1. DRUGS AND COSMETICS RULES, 1945 (Syllabus: GS Paper 2 – Health & Gov. Policies)

Context: The Supreme Court stayed a July 1, 2024 notification issued by the AYUSH Ministry in which Rule 170 of the Drugs and Cosmetics Rules, 1945 was “omitted”.

Drugs and Cosmetics Rules, 1945

• About: The Drugs and Cosmetics Rules, 1945 are established under The Drugs and Cosmetics Act, 1940 which regulates the import, manufacture, and sale or distribution of drugs and cosmetics through licenses and permits.
• Objective: To ensure that the drugs and cosmetics marketed in India are reliable, efficient, and in compliance with national standards.
• Classification: The rules classify drugs into various schedules, each with specific guidelines.
• Regulations: The rules provide guidelines for the storage, sale, display, and prescription of drugs based on their classification.
• Appointment: Drugs Controller, India, or the Joint Drugs Controller (India) or the Deputy Drugs Controller (India) appointed by the Central Government.

• Features:

o Licensing: Rule 67 outlines the conditions required for obtaining licenses to manufacture and sell drugs.

o Labeling: Rule 97 specifies the labeling requirements for drugs, ensuring proper warnings and instructions.

o Schedule G: Includes hormonal medications, anticonvulsants, and hypoglycemic drugs; labels must caution usage under medical supervision.

o Schedule H: Drugs under this schedule require a prescription for sale and must display the "Rx" symbol and a warning.

ü If a Schedule H drug is also a narcotic or psychotropic substance, it must display the "NRx" symbol.

o Schedule M: The revised Schedule M focuses on Good Manufacturing Practices (GMP) and sets standards for pharmaceutical manufacturing premises and equipment.

o Rule 170: The Rule deals with the power to take action against objectionable or misleading advertisements about Ayurvedic, Siddha, and Unani drugs.

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2. FIXED DOSE COMBINATIONS (Syllabus GS Paper 2/3 – Health/Sci and Tech)

Context: The government has banned 156 fixed- dose combination (FDC) drugs, including popular medicines such as Cheston Cold and Foracet, used for cold and fever and pain respectively.

Fixed Dose Combinations

• About: These are medicines that have two or more active ingredients in a single pill, capsule or shot.
• Purpose: FDCs are designed to simplify treatment for patients with conditions requiring multiple medications, such as tuberculosis and diabetes.
• Example: Cheston Cold, an FDC, contains paracetamol, cetirizine, and phenylephrine—useful for multiple symptoms but unnecessary for conditions like bacterial infections.

Government Banning Certain FDCs

• Banning Reason: The government banned certain FDCs because they contain ingredients that may not work well together or are unnecessary when combined.
• Regulatory Concerns: Many banned FDCs were approved by state licensing authorities without adequate trials, as the individual ingredients were previously approved.
• Rising Antibiotic Resistance: The primary reason for banning these FDCs is to curb the misuse of antibiotics, which contributes to antibiotic resistance and necessitates stronger treatments for infections.

o Despite earlier bans, FDCs as a share of total antibiotics sold in India increased from 32.9% in 2008 to 37.3% in 2020.

• 2019 Regulation: The 2019 new drug and clinical trial rules classify FDCs as new drugs, requiring approval from the central drug regulator before use.

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3. EXOTIC SPECIES (Syllabus: GS Paper 3 – Env and Eco)

Context: The Ministry of Environment, Forest and Climate Change (MoEFCC) has mandated that exotic pets listed under Schedule IV of the Wildlife Act be registered with state wildlife departments through the PARIVESH 2.0 portal within 6 months.

Exotic Species

• Definition: Exotic species are animals or plants that are relocated from their natural habitat to a new area, often as a result of human activities.
• Status of Registration: Delhi's forest and wildlife department has officially registered eight exotic species: ball python, iguana, cockatiel, red-eared slider turtle, African grey parrot, Amazonian parrot, blue-headed parrot, and conure.
• Criteria: The Living Animal Species (Reporting and Registration) Rules, 2024, require individuals to report and register any species listed under Schedule IV of the Wild Life (Protection) Act, 1972.
• Wild Life (Protection) Amendment Act, 2022: This amendment includes Section 49 M, which mandates the registration of possession, transfer, birth, and death of species listed in the CITES Appendices and Schedule IV of the Wild Life (Protection) Act, 1972.

