Daily Prelims Notes 7 January 2024
- January 7, 2024
- Posted by: OptimizeIAS Team
- Category: DPN
Daily Prelims Notes
7 January 2024
Table Of Contents
- How has Red Sea trouble impacted India?
- Shah to take stock of generic drug plan
- Centre notifies revised rules for quality control of pharma products
- Centre will bring quality norms for 2500 items soon
1. How has Red Sea trouble impacted India?
Subject: IR
Section: Places in news
Context:
- A spate of attacks on cargo ships in the Red Sea since November by the Houthi militia of Yemen has turned the quickest marine route linking Asia with Europe through the Suez Canal unsafe.
- It has forced freighters to take a longer transit around the Cape of Good Hope in Africa’s southern tip, making shipments both dearer and longer to deliver.
Why Are Attacks Happening?
- Yemen’s backed Houthi have been targeting vessels in the Red Sea since November to show their support for the Hamas in the war against Israel.
Importance Of Red Sea Trade Route
- Historical significance – red sea has been one of the most important route since ages that connected many civilizations and continents i.e. Asia, Africa, Europe.
- Economic significance – Suez Canal since its inception in 1869 has been the busiest trade route that reduced distance between Europe and Asia by 7000km.
- Geopolitical significance -because of its economic importance and strategic location (narrow width of Suez Canal) it has also become geopolitically significant.
How have the Red Sea attacks impacted freight rates?
- Ever since the attacks along the Bab-el-Mandeb Strait began earlier this month, global shipping firms have begun imposing war risk surcharges over and above the normal freight rates.
- Indian exporters said that freight rates for Indian shipments headed to Europe and Africa could surge as much as 25-30 per cent if the ongoing security concern along the Red Sea trade route continues.
- This is troubling, as the European Union is one of India’s second-largest export destinations. Slowing demand from the region has impacted India’s labour-intensive sectors, such as textiles, gems and jewellery exports.
Measures Taken by India
- The Indian Navy has substantially enhanced maritime surveillance efforts in the central/north Arabian Sea and augmented force levels.
- Task Groups comprising destroyers and frigates have been deployed to undertake maritime security operations and render assistance to merchant vessels in case of any incident
- Aerial surveillance by long-range maritime patrol aircraft and RPAs remotely piloted aircraft has been enhanced to have complete maritime domain awareness.
- Towards effective surveillance in economic exclusive zone , the Indian Navy is operating in close coordination with the Indian Coast Guard.
- The Indian navy is monitoring the overall situation in coordination with national maritime agencies.
- US Defense Secretary Lloyd Austin announced the creation of Operation Prosperity Guardian to protect Red Sea commerce but India is yet to decide on joining it.
2. Shah to take stock of generic drug plan
Subject: Schemes
Section: Health
Context:
- Recently, the Government of India has decided to allow 2000 Primary Agricultural Credit Societies (PACS) to open Pradhan Mantri Bhartiya Jan Aushadhi Kendras across the country.
About Generic Drugs
- Generic drugs can be defined as affordable versions of branded drugs which are brought into the market once the original drug manufacturer’s patent expires.
- These medicines have the same potency, quality, and implications and work in an identical manner as the branded drug. The generic medicines are marketed either by a salt or brand name.
Pradhan Mantri Bhartiya Jan Aushadhi Kendras:
- These are set up under Pradhan Mantri Bhartiya Janaushadhi Pariyojana, which was launched by the Department of Pharmaceuticals, Ministry of Chemicals and Fertilizers in November 2008.
- Objective: To provide quality medicines at affordable prices for all, particularly the poor, to reduce out-of-pocket expenses in healthcare.
- These Jan Aushadhi Kendras provide generic drugs, which are available at lesser prices but are equivalent in quality and efficacy to expensive branded drugs.
- Jan Aushadhi stores also sell allied medical products commonly sold in chemist shops to improve the viability of running the Jan Aushadhi store.
- Pharmaceutical & Medical Devices Bureau of India (PMBI) has been established under the Department of Pharmaceuticals, Govt. of India, with the support of all the CPSUs for co-coordinating procurement, supply, and marketing of generic drugs through the PMBKs.
- The incentive amount of Rs.5 lakh will be provided to set up Pradhan Mantri Bhartiya Jan Aushadhi Kendra.
Who can open a Jan Aushadhi Kendra?
- State Governments or any organization / reputed NGOs/ Trusts / Private hospitals / charitable institutions / Doctors / Unemployed pharmacists/ individual entrepreneurs are eligible to apply for the new Jan Aushadhi Kendra.
- The applicants shall have to employ one B Pharma / D Pharma degree holder as Pharmacist in their proposed store.
3. Centre notifies revised rules for quality control of pharma products
Subject: Science and Tech
Section: Health
Context:
- Recently, the Health Ministry notified revised Pharma manufacturing rules under schedule M to ensure quality control.
More on news:
- The Central government, after consultation with the Drugs Technical Advisory Board, notified the revised rules under the Drugs (Amendment) Rules, 2023.
