Illegal and Unprofessional Medical Practices by Unqualified Pharmacy Operators

[Legal, Regulatory and Public-Health Analysis with Reference to Manipur (India)]

• Biraj Kharel

Abstract:

The practice of medicine and pharmacy by unqualified individuals continues unabated in large parts of India. Apart from legal violations, this also poses some grave public health risks-from immediate iatrogenic harm to longer-term consequences like AMR, blood-borne infection transmission, and erosion of trust in health systems. This paper draws on an appraisal of the statutory regime prohibiting and punishing such practices, with particular reference to Manipur and discusses how these laws apply to a typical case where a person not qualified prescribes and dispenses prescription medicines, administers injections/drips, and runs an unregistered bed/clinic, and discusses wider public health implications and recommended enforcement and policy responses.

Principal statutes examined are the Manipur Medical Council Act, 2009, the National Medical Commission Act, 2019, the Pharmacy Act, 1948, the Drugs & Cosmetics Act and Rules, 1940/1945, the Manipur Nursing Home & Clinics Registration Act, 1992 and the Clinical Establishments (Registration & Regulation) Act, 2010, along with applicable sections of the Indian Penal Code (IPC). Public health analysis is supported by WHO guidance and peer-reviewed literature on AMR and unsafe injections.

Introduction:

The healthcare professional possesses a specific kind of social trust. They diagnose, prescribe, and intervene in the most personal areas of human life, and that is health and bodily integrity. This trust is protected through statutory regulations in many countries, such as licensure, registration, facility licensing/registration, drug control laws, and criminal prohibitions against impersonation and fraud. Unqualified individuals who bypass or undermine this regulatory architecture are committing not only crimes but also making care less safe and harming public health.

The problem is not merely hypothetical. In several Indian states, there have been documented incidents of unqualified persons masquerading as doctors, setting up clinical beds inside retail medicine shops, prescribing prescription medicines-including injectables undertaking invasive procedures without training or appropriate facilities. The state of Manipur has statutory instruments that address these acts, The Manipur Medical Council Act (2009) criminalizes false representation as a registered medical practitioner; a separate state Act governs registration of nursing homes and clinics alongside national laws (NMC Act, Pharmacy Act, Drugs & Cosmetics Act) which place further restrictions on who may practice, dispense, and administer medicines. Together with general criminal law (IPC), these provisions create a web of potential legal remedies and penalties. The public-health stakes, however, are high and require coordinated legal, administrative, and community responses.

Methodology and Scope

This paper synthesises primary statutes and authoritative public-health sources relevant to the conduct described:

a) Practising medicine without registration/qualification

b) Dispensing prescription medicines without permission

c) Administering injections/drips in non-clinical settings, and

d) Running an unregistered clinical establishment (bed/clinic inside a pharmacy).

Legal texts and government sources were consulted for statutory language and penalties; WHO and peer-reviewed literature provided the basis for evaluating public-health harms, with particular emphasis on AMR, infection transmission risk, and population trust effects. Primary legal sources cited include the Manipur Medical Council Act 2009, Manipur Nursing Home & Clinics Registration Act 1992, Pharmacy Act 1948, Drugs & Cosmetics Act & Rules 1940/45, National Medical Commission Act 2019, and the Clinical Establishments Act 2010.

Legal and Regulatory Framework: Statutes, Key Provisions, Penalties

a) Manipur Medical Council Act, 2009

The Manipur Medical Council Act establishes and maintains a State Medical Register and empowers the Council to regulate professional conduct within the State. It penalises unregistered persons who falsely represent that they are registered medical practitioners and contains disciplinary provisions to ensure practice by authorised persons only. The Act forms one of the primary state instruments in addressing personation and unqualified practice in Manipur.

Key provision-illustrative: Section provisions of the Act make misrepresentation as a registered medical practitioner a criminal offence, and prescribe fines and imprisonment for that. There are provisions to enforce it by way of complaints to the Registrar/State Medical Council.

b) National Medical Commission Act, 2019 — Bar to practice

The NMC Act modernised the national regulation of medical education and practice. It also contains an explicit bar, in that only persons enrolled in the National or State Register are permitted to practice modern-allopathic medicine. Section 34 on ‘Bar to practice’ is designed to preclude unregistered persons from practising medicine and holding out as qualified practitioners. Violations invite administrative and criminal recourse at the state and central levels.

c) Pharmacy Act, 1948: To regulate pharmacists and dispensing.

