Steps taken for Testing and Surveillance of Drugs

I have enough Tier-1 facts. Writing the note.

Steps Taken for Testing and Surveillance of Drugs

1. At a Glance

• CDSCO (Central Drugs Standard Control Organisation), under the Ministry of Health & Family Welfare, regulates drug quality jointly with State Drug Controllers (SDCs) under the Drugs & Cosmetics Act, 1940 [S1][S2].
• Topic covers risk-based inspections, sampling, NSQ (Not of Standard Quality) detection, laboratory expansion and ranking of state regulators — examinable under GS-II (Health) and GS-III (S&T regulation) [S1].
• Recent push: ~5 lakh drug samples tested in 5 years; ₹756 crore central share released for strengthening drug testing labs [S1].

2. Why in the News

• PIB release (10 March 2026) detailing strengthened drug quality monitoring — ~5 lakh samples tested in five years, 960+ manufacturing units inspected since Dec 2022, 860+ regulatory actions taken [S1].
• Launch of SHRESTH (State Health Regulatory Excellence Index) by Union Health Ministry to benchmark state drug regulators [S3].

3. Background & Evolution

• Drugs & Cosmetics Act, 1940 + Rules 1945: foundational statute for manufacture, sale, distribution [S1].
• CDSCO as Central Drug Authority; SDCs handle licensing of manufacturing for non-notified categories [S2].
• December 2022: CDSCO + State regulators launched risk-based inspections (RBI) of drug manufacturing/testing units [S2].
• February 2024: CDSCO published uniform regulatory guidelines for sampling of drugs, cosmetics and medical devices by Central & State drug inspectors [S2].
• 2025: SHRESTH index launched to rank state regulators [S3].

4. Core Static Facts

• Parent Ministry: Health & Family Welfare; Regulator: CDSCO under DGHS [S1][S2].
• Statute: Drugs & Cosmetics Act, 1940; Drugs and Cosmetics Rules, 1945; New Drugs and Clinical Trials (NDCT) Rules, 2019 [S1].
• Inspections since Dec 2022: 960+ units; Actions: 860+ (suspension/cancellation of licences, stop-production orders, product recalls) [S1].
• Samples tested (5 years): ~5 lakh [S1].
• Central share for lab expansion: ₹756 crore released [S1].
• SHRESTH Index — proposed by CDSCO; states split into Manufacturing States (27 indices) and Primarily Distribution States/UTs (23 indices) across 5 themes: HR, Infrastructure, Licensing, Surveillance, Responsiveness [S3].
• NSQ workflow: results uploaded as monthly Drug Alerts on CDSCO website; manufacturer must recall & halt distribution [S2].

5. Multi-Dimensional Analysis

Legal / Constitutional - Drugs are a Concurrent List subject — hence joint Centre-State regulation via CDSCO + SDCs [S1]. - NDCT Rules, 2019 amended in 2025 to reduce regulatory burden, ease of doing business [S3-related].

Administrative / Federalism - Licensing of manufacturing largely with SDCs; CDSCO sets standards, approves new drugs, monitors imports — creating uneven enforcement that SHRESTH seeks to address [S3]. - Risk-based inspections institutionalise joint Centre-State scrutiny [S2].

Scientific / Technological - Uniform sampling SOP (Feb 2024) standardises evidence collection [S2]. - Lab capacity expansion via ₹756 cr central tranche strengthens Central Drugs Testing Laboratories (CDTLs) and state labs [S1].

Ethical / Governance - Public Drug Alerts on CDSCO portal advance transparency [S2]. - SHRESTH introduces data-driven monthly scoring (collected by 25th, scored 1st of next month) of state regulators [S3].

Economic - Quality assurance critical for India's "Pharmacy of the World" export brand; NSQ findings have triggered international scrutiny (cough syrup incidents) [S1][S2].

