children in rural areas primarily use smartphones for fun rather than instructional purposes.

Key Highlights

(1) Smartphone Use and Entertainment

  • The poll indicated that 49.3% of rural students have access to cellphones, which influences their digital participation.
  • Entertainment Dominance: A considerable 76.7% of parents whose children have access to gadgets reported that their children mostly use smartphones for playing video games, highlighting the popularity of entertainment-related activities.
  • Media Consumption: According to the report, 56.6% of students with access to gadgets use cellphones to download and watch films, while 47.3% download and listen to music.
  • In comparison, only 34% of students use smartphones for study downloads, and only 18% use online learning tools such as tutorials.

(2) Demographics and Education Levels:

  • Age and Smartphone Access: According to the poll, students in higher grades (Class VIII and above) have more access to cellphones (58.32%) than their peers in lower grades (Classes I-III), who had 42.1% access.
  • Education Aspirations: An positive number emerged, with 78% of parents hoping to educate their daughters to at least a bachelor’s degree level, and 82% aspiring to do the same for their sons.

(3) Parental Participation and Insights

  • Learning interactions: According to the poll, just 40% of parents have regular interactions with their children regarding school-related learning. Another 32% conduct such chats on a regular basis.
  • Dropout Insights: Among a subgroup of 56 respondents, the reasons for children dropping out of school were the necessity for girls to contribute to family income (36.8%), a lack of interest in studies (31.6%), and home obligations (21.1%). The biggest factor for boys was disinterest in academics (71.8%), followed by the necessity to contribute to family wages (48.7%).
  • Parent-Teacher Meetings: An impressive 84% of parents reported attending parent-teacher meetings on a regular basis. Short notice and a lack of willingness were also obstacles to participation.

@the end

  • Despite limited access, our findings highlight the importance of balanced digital engagement that encourages both educational and entertaining activities.
  • The survey’s findings on parental ambitions, learning conversations, and the issues of dropout rates present a comprehensive picture of the rural education landscape and highlight the significance of holistic educational approaches.
Source: https://www.thehindu.com/news/national/more-students-using-smartphones-for-entertainment-than-study-survey/article67173226.ece
Categories
Security Issues

In India, a centre will investigate Havana Syndrome cases

Authorities are investigating Havana Syndrome, a peculiar collection of mental health problems suffered by US intelligence and embassy workers in India.

What is Havana Syndrome?

  • The phrase “Havana Syndrome” first appeared in Cuba in late 2016, when US diplomats at the newly opened US embassy in Havana reported symptoms such as cerebral pressure, headaches, and confusion. The cause of these symptoms aroused first suspicions of a “sonic attack” staged by Cuban intelligence.
  • Following the Cuban event, American personnel stationed in China, Russia, Poland, Georgia, Taiwan, Colombia, Kyrgyzstan, Uzbekistan, Austria, and even Washington DC, including near the White House, reported identical symptoms.

India’s Havana Syndrome

  • As of July 2023, the 2021 event involving a US intelligence official in India was the country’s only reported case of Havana Syndrome.
  • Indian Security Organisation: According to Indian security officials, they are not aware of any agency that possesses such microwave-based counter-espionage equipment.
  • Given India’s good relations with the US, officials believe it is improbable that an Indian agency or foreign force would target US leaders in this fashion.

The Possible Origins of Havana Syndrome

  • Microwave Exposure: According to scientific evidence and medical exams of the patients, high-powered microwaves may have injured or interfered with the neurological system, resulting in the described symptoms.
  • The disease was thought to be produced by high-powered microwave rays emitted through a specialised device known as a “microwave weapon.”
  • Counter-Intelligence Tactic: Since the Cold War, both Russia and the United States have experimented with employing microwaves as a counter-intelligence tactic.

