Table of Contents
1. GOOD MANUFACTURING PRACTICES (GMP)
TAG: GS 2: SOCIAL JUSTICE; GS 3: ECONOMY
THE CONTEXT: The government recently directed all pharmaceutical companies in the country to implement the revised Good Manufacturing Practices (GMP), bringing their processes to par with global standards.
EXPLANATION:
- Larger companies with a turnover of over Rs 250 crore have been asked to implement the changes within six months, while medium and small-scale enterprises with a turnover of less than Rs 250 crore have been asked to do so within a year.
- This comes at a time when India is promoting itself as the global manufacturing hub for generic medicines.
What is GMP?
- It is a system that consists of processes, procedures and documentation that ensures manufacturing products, such as food, cosmetics, and pharmaceutical goods, are consistently produced and controlled according to set quality standards.
- Implementing GMP can help cut down on losses and waste, and avoid recall, seizure, fines and jail time. Overall, it protects both company and consumer from negative food safety events.
- GMPs examine and cover every aspect of the manufacturing process to guard against any risks that can be catastrophic for products, such as cross-contamination, adulteration, and mislabeling.
- Some areas that can influence the safety and quality of products that GMP guidelines and regulation address are the following :
- Quality management
- Sanitation and hygiene
- Building and Facilities
- Equipment
- Raw materials
- Personnel
- Validation and qualification
- Complaints
- Documentation and recordkeeping
- Inspections & quality audits
What are the 5 Main Components of Good Manufacturing Practice?
- It is paramount to the manufacturing industry to regulate GMP in the workplace to ensure consistent quality and safety of products.
- Focusing on the following 5 P’s of GMP helps comply with strict standards throughout the entire production process.
What are the 10 Principles of GMP?
- Create Standard Operating Procedures (SOPs)
- Enforce / Implement SOPs and work instructions
- Document procedures and processes
- Validate the effectiveness of SOPs
- Design and use working systems
- Maintain systems, facilities, and equipment
- Develop job competence of workers
- Prevent contamination through cleanliness
- Prioritize quality and integrate into workflow
- Conduct GMP audits regularly
Benefits of the improved standards:
- Implementation of the new norms will bring the Indian industry on par with global standards.
- The improved standards will ensure that pharmaceutical companies follow standard processes, and quality control measures and do not cut corners, improving the quality of medicines available in India as well as sold in the global market.
- Implementation of the revised good manufacturing practices (GMP) will act as one of the measures to solve the string of incidents where other countries have reported alleged contamination of India-manufactured drugs.
- This will bring uniformity across states on processes followed for licensing and inspection, ensuring that the quality of medicine manufactured anywhere in the country would be the same.
- Instituting the same quality across the industry will give confidence to regulators from other countries.
- It will make India a quality pharmaceutical hub of the world. In addition, it will ensure that our citizens also receive export-quality medicines.
What are the major changes?
- The revised GMP guidelines focus on quality control measures, proper documentation, and IT backing to maintain the quality of medicines produced.
- The new guideline introduces a pharmaceutical quality system, quality risk management, product quality review, and validation of equipment. This will mean companies will have to carry out regular quality reviews of all their products, verify the consistency of the quality and the processes, and implementation of any preventive actions.
- It also suggests a change control system to evaluate all changes that may affect the production or quality of the product.
- The companies will also have to carry out stability studies as per the climate conditions. “Most companies at present keep their samples stored under recommended conditions and test for various parameters from time to time.
- The guidelines also state that companies should have GMP-related computerised systems, which ensure that there is no tampering of data related to the processes. Such GMP systems will prevent unauthorised access and changes to the data.
- In addition, the new schedule M also lists out the requirements for additional types of products, including biological products, agents with radioactive ingredients, or plant-derived products.
- The new schedule also lists the requirement for investigational products being manufactured for clinical trials.
2. NEW ONLINE DISPUTE RESOLUTION (ODR) OF SEBI
TAG: GS 2: GOVERNANCE; GS 3: ECONOMY
THE CONTEXT: SEBI is considering implementing a new online dispute resolution (ODR) system involving institutions, conciliators and arbitrators for the capital market.
