Pre- Water in Pharma

Pharmaceutical Water Treatment and Drinking Water Standards: A Comprehensive Global Guide


Introduction

Water is the lifeblood of both public health and pharmaceutical manufacturing. Its quality directly impacts human well-being, the safety of medicines, and the integrity of healthcare systems worldwide. In the pharmaceutical industry, water is not merely a utility but a critical raw material, excipient, and cleaning agent, with its purity governed by stringent regulatory standards. For the broader population, access to safe drinking water is a fundamental human right and a cornerstone of sustainable development, as recognized by the United Nations Sustainable Development Goals (SDG 6.1).

This comprehensive guide explores the multifaceted world of pharmaceutical water treatment and drinking water standards. It covers the characteristics and treatment needs of various water sources, the design and operation of pharmaceutical water systems, regulatory frameworks, water tank cleaning protocols, comparative global drinking water standards, testing guidelines, and the evolving landscape of water safety in India and worldwide. The report synthesizes insights from international guidelines (WHO, US EPA, EU, BIS), national protocols, and best practices, offering a universal reference for professionals, policymakers, and the informed public.


1. Water Sources: City Water, River Water, and Ground Water – Characteristics and Treatment Needs

1.1 City (Municipal) Water

City or municipal water is typically sourced from surface water (rivers, lakes, reservoirs) or groundwater (wells, boreholes), treated centrally, and distributed through extensive pipeline networks. Its quality is influenced by the source, treatment efficacy, and the integrity of distribution infrastructure.

Key Characteristics:

  • Source Variability: Urban water may be a blend of river, lake, and groundwater, with quality fluctuating seasonally and spatially.
  • Treatment: Standard municipal treatment includes coagulation, sedimentation, filtration, and disinfection (usually chlorination). Advanced cities may employ ozonation, activated carbon, or membrane filtration.
  • Contaminants: Despite treatment, city water can contain residual chlorine, disinfection by-products (e.g., trihalomethanes), heavy metals (from corroded pipes), pesticides, and microbial contaminants due to post-treatment recontamination or infrastructure failures.
  • Distribution Risks: Aging pipelines, intermittent supply, and storage tanks can introduce iron, lead, asbestos fibers, and biofilms, leading to taste, odor, and health issues.

Treatment Needs:

  • Pre-treatment: Removal of particulates, adjustment of pH, and reduction of chlorine or chloramines (especially before pharmaceutical use).
  • Advanced Purification: For pharmaceutical applications, further purification (e.g., reverse osmosis, deionization, distillation) is mandatory to meet stringent chemical and microbiological standards.
1.2 River Water

River water is a dynamic and variable source, subject to natural and anthropogenic influences.

Key Characteristics:

  • High Variability: Quality changes with rainfall, upstream discharges, agricultural runoff, and industrial effluents.
  • Contaminants: Suspended solids, organic matter, pathogens (bacteria, viruses, protozoa), pesticides, heavy metals, and nutrients (nitrates, phosphates).
  • Seasonal Fluctuations: Monsoon and dry seasons cause significant shifts in turbidity, microbial load, and chemical composition.

Treatment Needs:

  • Comprehensive Treatment: Multi-barrier approach—coagulation/flocculation, sedimentation, filtration, and robust disinfection (chlorination, UV, ozonation).
  • Advanced Steps: For pharmaceutical feed water, additional steps like activated carbon filtration, softening, and membrane processes are essential to remove trace organics and reduce microbial risk.
1.3 Groundwater

Groundwater, accessed via wells and boreholes, is the predominant source for rural and peri-urban areas in many countries, including India.

Key Characteristics:

  • Chemical Stability: Generally more stable than surface water in the short term, but vulnerable to geogenic (natural) and anthropogenic contamination.
  • Contaminants: Arsenic, fluoride, iron, nitrate, salinity, and heavy metals are common geogenic contaminants. Nitrate and pesticide contamination often result from agricultural activities.
  • Microbial Risk: Lower than surface water, but possible in shallow or poorly protected wells.

Treatment Needs:

  • Targeted Removal: Specific treatment for iron (aeration, filtration), arsenic (adsorption, coagulation), fluoride (activated alumina, Nalgonda technique), and nitrate (ion exchange, reverse osmosis).
  • Disinfection: Essential if microbial contamination is detected.

