Essential medicine and counterfeit medicines from spm indetaily and also take info from who website
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WHO essential medicines and counterfeit medicines 2024 2025
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counterfeit falsified substandard medicines definition impact WHO
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WHO essential medicines list concept selection criteria 2023 2024
I now have comprehensive information from both Park's SPM and the WHO website. Let me compile the full detailed response.
Essential Medicines & Counterfeit Medicines
Sources: Park's Textbook of Preventive and Social Medicine (SPM) + WHO
PART 1: ESSENTIAL MEDICINES
Definition
Essential medicines are those that satisfy the priority health care needs of the population. They are intended to be available within the context of functioning health systems at all times, in adequate amounts, in appropriate dosage forms, with assured quality and adequate information, and at a price the individual and the community can afford.
- Park's Textbook of Preventive and Social Medicine, p. 546
WHO's Concept
The concept was introduced by WHO to guide rational drug policy. Implementation is flexible and adaptable to national situations - exactly which medicines are "essential" remains a national responsibility.
Experience has shown that careful selection of a limited range of essential medicines results in:
- Higher quality of care
- Better management of medicines (including improved quality of prescribed medicines)
- More cost-effective use of available health resources
The WHO Model List of Essential Medicines (24th list, 2025) is the current global reference, updated by the WHO Expert Committee on Selection and Use of Essential Medicines. The 25th meeting was held in Geneva in May 2025.
National List of Essential Medicines of India - 2015 (NLEM)
India's first NLEM was prepared in 1996, subsequently revised in 2003, 2011, and 2015.
India adopted the WHO concept but its own list differs from the WHO model due to differences in national circumstances - India's list addresses its own disease burden, including medicines used in national health programmes and emerging/re-emerging infections.
Criteria for Inclusion in India's NLEM:
| # | Criterion |
|---|---|
| 1 | Must be approved/licensed in India |
| 2 | Useful in a disease that is a public health problem in India |
| 3 | Proven efficacy and safety based on valid scientific evidence |
| 4 | Must be cost-effective |
| 5 | Aligned with current treatment guidelines |
| 6 | Stable under Indian storage conditions |
| 7 | Price of total treatment considered (not just unit price) |
| 8 | Fixed-dose combinations (FDCs) generally excluded unless unequivocally proven advantage over individual ingredients |
| 9 | Categorized by level of healthcare: Primary (P), Secondary (S), Tertiary (T) |
- Park's SPM, p. 547
Level of Healthcare Classification:
- P (Primary) - available at primary health centres
- S (Secondary) - available at district/community hospitals
- T (Tertiary) - available at tertiary referral hospitals
Dosage Forms Covered in NLEM
| Category | Examples |
|---|---|
| Oral solid | Tablets (film-coated, enteric-coated, dispersible, chewable), capsules, sachets |
| Oral liquid | Syrups, suspensions, elixirs |
| Injectable | Conventional liquid injection, powder for injection, depot, liposomal/lipid complex |
| Topical | Ointment, cream, lotion, drops |
Sample Sections from India's NLEM
Section 1: Anesthetic Agents
| Medicine | Level | Dosage Form |
|---|---|---|
| Halothane | S, T | Inhalation |
| Isoflurane | S, T | Inhalation |
| Ketamine | P, S, T | Injection 10 mg/ml & 50 mg/ml |
| Nitrous oxide | P, S, T | Inhalation |
| Oxygen | P, S, T | Medicinal gas |
| Propofol | P, S, T | Injection 10 mg/ml |
| Sevoflurane | T | Inhalation |
| Thiopentone | P, S, T | Powder for Injection 0.5 g / 1 g |
Pharmacovigilance and Safety Monitoring
Safety monitoring is integral to essential medicines surveillance. Aims include:
- Identifying new adverse effects
- Quantifying risks
- Communicating findings to drug regulatory authorities, health professionals, and the public
The International WHO Programme for Drug Monitoring (voluntary reporting) has been effective in identifying previously unknown adverse drug effects. Risk magnitude is evaluated using observational epidemiological methods (case-control, cohort, case-population studies).
PART 2: COUNTERFEIT MEDICINES
Definition (WHO)
A drug/medicine is counterfeit if it is produced with the intention to cheat. This includes:
- Mis-labelling (including falsifying expiry dates)
- No active ingredients
- Wrong active ingredient
- Correct ingredient in insufficient quantity
Both branded and generic products can be counterfeited.
