Context: The recently released film ‘Dunki’ focuses on the issue of immigration.

Film Dunki Focuses on the Issue of Immigration

• The title Dunki is taken from the term “donkey journey”, which refers to the long-winding, often dangerous routes involved in dangerous immigration. 
• These trips are undertaken due to a lack of requisite legal permits or financial resources.
• The film delves into historical context, highlighting the recent origin of visas and passports.

Continue Reading: Bollywood Film ‘Dunki’: What Donkey Route Means?

Evolution of Passport

• Purpose: Passports function as permits and proofs of identity, allowing the residents of one country to travel to another.
• Early Passport Systems:  In France, a permit system similar to ‘Passport System’ had been well established before the French Revolution of 1789. 
  • Internal passports for local travel and overseas passports for foreign trips were mandatory..
  • The French State utilized passports to prevent skilled workers migration and capital outflow.  
• Modern Passport: 
  • Impact of World Wars on Passports: 
    • World War prompted countries to secure their border and regulate entry.
    • In 1914, the British Nationality and Status of Aliens Act was enacted and it provided for naturalization of non-citizens and other laws related to citizenship.
    • The first modern passport was a product of this Act. 
• Internationalization: 
  • League of Nations, held Conference on Passports and Customs Formalities to regulate travel through passports in 1920. 
  • The British passport model became widely adopted globally.
• 1920s Passports Legislation: 
  • The 1920s saw laws on passports from countries such as the US.
  • The U.S. passed the Emergency Quota Act of 1921 and later, the Immigration Act of 1924 limiting the inflow of immigrants.

Passport in India

• Origin: As per the Ministry of External Affairs, there was no practice of issuing Indian passports before the First World War.
• Adoption: During the First World War (1914 to 1918), the British government enacted the Defence of India Act making the possession of a passport necessary for leaving and entering India.  

Types of Passports in India

1. Ordinary Passports: These are blue-coloured passports for common citizens. 
2. Diplomat Passports: These maroon-colored passports are issued to Indian diplomats and senior government officials. 
3. Orange Passport: These ECR passports were introduced in 2018 to identify people who are at higher risk of getting exploited. People who have not studied beyond class 10 are issued this ECR (immigration check required) category passport. 
4. White Passport: It’s one of the most powerful passports given to government officials traveling abroad for official work. 

Source: Indian Express

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Context: Britain will deploy a naval ship near Guyana to support Guyana over the border dispute with neighbor Venezuela over the oil-rich Essequibo region. 

About Venezuela and Guyana Border Dispute

• History: Essequibo region is a disputed region between Venezuela and Guyana.
  • Geography: The 160,000-square-km Essequibo region lies west of the Essequibo River, which passes through Guyana. Essequibo region makes up two-thirds of Guyana’s territory. 
• Arbitral Award: Guyana’s claim has been internationally accepted since the 1899 Paris Arbitral Award. However, Venezuela has disputed this award. 
• Global Support: India, with diasporic ties, supports Guyana; the US also backs Guyana’s sovereignty. 

Continue Reading: Venezuela-Guyana Conflict Over The Disputed Essequibo

Source: The Hindu

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Context: December 25th, the birth anniversary of former Prime Minister Atal Bihari Vajpayee is celebrated as “Good Governance Day”.

About Atal Bihari Vajpayee:

• Birth: He was born on December 25, 1924, in the erstwhile princely state of Gwalior (now a part of the Indian State of Madhya Pradesh).
• Death: He died on 16th August 2018 due to age-related illness.

Timeline: 

• 1939:  He became a volunteer in the Rashtriya Swayamsevak Sangh (RSS). 
• 1942: He actively joined the Rashtriya Swayamsevak Sangh (RSS). 
  • He joined the Quit India Movement of 1942. 
• 1944:  His activism started in Gwalior with Arya Kumar Sabha, the youth wing of the Arya Samaj movement, of which he became the general secretary in 1944. 
•  1951:  He started working for the newly founded political group Bharatiya Jana Sangh.
• 1968:  He became the National President of the Jana Sangh, after the passing away of Deen Dayal Upadhyaya.
  • `Jana Sangh took the form of Bharatiya Janata Party (BJP). 
• He served three terms as the Prime Minister of India, in 1996, 1998-1999 and  1999- 2004. 
  • No-Confidence Motion: On 17 April 1999, the Bharatiya Janata Party (BJP) coalition government led by Prime Minister Atal Bihari Vajpayee failed to win a confidence vote in the Lok Sabha just by a single vote.
  • A Veteran Parliamentarian: He has been elected to the Lok Sabha nine times and to the Rajya Sabha twice, a record by itself.
  • Shaper of India’s Policies: As India’s Prime Minister, Foreign Minister, Chairperson of various important Standing Committees of Parliament and Leader of the Opposition, he has been an active participant in shaping India’s post-Independence domestic and foreign policy.