6. Recent Developments (last 12-18 months)

• 10 Mar 2026: PIB statement — 5L samples / 960+ inspections / 860+ actions / ₹756 cr lab funding [S1].
• 2025: SHRESTH virtually launched by Union Health Secretary Punya Salila Srivastava [S3].
• 2025: Amendments to NDCT Rules, 2019 notified to ease regulatory burden [S3-list].
• Feb 2024: CDSCO sampling guidelines for drugs/cosmetics/medical devices [S2].
• Dec 2022 onwards: Risk-based inspections — 905+ units inspected, 694+ actions (as of earlier release) climbing to 960/860 by 2026 [S1][S2].

7. Prelims Hooks

• Drugs & Cosmetics Act enacted in 1940 [S1].
• CDSCO functions under Directorate General of Health Services, MoHFW [S1].
• Risk-based inspections of drug units began December 2022 [S2].
• NDCT Rules year: 2019 [S3-list].
• SHRESTH = State Health Regulatory Excellence Index, proposed by CDSCO [S3].
• SHRESTH has 27 indices for Manufacturing States and 23 for Distribution States/UTs across 5 themes [S3].
• Central share released for drug testing lab expansion: ₹756 crore [S1].
• Drug samples tested over 5 years: ~5 lakh [S1].
• Inspections since Dec 2022: 960+; actions: 860+ [S1].
• NSQ list published as "Drug Alert" monthly on CDSCO website [S2].
• Drugs is on the Concurrent List; states issue manufacturing licences via SDCs [S1].
• Uniform sampling guidelines by CDSCO issued in February 2024 [S2].

8. Mains Relevance

• GS-II: Government policies/interventions in health sector; issues relating to development and management of Social Sector/Services relating to Health.
• GS-III: Awareness in S&T; regulatory framework for pharmaceuticals.
• Possible stems: 1. "Persistent reports of Not-of-Standard-Quality drugs reveal structural weaknesses in India's federal pharmaceutical regulation. Examine and suggest reforms." 2. "Discuss how initiatives like SHRESTH and risk-based inspections can strengthen India's claim as the 'Pharmacy of the World'." 3. "Critically analyse the adequacy of the Drugs & Cosmetics Act, 1940 in regulating contemporary pharma supply chains."

9. Related Topics to Study Next

• CDSCO & Drug Controller General of India (DCGI) — apex regulatory architecture.
• Jan Aushadhi (PMBJP) — quality concerns at affordable medicine outlets [S2-list].
• NDCT Rules, 2019 — clinical trial governance.
• Pharmacopoeia Commission of India (IPC) & Pharmacovigilance Programme (PvPI) — post-marketing surveillance.
• WHO GMP and Schedule M revisions — manufacturing standards convergence.
• PLI scheme for Pharmaceuticals & Bulk Drug Parks — supply-side policy linkage.
• Cough syrup export controversies (Gambia, Uzbekistan) — case studies in regulatory gaps.
• Medical Devices Rules, 2017 — adjacent regulatory regime.

10. Common Errors / Trap Areas

• CDSCO ≠ ICMR ≠ IPC: CDSCO regulates; ICMR researches; IPC publishes pharmacopoeia.
• Manufacturing licences are issued by State Drug Controllers, not CDSCO — only new drug approvals/imports are central.
• SHRESTH is a CDSCO/MoHFW index — not a NITI Aayog index (confusable with State Health Index).
• Drugs & Cosmetics Act is of 1940, not 1945 (1945 is the Rules).
• Risk-based inspections started in Dec 2022, not 2020 or 2023.

11. Sources

• [S1] Steps taken for Testing and Surveillance of Drugs — https://www.pib.gov.in/PressReleasePage.aspx?PRID=2237744 — (tier: 1)
• [S2] Status of Drug Quality Testing under CDSCO — https://www.pib.gov.in/PressReleasePage.aspx?PRID=2117207 — (tier: 1)
• [S3] Union Health Ministry Launches SHRESTH – State Health Regulatory Excellence Index — https://www.pib.gov.in/PressReleasePage.aspx?PRID=2155722 — (tier: 1)