Concerns with Exotic Species

• Non-Regulation: Many exotic species are imported and bred in India without proper registration, leading to potential risks such as zoonotic diseases.
• Pandemic Risk: The COVID-19 pandemic, being zoonotic, underscored the dangers associated with the unregulated trade and ownership of exotic animals.
• Smuggling Concerns: There is growing concern over the smuggling of endangered exotic animals into India, particularly from Southeast Asia. Significant seizures, including Kangaroos, Koalas, and Lemurs, have been reported in Assam and Mizoram.

PARIVESH 2.0 Portal

• Acronym: PARIVESH stands for Pro-Active and Responsive facilitation by Interactive, Virtuous, and Environmental Single Window Hub.
• Developed By: The portal was developed by the Ministry of Environment, Forest and Climate Change (MoEFCC).
• Functionality: PARIVESH 2.0 is a web-based application that provides a single-window solution for online submission and monitoring of proposals related to environmental, forest, wildlife, and coastal regulation zone clearances.
• Platform Focus: The platform focuses on process transformation, technology integration, and leveraging domain expertise to manage green clearances and ensure compliance across India.

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4. NATIONAL MEDICAL REGISTER PORTAL (Syllabus: GS Paper 2 – Govt Policies)

Context: Union Health Minister launched the National Medical Register Portal in New Delhi for the registration of all MBBS doctors eligible for registration in India.

National Medical Register Portal

• About: The NMR Portal is managed by the National Medical Commission (NMC) for the registration of all eligible MBBS doctors in India.
• Legal Mandate: The NMR is required under Section 31 of the National Medical Commission (NMC) Act, 2019, which directs the Ethics and Medical Registration Board (EMRB) to maintain an electronic National Register with doctors' names, addresses, and recognized qualifications.
• Database Scope: The NMR serves as a comprehensive and dynamic database for allopathic (MBBS) doctors registered in India.
• Link with: The portal links the NMR with doctors' Aadhaar IDs, ensuring their authenticity.
• Registration Process: The registration process on the NMR portal is straightforward and conducted online, with medical colleges, State Medical Councils (SMCs), and other institutions interconnected.
• Data Visibility: Some data on the portal is public, while other information is accessible only to the EMRB, SMCs, National Board of Examinations (NBE), medical institutions, and registered practitioners based on specific requirements.
• Features Offered: The portal provides various features such as adding qualifications, tracking applications, suspending licenses, and issuing NMR ID cards and digital doctor certificates.
• Improvement: The NMR portal will undergo regular upgrades and enhancements to improve the registration process.

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5. SMALL MODULAR REACTORS (SMRS) (Syllabus: GS Paper 2 – Sci and Tech)

Context: The Budget 2024-25 highlights 'Bharat Small Reactors' (BSR) as a key initiative for advancing clean energy and ensuring energy security.

Small Modular Reactors (SMRs)

• Definition: These are small nuclear fission reactors designed for factory construction, transportation to operational sites, and use for powering buildings or commercial operations.
• Physical Characteristics:

o Small: These reactors are much smaller in size compared to conventional nuclear reactors.

o Modular: SMRs are designed to be factory-assembled and then transported as a complete unit for installation.

o Reactors: SMRs utilize nuclear fission to generate heat, which is then converted into energy.

• Capacity: SMRs can produce up to 300 MW(e) per unit, about one-third of traditional nuclear reactors' generating capacity, contributing significant low-carbon electricity.
• Frequency: SMRs generally require refueling every 3 to 7 years, compared to 1 to 2 years for conventional reactors. Some SMRs can operate up to 30 years without refueling.

Benefits of SMRs

• Design Advantages: The small and modular nature of SMRs offers several benefits.
• Locational Accommodation: SMRs can be installed in locations unsuitable for larger nuclear plants.
• Affordability: Prefabricated units reduce construction and installation costs.
• Easy Construction: SMRs lower construction costs and times and can be deployed incrementally.

SMR in India

• Current Status: India operates 15 Pressurized Heavy Water Reactors (PHWR) of 220 MW each, contributing half of its 6780 MW nuclear power capacity.
• Future Prospects: The government is considering converting PHWRs into SMRs to enhance their efficiency and capabilities.

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6. NORTHERN BALD IBIS (Syllabus: GS Paper 3 – Env and Eco)

Context: The northern bald ibis, once extinct in Europe, has returned and now requires human assistance for its winter migration. Previously seen soaring over North Africa, the Arabian Peninsula, and Europe, this bird species is making a comeback.