Debunking the Havana Syndrome Theory:

  • Inadequate Evidence: Despite years of data collecting and experimentation, the United States has yet to find conclusive evidence supporting the existence of a “microwave weapon.”
  • Amplified Psychological Illness: Some medical specialists believe the syndrome is a psychological disease exacerbated by fear of being targeted.
  • Relationship Impact: In 2023, a report from various US security agencies suggested that foreign foes were unlikely to be behind the “anomalous health incidents,” which may have harmed US-Cuba ties.

Conclusion

  • The enigmatic Havana Syndrome continues to confound researchers and politicians around the world, with no conclusive evidence of its origins or causes.
  • As India investigates the matter in response to the current plea, the global enigma surrounding Havana Syndrome continues to be a source of concern for intelligence agencies and governments alike.
Source: https://www.indiatoday.in/india/story/central-government-investigate-possibility-of-havana-syndrome-india-2417986-2023-08-08#:~:text=The%20central%20government%20has%20agreed,mysterious%20illness%20in%20the%20country.
Categories
Science & Tech

How can you determine if a material is a superconductor?

  • South Korean researchers recently presented LK-99, a potential room-temperature superconductor that could revolutionise industrial and medical applications due to its capacity to transmit huge currents with zero resistance.
  • The significance of LK-99’s potential discovery is discussed in this article, which looks into the crucial qualities that define a superconductor.

Superconductors: An Introduction

A superconductor is a substance that exhibits four unique changes that indicate its transition to the superconducting state under particular conditions.

(1) Electronic Effect:

  • When transmitting electric current, a true superconductor exhibits zero resistance.
  • This attribute must be verified using advanced equipment and testing on a suitably large sample.

(2) Magnetic Effect:

  • Different types of superconductors respond differently to magnetic fields.
  • The Meissner Effect occurs when a type I superconductor emits a magnetic field below a critical value.
  • A type II superconductor in a mixed superconducting and non-superconducting phase, known as flux pinning, prevents magnetic fields from reaching its bulk.

(3) Thermodynamic Effect:

  • During the superconducting transition, the electronic-specific heat, which represents the heat required to raise electron temperature by one degree Celsius, changes dramatically.
  • The electronic-specific heat reduces when the material transitions to its superconducting state.
  • When the material is reheated to the critical temperature, the specific heat returns to its non-superconducting value.

(4) Spectroscopic Effect:

  • The occurrence of energy level gaps, which prohibit electrons from specific energy levels, is a distinguishing property of superconductors.
  • Mapping energy levels in a superconductor reveals these gaps, indicating the superconductor’s nature.

Superconductors, Conventional vs. Unconventional:

  • Traditional Superconductors: These materials follow the superconducting theory of Bardeen-Cooper-Schrieffer. They exhibit predictable behaviours that can be explained by recognised scientific principles.
  • Unconventional Superconductors: Unconventional superconductors, on the other hand, exhibit superconductivity that defies current theoretical interpretations. Researchers are attempting to solve the mystery origins of their superconducting abilities due to their unique features.

LK-99 Apatite Structure:

  • To create LK-99, the Korean team used copper-substituted lead apatite, a phosphate mineral with unusual tetrahedral patterns.
  • Superconducting qualities: LK-99 exhibited key superconducting qualities, including almost zero resistance to current flow and the rapid appearance of resistance above a critical current threshold.
  • Magnetic Resilience: LK-99 maintained superconductivity in the presence of a magnetic field until a critical threshold was reached.

The LK-99 Discovery and Its Implications

  • The prospective room-temperature superconductor LK-99 holds the possibility of revolutionising a wide range of industries and medical uses.
  • To verify its authenticity and potential influence, independent researchers must thoroughly validate it.
  • If validated, LK-99 has the potential to change the way we harness and use electrical currents in a variety of fields.
Source: https://www.cbc.ca/news/science/lk99-superconductor-resistance-explainer-1.6929966#:~:text=A%20material%20must%20have%20two,absolutely%20no%20energy%20is%20lost.
Categories
News Polity

Language Difficulties in India’s Judiciary

  • A petition to transfer a vehicle accident case from the vehicle Accident Claims Tribunal (MACT) in Farrukhabad, Uttar Pradesh, to the MACT in Darjeeling, West Bengal, was denied by the Supreme Court.
  • The court emphasised that language should not be an impediment to communication, and that witnesses should talk in Hindi, the national language, during proceedings.