The Pharmacy Act controls the profession of pharmacy and provides for the enrollment of pharmacists on State Registers, prohibits unregistered persons from representing themselves as pharmacists and precludes the dispensing of medicines by unregistered persons. Sections dealing with false claims of registration and with dispensing by unregistered persons form the statutory basis to prosecute an individual who dispenses prescription medicines without appropriate pharmacist registration.

d) Drugs & Cosmetics Act, 1940 and Drugs Rules, 1945 — Prescription drugs and control of sale

The Drugs & Cosmetics Act and the Rules classify many medicines as prescription-only (to be sold only against the prescription of a registered medical practitioner) and prescribe record keeping, storage and sale conditions. Sale or dispensing of Schedule H/H1/X drugs without valid prescriptions or by unqualified persons attracts criminal penalties and administrative sanctions in the form of seizure, license suspension/cancellation under the said Act.

e) Clinical Establishments (Registration & Regulation) Act, 2010 (central)

Where adopted by a State, the Act requires registration of clinical establishments and prescribes substantial monetary penalties for operating unregistered establishments. This is a complementary regulatory instrument to state nursing-home laws, designed to ensure minimum standards of infrastructure and staffing for clinical entities. Penalties for non-registration are significant and escalate for repeat contraventions.

f) Indian Penal Code (IPC) — Personation, Cheating, Negligence and Harm

Criminal law under the IPC provides additional remedies. Sections that are most commonly invoked in cases of quackery or impersonation include, inter alia, Section 419 on cheating by personation, Section 420 on cheating and dishonestly inducing delivery of property, Section 304A on causing death by negligence, and other sections on forgery or malicious acts. These provisions allow police to register FIRs and initiate criminal prosecution where the facts disclose personation, fraud, harm, or death.

How These Statutes Apply: A Fact-Pattern Analysis, Pharmacy-based Quack Clinic

Consider a typical fact pattern: a person without qualifications in medicine or registration as a pharmacist opens up a retail pharmacy, wears a stethoscope, prescribes and dispenses prescription medicines, including antibiotics and injectables and administers injections, drips on-site, placing a bed inside the shop to treat patients. How do the statutes map to this conduct?

1. Impersonation and prohibited practice: The candidate in question seems to have acted in apparent contravention of the Manipur Medical Council Act on account of misrepresentation, besides contravening the NMC Act concerning engaging in practice by an unregistered person. Both are primary offences that can form the core of complaints to the State Medical Council and to police for impersonation/cheating when intent to defraud or risk to patients is manifest.

2. Dispensing prescription medicines illegally: The Drugs & Cosmetics Act/Rules require that Schedule H/H1/X medications be sold only against prescriptions of registered practitioners; the Pharmacy Act restricts dispensing to registered pharmacists. Dispensing by an unregistered person, especially dispensing prescription antibiotics or controlled drugs, breaches both the Drugs Act rules and the Pharmacy Act and can be taken up with the Drug Controller and regulatory enforcement agencies.

3. Running an unregistered clinical establishment: Conversion of a retail outlet into a treatment area with a bed, drips/injections and monitoring of patients without registration under the Manipur Nursing Home & Clinics Registration Act or respective provisions of the Clinical Establishments Act is a statutory violation, attracting fines and closure orders.

4. Risk-based criminal liability: If the unqualified person’s conduct causes serious injury or death, for instance, due to wrong drug, wrong dose, contamination of injectable fluids, relevant IPC provisions may apply, especially Section 304A, apart from offences under the Drugs & Cosmetics Act for spurious/adulterated drugs or unsafe practices. Even assuming no death results, personation and cheating provisions may support a criminal prosecution.

Public-Health Implications: Expanded Analysis

Whereas the legal wrongs are significant and actionable, the public-health harms from such unprofessional practice are both immediate and systemic. In what follows, I expand on the principal public-health consequences with an emphasis on antimicrobial/drug resistance and hazards of unsafe administration practices.

