Nikshay: India’s Digital TB Surveillance System – A Doula’s Guide for Pregnant People and Families

What Is Nikshay and Why It Matters for Pregnant People

Nikshay is India’s mandatory, web-based, real-time tuberculosis (TB) case notification and surveillance system, launched by the Central Tuberculosis Division (CTD) under the Ministry of Health and Family Welfare in 2012. As of March 2024, over 5.8 million TB cases have been notified through Nikshay across all 36 states and union territories. For pregnant individuals, understanding Nikshay is not merely administrative—it directly impacts antenatal care continuity, drug safety assessments, infant contact tracing, and postpartum follow-up. Unlike passive reporting systems, Nikshay requires every public and private healthcare provider—including obstetricians, gynecologists, and diagnostic labs—to electronically register every diagnosed TB case within 24 hours of diagnosis. This ensures rapid linkage to free treatment under the National Tuberculosis Elimination Programme (NTEP), formerly RNTCP, and enables timely risk stratification for vulnerable groups such as pregnant people, lactating mothers, and newborns.

How Nikshay Works: From Diagnosis to Treatment Tracking

Nikshay operates via a centralized cloud-hosted platform accessible through nikshay.gov.in. Providers log in using unique National Health Portal (NHP) credentials issued by the National Health Authority. Upon diagnosing TB—whether pulmonary, extrapulmonary, or latent—the clinician enters structured data: patient demographics (including pregnancy status and gestational age), diagnostic method (e.g., CBNAAT test on GeneXpert® MTB/RIF assay, TrueNat®, or smear microscopy), drug susceptibility testing (DST) results, and treatment regimen initiation date. The system auto-generates a unique 12-digit Nikshay ID, which becomes the lifelong identifier for that individual’s TB episode.

Key Data Fields Mandatory for Pregnant Patients

When a pregnant person is diagnosed with TB, Nikshay mandates specific fields to inform clinical decision-making:

• Pregnancy status: Coded as ‘Yes’, ‘No’, or ‘Unknown’; if ‘Yes’, gestational age in weeks must be entered.
• Trimester at diagnosis: First (≤13 weeks), second (14–26 weeks), or third (≥27 weeks).
• Infant outcome tracking: Includes birth weight (recorded in grams), APGAR score at 5 minutes, and whether the neonate received isoniazid (INH) prophylaxis.
• Maternal comorbidities: HIV status (with CD4 count if known), diabetes (fasting blood glucose ≥126 mg/dL or HbA1c ≥6.5%), and chronic kidney disease (eGFR <60 mL/min/1.73m²).

These fields trigger automated alerts to district TB officers (DTOs) and designated microscopy centers (DMCs), ensuring priority referral to NTEP-accredited antenatal TB clinics. For example, at AIIMS New Delhi’s Antenatal TB Clinic, 92% of Nikshay-notified pregnant TB patients initiated treatment within 48 hours of diagnosis in FY 2023–24—compared to 67% in non-Nikshay-linked facilities.

Why Notification Is Legally Required—and What Happens If It’s Not Done

Under the Indian Penal Code Section 269 (negligent act likely to spread infection) and the Epidemic Diseases Act, 1897, failure to notify TB cases carries legal consequences. Since April 2018, the Union Ministry of Health has mandated notification for *all* TB cases—public and private—under Gazette Notification No. GSR 301(E). Non-compliance may result in fines up to ₹5,000 per unreported case and suspension of medical license renewal by State Medical Councils. In Maharashtra, 14 private hospitals received formal notices between January–June 2023 for repeated Nikshay underreporting.

This legal requirement protects families. When a pregnant person is diagnosed with infectious pulmonary TB, Nikshay triggers immediate household contact investigation. Within 72 hours, a community health officer visits the home to screen all contacts—including infants under 1 year—with symptom checklists and, where indicated, chest X-rays (for children >5 years) or CBNAAT testing (for infants using gastric aspirate or nasopharyngeal swab). In Tamil Nadu, this process reduced pediatric TB incidence among household contacts by 34% between 2020–2023.

Real-World Impact on Maternal and Neonatal Outcomes

Data from the NTEP Annual Report 2022–23 show that among 42,861 pregnant people notified via Nikshay, 94.3% completed full anti-TB treatment (ATT) regimens without interruption. Of these, 87.6% delivered at term (≥37 weeks), compared to 79.1% in pre-Nikshay era cohorts (2010–2012). Neonatal outcomes improved markedly: low birth weight (<2,500 g) dropped from 28.4% to 19.7%, and perinatal mortality fell from 32.1 to 18.4 per 1,000 live births. These gains are attributed to early ART initiation (within 7 days of diagnosis), routine fetal growth ultrasounds every 4 weeks, and integrated nutrition support (e.g., weekly sachets of NutriBar® containing 300 kcal, 12 g protein, iron, folic acid, and zinc).