Why are we debating this?

  • Given India’s linguistic diversity, the Supreme Court’s declaration that Hindi is the national language provoked dispute.
  • While no language is officially declared as the “national language,” Hindi retains an important position as the Union’s official language.

The Constitution and Official Languages

  • Article 343: The Constitution specifies Hindi in Devanagari script as the official language of the Union, with English used for official purposes for the first 15 years following the Constitution’s adoption in 1950.
  • Article 351: The Union is directed by the Constitution to foster the spread of Hindi while respecting the forms and expressions of the other languages listed in the Eighth Schedule.

Linguistic Diversity and the Eighth Schedule

  • Eighth Schedule: The Constitution’s Eighth Schedule recognises 22 languages, including Hindi, Bengali, Punjabi, Tamil, Telugu, and Urdu. The Schedule has grown over time to include languages such as Bodo, Dogri, Maithili, and Santhali.
  • Inclusion Demands: Several languages, including Bhojpuri, Garhwali (Pahari), and Rajasthani, are seeking to be included in the Eighth Schedule. The MHA recognises the dynamic nature of language evolution but confronts difficulty in setting inclusion criteria.
  • Despite the fact that Hindi is an official language, the Official Languages Act of 1963 ensures that English will continue to be used for official purposes after the first 15-year period.
  • English Status in Judiciary Apex Courts: The use of English is required in Supreme Court and High Court proceedings, guaranteeing consistency in legal communication. The Rajasthan High judicial used Article 348 (2) and the Official Languages Act to integrate Hindi into judicial proceedings.

Subordinate Courts and Regional Languages:

  • The State Government has the ability to choose the language of subordinate courts within the state under the Code of Criminal Procedure (CrPC).
  • While the language of subordinate courts is originally preserved, the State Government may define a language and character for applications and proceedings.
Source: https://www.scobserver.in/journal/language-barriers/
Categories
Governance

Changes in India’s Mining Policy

  • The Mines and Minerals (Development and Regulation) Amendment Bill, 2023, was just enacted by India’s Parliament.
  • This measure seeks to increase private sector involvement in mineral exploration and mining, thereby alleviating import dependence and supply chain weaknesses.

Mines and Minerals Bill 2023 Provisions

  • Increasing Exploration Rights: The Bill authorises the private sector to participate in the exploration of essential and strategic minerals that were previously reserved for government enterprises.
  • Exploration Licences (EL): The Bill creates a new form of licence, the EL, for private exploration. Exploration licences will be awarded through competitive bidding for certain important, strategic, and deep-seated minerals.
  • Money Model: ELs hope to gain money by sharing a portion of the premium paid by the miner after successfully auctioning off a mined deposit.

The Importance of Critical Minerals

  • Critical minerals are elements that are essential to contemporary technology and are vulnerable to supply chain disruptions.
  • Antimony, cobalt, gallium, graphite, lithium, nickel, niobium, and strontium are among the 22 minerals identified as vital for India.
  • Vulnerabilities in the Global Supply Chain: Global supply chains for a variety of commodities, including important minerals such as lithium, cobalt, graphite, and rare earth elements, have been found to be vulnerable to shocks, resulting in shortages and rising costs.
  • Impact on Various Industries: Critical minerals are required for industrial, infrastructure development, and the shift to sustainable energy. They are critical for the development of electric vehicle batteries, semiconductors, wind turbines, and other technical developments.

Dependence on Imports and Vulnerabilities

  • Import Dependence: India relies extensively on imports for important and long-lasting minerals such as lithium, cobalt, nickel, and rare earth elements.
  • Supply Chain Disruption: When extraction and processing are concentrated in a few geographical places, such as China’s supremacy in cobalt and rare earth elements, supply chain vulnerabilities might arise.
  • Demand Forecast: According to a World Bank report, demand for key metals such as lithium and cobalt will nearly double by 2050.

