Essential medicines and counterfeit medicines from spm indetail explanation
Reading File
Finding Sources
Finding Sources
Finding Sources
Reading File
Finding Sources
Reading File
Reading File
Reading File
Finding Sources
I now have comprehensive content from Park's Textbook on both topics. Let me compile a detailed, well-organized answer.
Essential Medicines and Counterfeit Medicines
From Park's Textbook of Preventive and Social Medicine (SPM)
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
- Present in adequate amounts and appropriate dosage forms
- Of assured quality with adequate information
- At a price the individual and the community can afford
The implementation of the concept is meant to be flexible and adaptable to different situations. Which medicines are regarded as essential remains a national responsibility.
"Careful selection of a limited range of essential medicines results in a higher quality of care, better management of medicines, and a more cost-effective use of available health resources."
- Park's Textbook of Preventive and Social Medicine, p. 546
WHO's Role
The concept of Essential Medicines was first introduced by the WHO in 1977 (Model List of Essential Medicines - EML). The EML is a recommendation document published biannually and forms the backbone of medicine procurement and availability globally, especially in low- and middle-income countries.
National List of Essential Medicines (NLEM) - India 2015
India adopted the WHO concept of essential medicines but developed its own list based on national disease burden and circumstances. The NLEM was first prepared in 1996 and has since been revised in 2003, 2011, and 2015.
Criteria for Inclusion in NLEM (India):
| # | Criterion |
|---|---|
| 1 | The medicine must be approved/licensed in India |
| 2 | Must be useful in a disease that is a public health problem in India |
| 3 | Must have proven efficacy and safety based on valid scientific evidence |
| 4 | Must be cost-effective |
| 5 | Must be aligned with current treatment guidelines for the disease |
| 6 | Must be stable under storage conditions in India |
| 7 | Price of total treatment (not unit price) must be considered |
| 8 | Fixed dose combinations (FDCs) are generally not included unless they have unequivocal proven advantage (increased efficacy, reduced side effects, or improved compliance) |
| 9 | Medicines are listed according to level of health care - Primary (P), Secondary (S), and Tertiary (T) |
Rationale for Level-based Classification:
The list is stratified at three levels because treatment facility, training, experience, and availability of health care personnel differ at primary, secondary, and tertiary levels of care.
Dosage Forms of Essential Medicines
Medicines are available in various dosage forms:
- Oral - tablets, capsules, syrups, elixirs
- Injectable - conventional liquid injection, powder for injection, depot, liposomal/lipid complex
- Topical - ointments, creams, lotions, drops
Pharmacovigilance and Safety Monitoring
Safety monitoring is an integral part of essential medicine use. Key aims include:
- Identifying new, previously unrecognized adverse effects
- Quantifying risks and communicating findings to drug regulatory authorities, health professionals, and the public
- The International WHO Programme for Drug Monitoring is based on voluntary reporting and has identified many previously undescribed adverse effects
- Risk magnitude is evaluated through observational epidemiological methods - case-control, cohort, and case-population studies
Sample Categories in NLEM India 2015
| Section | Category | Examples |
|---|---|---|
| 1 | Anesthetic agents | Halothane, Ketamine, Propofol, Sevoflurane, Thiopentone |
| 1.2 | Local anesthetics | Bupivacaine (S,T), Lignocaine (P,S,T) |
| 30 | Vitamins & Minerals | Ascorbic acid, Cholecalciferol, Vitamin A, Pyridoxine |
(P = Primary care level; S = Secondary care level; T = Tertiary care level)
PART 2: COUNTERFEIT MEDICINES
"Counterfeit medicines are a crime against humanity"
- Park's Textbook of Preventive and Social Medicine, p. 557
WHO Definition
A drug/medicine is counterfeit if it is produced with an intention to cheat. This can include:
- Mis-labelling (including falsifying expiry dates)
- No active ingredients
- A wrong ingredient
- The correct ingredient in an insufficient quantity
Both branded and generic products can be counterfeited.
Classification of Problem Medicines (SSFFC Framework)
The WHO uses a broader SSFFC (Substandard/Spurious/Falsely-labelled/Falsified/Counterfeit) framework:
| Type | Definition |
|---|---|
| Sub-standard medicines | Also called "out of specification" medicines - authorized medical products that fail to meet their quality standards or specifications, or both |
| Falsified medical products | Deliberately/fraudulently misrepresent their identity, composition, or source |
| Unregistered/unlicensed products | Have not undergone evaluation/approval by the National or Regional Regulatory Authority for the market in which they are distributed or used |
What Do Falsified Products Contain?