Atal Bihari Vajpayee’s Worldview:

• Social: Social divisions in Indian society had led to the nation becoming an easy victim of foreign aggression. He argued that the caste system fragmented Indian society, leaving only the Kshatriyas with the right to bear arms. 
  • Similarly, it denied almost everybody access to the Vedas and the Upanishads.
• Religion: The State should not discriminate on the basis of beliefs, rather it should respect all belief systems since they were a part of society.
• Economic: He ushered in an infrastructural revolution in India. 
  • He initiated the Delhi Metro rail as a mass transit system.
  • He brought in National Highway Development Project leading to East West North South Corridor or the Golden Quadrilateral,
  • He envisaged and executed the first round of Pradhan Mantri Gram Sadak Yojana which connected rural India greatly.
• Science: He coined the slogan: ‘Jai Jawan, Jai Kisan, Jai Vigyan’.  

 Atal Bihari Vajpayee: His Achievements and Honors

• Successful Nuclear Test: In May 1998, India successfully conducted the second series of underground nuclear tests in the Pokhran in Rajasthan. 
• Success of Kargil War: In 1999, the Indian military launched Operation Vijay to push back Pakistani soldiers and militants who had captured positions along the Kargil sector. 
• Diplomatic Gesture with Pakistan: He sought to improve diplomatic relations with Pakistan by traveling to Lahore by bus to meet with Prime Minister Nawaz Sharif.
• Famous Hindi Speech in the United Nations: He was the first Indian foreign minister in the United Nations during the Janata Party government who gave a speech in Hindi to gave respect to his native language. 
• Bharat Ratna: Vajpayee was conferred India’s highest civilian honour Bharat Ratna in 2015.
• Padma Vibhushan: Vajpayee was conferred India’s second highest civilian honour, the Padma Vibhushan in 1992.
• Best Parliamentarian: In 1994, he was named India’s ‘Best Parliamentarian.’ 
• Bangladesh Liberation War Honour: It is the second-highest honour of Bangladesh awarded to foreign dignitaries.

News Source: PIB

Click here to read more about the Atal Bihari Vajpayee and Good Governance

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Context: India to reconsider its proposed Free Trade Agreement talks with Bangladesh if it moves ahead with its plan to join the China-backed RCEP (Regional Comprehensive Economic Partnership) bloc.

Bangladesh decides to join China-Backed RCEP

• Both Countries agreed to start negotiations on an India-Bangladesh Comprehensive Economic Partnership Agreement (CEPA)  in September 2022.
• Bangladesh point of view: Bangladesh is pursuing free trade pacts to maintain preferential access to the  markets of its partner countries after it gains developing country status in 2026.
  •  As an LDC member of the South Asia Free Trade Agreement (SAFTA), Bangladesh enjoys duty-free quota-free access for most of its items into the Indian market, which it would lose after 2026.

Why is Bangladesh joining RCEP a concern for India?

• Circumventing rules of origin ( ROO): The India-Bangladesh FTA could facilitate the flow of Chinese goods into India from Bangladesh through the FTA route, burdening Indian markets and affecting Indian industries.
  • India withdrew from RCEP negotiations precisely because of the concern surrounding the misuse of the ROO provisions. 
  • Rules of origin: It is a Rule or criteria which will be used to determine the national source of a product.

About RCEP

• RCEP is a 15-member regional free trade agreement  between the Association of Southeast Asian Nations and ASEAN’s free trade agreement partners (Australia, China, Japan, New Zealand and the Republic of Korea.
• India withdrew from RCEP negotiations in November 2019.
• RCEP is the world’s largest free trade agreement by members’ GDP.
• It is estimated that through its trade liberalizing provisions RCEP could lead to income gains of over $200 billion by 2030 and add $500 billion to world trade.

Also Read: China Celebrating 10th Anniversary Of Belt And Road

News source: the hindu

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Context: The Chief Minister of MP has vowed to relocate the Prime Meridian, the global reference for time, from Greenwich in England to Ujjain.