Mineral Security Partnership (MSP):

  • Global Initiatives for Supply Chain Resilience The MSP was developed by major economies such as the United States, the United Kingdom, Japan, and the European Union to maintain supply chain resilience for essential minerals. India joined this collaboration to have access to these resources.
  • Strategic Lists: Countries are establishing lists of key minerals based on economic demands and supply threats, and these lists are aligned with their industrial strategy. This is done to provide consistent access to these resources.

Exploration and Mining by the Private Sector:

  • Mineral exploration is a multi-stage process that begins with reconnaissance and progresses to extensive exploration before mining begins. India’s exploration operations have been led by government bodies, with little engagement from the commercial sector.
  • Resource Potential: Similar to mining-rich locations, India’s geological setting has the potential for mineral resources. Only a small portion of its obvious geological potential has been exploited.

Problems and Concerns

  • Incentives and Risks: Private sector involvement in exploration necessitates significant investments and includes inherent risks, necessitating the creation of favourable circumstances and incentives.
  • Delays in Revenue Generation: The principal source of revenue for private explorers is a portion of auction premiums, which is dependant on successful mine auctioning, which can take a long time due to government clearances.
  • Challenges of the Auction Process: Auctioning ELs before exploration begins adds uncertainty about future revenue and value estimation.
  • Supreme Court judgement: In its 2012 judgement, the Supreme Court emphasised the importance of secure utilisation of explored resources, which the new strategy does not guarantee.
Source: https://www.ibef.org/blogs/mining-sector-reforms-and-the-road-ahead
Categories
Governance

The Delhi Services Bill, 2023

  • Four days after the Lok Sabha approved the Government of National Capital Territory of Delhi (Amendment) Bill, 2023, the Rajya Sabha passed it.
  • Once signed by the President of India, it will become law.

Background Information on the Delhi Services Bill, 2023

  • The Supreme Court decided in favour of the Delhi government in May 2023, allowing it power over most services in the capital city, with the exception of public order, land, and police issues.
  • However, on May 19, the Centre submitted an ordinance to override the Supreme Court’s judgement, granting the Lieutenant Governor (LG) more jurisdiction in areas of appointments and transfers of officials.

Key Bill Provisions

  • National Capital Civil Services Authority: The bill creates the National Capital Civil Services Authority, which would offer recommendations to the LG on service-related issues like as transfers, vigilance, and disciplinary processes.
  • Powers of the LG: The measure expands the LG’s discretionary authority, allowing him to override the Authority’s recommendations and act on his own in certain circumstances.
  • Ministerial Matter Disposal: The law empowers Delhi government ministers to issue standing orders for matter disposition, subject to consultation with the relevant Department Secretary. However, before issuing any order, certain sensitive subjects must be submitted to the LG for his view.
  • Secretaries’ responsibilities include bringing specific issues to the attention of the LG, Chief Minister, and Chief Secretary, particularly those that may result in a dispute with other state governments, courts, or the federal government.

Significant revisions to the Services Clause 3A removal:

  • The bill repeals a provision in the ordinance that barred the Delhi Assembly from passing legislation concerning ‘State Public Services and State Public Service Commission.’ This grants the assembly the authority to create service regulations.
  • The National Capital Civil Service Authority (NCCSA) would no longer be required to submit an annual report to Parliament or the Delhi Assembly, eliminating the requirement to deliver the report before both legislative bodies.
  • Changes to the Appointment Cycle: The law weakens regulations governing the appointment of chairpersons and members of Delhi’s numerous authorities, boards, commissions, and statutory organisations. It does away with the need for “orders/directions of ministers” on topics that must be communicated to the central government before the Lieutenant Governor and Chief Minister.
  • Appointment of Delhi LG Powers: The bill gives the Lieutenant Governor the authority to appoint members of the Delhi government’s Boards and Commissions from a list of names proposed by the NCCSA, which includes recommendations from the Delhi Chief Minister. The Delhi Assembly passes regulations that establish these boards and commissions.