1. Antimicrobial resistance (AMR) and antibiotic misuse: AMR is a global and national crisis. The WHO defines AMR as the capacity of microbes to withstand previously effective treatments. The result is infections that are harder to treat and that carry a higher risk of complications, prolonged hospitalisation, and death. Unqualified prescribers who dispense antibiotics empirically, in inappropriate doses or durations, or as a first resort for non-bacterial complaints, directly contribute to the selection pressure that drives AMR.

Empiric and irrational prescribing-even of broad-spectrum antibiotics for self-limited viral illnesses, incomplete courses, or duplicate therapy-encourages multidrug-resistant organisms. Recent Indian studies have identified high inpatient antibiotic use and frequent empiric prescribing without laboratory confirmation, which are patterns accelerating resistance emergence. The misuse of antibiotics at the community level-that is, by untrained providers-amplifies this trend because such providers may not adhere to diagnostic stewardship, dosage guidelines, or national antibiotic policies.

Some of the public-health consequences of AMR include the following: increased treatment costs; requirement for second-line or last-resort drugs (which are more toxic and expensive), increased morbidity and mortality, and increased pressure on tertiary healthcare facilities. From a systems point of view, unchecked community misuse erodes national and global AMR containment efforts of surveillance, stewardship, and infection control.

Example: Declining Effectiveness of Azithromycin Due to Quack Prescribing

According to Dr Shivaranjani Santosh, a paediatrician, social activist, and an impactful voice in the field of public health, Azithromycin is an antibiotic that was considered very potent and dependable for ordinary respiratory and soft-tissue infections, but is proving to be markedly less effective in many patients today. The main contributor to this is the unregulated and frequent use of the drug by unqualified practitioners who have no problem in prescribing it for some low-grade fevers, minor viral illnesses, or nonspecific body ache conditions. Due to such rampant misuse, infections no longer responding to azithromycin are now commonplace, besides causing delayed recovery and prolonging the illness, and often requiring stronger or second-line antibiotics. This trend reflects a growing public-health concern: a drug once reserved for clinically justified conditions is gradually becoming useless for even simple infections. Such irrational prescribing by unlicensed persons not only jeopardises patient safety but also amounts to a clear medico-legal violation and undermines antimicrobial stewardship, with treatment failures at the community level.

2. Unsafe injections, drips and transmission of blood-borne infection: Administration of injections/drips outside regulated clinical settings without sterile technique or trained staff tremendously increases the risk of bloodstream infections. Contaminated needles, poor re-use, and aseptic technique result in the transmission of many pathogens. Furthermore, unsuitable preparation of IV fluids, such as non-sterile dilution and re-use of multi-dose vials, can lead to septicemia and localised outbreaks. Injectable administration by untrained persons, coupled with unduly inadequate infection control, amplifies the risk for both individual patient and community transmission. WHO has time and again stressed that safe injection practices are at the core of infection-control and AMR efforts.

3. Toxicity from inappropriate high doses, polypharmacy, and drug interactions: Unqualified prescribers often do not know dosing limits, contraindications, and drug interactions. High doses of nephrotoxic or hepatotoxic drugs may cause acute organ damage. Polypharmacy, or taking multiple drugs at the same time without consideration for interactions, greatly increases the risk for adverse drug reactions, hospitalisation, and mortality. Furthermore, unrecognised comorbidities such as renal failure, liver disease, or pregnancy may make ordinary doses of drugs unsafe. A qualified practitioner considers such risks, while an unqualified person does not.

4. Delay in correct diagnosis and care escalation: A patient treated by an unqualified individual may face a delay in receiving appropriate diagnosis and specialist referral. Mismanagement, such as symptomatic treatment of a surgical abdomen or antibiotic cover for a malaria case misdiagnosed as viral fever, can lead to disease progression. Delay in referral, particularly for time-sensitive conditions such as myocardial infarction, stroke, and sepsis, will lead to irreversible consequences.

5. Erosion of public trust and fragility of the health system: Repeated negative experiences of quack practice breed distrust, as communities may become sceptical either of formal medical institutions where informal providers are seen as harmful or continue to prefer cheaper but unsafe local providers. Both outcomes strain public health messaging, vaccination campaigns, and community participation in preventive health. Trust is a fragile social good, and its erosion through visible malpractice undermines the public health interventions that depend on community cooperation.

Enforcement, Remedies and Administrative Pathways

The intersection of legal violations and public-health hazards demands a multi-agency response.