Ujjain is the Global Prime Meridian: MP CM

• India’s Role: He highlighted that India originally established the world’s standard time around 300 years ago. 
• Ujjain’s Significance: The CM pointed out that the time observatory in Ujjain carries proof that it is the centre point of the world for timekeeping purposes. 
• Westernization: He further claimed that Prime Meridian, established during the International Meridian Conference in 1884, was influenced by the dominance of the British Empire in the 19th century.
  • Challenging the convention, CM questioned the practicality of starting a new day at midnight 
  • He advocated for a shift to a system aligned with natural wake-up times, like sunrise. 
• Calendar: He also criticized the Gregorian calendar, asking to replace it by Hindu calendar, known as Vikram Samvat.
  • Vikram Samvat is the historical Hindu calendar used in the Indian subcontinent. It uses lunar months and solar years and is 57 years ahead of the Gregorian calendar. 

About Prime Meridian: Its Position, Names, and Uses

• It is an imaginary reference line that represents the starting point for measuring longitude across the globe. 
• Position: This longitude runs from the North Pole to the South Pole, passing through Greenwich, England. And has been accepted as the reference point to measure time. 
• International Acceptance: In 1884, the International Meridian Conference held in Washington, D.C., adopted the Greenwich Meridian, passing through the Royal Observatory in Greenwich as the Prime Meridian. 
• Other names: It is also known as the Greenwich Meridian or Longitude Zero (0° longitude). 
• Uses: As a standard for zero-degree longitude, it impacts the Global Positioning, timekeeping and International Date Line.
  • Global Positioning: By providing a universal reference, the Prime Meridian aids in the consistent and precise positioning of places worldwide.  
  • Timekeeping: Time zones worldwide are calculated based on their distance east or west of this meridian. Time zones such as Coordinated Universal Time (UTC) and Indian Standard Time (IST) are based on this. 
  • International Date Line: It is located approximately 180 degrees east or west of the Greenwich Meridian, which marks the end of one day, and the shift into another. 
• Indian Standard Time: It is 5.30 hours ahead of Greenwich Meridian Time (GMT) and is calculated from Mirzapur in Uttar Pradesh (UP), which lies at 82°30’E longitude.

More about Ujjain

• Relation with Timekeeping: In Hindu astronomy, the Prime Meridian is considered to pass through Ujjain. Thus it is considered as the starting point for measuring longitudes.
  • It is believed that Ujjain is located at the precise point of interaction with the zero meridian and the Tropic of Cancer. 
• Time Observatory: In Ujjain lies India’s oldest observatory, built by Sawai Jai Singh II of Jaipur in the early 18th century.
• Geography: It lies on the bank of Kshipra River and the plateau of Malwa. The Tropic of Cancer passes through the city.
• Culture: Kumbh Mela festival occurs every 12 years in the city. 
• Religious Significance: For centuries, Ujjain has been a centre of religion for the Hindu, Jain and Buddha religions. It is well known for one of the twelve Jyotirlingas referred to as Mahakaleshwar Jyotirlinga.

Source: Indian Express

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Context: On the occasion of the 162nd birth anniversary of Pandit Madan Mohan Malaviya, the Indian Prime Minister  released the first series of 11 volumes of “Collected Works of Pandit Madan Mohan Malaviya”.

About Pandit Madan Mohan Malviya

• Birth: Pandit Madan Mohan Malaviya was born on December 25, 1861, in Allahabad, Uttar Pradesh. 
• Titles: He was given the title of Mahamana by Mahatma Gandhi.
• Various Views:
  • Jawahar Lal Nehru: Nehru called him “a great soul, one of those who laid the foundation of modern Indian Nationalism”.
  • Dr S. Radhakrishnan: He was given the status of a ‘Karmayogi’ by Dr S. Radhakrishnan.
• Honour: The Highest Civilian Award: In 2014, Pandit Madan Mohan Malaviya was posthumously conferred with Bharat Ratna, the country’s highest civilian award.
  • Express on his Name: In 2016, the Indian Railways started the Varanasi-New Delhi Mahamana Express
• Death: Carrying on with ill health for the last few years, he passed away on 12th November 1946.