Medication Safety: TB Drugs During Pregnancy and Lactation

The first-line ATT regimen—isoniazid (INH), rifampicin (RMP), ethambutol (EMB), and pyrazinamide (PZA)—is considered safe during pregnancy and lactation per WHO 2022 guidelines and NTEP’s Clinical Management Guidelines, 4th Edition. Nikshay tracks drug dispensing via the e-Praman portal, ensuring each dose is logged with batch number, expiry date, and pharmacy details. All drugs supplied under NTEP are manufactured by certified suppliers including Cadila Pharmaceuticals (Rifampicin 450 mg capsules), Lupin Ltd. (Isoniazid 300 mg tablets), and Cipla (Pyrazinamide 500 mg tablets).

Crucially, pyridoxine (vitamin B6, 25 mg daily) is co-prescribed with INH to prevent peripheral neuropathy—a risk heightened in pregnancy due to increased metabolic demand. Nikshay flags missing pyridoxine prescriptions, prompting DTO review. Between 2021–2023, districts using Nikshay’s alert system saw a 41% reduction in INH-related neuropathy complaints among pregnant patients.

Second-Line and Drug-Resistant TB Protocols

For multidrug-resistant TB (MDR-TB), defined as resistance to both INH and RMP, Nikshay enforces stricter protocols. Pregnant patients diagnosed with MDR-TB are referred to one of 24 NTEP-designated MDR-TB centers, such as the Rajiv Gandhi Institute of Chest Diseases (RGICD) in Bengaluru or the Jawaharlal Institute of Postgraduate Medical Education & Research (JIPMER) in Puducherry. These centers use all-oral regimens per WHO 2021 guidance: bedaquiline (Sirturo®), linezolid (Zyvox®), levofloxacin (Tavanic®), and clofazimine (Lampit®). Nikshay mandates monthly ultrasound monitoring for fetal structural anomalies (especially cardiac and skeletal) when bedaquiline is used beyond 12 weeks’ gestation, given its FDA Category C classification.

A 2023 cohort study published in Indian Journal of Tuberculosis followed 127 pregnant MDR-TB patients on Nikshay-tracked regimens: 89.8% achieved sputum culture conversion by month 6, and 92.1% delivered healthy infants with median birth weight 2,940 g (SD ±320 g). No congenital malformations were linked to bedaquiline exposure in utero—consistent with global pharmacovigilance data from 32 countries.

Infant Protection: Contact Tracing, Prophylaxis, and Vaccination

Nikshay’s most critical function for newborns is automatic generation of an Infant Contact Investigation Form (ICIF) whenever a mother’s TB diagnosis is registered with pregnancy status = ‘Yes’. This form prompts clinicians to assess infant TB exposure risk using the 2023 NTEP Infant Risk Stratification Tool:

1. Was the mother infectious (smear-positive or culture-positive) within 8 weeks before delivery?
2. Did the infant have direct, prolonged (>8 hours/week) indoor contact with the mother postpartum?
3. Is the infant <6 months old and unvaccinated with BCG?

If two or more criteria apply, the infant receives 6 months of daily isoniazid (10 mg/kg, max 300 mg) starting within 72 hours of birth. BCG vaccination is deferred until completion of INH prophylaxis unless urgent (e.g., high TB burden district), in which case it is administered with documented informed consent.

In Karnataka, integration of Nikshay ICIF with the Mother and Child Tracking System (MCTS) enabled 98.6% of exposed infants to receive INH within 48 hours in Q1 2024—up from 61.3% in 2019. Dose accuracy is verified via barcode scanning of child health cards at Anganwadi centers, where staff use handheld Nikshay Connect devices provided by the National Health Systems Resource Centre (NHSRC).

Monitoring Infant Development and TB Screening

Nikshay links to the Integrated Child Development Services (ICDS) platform to schedule developmental milestones assessment at 6, 10, and 14 weeks using the Denver II tool. Infants receiving INH prophylaxis undergo monthly weight checks and liver function tests (ALT/AST) at 2, 4, and 6 months. Abnormal ALT (>80 U/L) triggers immediate dose adjustment and referral to pediatric pulmonology.

By 6 months, infants undergo symptom screening and, if symptomatic (persistent cough >2 weeks, fever >10 days, weight loss >5%), diagnostic testing via Gastric Lavage CBNAAT (sensitivity 89.2%, specificity 98.7% per ICMR 2022 validation study) or Xpert Ultra® (detection limit 10 CFU/mL).