- Park's SPM, p. 557
WHO Classification - Three Categories
WHO now distinguishes three related but separate categories:
| Category | Definition |
|---|---|
| Substandard (out-of-specification) | Authorized medical products that fail to meet their quality standards or specifications |
| Falsified | Products that deliberately/fraudulently misrepresent their identity, composition or source |
| Unregistered/Unlicensed | Products that have not undergone evaluation/approval by the National or Regional Regulatory Authority |
- Park's SPM, p. 557; WHO Fact Sheet, December 2024
Composition of Falsified Products
Falsified medical products may contain:
- No active ingredient
- Wrong active ingredient
- Wrong amount of correct active ingredient
- Commonly found fillers: corn starch, potato starch, chalk
- Some have been toxic - fatal levels of wrong active ingredient or other toxic chemicals
Scale of the Problem (WHO, 2024)
- 1 in 10 medicines in low- and middle-income countries (LMICs) are substandard or falsified
- Countries spend an estimated US$ 30.5 billion per year on substandard and falsified medical products
- Anti-malarials and antibiotics are the most commonly reported substandard/falsified products
- Both generic and innovator (branded) medicines can be falsified
- Substandard and falsified products contribute to antimicrobial resistance and drug-resistant infections
- These products are frequently sold online or in informal markets
Health Impact
| Effect | Details |
|---|---|
| Treatment failure | Insufficient or absent active ingredient |
| Poisoning/death | Toxic substances or overdose of wrong ingredient |
| Drug resistance | Subtherapeutic dosing accelerates antimicrobial resistance |
| Economic harm | Families deplete savings on ineffective treatments; health systems waste resources |
| Erosion of trust | Undermines confidence in healthcare providers and systems |
| Global reach | No region spared - both developed and developing countries affected |
How Counterfeits Enter the Market - Online Risk Factors
Consumers should be cautious of:
- Spam email advertising medicines
- Lack of authenticity or no verification logo/certificate
- Spelling mistakes and poor grammar on packaging
- Websites that do not display a physical address or landline
- Websites offering prescription-only medicines without a prescription
Unregulated websites, social media platforms, and smartphone applications are direct conduits for substandard and falsified medical products.
Identifying a Substandard or Falsified Product
Some falsified products are visually identical to genuine ones. Identification clues:
- Examine packaging for condition, spelling mistakes, or grammatical errors
- Check manufacture and expiry dates; ensure outer and inner packaging dates match
- Ensure medicine looks correct - not discoloured, degraded, or with unusual smell
- Consult pharmacist/doctor if product is not working or adverse reaction occurs
- Report suspicious products to the National Medicines Regulatory Authority (NMRA)
WHO Response
International Initiatives
| Initiative | Year | Details |
|---|---|---|
| IMPACT (International Medical Products Anti-Counterfeiting Taskforce) | 2006 | Launched by WHO; multi-stakeholder global coalition |
| GSMS (Global Surveillance and Monitoring System) | 2013 | Structured, systematic reporting of substandard/falsified products globally |
| Member State Mechanism (MSM) | Ongoing | Facilitates global collaboration; promotes/reinforces national and international efforts |
Technical Tools Being Used (WHO, 2024)
- Handheld spectrometer devices
- Mobile apps
- Blockchain technology
- Track-and-trace systems
- Laboratory verification methods
Recent WHO Alerts (2024-2026)
- June 2024: WHO issued alerts on falsified semaglutides (used for type 2 diabetes and obesity/weight loss)
- May 2026: Substandard ACCUPAQUE/OMNIPAQUE/VISIPAQUE (iohexol/iodixanol contrast agents)
- June 2026: Falsified JAKAVI (ruxolitinib)
Summary Comparison Table
| Feature | Essential Medicines | Counterfeit/Falsified Medicines |
|---|---|---|
| Purpose | Meet priority health needs | Deceive consumers for financial gain |
| WHO role | Model list, selection criteria | Surveillance, alerts, GSMS, IMPACT |
| Key challenge | Access, affordability, availability | Detection, regulation, online sales |
| India context | NLEM 2015 (revised from 1996) | Regulated by CDSCO |
| Public health risk | Inadequate availability = death | Toxicity, treatment failure, resistance |
Key references:
- Park's Textbook of Preventive and Social Medicine, 25th edition, pp. 546-548, 557
- WHO Model Lists of Essential Medicines (24th list, 2025)
- WHO Fact Sheet: Substandard and Falsified Medical Products (updated December 2024)
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