Pandit Madan Mohan Malaviya: Major Contributions

• Education: 
  • Banaras Hindu University (BHU): Pandit Madan Mohan Malaviya founded the Banaras Hindu University in 1916. 
  • He served as Vice-Chancellor of BHU from 1919 to 1938.
  • Introduction of Devnagri in the British-Indian Courts: Malviya’s efforts with the British government resulted in the introduction of Devnagri in the British-Indian Courts.
  • He favoured free and compulsory primary education.
• Political:
  • Pandit Madan Mohan Malaviya founded Ganga Mahasabha (1905), Hindu Mahasabha (1906), United Provinces Kisan Sabha (1918) 
  • He was a successful legislator (a member of the Imperial Legislative Council for 11 years from 1909–20). 
  • He opposed the indentured labour system in the British Empire and supported the nationalization of railways.
• National Movement: 
  • Pandit Madan Mohan Malaviya joined the Indian National Congress (INC) at its Calcutta session in 1886.
  • Four Time President: In 1909 (Lahore), in 1918 (Delhi), in 1930 (Delhi), and in 1932 (Calcutta). 
  • He acted as a bridge between the Moderates and the Extremists in the Congress.
  • Supporter of Gandhi’s Movements: He played a significant role in the Civil Disobedience and Non-Cooperation Movement led by Mahatma Gandhi.
• Role in Media: 
  • Pandit Madan Mohan Malaviya was the chairman of Hindustan Times from 1924 to 1946, and he launched his Hindi-language weekly, the Abhyudaya (1907), the Leader of Allahabad, an English-language daily (1909), and the Hindi monthly the Maryada (1910).
• Slogan: During his presidency of the 1918 Indian National Congress Session, Pandit Madan Mohan Malaviya used the famous slogan, ‘Satyamev Jayate’.

News Source: PIB

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Context: India is set to finalize an agreement to acquire five lithium blocks for exploration and development in Argentina.

India to Acquire five Lithium Reserves in Argentina

• India-Argentina Lithium Deal: An agreement will be signed between Khanij Bidesh India Ltd. (KABIL)  and Catamarca Minera Y Energética Sociedad Del Estado (CAMYEN), a state-owned mining and energy company in the Argentine province of Catamarca.
• Mineral Partnership: This is India’s second attempt to sign a foreign partnership for sourcing critical minerals after Australia. 
• In 2022, India signed a memorandum of understanding with Australia’s Critical Minerals Facilitation Office (CMFO) to explore five blocks of lithium and cobalt.

Lithium Reserves in Argentina

• Global status: According to the United States Geological Survey’s (USGS) Lithium Statistics and Information 2023 report, Argentina holds 21 per cent of the world’s 98 million tonnes of lithium reserves, second only to Bolivia.
• Concentration in Salt Flats: These reserves are primarily concentrated in salt flats within the provinces of Catamarca, Salta, and Jujuy, forming part of the Lithium Triangle.
  • Its salt-lake lithium provides a cost-effective extraction method compared to hard-rock mining. 

About Lithium:

• About: It is a soft, silvery metal having the lowest density of all metals. It reacts vigorously with water.
• Applications: 
  • Manufacturing lithium-ion batteries used in smartphones, laptops, electric vehicles (EVs) and energy storage systems. 
  • Lithium is employed in certain medical treatments, ceramics, and as a component in aerospace technology.

Lithium Status in India

• Lithium Reserves in India: Reasi district in Jammu and Kashmi holds approximately 5.9 million tonnes (mt) of lithium reserves. 
• Lithium Import: Currently, India meets its complete lithium demand through import. 
  • According to the Ministry of Commerce and Industry data, India’s lithium imports in FY23 marked a 58 percent increase from FY22,. 
• Source of Lithium Import: Over 95 per cent of India’s lithium imports originate from Hong Kong and China.

To Read More: Lithium Reserves

News Source: Business Standard

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Context: The Reserve Bank of India (RBI) recently directed banks and non-banking financial companies (NBFCs) to increase their risk weightage against such loans from 100 per cent to 125 per cent.

Current Challenges in Indian Fintech Startups

• Rise in cost of Loans: Banks and NBFCs will need more capital, which will lead to an increase in the interest rates for loans to consumers. This will have a direct impact on fintech firms.
• Fintech companies facing a funding crunch may be forced to seek capital through the public markets with a greater share of unsecured loans.
• Decline in Fintech Funding: The year  2023 witnessed a steep decline in funding by Indian fintech startups, mainly due to a decline in seed-stage funding.
  • FinTechs in India raised only USD 2.1 billion in 2023, down by almost 300 per cent as compared to 2022.

What is Fintech?

• Fintech,  a combination of the terms “financial” and “technology,” refers to businesses that use technology to enhance or automate financial services and processes.

