The Central Drugs Standard Control Organisation (CDSCO) occupies an unusual institutional position in India’s regulatory landscape: it is simultaneously the authority that approves new drugs for market entry, the body that monitors ongoing drug quality compliance, and the authority that initiates prosecution for quality violations. This concentration of licensor, monitor, and prosecutor functions within a single body creates a conflict of interest within CDSCO in drug prosecution, reflected in India’s persistently low prosecution rates. This article analyses the structural problem, compares the Indian model with international practice (US FDA/DOJ model; UK MHRA/CPS model), examines the role of the screening committee as an internal conflict management device, and proposes structural reforms — including creation of an independent drug prosecution authority.

INTRODUCTION

India’s drug regulatory framework vests extraordinary — and conflicting — powers in CDSCO. The DCGI approves new drugs for market entry. CDSCO’s drug standards division monitors post-market compliance. CDSCO’s enforcement division initiates prosecution for quality failures. The same institutional family that says ‘this drug is safe and effective’ must also say ‘this drug is substandard and its manufacturer must be prosecuted.’

This is not a design flaw unique to India — regulatory bodies worldwide struggle with the tension between promotional and enforcement mandates. But in India, where the screening committee that recommends prosecution sits within CDSCO, where the Drug Inspector who collects samples reports to the same authority that decides whether to prosecute, and where no independent prosecutorial authority exists to provide checks, the conflict of interest is structurally built into the enforcement process.

THE THREE CONFLICTS

CONFLICT 1 — LICENSOR vs. PROSECUTOR: When CDSCO has approved a drug for manufacture (granted a central manufacturing licence), discovering that the approved manufacturer is producing NSQ drugs creates a reputational problem for CDSCO itself. Prosecution draws attention to the quality failure — which is also evidence that CDSCO’s licensing and monitoring functions failed to prevent the problem. The institutional incentive is toward resolution through administrative action, not public prosecution.

CONFLICT 2 — MONITOR vs. PROSECUTOR: Drug Inspectors who build ongoing relationships with regulated manufacturers — visiting their premises, reviewing their records, advising on compliance — have institutional incentives to resolve quality failures through informal compliance guidance rather than prosecution. The monitoring relationship is incompatible with the adversarial relationship required for prosecution.

CONFLICT 3 — NATIONAL AUTHORITY vs. STATE ENFORCEMENT: For state-licensed drugs, prosecution is initiated by state Drug Inspectors supervised by State Drug Controllers. CDSCO’s prosecution guidelines (which are non-binding) attempt to coordinate this state-level enforcement — but CDSCO has no direct authority over state enforcement officers. The screening committee process at the state level reflects local regulatory cultures, not national standards.

THE SCREENING COMMITTEE: AN INADEQUATE INTERNAL FIX

The DCC’s screening committee requirement — that proposed prosecutions be reviewed by a committee before the Drug Inspector files a complaint — was designed precisely to address the conflict of interest within the Central Drugs Standard Control Organisation (CDSCO). By interposing a committee review between the Inspector’s recommendation and the filing of the complaint, the process was intended to ensure that prosecution decisions were deliberate, consistent, and well-founded.

In practice, the screening committee has operated as a prosecution filter rather than a prosecution quality control mechanism. RTI data reveals that the vast majority of NSQ cases are resolved at the screening committee stage through administrative action — not because the screening committee affirmatively determined that prosecution was unwarranted, but because the institutional culture defaults to non-prosecution.

Further, as established in this research series, the screening committee requirement has no statutory basis. It is an administrative overlay on a statutory framework that requires no such step. A Drug Inspector who bypasses the screening committee and files a complaint directly has not violated any law. The screening committee’s filtering function operates entirely through internal discipline, not through legal authority.

INTERNATIONAL COMPARISON

US MODEL — FDA/DOJ: The US Food and Drug Administration is the regulatory and monitoring body. Criminal prosecution of drug quality violations is referred by the FDA to the US Department of Justice (DOJ), which makes independent prosecutorial decisions. The FDA cannot itself initiate criminal prosecution — it can only refer. This separation ensures that prosecutorial decisions are made by a body with no institutional conflict of interest in the outcome.

UK MODEL — MHRA/CPS: The Medicines and Healthcare products Regulatory Agency (MHRA) regulates and monitors. Criminal prosecution is referred to the Crown Prosecution Service (CPS), which applies the Code for Crown Prosecutors — an independent national standard — to the decision whether to prosecute. MHRA can conduct investigations but cannot prosecute.

BOTH MODELS share the same structural feature: separation of the monitoring/regulatory function from the prosecution function. The regulatory body investigates and refers; an independent prosecution authority decides whether to prosecute and on what standard.

India’s model inverts this: CDSCO/State Drug Controllers both regulate and prosecute — with the only check being an internal screening committee that is itself subject to the institutional conflict.

PROPOSED REFORMS

Three structural reforms could address the CDSCO conflict of interest:

Reform 1 — Independent Drug Prosecution Division: Create a dedicated Drug Prosecution Division, either within the Ministry of Health or as an independent statutory authority, with power to make final prosecutorial decisions on Drug Inspector referrals. The Division would apply published prosecution standards (ideally issued under Section 33P) rather than internal administrative guidelines.

Reform 2 — Mandatory Referral to Public Prosecutor: Amend Section 32 of the Act to require that Drug Inspector complaints for serious NSQ findings (Category A and serious Category B) be routed through the Public Prosecutor’s office, which then decides whether to file the complaint. This leverages the existing public prosecutorial infrastructure without creating a new institution.