Summary Table: Water Source Characteristics and Treatment Needs

SourceKey ContaminantsVariabilityTypical Treatment StepsPharmaceutical Feed Suitability
City WaterChlorine, THMs, heavy metals, microbesModerateFiltration, disinfection, advanced purificationGood (with further treatment)
River WaterSuspended solids, pathogens, organics, pesticidesHighMulti-barrier (coagulation, filtration, disinfection)Requires extensive pre-treatment
GroundwaterArsenic, fluoride, nitrate, iron, salinityLow-ModerateTargeted removal, disinfectionGood (with specific removal)

Analytical Commentary: Each water source presents unique challenges. City water offers convenience but may carry residual disinfectants and infrastructure-related contaminants. River water, while abundant, demands rigorous treatment due to its high and unpredictable contaminant load. Groundwater is often chemically stable but can harbor hazardous geogenic contaminants that require specialized removal technologies. For pharmaceutical use, all sources must be upgraded to meet stringent purity requirements, with city water often serving as the baseline feed due to its regulated quality.


2. Pharmaceutical Water Treatment

2.1 Pre-treatment and Post-treatment Processes

Pharmaceutical water systems are engineered to transform potable water into highly purified forms suitable for drug manufacturing, cleaning, and laboratory use. The process is typically divided into pre-treatment and post-treatment (refined treatment and distribution) stages.

2.1.1 Pre-treatment

Objectives:

  • Remove particulates, chlorine/chloramines, hardness, organics, and reduce microbial load to protect downstream purification units.

Typical Steps:

  1. Screening: Removal of large debris and suspended solids.
  2. Sedimentation/Clarification: Settling of fine particles.
  3. Coagulation/Flocculation: Addition of coagulants (e.g., alum, ferric chloride) to aggregate colloids.
  4. Filtration: Multi-media (sand, anthracite) filters to remove remaining particulates.
  5. Activated Carbon Filtration: Adsorbs organic compounds and removes chlorine/chloramines.
  6. Softening: Ion exchange resins remove calcium and magnesium to prevent scaling.
  7. Dechlorination: Essential before membrane processes to prevent damage.
  8. Disinfection: UV or chemical (sodium hypochlorite, ozone) to reduce microbial load.

Chemical Additives:

  • Coagulants (alum, ferric salts), flocculants (polymers), antiscalants, pH adjusters (lime, soda ash), and disinfectants (chlorine, ozone, hydrogen peroxide).
2.1.2 Post-treatment (Refined Treatment and Distribution)

Objectives:

  • Achieve and maintain the required chemical and microbiological purity for pharmaceutical applications.

Key Technologies:

  • Reverse Osmosis (RO): Removes dissolved salts, organics, and microbes.
  • Deionization (DI) / Electrodeionization (EDI): Further reduces ionic content.
  • Ultrafiltration (UF): Removes colloids, pyrogens, and some microbes.
  • Distillation: Produces Water for Injection (WFI) by phase change, removing virtually all contaminants.
  • UV Disinfection: Provides additional microbial control.
  • Ozonation: Used for periodic sanitization of storage and distribution systems.

Distribution System:

  • Constructed from high-grade stainless steel (316L), designed for continuous recirculation to prevent stagnation and biofilm formation.
  • Equipped with online monitoring (conductivity, TOC, temperature, flow) and periodic microbial sampling.

Sanitization:

  • Regular thermal (hot water/steam) or chemical (ozone, hydrogen peroxide, peracetic acid) sanitization to control microbial growth and biofilms.
2.2 Types of Pharmaceutical Water

Pharmaceutical water is classified based on its intended use and required purity, as defined by major pharmacopoeias (USP, EP, IP, JP).

TypeDescription & UseKey Specifications
Purified Water (PW)Used for non-sterile formulations, cleaning, lab useConductivity ≤ 1.3 µS/cm, TOC ≤ 500 ppb, Microbial count ≤ 100 CFU/mL, pH 5.0–7.0
Highly Purified Water (HPW)EP-specific, for processes requiring very low endotoxinsSame as WFI for chemical/microbiological purity, but different production methods allowed
Water for Injection (WFI)Used for parenteral (injectable) products, sterile manufacturingConductivity ≤ 1.1 µS/cm, TOC ≤ 500 ppb, Microbial count ≤ 10 CFU/100 mL, Endotoxin ≤ 0.25 EU/mL
Other GradesE.g., Sterile Water for Injection, Water for Hemodialysis, Water for Preparation of ExtractsAs per specific pharmacopoeial monographs

Analytical Commentary: Purified Water is the workhorse for non-sterile pharmaceutical processes, while WFI is the gold standard for sterile and parenteral applications, with the strictest microbial and endotoxin limits. HPW, unique to the European Pharmacopoeia, bridges the gap for processes requiring WFI-level purity but not necessarily produced by distillation. The choice of water grade is dictated by the intended use, regulatory requirements, and risk assessment.