Fintech Companies in India: Types

• Payment: These offer digital payment solutions, such as mobile wallets, online payment gateways, and peer-to-peer (P2P) payments. Ex-Bharatpe
• Lending: These offer digital lending solutions, such as personal loans, business loans, and credit cards. Ex-CRED
• Insurance: These offer digital insurance solutions, such as health insurance, life insurance, and car insurance.Ex-Digit Insurance
• Investment: They offer digital investment solutions, such as stock trading, mutual funds, and cryptocurrency trading. Ex-Zerodha
• RegTech: They offer regulatory technology solutions, such as compliance software and risk management tools. Ex-Razorpay

Fintech Sector: Its Significance to India

• Fintech Sector: India is home to the third-highest number of fintechs globally, with more than 9,000 fintechs, holding a 14 per cent share of Indian start-up funding. 
• Adoption Rate:  As per the Economic Survey 2022-23, Indian fintech companies witnessed an 87% adoption rate across varied user bases as opposed to the global average rate of 64%.
• Digital Transactions: Fintech companies account for 70 per cent of digital payment transactions, marking a twofold rise in their share during FY22 compared to FY19. 
• Financial Inclusion: More than 10 million people and small businesses gained access to savings accounts, insurance, investment options, and credit facilities through mobile-based services and digital platforms. 
  • The adult population with bank accounts increased from 53% to 78%.
•  Democratising Lending Process: Peer-to-peer lending platforms are democratizing lending, providing individuals and small businesses with access to funds without the need for traditional financial institutions.
  •  Mobile payment platforms and digital wallets offer users a convenient and secure transaction method.
• Rise in Public Investment: Investment platforms and robo-advisors are making investing in stocks, mutual funds, and other financial instruments more accessible.. 
  • These platforms use advanced algorithms and artificial intelligence to provide personalized investment advice, enhancing the efficiency and affordability of wealth management services.

Government Initiatives Supporting Fintech Penetration in India

• JAM Trinity:
  • Jan Dhan Yojana: It has helped in new bank account enrolment of over 508.9 Mn beneficiaries
  • Aadhaar: The world’s largest biometric identification system (>1.3 Bn Aadhaars generated so far)
  • Mobile connectivity: India has the 2nd highest number of smartphone users
• India Stack: It is a set of APIs that allows governments, businesses, startups and developers to utilise unique digital Infrastructure to solve India’s hard problems towards presence-less, paperless, and cashless service delivery. 
• UPI (Unified Payments Interface): The advanced mobile app-based payment system is the multiplier force behind the Fintech revolution in India.
  • Cross-border linkage of UPI & RuPay network with other countries enhances the global footprint.
• Digital Rupee: Central Bank Digital Currency (CBDC) or digital rupee is an electronic version of cash helping accelerate the growth of the FinTech market in India.

Continue Reading: E-Rupee’s Journey

• Open Network for Digital Commerce (ONDC):  It fosters a competitive and inclusive digital commerce ecosystem.
  • It supports the digitization of small businesses by linking them with a payments and logistics infrastructure. 
• Open Credit Enablement Network (OCEN): It democratises credit for small borrowers and enables lending as a feature for marketplaces. 
• National Centre for Financial Education:  It aims to promote financial education across India for all sections of the population.

What challenges are associated with Fintech lending?

• Cyber Attacks: The increasing digitization of financial services has increased the risks of cyber threats.
  • Recent data from the Indian Computer Emergency Response Team (CERT-In) highlights that almost 100% of fintech companies had issues related to privacy, security, and compliance, owing to APIs, subdomains, and abandoned web applications.
  • In 2022,  a total of 13.91 lakh cases were reported.