Debate on the Constitution

  • Critics argue that the bill may violate the principle of parliamentary democracy by potentially giving the central government powers over Delhi services, breaking the triple chain of accountability between civil servants, ministers, and the electorate.
  • Discretionary Powers of the LG: The measure enhances the LG’s discretionary powers by allowing him to override Council of Ministers decisions, which might potentially impair the operation of the democratically elected government.
  • Certain terms in the bill, such as the LG’s “sole discretion” and criteria for concerns brought to his attention, are regarded unclear and could create to ambiguity in execution.
  • Concerns of the Opposition: Opposition leaders have spoken out strongly against the law, alleging that it violates democratic heritage, the spirit of federalism, and the authority of an elected government.

Defence of the Government

  • The Centre has justified the measure by claiming that India has a quasi-federal structure in which the Centre is supreme.
  • The measure seeks to strike a balance between the interests of Delhi and the nation.
Source: https://www.wionews.com/india-news/explained-what-is-delhi-services-bill-how-will-it-affect-national-capitals-governance-623158#:~:text=The%20Delhi%20Services%20Bill%2C%20formally,of%20Delhi%20over%20most%20services.
Categories
Environment & Biodiversity

Clouded Leopards

  • Since 2018, the 4th of August has been designated as International Clouded Leopard Day.
  • The Wildlife Institute of India (WII) conducted a research on clouded leopards in western Assam’s Manas National Park and Tiger Reserve.

The Clouded Leopard

  • The clouded leopard (Neofelis nebulosa) is a wild cat that lives in deep woods ranging from the Himalayan foothills to mainland Southeast Asia and South China.
  • It features big dusky-grey blotches, irregular dots and stripes, and dark grey or ochreous fur that resembles clouds, hence the name.
  • It is the first cat to have genetically separated from the pantherine cats’ common ancestor between 9.32 and 4.47 million years ago.
  • The clouded leopard is currently classified as Vulnerable on the IUCN Red List.
  • It is listed in CITES Appendix I and is protected throughout the majority of its range.

India’s habitat

  • It lives in deep forests in Sikkim, northern West Bengal, Tripura, Mizoram, Manipur, Assam, Nagaland, and Arunachal Pradesh, among other places.
  • It is Meghalaya’s state animal (Note: Clouded Leopard National Park is in Tripura).

Clouded Leopard Characteristics

  • Because of its huge canines, the mainland clouded leopard is agile and robust, and is frequently compared to the Ice Age sabretooth.
  • It is distinguished from other felines by its spinning rear ankles, which allow it to descend headfirst from trees.
  • The cat’s hide contains cloud-like markings that make it clearly recognisable.
Source: https://indianexpress.com/article/north-east-india/nagaland/clouded-leopard-sighted-nagaland-mountains-7709328/
Categories
Governance

Lowering the Minimum Age for Election Participation

  • A Parliamentary Standing Committee has suggested that the minimum age for competing Lok Sabha and Assembly elections be reduced to 18 years old, in line with the minimum voting age in India.
  • The Committee thinks that, with worldwide practises and increased political consciousness among youth, young people can be responsible political actors.

Minimum Age Requirements in Effect

  • Lok Sabha and Assembly Elections: A person must be at least 25 years old to contest elections to the Lok Sabha or State Legislative Assembly, according to Article 84 of the Indian Constitution and Section 36 of the Representation of the People Act, 1951.
  • Rajya Sabha and Legislative Council: To become a member of the Rajya Sabha or the State Legislative Council, a person must be at least 30 years old, according to Article 80(4) of the Constitution and Section 43 of the RP Act, 1951.