EXPLANATION:
- Recently, SEBI issued a circular streamlining the existing dispute resolution mechanism in the securities market under the aegis of stock exchanges and depositories Market Infrastructure Institutions (MII) by establishing a common ODR portal.
- The new system will harness online conciliation and online arbitration for resolution of disputes arising in the securities market.
- The introduction of ODR to resolve securities market disputes serves to revolutionize both the process and timeframes for the resolution of such disputes.
What are ODR institutions?
- According to SEBI, each MII will identify and empanel one or more independent ODR institutions.
- These institutions will have qualified conciliators and arbitrators.
- MIIs will, in consultation with their empanelled ODR institutions, establish and operate a common ODR portal.
- All listed companies specified intermediaries and regulated entities in the securities market (referred to as market participants) would enrol on the ODR portal.
SEBI’s Adoption of ODR:
- The adoption of ODR by SEBI is more than just an incremental increase in the reach of ODR.
- It is a revolutionary change that has the potential to fundamentally disrupt the landscape of ADR and ODR, not just in India but globally.
- The adoption of ODR by SEBI is among the first of its kind globally, where statutory conciliation and arbitration with private ODR players has been provided for.
- Securities market disputes can range from the super-simple to extremely complex. The fact that ODR has now been provided for the entire spectrum of disputes represents a marked shift in attitude.
- The adoption by SEBI marks an important milestone of regulatory/government bodies delegating the power of appointment of neutrals to private ADR/ODR participants while also imposing sufficient checks and balances on the exercise of such power.
- This is particularly relevant in a country like India where appointment of arbitrators by courts (in ad hoc arbitrations) and government-run facilitation councils and equivalent (in cases like MSME disputes) has been among the largest contributors of delay in dispute resolution.
- This opens up the possibility of using private sector participants with a degree of ongoing accountability that any long-term engagement with one or more participants cannot achieve.
Salient features of the SEBI ODR Circular
- The SEBI ODR Circular provides a detailed framework for the escalation of cases to ODR, the manner of selection of ODR institutions, the conduct of various ODR processes, the timelines for each process and the cost of each process.
- The SEBI ODR Circular enables resolution of disputes arising out of securities market transactions by ODR institutions capable of undertaking time-bound online conciliation and/or arbitration in accordance with the Arbitration and Conciliation Act, 1996.
- Under the Circular, each Market Infrastructure Institution (MII) has to empanel one or more ODR institutions and establish and operate on a common Online Dispute Resolution Portal (ODR Portal), whose creation will be overseen by the various MIIs together.
- The ODR portal shall establish due connectivity with the SEBI SCORES portal/ SEBI Intermediary portal.
- All Market Participants are required to enrol on the ODR portal within a specific timeline identified in the Circular.
- They are also required to clearly communicate the availability of the SCORES portal and the ODR portal to the investor to resolve their disputes if the investor is unsatisfied with the response (or the lack thereof) of the Market Participant.
- The ODR portal will have the following features- Enrolling an investor and market participant, filing a complaint, uploading documents and papers, and status update on the complaint, which would be provided by the ODR institution.
- A complaint initiated through the portal will be referred to an ODR institution empanelled by an MII and the allocation system on a market-wide basis to govern the allocation of each such dispute among all such empanelled ODR institutions.
SCORES (SEBI Complaints Redress System)
- SCORES is a web-based centralized grievance redress system of SEBI. SCORES enables investors to lodge and follow up their complaints and track the status of redressal of such complaints online from the above website from anywhere.
- This enables the market intermediaries and listed companies to receive complaints online from investors, redress such complaints and report redressal online.
- All the activities starting from the lodging of a complaint till its closure by SEBI, would be online in an automated environment, and the complainant can view the status of his complaint online.
- An investor, who is not familiar with SCORES or does not have access to SCORES, can lodge complaints in physical form at any of the offices of SEBI. Such complaints would be scanned and also uploaded in SCORES for processing.
What types of complaints can be registered in the SCORE portal?