Continue Reading: NCRB Report 2022 On Crime In India

• Regulatory Issues: The absence of a single umbrella legislation regulating the sector’s functioning, constantly evolving regulations and numerous regulatory approvals pose a major challenge to FinTechs in India.No specific set of laws and regulations governing fintech services and products in the country. 
• Illegal Digital Lending: The ease of access to fintech loan apps has led to a rise in numerous instances of harassment,  unethical recovery practices and suicide linked to unregulated lending apps.
  • Digital lending is a method that uses digital platforms for ” customer acquisition, credit assessment, loan approval, disbursement, recovery, and associated customer services.”
  • A recent incident reported involved the arrest of two individuals from Assam linked to a case where an individual’s suicide was connected to an online loan probe.
• Financial Illiteracy: There is a lack of necessary digital exposure and adequate digital knowledge to understand the risks associated with online transactions. 
  • This lack of awareness leads to risky behaviours, such as sharing passwords and personal information.
• Infrastructural Issues: Due to network/ connectivity problems in rural areas, online transactions are more prone to interruptions and slower response times, leading to security threats.
• Co-Lending Partnerships:  There is an increasing number of fintech firms entering into co-lending partnerships with banks and Non-Banking Financial Companies (NBFCs). 
• • This has created complicated lending layers, posing challenges for the regulator in monitoring connected-party lending. 
  • In response, the RBI has advocated for a comprehensive framework to oversee such lending, ensuring uniform application across all entities regulated by the RBI.
• Data Privacy Issues: The RBI has mandated that all financial institutions conduct Know Your Customer (KYC) verification for each customer. 
  • It necessitates huge amounts of company funds, given the substantial number of customers and the need for the data to be collected, stored, and monitored.
  • Private data and sensitive information are at risk with every digital and electronic transaction as the businesses exploit this data for financial gain.

Way Forward

• Strengthening the Cybersecurity Infrastructure: A robust cybersecurity regulation is the first defence against cyberattacks and fraud. 
  • Fintech companies can collaborate with local law enforcement agencies to address cyber threats specific to the region. 
  • Reporting mechanisms for cybercrimes can also be established to encourage users to report any suspicious activities.
• Improving the Cybersecurity of payment infrastructure in rural India:  Fintech applications should have robust security features, including multi-factor authentication, encryption, and biometric recognition.
  • These security layers can significantly reduce the risk of unauthorised access to financial data. Companies must prioritise the security of users and personal and financial data.
• Addressing Infrastructural issues: Given the intermittent internet connectivity in rural areas, fintech companies should enable offline access to financial services simultaneously. 
  • This will ensure that users can perform essential transactions with limited or no internet connectivity..
• Digital Literacy Programs: Fintech firms should invest in digital literacy programs to educate rural users about the risks and best practices associated with online transactions. 
  • These campaigns can reach a broader audience by collaborating with local organizations and government bodies. 
  • Offering 24/7 customer support and educational resources in local languages can bridge the knowledge gap and help rural users navigate any issues. 
  • Fintech companies can organise community outreach programs to connect with rural users directly.
• Creation of a unified regulatory framework on connected lending: As suggested by RBI, this must be created to regulate connected lending – where a borrower might influence the lender’s decision – for all its regulated entities.
• Compliance Program for Fintechs: Fintechs should develop a compliance program to ensure they comply with all applicable laws and regulations. 
  • It should include policies and procedures for managing risk, conducting due diligence on customers and counterparties, and reporting suspicious activity to the authorities.

Conclusion

The Indian Fintech sector faces challenges in funding and regulation, requiring collaborative efforts for sustainable growth and financial inclusion.

News Source: Business Standard

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Context: This article is based on the news “‘Fake’ drugs row: Directorate of Vigilance asks health department to withdraw drugs that failed tests” which was published in the Economic Times. The Directorate of Vigilance of the Delhi government has written to the health department to withdraw the drugs that failed quality standard tests.

The Rise of Counterfeit Drugs in India: A Major Public Health Threat

• Supply of Sub-Standard Quality Drugs: Lieutenant Governor of Delhi recommended a CBI inquiry into the matter of the alleged supply of drugs that failed quality standard tests and have the potential to endanger lives in Delhi government hospitals.
• Sub-Standard Quality Drugs: The drugs that were found to be of sub-standard quality drugs included:
  • Cephalexin: Critical life-saving antibiotics used for the treatment of lung and urinary tract infections.
  • Dexamethasone: A steroid for curing life-threatening inflammation in the lungs, joints and swelling in the body. 
  • Levetiracetam: Anti-epilepsy and anti-anxiety psychiatric drug. 
  • Amlodipine: Anti-hypertension drug 
• Counterfeit Drugs Sieze: Recently, counterfeit drugs of about ₹2 crores from leading manufacturers were seized from unlicensed premises situated in Kolkata.
• Spurious Drugs Circulation: Globally and in India, the pharma industry has been grappling with issues related to counterfeit or spurious drugs for a while now. However, these have been amplified post the pandemic.
  • In terms of volume, India’s pharmaceutical industry ranks third in the world. However, there have also been multiple incidents of counterfeit drugs and medication  hitting the market. 

Also Read about Generic Medicines, here. 