Evidence from Global Practises from the Parliamentary Committee:

  • The Committee cited instances from Canada, the United Kingdom, and Australia of young people who have proven to be trustworthy and responsible political actors.
  • Youth Representation: It supports lowering the minimum age for candidature, noting global practises and young people’s growing political consciousness. It thinks that, as a result of greater education, globalisation, and digitization, young people are more than capable of standing for government in the twenty-first century.
  • Age Disparity: The Committee raised worry over the large age disparity between MPs and India’s median age, emphasising the need for more youth representation.
  • Diverse Points of View: According to the Committee, lowering the minimum voting age will offer new perspectives to policy debates and address the underrepresentation of young voices in the political sphere.

The Election Commission’s Point of View

  • Impractical Expectations: The European Commission opposes the proposal, claiming that expecting 18-year-olds to have the appropriate experience and maturity for legislative duties is impractical.
  • Current Age restrictions Appropriate: The EC finds that the current minimum voting and contesting age restrictions are adequate.

Actions Suggestions

  • Delimitation Process: The Committee recommends that the EC work with the legislative department to investigate the consequences of the delimitation process, particularly in difficult terrain. Treating all regions of India as if they were the same may cause problems, and appropriate steps should be implemented to meet this fact.
  • Common Electoral Rolls: The Committee emphasises the advantages of Common Electoral Rolls for State and Lok Sabha elections, which can be developed through the collaborative participation of officials from the ECI and State ECs.
Source: https://www.outlookindia.com/national/parliamentary-committee-urges-lowering-minimum-age-for-contesting-elections-citing-youth-empowerment-news-308169
Categories
Economics

Financial Action Task Force (FATF)

Pakistan’s Senate has adopted a measure to create a central body to combat money laundering and terror funding by uniting all Financial Action Task Force (FATF) institutions under one leadership.

What is FATF?

  • The Financial Action Task Force (FATF) is an intergovernmental organisation founded in 1989 to combat money laundering and financial crimes.
  • Pakistan was added to the FATF grey list in 2018 as a result of its efforts to combat money laundering and terrorist financing.
  • However, Pakistan was able to depart the grey list by implementing thorough reforms and strategic actions.
  • The country’s progress in improving legislation relating to money laundering and terrorism financing was critical in reaching this milestone.

Role of FATF

  • Combating Global Financial Crimes: In response to the growth of the global economy and international trade, the FATF sets rules to combat money laundering and terrorist funding.
  • Regulatory suggestions: The organisation makes suggestions to combat financial crime, examines members’ policies and procedures, and advocates for the global acceptance of anti-money laundering rules.
  • FATF frequently changes its recommendations in order to remain abreast of changing financial crime strategies.

Important initiatives: Black and Grey Lists

  • The FATF grey list includes countries that are deemed safe havens for terrorist funding and money laundering. Inclusion on this list serves as a warning for possible inclusion on the more serious blacklist.
  • Call to Action (Black List): The “Non-Cooperative Countries or Territories” (NCCTs) list, also known as the “black list,” lists countries that do not follow FATF recommendations.

The Importance of FATF Membership Economic

  • Sanctions on the Grey List and Reduced Trade: Countries on the grey list may face economic sanctions as well as reduced international trade prospects.
  • Loan Difficulties: Access to loans from international financial institutions such as the IMF, World Bank, and ADB may be constrained.
  • International Boycott: The country’s global reputation may suffer as a result of international boycotts.

What is Pakistan doing now?

  • The law intends to establish a National Anti-Money Laundering and Counter-Terrorism Financing Authority, which will be overseen by a chairman selected by the Prime Minister.
  • Coordination and cooperation: The authority will serve as a hub for the FATF and other similar organisations.
  • Cohesive Response: The proposed authority will serve as a central institution, allowing Pakistan to respond to money laundering and terror financing in a cohesive manner.
  • Entity Institutionalisation: The bill attempts to institutionalise various institutions, resulting in increased efficiency and collaboration in dealing with financial concerns.