Falsified/counterfeit medical products may contain:
- No active ingredient
- The wrong active ingredient
- The wrong amount of the correct active ingredient
- Corn starch, potato starch, or chalk (as fillers in place of active ingredients)
- Some have been found to be toxic - with fatal levels of wrong ingredients or other toxic chemicals
Magnitude of the Problem
- An estimated 10% of medical products in low- and middle-income countries are sub-standard or falsified
- Anti-malarials and antibiotics are among the most commonly reported sub-standard and falsified medical products
- Both generic and innovator (branded) medicines can be falsified
Sources and Risk Factors
Unregulated sources increase consumer risk significantly:
- Unregulated websites
- Social media platforms
- Smartphone applications
- Obtaining medicines from unlicensed and unregulated sources
Warning Signs for Consumers:
- Spam email advertising medicines
- Lack of authenticity - no verification logo or 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
Identifying a Sub-standard or Falsified Product
Some falsified products are visually nearly identical to genuine products. However, many can be detected by:
- Examining packaging condition - look for spelling mistakes or grammatical errors
- Checking manufacture and expiry dates - ensure details on outer packaging match inner packaging
- Ensuring the medicine looks correct - check for discolouration, degradation, or unusual smell
- Consulting a pharmacist or doctor if the product is not working properly or causes adverse reactions
- Reporting suspicious products to the National Medicines Regulatory Authority
Anti-Counterfeit Initiatives
| Year | Initiative |
|---|---|
| 2006 | WHO launched IMPACT (International Medical Products Anti-Counterfeiting Task Force) |
| 2013 | WHO launched the Global Surveillance and Monitoring System - to encourage countries to report sub-standard and falsified products in a structured, systematic format |
Combating Counterfeit Medicines
Measures include:
- Actions taken by drug regulatory authorities and cooperation between law enforcement agencies
- Providing simple, cheap markers of authenticity
- Coordinating international surveillance for fake and sub-standard drugs
- Educating patients and healthcare workers
- Legislation - forms the basis for drug regulation (medicines must be safe, effective, and of good quality)
- Law enforcement - governments must reduce corruption and promote intersectoral cooperation between regulatory authorities, police, customs, and the judiciary
Quality Control in India - CDSCO
Central Drugs Standard Control Organization (CDSCO):
- Quality control of drugs in India is regulated under the Drugs and Cosmetics Act, 1940 and Drugs and Cosmetics Rules, 1945
- CDSCO operates under the Directorate of Director General of Health Services
- Headed by the Drugs Controller General of India (DCGI) under the Ministry of Health and Family Welfare
- State Drug Controllers are appointed by State Governments
Functions of CDSCO include:
- Control of quality of drugs imported into the country
- Regulation of drug manufacture, distribution, and sale
- Ensuring safety, efficacy, and quality of drugs
Summary Comparison Table
| Feature | Essential Medicines | Counterfeit Medicines |
|---|---|---|
| Purpose | Meet priority health needs | Deceive consumers for profit |
| WHO Role | EML (since 1977); biannual updates | IMPACT (2006), Global Surveillance (2013) |
| India Regulation | NLEM 2015; revised periodically | CDSCO under Drugs & Cosmetics Act 1940 |
| Key Criteria | Efficacy, safety, cost-effectiveness, availability | Mislabelling, wrong/absent ingredients, fraudulent source |
| Main Risk groups | None - beneficial | Anti-malarials, antibiotics most commonly falsified |
| Detection | Quality assured by regulatory approval | Packaging checks, reporting systems |
Source: Park's Textbook of Preventive and Social Medicine, Chapter on Essential Medicines and Counterfeit Medicines, pp. 546-558
In india NLEM IS UPDATED
Searching the Web
India NLEM 2022 National List Essential Medicines update details
Finding Sources
Reading Web Page
NLEM 2022 total medicines added deleted changes from 2015
Searching the Web
NLEM 2022 India 384 medicines total sections key features changes from 2015
Excellent data gathered. Here is the complete updated information on NLEM 2022:
NLEM 2022 - Updated National List of Essential Medicines (India)
Released: September 13, 2022 (5th edition)
Regulatory body: Ministry of Health and Family Welfare, Government of India; implemented by CDSCO
Evolution of NLEM - Historical Comparison
| Year | Medicines Added | Medicines Deleted | Total Medicines |
|---|---|---|---|
| 1996 | - | - | First list |
| 2003 | - | - | Revised |
| 2011 | 47 | 43 | 348 |
| 2015 | 106 | 70 | 376 |
| 2022 | 34 | 26 | 384 |
Note: The 2022 update was more conservative with fewer additions and deletions compared to the 2015 revision.