About Counterfeit Drugs

• Counterfeit Drugs: Drugs manufactured or packaged fraudulently are referred to as counterfeit/fake/spurious/falsified drugs because they either lack active ingredients or have incorrect dosages. 
• Global Issue: The World Health Organization states the frightening figure in which almost 10.5% of the medications worldwide are either subpar or fake. 
  • Although developing and low-income countries are the targets of large-scale drug counterfeiting activities, these drugs are also making their way into developed nations, including the USA, Canada, and European countries. 

About India’s Pharma Industry 

• Pharmacy of the World: India is known as the “pharmacy of the world” due to the low cost and high quality of its medicines.
  • India is the largest provider of generic drugs globally and is known for its affordable vaccines and generic medications. 
• Global Leader: The Indian Pharmaceutical industry is currently ranked 3rd in pharmaceutical production by volume after evolving over time into a thriving industry growing at a CAGR of 9.43% since the past nine years. 
  • Indian pharmaceutical sector supplies over 50% of global demand for various vaccines, 40% of generic demand in the US and 25% of all medicine in the UK. 
  • Presently, over 80% of the antiretroviral drugs used globally to combat AIDS (Acquired Immune Deficiency Syndrome) are supplied by Indian pharmaceutical firms. 
• Compliant with USFDA: India has the most number of pharmaceutical manufacturing facilities that are in compliance with the US Food and Drug Administration (USFDA) and has 500 active pharmaceutical ingredients (API) producers that make for around 8% of the worldwide API market.
• Future Prospects: According to a recent EY FICCI report, as there has been a growing consensus over providing new innovative therapies to patients, Indian pharmaceutical market is estimated to touch US$ 130 billion in value by the end of 2030.

How are drugs regulated in India?

• Drug Cosmetics Act 1940: The Drug & Cosmetics Act was passed to oversee medication imports into India, ensuring that no substandard or counterfeit drugs enter the country.
• Drug and Cosmetics Rules, 1945: These rules categorized the drugs into schedules and provided regulations on the sale, storage, and prescription of each category.
  • Schedule M: It is a part of the Drugs and Cosmetics Rules and explains the detailed requirements for manufacturing and quality control of medicines.
• Central Drugs Standard Control Organisation (CDSCO)
  • Nodal Ministry: Ministry of Health & Family Welfare, Government of India.
  • It is the National Regulatory Authority (NRA) of Drugs in India. 
  • Functions:
    • CDSCO is responsible for the approval of Drugs, Conduct of Clinical Trials, laying down the standards for Drugs, and control over the quality of imported Drugs in the country.
    • CDSCO along with state regulators is jointly responsible for granting licenses of certain specialized categories of critical Drugs such as blood and blood products.
• Good Manufacturing Practices (GMP): They cover things like the design of the manufacturing facility, training of employees, and quality control procedures.
• Drugs and Cosmetics Act: It controls the import, production, distribution, and sale of export pharmaceutical products and cosmetics.
• Pharma Export-Import Laws and Regulations: These rules include getting the required Importer-Exporter Code (IEC) and following export documentation requirements.

Continue Reading: India Pharma Products And Drug Safety

Counterfeit Drugs: Challenges to Eliminate Them

• Complexity of Scale of Manufacturing: The domestic pharmaceutical industry of India is a network of around 3,000 drug companies and nearly 10,500 manufacturing units. The monitoring of the quality of the ingredients at every stage of the value chain is not easy. 
• Complexity of Supply Chain: Manufacturing of a drug right from the beginning to the latter stages of marketing, distribution and sale involves not only a large number of ingredients and materials but also a large number of players, including suppliers, packaging and logistics entities, wholesalers and distributors, retailers and even resellers. 
  • This fragmented ecosystem opens the way for several points of entry and exit which leaves the material susceptible to adulteration, contamination or usage of substandard type, and the process likely to be compromised.
• Lack of Testing Facilities and Monitoring Personnel: India lacks an adequate number of testing facilities and inspectors and monitors. 
  • According to reports, under the National Good Laboratory Practice programme, India has only 47 drug testing facilities and six central labs, testing just 8,000 samples per year. Moreover, the country has only 20-30 test laboratories that can affirm whether a drug is counterfeited, authentic or of relatively poor make. 
  • India is severely understaffed in terms of numbers of drug inspectors and is yet to fulfil the Mashelkar Committee’s recommendation of having one drug inspector for every 50 manufacturing units and one per 200 distribution retailers.
• Dented Image: India is known as the ‘pharmacy of the world’, but that image has been dented by the death of around 18 children in Uzbekistan last year after they consumed an Indian-manufactured cough syrup. 
  • India has launched an investigation into these deaths of 18 children in Uzbekistan 
• Supply Chain Disruptions: During the COVID-19 pandemic induced supply chain disruptions, incidents of substandard and falsified medical products increased by almost 47% from 2020 to 2021. 
  • The  COVID-19 pandemic fuelled the demand for certain categories of medicines such as antipyretics, remdesivir, corticosteroids, vaccines, etc., thus increasing the demand and manufacture of fake medicines.
• Public Health Concerns: Substandard products across the pharma industry have a high potential for life-threatening damage. In addition to increased morbidity and mortality, counterfeit products might also worsen drug resistance and lead to treatment failure. 
  • The World Health Organisation (WHO) estimates that there are over 1 million deaths per annum from substandard and counterfeit drugs, causing $21 Billion of global financial impact. 
• Counterfeits Affecting Pharma Growth: Counterfeit drugs and their circulation tend to prove detrimental to the growth of the pharma industry, which can only flourish based on quality and trust. 