Northern Bald Ibis

• About: It a distinctive bird known for its iridescent plumage and bald red head.
• Geographic Range: European Alps, Northern Africa, and the Middle East until the start of the 1900’s.
• Migration: Eastward from Morocco and Turkey through countries such as Jordan and Saudi Arabia.
• Habitat: Northern bald ibises are found in semi-arid desert, steppe regions.
• Numbers: It disappeared from Europe over 300 years ago, although reintroduction programmes in the region are underway.

o In 2019 there were about 700 wild birds remaining in southern Morocco, and fewer than 10 in Syria, where it was rediscovered in 2002 but where their number declined in the following years, maybe to zero.

• Conservation Status:

o IUCN Red List: Endangered. It was categorised as “Critically Endangered” but moved to endangered category in 2018.

o CITES: Appendix I species.

Reintroduction of the Northern Bald Ibis

• About: It is the first time that a migratory bird population has been built from zero by establishing a new migration tradition and by the use of chicks from zoo colonies. The project have been instituted internationally in recent times, with a semi-wild breeding colony in Turkey as well as sites in Austria, Italy, Spain, and northern Morocco.
• Achievment: Reintroduction of the critically endangered northern bald ibis into Europe and the establishment of a pattern of migration that will ensure the survival of the species.

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7. RT-PCR TESTING KITS (Syllabus: GS Paper 2 – Health)

Context: The Central Drugs Standard Control Organisation has granted approval to Siemens Healthineers for the manufacture of RT-PCR testing kits for detection of Mpox.

RT-PCR Testing Kits

• About: It is a molecular diagnostic test that targets two distinct regions in the viral genome, spanning both clade I and clade II variants of the virus.
• Introduced under: Brand name ‘ErbaMDx Monkeypox RT-PCR Kit.
• Developed by: Andhra Pradesh MedTech Zone (AMTZ), a research body of the state government, in collaboration with Transasia Diagnostics.
• Utilization: This assay can leverage existing COVID-19 testing infrastructure, enhancing efficiency and minimizing the need for new equipment.
• Features:

o Shelf Life: With a 12-month shelf life and zero cross-reactivity with other orthopoxviruses, the kit promises exceptional accuracy and dependability.

o Its use of lyophilised components, which allows it to be shipped and stored at ambient temperatures.

o Focus: These assay kits demonstrate Siemens Healthineers' commitment to improving 'Access to Care,' making advanced diagnostics more widely available.

• Boost to "Make in India" Initiative: The approval marks a significant achievement for the "Make in India" initiative, highlighting the company's commitment to local manufacturing.
• Contribution to Public Health: This assay represents a critical advancement in combating the Monkeypox public health emergency by enabling early and accurate detection.

MPOX Virus

• About: Mpox, formerly known as monkeypox, is a viral disease caused by the Monkeypox virus.
• Belongs to: Same family as the virus that causes smallpox.
• Virus Type: There are two main types of Monkeypox virus: Clade I and Clade II.

Central Drugs Standard Control Organization (CDSCO)

• About: CDSCO establishes standards and measures to ensure the safety, effectiveness, and quality of drugs, cosmetics, diagnostics, and medical devices within the country.
• Headquarters: New Delhi.
• Ministry: Ministry of Health & Family Welfare.

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8. NANO DIAMMONIUM PHOSPHATE (Syllabus: GS Paper 3 – Agriculture)

Context: A two-year field experiment on the efficacy of nano diammonium phosphate (DAP) by scientists from the Punjab Agricultural University (PAU) has found a substantial decrease in wheat yields compared to conventional nitrogen fertiliser application.

Nano Diammonium Phosphate (DAP)

• About: It is an efficient source of available nitrogen (N) and phosphorus (P2O5) for all the crops and helps in correcting the Nitrogen & Phosphorus deficiencies in standing crops.
• Nutrient Content: It provides essential nutrients for crops with 8% Nitrogen and 16% Phosphorus by volume.
• Enhanced Efficiency: With a particle size less than 100 nanometers, it offers a greater surface area to volume ratio, enhancing nutrient uptake.
• Regulatory Approval: IFFCO’s Nano DAP is the only Nano fertilizer approved by the Ministry of Agriculture and listed in the Fertilizer Control Order.
• Nano DAP (Liquid) Plant: It is India’s first liquid nano-ammonia phosphate (DAP) plant.
• Significance of Nano DAP

o Nano DAP supports smart agriculture practices and contributes to climate change mitigation by reducing chemical runoff and minimizing environmental impact.

o The nano-sized particles of Nano DAP allow for superior absorption through seed surfaces and plant openings, leading to more effective nutrient uptake.

o Functionalized nano clusters enhance seed vigor, boost chlorophyll levels, and increase photosynthetic efficiency for better plant growth.