- Entities against which complaints are handled by SEBI include:
- Listed companies / registrar & transfer agents
- Brokers / stock exchanges
- Depository participants / depository
- Mutual funds
- Portfolio Managers
- Other entities (KYC Collective investment scheme, Merchant banker, Credit rating, Foreign institutional investor etc)
3. AMRIT BHARAT STATION SCHEME
TAG: GS 3: ECONOMY
THE CONTEXT: In a bid to keep it safe for passengers as well as freight transportation, it is essential to modernise its infrastructure with the latest technologies, amenities and others from time to time. In this context, the government is working to transform the railway stations across the country under Amrit Bharat Station Scheme (ABSS).
EXPLANATION:
- Amrit Bharat Station Scheme was launched by the Ministry of Railways in 2022 for the development of stations with a long-term vision.
- The scheme involves creating a Master Plan for each station, considering its long-term requirements and the needs of its passengers.
- This will guarantee that the modernization process is efficient and tailored to the specific demands of each station.
- Out of the 508 stations whose redevelopment has started, 48 are of Bihar, 31 are of Assam, and 18 of Andhra Pradesh.
The broad objectives of the Amit Bharat Station Scheme are:
- To prepare Master Plans for railway stations and implement them in phases to improve facilities, including beyond the Minimum Essential Amenities (MEA).
- To aim for the creation of Roof Plazas and city centres at stations in the long run.
- To prioritize stakeholder needs and station usage studies based on available funds.
- To introduce new amenities and upgrade or replace existing ones.
- To cover stations where techno-economic feasibility studies have been conducted.
- To focus on implementing Master Plans in phases, with special emphasis on relocating structures and utilities as needed.
The scope of work under the Amrit Bharat Station scheme includes the following:
- Improve the structure and create aesthetically pleasing entrance porches in a cost-efficient manner.
- Relocate old buildings efficiently to make space for priority passenger activities and future development.
- Minimize new building construction, except for necessary relocations or improvements.
- Provide combined waiting halls and good cafeteria/retail facilities where possible.
- Allocate space for at least two stalls for “One Station One Product.”
- Improve station approaches with widened roads, proper signages, pedestrian pathways, parking areas, and better lighting.
- Incorporate landscaping, green areas, and local art and culture to enhance the station experience.
4. OPTICAL FIBERS BASED CONNECTIVITY
TAG: GS 2: GOVERNANCE; GS 3: SCIENCE AND TECHNOLOGY
THE CONTEXT: The cabinet has approved a last-mile broadband connectivity plan under the BharatNet project for 6.4 lakh villages across the country with a financial outlay of Rs 1.39 lakh crore.
EXPLANATION:
- The Union Cabinet has approved an allotment of ₹1,39,579 crore for the next phase of Bharat Net to make 5G network available to remote areas of the country.
- Its plan is to reach 6.4 lakh villages within the next two years from the current 1.94 lakh connected villages.
BHARATNET PROJECT
- BharatNet is one of the biggest rural telecom projects in the world.
- It is implemented in a phased manner to all Gram Panchayats (approximately 2.5 lakh) in the country for providing non-discriminatory access to broadband connectivity to all the telecom service providers.
- Objective is to enable access providers like mobile operators, Internet Service Providers (ISPs), Cable TV operators, content providers to launch various services such as applications like e-health, e-education, and e-governance in rural and remote India.
- The project has been approved by Union Cabinet in 2011.
- The project is being executed by a Special Purpose Vehicle (SPV) namely Bharat Broadband Network Limited (BBNL).
- BBNL has been incorporated in 2012 under Indian Companies Act 1956.
- In 2016, the Telecom Commission approved to implement the project in three phases.
NATIONAL OPTICAL FIBRE NETWORK (NOFN)
- National Optical Fibre Network (NOFN) is an ambitious initiative to trigger a broadband revolution in rural areas.
- NOFN was envisaged as an information super-highway through the creation of a robust middle-mile infrastructure for reaching broadband connectivity to Gram Panchayats.
- The National Optical Fibre Network (NOFN) aims to connect all the 2,50,000 Gram panchayats in the country and provide 100 Mbps connectivity to all gram panchayats (GPs).