Counterfeit Drugs: Steps Taken to Eliminating Them

• Task Force for Providing Solutions: The Indian government formed a task force to tackle the issue of drug counterfeiting. The task force ultimately concluded that for track and trace to be effective, the following two systems must be implemented concurrently: 
  • A unique identification number for each primary pack allows consumers to identify the medicine. 
  • A 2-D barcoding that incorporates all product information for quick data retrieval at each stage of the supply chain.
• The Indian Government’s New Barcode Regulation: Mandatory application of barcodes or QR codes to the packaging of India’s leading 300 medicine brands. 
  • The new rule demands pharmaceutical companies to strictly adhere to this unique product identification system, with non-compliance leading to hefty penalties. 
  • These barcodes will contain crucial information, including the drug’s name, brand name, the manufacturer’s details, batch number, manufacturing and expiry dates, and the manufacturing license number.
• Legislative Measures: India has provisions under intellectual property law (The Trademark Act, 1999 and The Patents Act, 1970) to punish the drug counterfeiters.
• Measures Undertaken by WHO: WHO further launched a project on counterfeit drugs in 1995. Further, in 2006, the International Medical Products Anti-Counterfeiting Taskforce was established by the WHO, and it has since become the primary vehicle for the organisation’s efforts to combat fake drugs.

Way Forward to Combate Counterfeit Drugs

• India as World’s Pharmacy: To further bolster India’s image as the “Pharmacy of the World”, all stakeholders must work together to ensure issues such as counterfeit drugs do not dent this image. 

• Pharmaceutical products contribute around 8% to India’s overall merchandise exports and 2% to India’s gross domestic product (GDP). Safeguarding India’s image as a trusted, reliable supplier of pharmaceutical products is imperative to realise India’s ambition of ‘Atmanirbhar Bharat’.
• Role of Various Stakeholders in Protecting Against Counterfeiting of Drugs: Role of the Consumers, Pharmacists, Pharmaceutical Companies and  Regulators to ensure that their people receive genuine medicines. 
  • For instance, based on the recommendations of the task force, India has implemented the suggestion of including a unique identification number and a bar code on each drug pack. One can verify the authenticity by sending the unique code behind the bottle or package to the Drug Technical Advisory Board’s (DTAB) number via SMS. 
• Utilising Technologies to Prevent Drug Counterfeiting: Technology must be adopted at all levels of the value chain keeping an eye on material and ingredients used at every step. 
  • For example, track and trace technologies marked by mass serialization of pharma products with barcodes, RFIDs and holograms, along with tamper-evident seals, must increasingly become standard practice. 
• Utilising Blockchain Technology: Blockchain technology uses a decentralised peer-to-peer architecture for transaction processing with little potential for record-tampering. 
  • This would make it possible to maintain a permanent record of all transactions that will be accessible to all the parties involved and include details such as location, data, quality, and pricing. 
  • Implementation of blockchain technology in the supply chain will help to make it safe, transparent and decentralised, thus enabling savings in expenditure while ensuring the ability to track down doubtful areas and close any gaps in the supply chain of genuine drugs. 
• Awareness Campaigns: There should be a country-wide campaign to make patients and lay people aware of the risks and the precautionary steps that they must take to verify the authenticity of medicines that they would procure.

Conclusion

The fight against counterfeit drugs in India demands a comprehensive approach, combining legislative measures, technological innovations, and heightened awareness to safeguard public health and uphold the nation’s reputation as the “Pharmacy of the World.

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