Diammonium Phosphate (DAP)

• About: It is rich in phosphorus (P), essential for root establishment and growth, making it crucial at sowing time.
• DAP is the second-most consumed fertilizer in the country, leading to government promotion of its liquid form to reduce imports and cut fertilizer subsidies.
• Efficiency Comparison: Compared to Nano DAP, traditional DAP is less efficient, offering reduced performance in nutrient delivery.

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9. PRADHAN MANTRI JAN DHAN YOJANA (Syllabus: GS Paper 3 – Economy)

Context: After a decade, the Pradhan Mantri Jan Dhan Yojana (PMJDY) has reached 53.13 crore accounts, with 55.6% held by women and 66.6% in rural and semi-urban areas.

Pradhan Mantri Jan Dhan Yojana (PMJDY)

• About: PMJDY is National Mission for Financial Inclusion named as the Pradhan Mantri Jan Dhan Yojana to ensure access to financial services, namely, Banking/ Savings & Deposit Accounts, Remittance, Credit, Insurance, Pension in an affordable manner.
• Announced on: 15th August 2014
• Implementation of the Scheme: 

o Phase I: 15 August 2014 - 14 August 2015.

o Phase II: 15 August 2015 - 14 August 2018.

o Phase III: beyond 14 August 2018.

• Objectives:

o Ensure access of financial products & services at an affordable cost

o Use of technology to lower cost & widen reach

• Features of the Scheme: 

o PMJDY provides one basic bank account for every unbanked adult. For this account, there is no need to maintain any balance and also no charges are levied on this account.

o In the account, a free-of-cost RuPay Debit card with in-built accident insurance cover of Rs. 2 lakh is also provided to promote digital transactions.

o PMJDY account holders are also eligible for getting an overdraft of up to Rs. 10,000 to cover exigencies.

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10. EXCEPTION UNDER SECTION 45 UNDER PMLA (Syllabus: GS Paper 3 – Economy/Internal Security)

Context: The Supreme Court has granted bail to Bharat Rashtra Samithi (BRS) leader in the Delhi Excise policy case, overturning the Delhi High Court's earlier denial of her bail plea under the Prevention of Money Laundering Act (PMLA) which was based on a key exception for women.

Section 45 of the PMLA

• About: It provides for bail on money laundering charges.
• Bail Provision: This provision in the law, like the stringent bail standard in the Unlawful Activities (Prevention) Act, 1967 (UAPA), puts the onus on the accused to prove that there is no prima facie case against them while seeking bail.
• Section 45(1): “No person accused of an offence under this Act shall be released on bail or on his own bond unless:

o the Public Prosecutor has been given an opportunity to oppose the application for such release; and 

o where the Public Prosecutor opposes the application, the Court is satisfied that there are reasonable grounds for believing that he is not guilty of such offence and that he is not likely to commit any offence while on bail.”

• Exception to the Bail Standard: There is an exception to this bail standard for individuals under sixteen years old, women, or those who are sick or infirm, provided the Special Court directs their release. This exception aligns with similar provisions in the Indian Penal Code.

Crucial Exception of Section 45 of PMLA

• Special Exception for Vulnerable Groups: Section 45 includes an important exception allowing bail for women, minors, or those who are sick or infirm, subject to the Special Court's direction.
• Mirroring Other Laws: This exception is consistent with exemptions in other Indian laws, such as the Indian Penal Code, concerning women and minors.
• Preeti Chandra Case (2023): The Delhi High Court cited the case of Preeti Chandra v. Directorate of Enforcement, emphasizing the application of the exception for women under Section 45.
• Clarification by Court: The court rejected the Enforcement Directorate's argument that the accused's social status should impact bail eligibility, affirming that the exception applies universally, provided there is no flight risk or threat to witnesses.

Legal Precedent

• About: A precedent is a previous instance or case which furnishes an example or rule for subsequent conduct, and a pattern upon which subsequent conduct is based.

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