1. Criminal and administrative complaints

· Police: In cases of personation/cheating or where harm/death may have resulted, an FIR should be filed citing relevant IPC sections, such as Sections 419/420/304A, along with the facts of the false representation and harm.

· Manipur Medical Council complaint: The Registrar can be asked to investigate and recommend disciplinary/prosecutorial action under the Manipur Medical Council Act for unqualified practice and false representation on registration matters.

· Drug Control/State Drug Controller: For unauthorised sale of Schedule H/H1/X medicines and license violation — send a request to inspect, seize the non-complying drugs, prosecute under the Drugs & Cosmetics Act.

· Health Department/ District Health Officer: For an unregistered nursing home or clinical establishment, for the purpose of ordering closure, inspection, and registration scrutiny under state nursing-home legislation.

2. Inter-agency inspections and public-health measures: Joint inspections (health + drug control + medical council) allow coordinated enforcement: closure of unsafe premises, seizure of drugs, cancellation of any facilitative licenses, and referral for criminal prosecution where appropriate. Public-health departments should also issue community advisories and escalate surveillance for any outbreak signals-e.g., unusual sepsis cases linked to the premises.

3. Preventive measures and community education: Legal enforcement should be accompanied by community education on the risks associated with unqualified practice, safe use of antibiotics, and the use of registered practitioners. Stronger local health literacy means lower demand for unsafe providers. In addition, easy mechanisms for anonymous complaints, backed by rapid response teams, can help in better detection and enforcement.

Policy Recommendations

1. Stringent implementation of the registration and drug-sale regulations with visible, regular joint inspections in prone local areas (markets, peri-urban clusters).

2. Compulsory public registers of registered practitioners/pharmacies and a public helpline to check the credentials.

3. Community awareness campaigns on AMR, dangers of injectable procedures in unregulated settings, and how to verify a practitioner

4. Strengthen prescription surveillance, both electronic and paper-audit, for Schedule H/H1 drugs at retail outlets to identify patterns in illegal dispensing.

5. Speedy complaint redressal and legal aid for the complainants; protection for whistleblowers to report quack clinics without fear.

6. Capacity building for district drug controllers and health inspectors in forensic evidence collection and cross-agency prosecution for complex cases spanning IPC, Drugs Act and state Acts.

7. Integration with AMR national action plans to ensure community-level misuse from quacks is a reporting and intervention priority.

Conclusion

The fact that unqualified individuals prescribe and dispense medicines, administer injections, and run bed-based clinics inside retail pharmacies represents a regulatory failure and public-health hazard. India’s legal framework combines state Acts like the Manipur Medical Council Act, the Nursing Home Registration Act-while central statutes include the NMC Act, Pharmacy Act, Drugs & Cosmetics Act-along with criminal law-provides strong instruments for combating this conduct. However, effective mitigation requires coordinated enforcement, community education, and integration of efforts with national AMR strategies and infection-control priorities. Protection of patients from harm and prevention of the wider societal costs of AMR demand urgent, decisive action locally and at the state level.

References (selected primary sources and authoritative background)

1. The Manipur Medical Council Act 2009 (Manipur Act №4 of 2012). (Official text).

2. Manipur Nursing Home and Clinics Registration Act, 1992 (full text).

3. The Pharmacy Act, 1948 (text) — Sections on false claim of registration and dispensing.

4. The Drugs & Cosmetics Act, 1940 and Drugs Rules, 1945 (text and Schedules — H/H1/X).

5. National Medical Commission Act, 2019 — Section 34, Bar to practice.

6. The Clinical Establishments (Registration & Regulation) Act, 2010 (text — penalties and monetary fines).

7. Indian Penal Code (IPC) — Sections 419, 420, 304A and relevant provisions

8. World Health Organisation — Antimicrobial Resistance fact sheet (WHO)

9. WHO — Bacterial Priority Pathogens List, 2024.

10. Farooqui HH, et al., “The impact of stringent prescription-only antimicrobial sale” (review/analysis on Schedule H and prescribing patterns). (PMC).

11. News and studies showing rising AMR and empiric antibiotic use in India: example reporting/studies.

12. Directorate of Health Services, Manipur — official site — information on nursing homes/health administration.