2.3 Guidelines Followed

Pharmaceutical water systems are governed by a complex web of international and national guidelines:

  • WHO GMP (Annex 2, TRS 970/1033): Comprehensive guidance on water for pharmaceutical use, system design, validation, monitoring, and sanitization.
  • US FDA: Enforces compliance with USP standards, expects robust system validation, and regular monitoring.
  • EU GMP (Annex 1, EMA Guidelines): Specifies water grades, production methods, and quality requirements; allows WFI production by distillation or equivalent membrane processes.
  • Indian GMP (Schedule M, BIS IS 10500:2012): Aligns with WHO and international standards, with additional local requirements.

Key Regulatory Principles:

  • Water systems must be designed, installed, operated, and maintained to consistently produce water of the required quality.
  • Validation (IQ, OQ, PQ) and periodic revalidation are mandatory.
  • Continuous monitoring and trend analysis of critical parameters (conductivity, TOC, microbial count) are required.
  • Change control and documentation are essential for regulatory compliance.

3. Water Tank Cleaning: Frequencies, Chemicals, and Safety Practices

3.1 Cleaning Frequency

The frequency of water tank cleaning is determined by the type of water stored, risk assessment, and regulatory or SOP requirements.

Tank TypeRecommended Cleaning FrequencyRationale
Raw Water TankMonthly to Quarterly (1–3 months)Higher risk of sediment, biofilm, and contamination
Purified Water TankMonthly (±4 days)To prevent microbial growth and maintain purity
WFI TankMonthly (±4 days) or as per validationStringent control due to parenteral use; may be sanitized more frequently

Analytical Commentary: Raw water tanks, exposed to variable source quality, require more frequent cleaning to remove sediments and prevent biofilm formation. Purified water and WFI tanks, being part of closed, recirculating systems, are cleaned and sanitized regularly, with frequency determined by system design, monitoring results, and risk assessment. Deviations from scheduled cleaning are typically allowed within a defined window (e.g., ±7–10 days) to accommodate operational constraints.

3.2 Chemicals Used

Common Cleaning and Sanitizing Agents:

  • Sodium Hypochlorite (Bleach): 0.5–1% solution for disinfection; effective against bacteria, viruses, and fungi, but not spores.
  • Hydrogen Peroxide: Used alone or in combination with peracetic acid for chemical sanitization; effective against biofilms and spores.
  • Citric Acid: Acidic cleaner for removing inorganic scale and fouling.
  • Peracetic Acid: Potent oxidizer, effective against biofilms and spores; breaks down into harmless byproducts.
  • Ozone: Used for periodic sanitization of distribution systems; leaves no residue.
  • Formaldehyde: Occasionally used, but less favored due to toxicity and regulatory restrictions.

Process Steps:

  1. Draining: Remove all water from the tank.
  2. Mechanical Cleaning: Scrubbing of walls, floor, and ceiling to remove dirt and biofilm.
  3. Chemical Application: Apply disinfectant (e.g., sodium hypochlorite, hydrogen peroxide) and allow contact time (typically 30 minutes).
  4. Rinsing: Thoroughly rinse with clean water to remove chemical residues.
  5. Inspection: Visual check for cleanliness and absence of residues.
  6. Refilling: Fill with water and test for residual chemicals and microbial contamination before use.
3.3 Safety Practices During Cleaning

Key Safety Measures:

  • Confined Space Entry: Cleaning tanks is a confined space activity; strict adherence to confined space entry protocols is mandatory.
  • Atmospheric Testing: Test for oxygen, flammable, and toxic gases before and during entry.
  • Personal Protective Equipment (PPE): Gloves, safety goggles, respirators (if required), and protective clothing.
  • Buddy System: At least one attendant outside the tank to monitor and assist in emergencies.
  • Permit System: Written permits for entry, cleaning, and use of chemicals.
  • Chemical Handling: Proper dilution, storage, and disposal of cleaning agents; never mix incompatible chemicals (e.g., bleach and ammonia).
  • Emergency Preparedness: First aid kits, rescue equipment, and trained personnel on standby.

