- NATIONAL
SC STAYS AYUSH MINISTRY’S NOTIFICATION OMITTING KEY RULE PROHIBITING MISLEADING ADVERTISEMENTS
- Background:
- Rule 170 of the Drugs and Cosmetics Rules, 1945: This rule empowers authorities to take action against objectionable or misleading advertisements related to Ayurvedic, Siddha, and Unani drugs.
- Controversy: On August 29, 2023, the AYUSH Ministry issued a letter to drug licensing authorities across States and Union Territories, informing them that Rule 170 was no longer operational.
- This was based on a recommendation by the Ayurvedic, Siddha, and Unani Drugs Technical Advisory Board (ASUDTAB). ○ The Supreme Court, in a May 7 order, directed the Ministry to withdraw this letter, emphasising the enforcement of Rule 170.
- Recent Developments: Despite the Supreme Court’s order, the Ministry issued a notification on July 1, 2024, omitting Rule 170 from the Drugs and Cosmetics Rules, 1945, without withdrawing the August 2023 letter.
- This led to the Supreme Court staying the July 1 notification and expressing strong disapproval of the Ministry’s actions
2. SCIENCE AND TECHNOLOGY
ADVANCING EQUITY, FROM COVID-19 TO MPOX
- The global health community’s response to the mpox (formerly known as monkeypox) outbreak has been declared a Public Health Emergency of International Concern (PHEIC) by the World Health Organization (WHO).
- This declaration, along with the Africa Centres for Disease Control and Prevention’s (AfricaCDC) declaration of a Public Health Emergency of Continental Security (PHECS), underscores the severity of the outbreak and the need for a coordinated international response.
- Vaccine Availability and Production: MVA-BN Vaccine: The Modified Vaccinia Ankara-Bavarian Nordic (MVA-BN) vaccine, also known as Jynneos, is already in production and approved by regulatory authorities in the EU, UK, US, Switzerland, and Canada.
- Production Capacity: Bavarian Nordic has the capacity to manufacture 10 million doses by the end of 2025, but immediate availability is limited to about 0.21 million doses. The price per shot is estimated at $100.
- Role of Indian Manufacturers: Potential for Scale-Up: Indian manufacturers like the Serum Institute of India, Bharat Biotech, and Zydus Cadila have the expertise and infrastructure to produce vaccines using CEF cells, which could be leveraged to ramp up MVA-BN production.
- Technology Transfer: Comprehensive technology transfer, including sharing biological resources, know-how, and patents, is crucial for scaling up production. This would ensure that LMICs are not reliant on charity from high-income countries and can maintain self-sufficiency.
- Regulatory Facilitation: CDSCO Waiver: India’s Central Drugs Standard Control Organization (CDSCO) has waived the requirement for clinical trials in India for drugs approved in the US, UK, Japan, Australia, Canada, and the EU.
- This waiver will expedite the availability of critical vaccines like MVA-BN in India.
3. ECONOMY
INDIA NEEDS TO DEVELOP A CARE ECOSYSTEM
- The issue of low Female Labour Force Participation Rate (FLFPR) in India is a significant concern for women’s empowerment and economic development.
- According to the Economic Survey 2023-24, the FLFPR in India was 37% in 2022-23, which is below the world average of 47.8% in 2022.
- Although this marks an increase from 23.3% in 2017-18, a substantial portion (37.5%) of this participation comprises “unpaid helpers in household enterprises,” indicating that many women are not compensated for their work outside of domestic chores.
- Key Factors Affecting FLFPR
- Burden of Care Responsibilities:
- Women in India bear a disproportionately high burden of care within the family, including childcare, elder care, and care for the sick and disabled. This significantly limits their ability to participate in the formal labor market.
- Women aged 15-64 years spend about three times more time daily than men on unpaid domestic work.
- Childcare and Support Services: Some State governments have focused on building support services through the existing Anganwadi network.