- To achieve this, the existing fibres of PSUs (BSNL, Railtel and Power Grid) were utilised and incremental fibre was laid to connect to Gram Panchayats wherever necessary.
- Dark fibre network thus created was lit by appropriate technology thus creating sufficient bandwidth at the Gram Panchayats.
OPTICAL FIBERS
- Fiber optics, or optical fiber, refers to the technology that transmits information as light pulses along a glass or plastic fiber.
- A fiber optic cable can contain a varying number of these glass fibers from a few up to a couple hundred. Another glass layer, called cladding, surrounds the glass fiber core.
- The buffer tube layer protects the cladding, and a jacket layer acts as the final protective layer for the individual strand.
- Fiber optic cables are commonly used because of their advantages over copper cables. Some of those benefits include higher bandwidth and transmit speeds.
- Fiber optics is used for long-distance and high-performance data networking.
- It is also commonly used in telecommunication services, such as internet, television, and telephones.
- For example, Verizon and Google use fiber optics in their Verizon FIOS and Google Fiber services, respectively, providing Gigabit internet speeds to users.
5. REINTRODUCTION OF RHINO CONSERVATION SCHEME
TAG: GS 3: ECOLOGY AND ENVIRONMENT
THE CONTEXT: Bihar government is constituting a ‘Rhino Task Force’ for suggesting measures for the reintroduction of the terrestrial mammals in the Valmiki Tiger Reserve (VTR) in West Champaran district of Assam.
EXPLANATION:
- A committee was set up to assess the habitat and security conditions in VTR of Assam and to suggest measures for reintroduction of rhinos in the reserve, about two years back.
- The committee recently submitted its report to the Department of Environment, Forest and Climate Change (DEFCC).
- Based on the recommendations, State government is preparing to constitute a ‘Rhino Task Force’ for suggesting measures for the reintroduction of rhinos in the VTR.
- The process of the reintroduction of the rhino scheme in VTR will start based on the recommendations of the task force.
- It has been decided to increase the rhino-bearing areas in VTR by 5% in the next two years.
- As per the plan rhinos will be taken out of crowded habitats and shifted to identified areas in the VTR.
- The objective is to provide more room for the rhinos to breed and multiply.
- The potentially identified areas for the reintroduction scheme in VTR are — Ganauli and Madanpu.
INDIAN RHINO VISION 2020 (IRV2020) / PROJECT RHINO
- IRV2020 was initiated as a collaboration between the Assam Forest Department, International Rhino Foundation, and WWF India.
- The program was established in 2005 for the purpose of increasing the rhino population in Assam to 3,000 by establishing populations in seven protected areas.
- In 2021, a final translocation of two rhinos from Kaziranga National Park to Manas National Park was completed.
- Rhinos are now found in four Protected Areas in Assam: Pobitora Wildlife Sanctuary, Orang National Park, Kaziranga National Park and Manas National Park.
- In 2022, the IRV2020 partners met to outline goals for the coming years, with plans to build on the successes and learnings from the previous program.
- Meetings to approve the plan, known as IRV 2.0, have been delayed due to the global pandemic.
- The New Program is scheduled to begin soon under the leadership of Assam Forest Department, along with supporting partners, and translocations could begin again by the end of the year.
WORKING WITH LOCAL COMMUNITIES TO RESTORE HABITAT IN INDIA
- Local community members successfully restored 50 acres of prime rhino habitat under the supervision of our on-the-ground partner, Aaranyak, and Manas National Park officials.
- It planned to restore another 250 acres over the next two years.
- Engagement of local people in removal of invasive plant species also offers them livelihood and, in that way, it helps park officials to garner better support from local communities along with improvement of grassland habitats.
VALMIKI TIGER RESERVE (VTR)
- The VTR occupies a core area of 909.86 sq. km of the Valmiki Sanctuary located in the West Champaran district of Bihar.
- VTR has been selected as one of the potential sites under the National Rhino Conservation strategy where rhinos may be brought from other reserves in the country.
- The VTR was established as the 18th tiger reserve in 1990 and ranked fourth in the density of the tiger population.
- The rivers Gandak and Masan flow through this area.