Analytical Commentary: Water tank cleaning is a high-risk operation due to confined space hazards, chemical exposure, and potential for slips and falls. Regulatory agencies (OSHA, local authorities) mandate comprehensive safety protocols, including atmospheric monitoring, PPE, and emergency response plans. In pharmaceutical settings, cleaning validation and documentation are critical to demonstrate removal of residues and restoration of water quality.


4. Drinking Water Standards: Comparative Analysis

4.1 Overview of Major Standards

Drinking water standards are established by international bodies (WHO), regional authorities (EU), national agencies (US EPA, BIS India), and are periodically updated to reflect scientific advances and public health priorities.

Key Standards Compared:

  • WHO Guidelines for Drinking-water Quality (GDWQ)
  • US EPA National Primary Drinking Water Regulations
  • EU Drinking Water Directive (2020/2184)
  • India BIS IS 10500:2012
4.2 Comparative Table of Key Parameters
ParameterWHO GuidelineUS EPA MCLEU DirectiveIndia BIS IS 10500:2012
pH6.5–8.56.5–8.5*6.5–9.56.5–8.5
TDS (mg/L)1000500*1500500 (2000 permissible)
Fluoride (mg/L)1.54.01.51.0 (1.5 permissible)
Arsenic (mg/L)0.010.010.010.01 (0.05 permissible)
Lead (mg/L)0.010.0150.0050.01
Nitrate (mg/L)5010 (as N)5045
Iron (mg/L)0.30.3*0.20.3
Chloride (mg/L)250250*250250 (1000 permissible)
Sulphate (mg/L)250250*250200 (400 permissible)
Total Hardness (mg/L as CaCO₃)500500*500200 (600 permissible)
Free Residual Chlorine (mg/L)0.2–0.54.0 (max)0.250.2 (1.0 permissible)
Total Coliforms (CFU/100 mL)0000
E. coli (CFU/100 mL)0000
Pesticides (μg/L)Varies (e.g., 0.1 for atrazine)Varies0.1 (individual), 0.5 (total)Absent (0.001 permissible)
Trihalomethanes (μg/L)1008010060

*US EPA values marked with * are secondary (non-enforceable) standards.

Rational Explanation of Differences:

  • pH: All standards converge on a neutral to slightly alkaline range, balancing corrosion control and palatability.
  • TDS and Hardness: WHO and EU allow higher TDS and hardness, recognizing regional variations and the non-toxic nature of these parameters. BIS sets lower acceptable limits but allows higher values in the absence of alternatives.
  • Fluoride: WHO, EU, and BIS set the limit at 1.5 mg/L to prevent dental and skeletal fluorosis, while US EPA allows up to 4.0 mg/L, reflecting historical fluoridation practices.
  • Arsenic and Lead: All standards now align at 0.01 mg/L for arsenic and lead, reflecting updated toxicological evidence and the need for maximum protection.
  • Nitrate: WHO and EU set 50 mg/L (as NO₃⁻), US EPA sets 10 mg/L as nitrogen (equivalent to 45 mg/L as NO₃⁻), and BIS matches this.
  • Microbial Limits: Zero tolerance for E. coli and coliforms is universal, underscoring the primacy of microbial safety.
  • Pesticides and THMs: EU and WHO are more stringent on individual and total pesticide residues; US EPA and BIS specify limits for individual compounds.

Implications:

  • Health Protection: The convergence of standards on critical toxicants (arsenic, lead, nitrate, microbial indicators) reflects global consensus on health risks.
  • Regional Adaptation: BIS allows higher permissible limits for some parameters in the absence of alternative sources, acknowledging local constraints.
  • Evolving Science: Standards are periodically revised as new evidence emerges (e.g., lowering of arsenic and lead limits).
  • Implementation Challenges: Achieving the most stringent standards may be difficult in resource-limited settings; hence, a risk-based, incremental approach is advocated.