Reform 3 — Publication and Accountability: Require CDSCO and State Drug Controllers to publish annually: the number of NSQ findings, the number referred for prosecution, the number where prosecution was declined, and the reasons for declination. Public accountability, even without structural change, creates pressure for enforcement consistency.

CONCLUSION

CDSCO’s dual role as regulator and prosecutor is not merely a theoretical conflict — it has practical enforcement consequences that manifest in India’s low prosecution rates for drug quality violations. The DCC’s screening committee, far from resolving the conflict, institutionalises it within a non-statutory process that lacks legal accountability.

Structural separation of regulatory and prosecutorial functions — on the US FDA/DOJ or UK MHRA/CPS model — is the appropriate long-term solution. In the interim, mandatory referral to the Public Prosecutor, Section 33P prosecution directions, and publication of enforcement statistics would each incrementally address the accountability deficit.

Frequently Asked Questions (FAQs)

1. What is the role of Central Drugs Standard Control Organisation (CDSCO)?
CDSCO is India’s national drug regulatory authority responsible for approving new drugs, monitoring drug quality, and initiating enforcement action against violations.

2. Why is CDSCO’s structure considered a conflict of interest?
Because CDSCO performs three roles simultaneously—licensor, monitor, and prosecutor. This creates institutional tension when the same authority must both approve a drug and later prosecute its manufacturer for quality failures.

3. What is the role of the DCGI in this framework?
The Drug Controller General of India (DCGI), operating under CDSCO, grants approvals for new drugs and oversees regulatory decisions related to drug safety and efficacy.

4. What are NSQ (Not of Standard Quality) drugs?
NSQ drugs are pharmaceutical products that fail to meet prescribed quality standards under the Drugs and Cosmetics Act, 1940, making them potentially unsafe or ineffective.

5. What is the screening committee in drug prosecution cases?
The screening committee is an administrative body that reviews prosecution proposals before a complaint is filed. However, it has no statutory basis and functions as an internal filter rather than a legally mandated step.

6. Is the screening committee legally required under the Drugs and Cosmetics Act, 1940?
No. The Act does not mandate a screening committee. A Drug Inspector can legally initiate prosecution without going through this committee.

7. Why are prosecution rates for drug quality violations low in India?
Low prosecution rates are attributed to institutional conflicts within CDSCO, reliance on administrative resolutions, and the filtering effect of internal screening committees.

8. How does the U.S. model handle drug regulation and prosecution?
In the United States, the Food and Drug Administration (FDA) regulates drugs, but prosecution is handled independently by the Department of Justice (DOJ), ensuring separation of powers.

9. How does the UK model differ from India’s approach?
In the UK, the Medicines and Healthcare products Regulatory Agency (MHRA) regulates drugs, while prosecution decisions are made by the Crown Prosecution Service (CPS), an independent authority.

10. What is the key difference between India and international models?
International models separate regulatory and prosecutorial functions, while in India, both functions are concentrated within CDSCO and State Drug Controllers.

11. What reforms are suggested to address this conflict of interest within CDSCO?
The article proposes reforms to address the conflict of interest within the Central Drugs Standard Control Organisation (CDSCO) arising from its combined regulatory and prosecutorial roles:

• Creating an independent drug prosecution authority
• Mandatory referral of serious cases to public prosecutors
• Publishing enforcement and prosecution data annually

12. What is Section 32 of the Drugs and Cosmetics Act, 1940?
Section 32 governs who can initiate prosecution under the Act, primarily authorizing Drug Inspectors and certain government authorities.

13. What is Section 33P and how is it relevant?
Section 33P empowers the Central Government to issue directions to ensure uniform enforcement, including potentially setting prosecution standards.

14. Why is transparency in enforcement important?
Publishing data on drug quality violations and prosecution decisions promotes accountability, consistency, and public trust in the regulatory system.

15. What is the main takeaway from this article?
The central issue is structural: combining regulatory and prosecutorial roles within CDSCO undermines enforcement. Long-term reform requires institutional separation and greater accountability mechanisms.

REFERENCES

[1] The Drugs and Cosmetics Act, 1940, Sections 7, 32, 33, 33P.  https://www.indiacode.nic.in/bitstream/123456789/15278/1/drug_cosmeticsa1940-23.pdf

[2] Dinesh Thakur & Prashant Reddy T., ‘A Report on Fixing India’s Broken Drug Regulatory Framework’ (June 2016).  https://spicyip.com/wp-content/uploads/2016/06/Report_India-Drug-Regulatory-Framework_June-2016.pdf

[3] DCC Guidelines for Taking Action on Samples of Drugs Declared Spurious or NSQ — CDSCO (2008).  https://cdsco.gov.in/opencms/export/sites/CDSCO_WEB/Pdf-documents/Consumer_Section_PDFs/DCC_Guidelines_Spurious_Drugs.pdf

[4] PMC: ‘Regulating New Drugs in India Needs to Be Improved’ (2023).  https://pmc.ncbi.nlm.nih.gov/articles/PMC10305928/

[5] CDSCO Guidance Document for Zonal/Sub-Zonal/Port Offices (2022 Edition).  https://www.cdsco.gov.in/opencms/resources/UploadCDSCOWeb/2022/Guidance_doc/CDSCO%20Guidance%20Document.pdf

[6] Cyril Amarchand Mangaldas, ‘A Guide to Prosecutions under the Drugs and Cosmetics Act, 1940’ (2025).  https://www.cyrilshroff.com/wp-content/uploads/2025/10/A-Guide-to-Prosecutions-under-the-Drugs-and-Cosmetics-Act-3.pdf

[7] ICLG India — Drug and Medical Device Litigation 2026.  https://iclg.com/practice-areas/drug-and-medical-device-litigation/india

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