- The revised Schedule M prescribes the Good Manufacturing Practices (GMP) and requirements of premises, plant, and equipment for pharmaceutical products as per global standards.
- The Ministry had set a six-month deadline for small manufacturers and 12 months for large units to get their World Health Organization-Good Manufacturing Practices (WHO-GMP) certification.
Schedule M of the Drugs and Cosmetics Act, 1940:
- It includes requirements of facilities and their maintenance, personnel, manufacture, control, safety testing, storage and transport of material, written procedures and records, and traceability for pharmaceutical products.
Revised Schedule M of the Drugs and Cosmetics Act, 1940:
- The changes introduced in the revised Schedule M include introduction of a pharmaceutical quality system (PQS), quality risk management (QRM), product quality review (PQR), qualification and validation of equipment, and a computerized storage system for all drug products.
- Manufacturers must assume responsibility for the quality of the pharmaceutical products to ensure that they are fit for their intended use, comply with the requirements of the license, and do not place patients at risk due to inadequate safety, quality, or efficacy.
- Companies must market a finished product only after getting “satisfactory results” on tests of the ingredients.
- Companies must retain a sufficient quantity of the samples of intermediate and final products to allow repeated testing or verification of a batch.
- The focus will be on risk management, qualification and validation of equipment, and self-inspection will be vital contributions.
- The revised Schedule M has 13 parts which provide GMP guidelines for the specific requirements for manufacturing pharmaceutical drugs.
- The revised rules has five new categories of drugs including pharmaceutical products containing hazardous substances such as sex hormones, steroids (anabolic and androgenic), cytotoxic substances, biological products and radiopharmaceuticals.
About Good Manufacturing Practices (GMP):
- GMP is mandatory standards which build and bring quality into a product by way of control on materials, methods, machines, processes, personnel, and facility/environment, etc.
- GMP was first incorporated in Schedule M of the Drugs and Cosmetics Rules, 1945 in the year 1988
- Amendment to this act was done in June, 2005 to replace the word, ‘Good Manufacturing Practices’ (GMP) with ‘Good Manufacturing Practices and Requirements of Premises, Plant and Equipment for Pharmaceutical Products’.
Implementation Plans:
- The revised rules are to be implemented on the basis of company turnovers
- Medium and small manufacturers (with an annual turnover of less than ₹250 crore) who will have to implement the revised rules within 12 months from its date of publication.
- Large manufacturers with an annual turnover of over ₹250 crore will be given six months to do so.
Benefit of revised guidelines.
- The revised regulations of Schedule M will help ensure compliance with international quality standards.
- It will benefit both patients and the industry by promoting the manufacturing of safe, effective, and high-quality drugs.
About Drugs Technical Advisory Board:
- It is the highest statutory decision making body on technical matters pertaining to drugs in the country.
- The body was formed under Drugs and Cosmetics Rules, 1940.
- It is part of the Central Drugs Standard Control Organization which comes under the Ministry of Health and Family Welfare.
- Its function is to advise the Central Government and the State Governments on technical matters arising out of the administration of this Act
4. Centre will bring quality norms for 2500 items soon
Subject: Economy
Section: External Sector
Context:
- Union Commerce, Food and Consumer Affairs Minister Piyush Goyal has said that the Centre will soon bring Quality Control Orders (QCO) for about 2,500 items.
More on news:
- Addressing a meeting on the 77th foundation day of the Bureau of Indian Standards (BIS), The minister said that there were only 14 QCOs of 106 products till 2014 and increased to around 156 QCOs of 672 products.
- Complying with high quality standards in products and services will help India achieve high goals and become a developed nation.
- QCOs are being processed in nearly 2,500 more items which reflects the commitment towards quality by providing high standards goods and services.
- The initiative is inclined towards the vision of ‘zero defect, zero effect’ to make products of high quality that are sustainable, eco-friendly and have zero climate impact.
- BIS recently agreed to invest ₹40 crore to set up 21 labs for cotton testing.
About Quality Council Of India:
- QCI is a non-profit organization registered under the Societies Registration Act XXI of 1860.
- The Department of Industrial Policy and Promotion, Ministry of Commerce and Industry was designated as the nodal point for all matters connected with the Quality Council Of India.
- QCI was set up through a PPP model as an independent autonomous organization with the support of Government of India and the Indian Industry represented by the three premier industry associations, (i) Associated Chambers of Commerce and Industry of India (ASSOCHAM), (ii) Confederation of Indian Industry (CII) and (iii) Federation of Indian Chambers of Commerce and Industry (FICCI).
- It plays a pivotal role at the national level in propagating, adoption and adherence to quality standards in all important spheres of activities
About PARAKH
- PARAKH Portal was launched on 7th January 2022 by Secretary Higher Education, MoE-Government of India, for all AICTE approved institutes.
- Vision of AICTE – SLA (PARAKH) is to bridge the gap between academics and industry by providing a platform for self assessment of knowledge.
- It will enable policymakers and institutions to assess global competitiveness of students, faculty members and stakeholders to trigger necessary interventions creating a more effective system of education in the country.