Challenges Addressed:

  • The bill targets three areas of difficulty: anti-money laundering, counter-terrorism financing, and targeted financial sanctions encountered by Pakistan when it was on the FATF grey list.
  • Threats to the Global Financial System: When Pakistan was placed on the FATF grey list in 2018, money laundering and terror funding were regarded as serious dangers to the global financial system.

FATF Review and India’s Position Multifaceted Review:

  • The FATF review evaluates 40 parameters pertaining to law, justice, revenue, banking, and insurance, as well as nine parameters connected to terror financing.
  • Review Timeline: The review began early this year and is slated to conclude by the end of 2024, with India being the only country to have postponed its review owing to COVID-19.
Source: https://www.fatf-gafi.org/en/home.html
Categories
Science & Tech

What modifications have been made to the manufacturing rules for pharmaceutical companies, and why?

The Indian government recently required all pharmaceutical companies in the country to apply new Good Manufacturing Practises (GMP) in order to align their procedures with global standards.

Central Idea

The new standards are intended to address major issues such as suspected contamination instances in India-made items, flaws in quality control methods, and a lack of conformity to worldwide requirements. India hopes to improve the quality of pharmaceuticals offered in both domestic and global markets by guaranteeing adherence to the amended GMP.

Concerning Good Manufacturing Practises (GMP)

  • GMP is a set of guidelines and quality management concepts that assure pharmaceutical items, as well as other products in the food and healthcare industries, are produced and regulated in a consistent manner to satisfy quality standards acceptable for their intended use.
  • GMP encompasses all parts of the manufacturing process, such as the premises, equipment, staff, materials, production, quality control, documentation, and completed product storage.

The Need for Improved Standards

  • Alignment with Global Standards: Implementing the new GMP requirements will align the Indian pharmaceutical industry with global standards, ensuring that the country’s products match international regulators and consumers’ expectations.
  • Incidences of Contamination: Numerous incidences of contamination in India-made syrups, eye drops, and eye ointments have been documented in different countries, with terrible results. These accidents have highlighted the importance of tighter quality control methods.
  • Deficiencies discovered: A risk-based assessment of manufacturing units showed various flaws, including a lack of testing incoming raw materials, insufficient product quality review, a lack of quality failure investigation, infrastructure concerns, and a lack of competent people.

Importance of Revised GMP

  • Standardised procedures: The revised standards will ensure that pharmaceutical businesses follow standardised procedures and quality control systems, hence improving the quality of medications manufactured and sold in India and around the world.
  • Chitan Shivir’s recommendations: Following the contamination occurrences, one of the advised measures at a Chitan Shivir was the implementation of the amended GMP. The stakeholders also advocated for the establishment of a national IT platform to enhance consistency in licencing and inspection processes across states.

The Advantages of Revised GMP Implementation

  • Increasing Regulatory Trust: Uniform quality standards across the business will establish trust in foreign regulators, potentially decreasing the need for repeat inspections.
  • Improving Domestic Market Quality: The adoption of updated GMP would improve the quality of pharmaceuticals sold in India, benefiting both consumers and public health.

Significant Changes in the Revised GMP Guidelines

  • The new requirements include a pharmaceutical quality system to assure consistent product quality and a thorough assessment of deviations or failures.
  • Quality Risk Management: Companies will be obliged to undertake risk assessments and execute preventive measures in order to effectively manage quality hazards.
  • Product Quality Review: All items will be subjected to regular quality checks to ensure consistency of quality and processes.
  • Equipment Validation: Pharmaceutical organisations will need to validate equipment in order to assure the accuracy and dependability of production operations.
  • GMP-related Computerised Systems: To avoid data manipulation and unauthorised access, the recommendations emphasise the use of computerised systems for GMP-related operations.
  • Other Product Requirements: The new schedule M specifies the standards for biological goods, radioactive agents, plant-derived products, and investigational products for clinical trials.
Source: https://indianexpress.com/article/explained/explained-health/revised-manufacturing-rules-for-drug-firms-what-changes-and-why-8879305/
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