- The 2024-25 Budget saw a 3% increase in the Ministry of Women and Child Development’s budget for the integrated childcare and nutrition programme (Saksham Anganwadi and Poshan 2.0 scheme).
- Various models of community-based creches are operational in parts of some States, often in partnership with non-governmental bodies. These models need to be reviewed for replicability, financial sustainability, and scalability.
- Broader Care Responsibilities: Recognizing only childcare needs is limiting. Women are primary caregivers across the life course of household members. To facilitate women’s participation in the economy, their care responsibilities need to be shifted elsewhere.
- Demand for External Support: The demand for external support in the form of hired caregivers is rising in urban and peri-urban areas.
- There are no standardised processes for the employment of such workers, who often lack training, protection, and fair wages.
- Creating a Care Ecosystem: An ecosystem that responds to household care needs while protecting the rights of care workers is crucial.
- This ecosystem must provide safe, quality, and affordable care by well-trained care workers who earn decent wages and command dignity and respect for their work.
4. BILATERAL
IIL, AUSTRALIAN VARSITY DEVELOP NEEDLE FREEC OVID-19 VACCINE
- Indian Immunologicals Ltd (IIL), in collaboration with Griffith University, Australia, has developed a needle-free intranasal booster vaccine against SARS-CoV-2. This vaccine employs a novel technology called “codon de-optimisation.”
- Codon De-Optimisation Technology: Definition: Codon de-optimisation involves decreasing the frequency of under-represented codon pairs (genetic determinants for amino acids) without altering the amino acid sequences.
- Mechanism: This method is used to attenuate (weaken) the virus, making it less virulent while still capable of eliciting an immune response.
- Advantages:
- Safety: The technology is extremely safe and allows for precise control over the degree of attenuation.
- Efficiency: It takes less time compared to conventional methods of virus attenuation, which can take several years.
- Intranasal Vaccine:
- Delivery Method: The vaccine is administered through the nasal route, eliminating the need for needles.
- Benefits:
- Ease of Administration: Needle-free delivery is less invasive and can improve vaccine acceptance.
- Mucosal Immunity: Intranasal vaccines can induce a strong immune response in the mucosal tissues, which are the primary entry points for respiratory viruses like SARS-CoV-2.
- Impact on COVID-19 Management: Booster Dose: The vaccine serves as a booster, enhancing immunity in individuals who have already received their primary vaccination series.
- Targeted Attenuation: The use of codon de-optimisation allows for targeted attenuation of the virus, making it a promising candidate for future vaccine development.
5. ENVIRONMENT
CDSCO GRANTS APPROVAL FOR MAKING RT-OCR TESTING KITS TO DETECT MPOX IN INDIA
- The Central Drugs Standard Control Organisation (CDSCO) has granted approval to Siemens Healthineers for the manufacture of RT-PCR testing kits for the detection of Mpox (Monkeypox). These kits will be produced in Vadodara with a capacity of one million units per year.
- RT-PCR Testing Kits: Technology: RT-PCR (Reverse Transcription Polymerase Chain Reaction) is a molecular diagnostic technique used to detect the presence of specific genetic material from a pathogen.
- Speed: The Siemens Healthineers RT-PCR kits can deliver test results in 40 minutes, significantly faster than traditional methods.
- Production Capacity: The kits will be manufactured in Vadodara with a production capacity of one million units per year.
- Mpox Detection:
- Target Regions: The IMDX Monkeypox Detection RT-PCR Assay targets two distinct regions in the viral genome, covering both clade I and clade II variants. This ensures comprehensive detection across various viral strains.
- Platform-Agnostic: The assay is compatible with existing PCR setups, eliminating the need for new instruments and allowing the use of existing COVID-19 testing infrastructure.
- Clinical Validation: Validation: The assay has been clinically validated by the Indian Council of Medical Research-National Institute of Virology (ICMR-NIV), Pune.
- Sensitivity and Specificity: The assay boasts 100% sensitivity and specificity, ensuring accurate and reliable detection of Mpox
ONE LINER
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