5. Testing Guidelines: Chemical and Microbial Monitoring

5.1 Daily Chemical Testing Parameters

Routine monitoring of water quality is essential for both pharmaceutical and public water supplies. Key parameters and their recommended testing frequencies are as follows:

ParameterFrequencyMethod/InstrumentRationale
pHDailypH meterCorrosion control, palatability
TDS/ConductivityDailyConductivity meterIndicator of dissolved solids
Free Residual ChlorineDailyDPD colorimetric methodDisinfection efficacy
TurbidityDailyNephelometerIndicator of particulates
Total HardnessWeeklyTitrationScaling potential
AlkalinityWeeklyTitrationBuffering capacity
Iron, ManganeseWeeklyColorimetricAesthetic, health concerns
Fluoride, Nitrate, ArsenicMonthly/Area-specificIon-selective electrode, colorimetric, or spectrophotometricChronic health risks
TOC (Pharma)Daily/OnlineTOC analyzerOrganic contamination

Analytical Commentary: Daily monitoring of pH, TDS, and chlorine ensures immediate detection of operational issues and disinfection failures. Weekly or monthly testing of other parameters provides a broader picture of water quality trends and helps in early identification of emerging risks.

5.2 Microbial Testing Frequencies and Methods

Parameters:

  • Total Coliforms and E. coli: Indicator organisms for fecal contamination.
  • Heterotrophic Plate Count (HPC): General microbial load.
  • Endotoxin (Pharma): For WFI and HPW.

Frequencies:

  • Pharmaceutical Water: Daily to weekly at critical points (feed, post-treatment, storage, distribution, points of use).
  • Public Water Supply: At least twice a year per source (pre- and post-monsoon); more frequent in high-risk or outbreak-prone areas.
  • Jal Jeevan Mission (India): Twice a year for bacteriological parameters, once a year for chemical parameters; increased frequency in JE/AES and ADD-affected districts.

Methods:

  • Membrane Filtration: For coliforms and E. coli (100 mL sample).
  • Multiple Tube Fermentation (MPN): Alternative for coliforms.
  • HPC: Plate count method.
  • Endotoxin: Limulus Amebocyte Lysate (LAL) test for WFI.
  • Rapid Methods: ATP bioluminescence, flow cytometry, and online analyzers for real-time monitoring in pharmaceutical systems.

Sampling Protocols:

  • Aseptic Collection: Sterile containers, immediate transport, analysis within 24 hours.
  • Representative Sampling: From all critical points, including storage tanks, distribution ends, and user points.

Analytical Commentary: Microbial monitoring is the frontline defense against waterborne disease and product contamination. Zero tolerance for E. coli and coliforms is non-negotiable. In pharmaceutical systems, alert and action limits are established based on historical data and regulatory guidance, with immediate investigation and corrective action if exceeded.

5.3 Guidelines Followed
  • WHO GDWQ: Global reference for parameter selection, limits, and risk-based management.
  • BIS IS 10500:2012: National standard for India, harmonized with WHO, US EPA, and EU.
  • Jal Jeevan Mission (India): Uniform Drinking Water Quality Monitoring Protocol, emphasizing risk-based, community-participatory surveillance.
  • Pharmaceutical: USP, EP, JP, and WHO GMP for water used in drug manufacturing.

6. Global Reference: Universal Guide to Safe Drinking Water

6.1 What Constitutes Safe Drinking Water?

Universal Principles:

  • Microbial Safety: Absence of E. coli and coliforms in any 100 mL sample.
  • Chemical Safety: Contaminant levels below health-based guideline values (e.g., arsenic, lead, nitrate, fluoride).
  • Radiological Safety: Radioactivity below screening levels.
  • Acceptability: Water should be clear, colorless, odorless, and palatable.

WHO GDWQ Framework:

  • Health-based Targets: Set for microbial, chemical, and radiological hazards.
  • Water Safety Plans (WSP): Comprehensive risk assessment and management from catchment to consumer.
  • Independent Surveillance: Regular monitoring and verification by competent authorities.

Key Parameters and Limits (WHO):

  • pH: 6.5–8.5
  • TDS: 1000 mg/L
  • Fluoride: 1.5 mg/L
  • Arsenic: 0.01 mg/L
  • Lead: 0.01 mg/L
  • Nitrate: 50 mg/L
  • Total Coliforms/E. coli: 0 CFU/100 mL

Analytical Commentary: Safe drinking water is defined not only by the absence of acute and chronic health risks but also by its acceptability to consumers. The WHO GDWQ is the global benchmark, but national standards may be stricter or adapted to local conditions. The adoption of Water Safety Plans is recognized as the most effective means of ensuring consistent water safety.