Salient Features of NLEM 2022
1. Total Medicines
- 384 medicines (up from 376 in 2015)
- 34 medicines added, 26 medicines deleted
- Some drugs appear in more than one therapeutic category:
- 342 medicines appear in a single therapeutic category
- 41 drugs appear in two therapeutic categories
- 11 appear in three therapeutic categories
- 4 drugs appear in four therapeutic categories
- Hence, the total listing is 440 items long
2. Structural Change - Therapeutic Categories
| Feature | NLEM 2015 | NLEM 2022 |
|---|---|---|
| Number of sections | 30 | Consolidated (fewer sections) |
| Neurological drugs | 4 separate sections (antiepileptics, antimigraine, antiparkinson, dementia) | Merged into Section 5: "Medicines used in Neurological Disorders" |
3. Key Medicines Added in NLEM 2022 (Alphabetical)
| # | Medicine | Significance |
|---|---|---|
| 1 | Amikacin | Antibiotic (TB/resistant infections) |
| 2 | Bedaquiline | Drug-resistant TB |
| 3 | Bendamustine Hydrochloride | Anticancer |
| 4 | Buprenorphine | Opioid use disorder |
| 5 | Buprenorphine + Naloxone | Opioid use disorder (FDC) |
| 6 | Cefuroxime | Antibiotic |
| 7 | Dabigatran | Anticoagulant (cardiovascular) |
| 8 | Daclatasvir | Hepatitis C (patent drug) |
| 9 | Darunavir + Ritonavir | HIV/AIDS |
| 10 | Delamanid | Drug-resistant TB |
| 11 | Dolutegravir | HIV/AIDS |
| 12 | Fludrocortisone | Adrenal insufficiency |
| 13 | Insulin Glargine | Diabetes (long-acting insulin) |
| 14 | Irinotecan HCl | Anticancer |
| 15 | Itraconazole | Antifungal |
| 16 | Ivermectin | Antiparasitic |
| 17 | Lamivudine | HIV/Hepatitis B |
| 18 | Latanoprost | Glaucoma |
| 19 | Lenalidomide | Anticancer (myeloma) |
| 20 | Leuprolide acetate | Anticancer/hormonal |
| 21 | Meropenem | Broad-spectrum antibiotic |
| 22 | Montelukast | Asthma/allergic rhinitis |
| 23 | Mupirocin | Topical antibiotic |
| 24 | Nicotine replacement therapy (NRT) | Tobacco cessation |
| 25 | Ormeloxifene (Centchroman) | Contraceptive |
| 26 | Phenoxymethyl penicillin | Antibiotic |
| 27 | Procaine Benzyl penicillin | Antibiotic |
| 28 | Rotavirus vaccine | Immunization |
| 29 | Tenecteplase | Thrombolytic (cardiac emergency) |
| 30 | Teneligliptin | Diabetes (DPP-4 inhibitor) |
| 31 | Tenofovir + Lamivudine + Dolutegravir | HIV (triple FDC) |
| 32 | Tenofovir Alafenamide Fumarate (TAF) | HIV |
| 33 | Terbinafine | Antifungal |
| 34 | Valganciclovir | Antiviral (CMV) |
4. Category-wise Highlights
| Therapeutic Category | Notes |
|---|---|
| Anti-infective | Largest category - 108 medicines; 18 added, 9 deleted |
| Anti-cancer | 2nd largest - 63 medicines; includes 4 patent drugs (bedaquiline, delamanid, daclatasvir, dolutegravir) |
| HIV/AIDS | Strengthened with newer ARV regimens |
| Psychiatric disorders | Section 23 - 16 medicines; 3 new additions under "Psychoactive substance abuse" subsection |
| Diabetes | Insulin glargine and teneligliptin added |
| Cardiovascular | Dabigatran, tenecteplase added |
5. Psychiatric Medicines Update (NLEM 2022 vs 2015)
| Disorder | Drug | NLEM 2015 | NLEM 2022 |
|---|---|---|---|
| Psychotic disorders | Fluphenazine | S, T | P, S, T (expanded) |
| Depressive disorders | Escitalopram | S, T | P, S, T (expanded) |
| Bipolar disorders | Carbamazepine | Not included | P, S, T (newly added) |
| Neurological/Dementia | Donepezil | Not included | S, T (newly added) |
| Substance use | Buprenorphine | Not included | P, S, T (newly added) |
| Substance use | NRT (Nicotine) | Not included | P, S, T (newly added) |
6. Uses of NLEM 2022
The NLEM serves multiple purposes:
- Basis for State governments to prepare their own state essential medicine lists
- Developing Standard Treatment Guidelines (STGs)
- Preparing hospital formularies
- Procurement and supply of medicines in public sector hospitals
- Reimbursement by employers and insurance companies
- Defining the "Must Know" domain for teaching and training of health care professionals (medical, dental, pharmacy, nursing)
7. Notable Points
- 4 patent drugs included - this is significant as it improves affordability through price regulation under DPCO (Drug Price Control Order)
- COVID-related medicines and COVID vaccines approved under Emergency Use Authorization were NOT included
- The list retains its three-tier structure (Primary/P, Secondary/S, Tertiary/T)
- FDCs are generally still avoided except where combinations show clear clinical advantage (e.g., Buprenorphine + Naloxone for opioid use disorder; HIV triple therapy)
Summary: Park's 2015 vs NLEM 2022
| Feature | NLEM 2015 (Park's) | NLEM 2022 (Current) |
|---|---|---|
| Total medicines | 376 | 384 |
| Therapeutic sections | 30 | Consolidated |
| Anti-infective emphasis | 86 | 108 |
| Anticancer medicines | 59 | 63 |
| Psychiatric additions | - | Substance use, carbamazepine, donepezil |
| Patent drugs | None significant | 4 patent drugs |
| Released | 2015 | Sep 13, 2022 |
Source: CDSCO Official NLEM 2022 | NLEM 2022 Report
This is a shared conversation. Sign in to Orris to start your own chat.