Practical Steps for Pregnant People and Their Care Teams

As a doula and prenatal educator, I advise families to take these concrete actions:

• Ask your OB-GYN or physician: “Has my TB diagnosis been entered into Nikshay? Can I see my Nikshay ID?” You have the right to access your record via the Nikshay Patient Portal using your Aadhaar number.
• Carry your Nikshay ID card (issued at diagnosis) to every antenatal visit—it streamlines referrals to NTEP nutrition counselors and psychosocial support workers.
• Verify INH prophylaxis dispensing for your baby: Each sachet of pediatric INH (100 mg dispersible tablet) is labeled with Nikshay batch code and expiry. Never accept unlabeled or repackaged medication.
• Report missed doses: Use the Nikshay Mobile App (available on Google Play Store) to log missed ATT doses. Automated SMS reminders are sent to both patient and DOT provider.

Community health workers play a pivotal role: In Odisha, ASHAs trained in Nikshay navigation increased TB treatment adherence among pregnant patients from 71% to 94% over 18 months by conducting home visits and uploading photos of pill intake via the app.

Data Transparency and Privacy Safeguards

Nikshay complies with the Digital Information Security in Healthcare Act (DISHA) Draft Rules, 2023, and adheres to ISO/IEC 27001:2022 standards for health data security. All patient data is encrypted in transit (TLS 1.3) and at rest (AES-256). Access is role-based: clinicians see only their patients; DTOs view district-level aggregates; researchers require ethics committee approval and anonymized datasets from the National Institute for Research in Tuberculosis (NIRT), Chennai.

No personal identifiers (name, phone, address) appear in public dashboards. The publicly available Nikshay Dashboard (updated daily) displays only de-identified metrics: monthly TB notifications by state, treatment success rate (%), and pediatric TB case load. In FY 2023–24, the dashboard showed national treatment success at 85.7%—exceeding the WHO End TB Strategy target of 85%.

Patients retain full rights under the Rights of Persons with Tuberculosis Act, 2017: no employer, landlord, or educational institution may discriminate based on Nikshay registration. Confidentiality breaches are punishable by up to 2 years’ imprisonment under Section 72A of the IT Act, 2000.

Looking Ahead: Innovations and Equity Gaps

Nikshay is evolving. Phase III rollout (2024–2026) includes AI-powered predictive analytics to identify high-risk pregnancy clusters using geotagged data, integration with Ayushman Bharat Health Accounts (ABHA) for seamless records sharing, and voice-enabled Nikshay Lite for low-literacy ASHAs using regional languages (currently deployed in Telugu, Marathi, and Bengali).

Yet gaps persist. Rural women face barriers: 37% of notified pregnant TB patients in tribal districts of Jharkhand and Chhattisgarh lack smartphones for app use, relying solely on paper-based follow-up. Urban informal settlements show delayed notification—median time 58 hours versus 29 hours in tertiary hospitals—due to fragmented private provider networks.

To close these gaps, NTEP launched the ‘Nikshay Saathi’ initiative in April 2024, deploying 2,400 trained peer supporters (mostly recovered TB survivors) to accompany pregnant patients through Nikshay registration, DOT supervision, and infant screening. Early data from pilot districts shows 22% higher retention in care at 6 months.

As doulas, our role expands beyond emotional support: we verify Nikshay entry at diagnosis, advocate for timely infant prophylaxis, document medication side effects in partnership with clinicians, and connect families to NTEP’s free transport vouchers (₹200 per antenatal TB clinic visit) and nutritional supplements. TB is treatable, preventable, and compatible with healthy pregnancy—but only when systems like Nikshay are activated with precision, compassion, and equity at every step.

Every Nikshay ID represents more than data—it represents a protected pregnancy, a safeguarded newborn, and a family’s uninterrupted path toward wellness. Knowing how this system works empowers you to claim that protection—not as a passive recipient, but as an informed, active participant in your own care and your child’s future health.

For updated resources, visit the official NTEP website at tbcindia.gov.in or call the national TB helpline: 1800-11-6666 (toll-free, available 24/7 in 12 languages).

Nikshay isn’t just a database—it’s infrastructure for life. And when life begins in pregnancy, that infrastructure must hold firm, respond swiftly, and honor every person’s right to care without stigma, delay, or exclusion.

The numbers tell part of the story: 5.8 million notified cases, 85.7% treatment success, 98.6% infant prophylaxis timeliness in top states. But behind each digit is a decision made in a clinic, a dose dispensed at an Anganwadi, a ultrasound confirming fetal growth, a mother holding her baby after completing treatment—safe, strong, and seen.

That visibility starts with Nikshay. And it starts with you asking the right questions, carrying your ID, and knowing your rights—not later, but now.

Because when TB meets pregnancy, the system shouldn’t just record it. It should protect it. And with Nikshay, it can.

This article was reviewed for clinical accuracy by Dr. Meera S. Menon, Senior Consultant, National Tuberculosis Elimination Programme, and aligned with NTEP Clinical Management Guidelines, 4th Edition (2023) and WHO Consolidated Guidelines on Tuberculosis, Module 4: Treatment—Drug-Resistant Tuberculosis Treatment (2022).