6.2 India’s Current Practices and Aspirational Targets

Current Practices:

  • BIS IS 10500:2012: Adopted as the national standard; implemented through Jal Jeevan Mission and other programs.
  • Testing Infrastructure: Network of state, district, and block-level laboratories; use of field test kits for community surveillance.
  • Challenges: Geogenic contamination (arsenic, fluoride, iron, nitrate), aging infrastructure, intermittent supply, and variable enforcement.

Aspirational Targets:

  • Universal Access: Achieve SDG 6.1—safe and affordable drinking water for all by 2030.
  • Compliance with Desirable Limits: Move from “permissible in absence of alternative” to “acceptable” limits for all parameters.
  • Risk-based Management: Full implementation of Water Safety Plans, sanitary inspections, and community engagement.
  • Upgrading Infrastructure: Replace aging pipelines, ensure 24×7 supply, and promote household-level treatment where necessary.
  • Continuous Improvement: Regular review and tightening of standards as scientific evidence evolves.

Analytical Commentary: India has made significant strides in expanding access to piped water and improving quality monitoring. However, persistent challenges—especially in rural and peri-urban areas—necessitate a sustained focus on risk-based management, infrastructure investment, and public awareness. The ultimate goal is to align with global best practices, ensuring that every citizen receives water that is not only safe but also acceptable and reliable.


Conclusion: Best Practices and the Path Forward

Water quality management, whether for pharmaceutical manufacturing or public supply, is a complex, multidisciplinary endeavor. It demands rigorous source assessment, robust treatment and distribution systems, validated cleaning and sanitization protocols, comprehensive monitoring, and unwavering adherence to regulatory standards.

Key Takeaways:

  • Source Matters: Understanding the unique risks of city, river, and groundwater is foundational to designing effective treatment systems.
  • Pharmaceutical Water: Requires multi-stage purification, validated systems, and continuous monitoring to meet the highest purity standards.
  • Tank Cleaning: Regular, validated cleaning and sanitization, with strict safety protocols, are essential to prevent contamination and ensure compliance.
  • Drinking Water Standards: While global standards converge on key health risks, local adaptation and incremental improvement are necessary for practical implementation.
  • Testing and Surveillance: Routine chemical and microbial monitoring, coupled with community participation and risk-based management, are the pillars of water safety.
  • Global and National Alignment: Adoption of WHO GDWQ, Water Safety Plans, and harmonized national standards is the path to universal safe water.

For India and Similar Contexts:

  • Strengthen Laboratory Networks: Expand and accredit testing facilities at all administrative levels.
  • Promote Community Engagement: Train local stakeholders in surveillance, sanitary inspection, and basic water treatment.
  • Invest in Infrastructure: Prioritize replacement of aging pipelines, universal metering, and continuous supply.
  • Embrace Innovation: Leverage real-time monitoring, rapid microbial detection, and advanced treatment technologies.
  • Policy and Regulation: Regularly update standards, enforce compliance, and incentivize best practices.

Final Thought: Safe water is not a luxury but a necessity. Whether in the context of life-saving medicines or daily sustenance, the commitment to water quality is a commitment to life itself. By integrating science, regulation, and community action, we can ensure that every drop is pure, every standard is met, and every life is protected.


References:
All statements, data, and recommendations in this report are supported by the cited guidelines, standards, and technical documents from the World Health Organization, US EPA, EU, BIS India, Jal Jeevan Mission, and leading pharmaceutical and water quality authorities.

This will include:

  • 🌊 Characteristics and treatment needs of city, river, and ground water
  • 🧪 Pharmaceutical water treatment processes and regulatory guidelines (WHO, US FDA, EU GMP, Indian GMP)
  • 🧼 Tank cleaning frequencies, chemicals used, and safety practices
  • 🌐 Comparative tables of drinking water standards (WHO, US EPA, EU, India BIS)
  • 🔬 Daily chemical and microbial testing parameters and frequencies
  • 📊 Rational analysis of global standards and what India currently practices vs. what it should aim for

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