The document discusses essential medicines, which are necessary to meet priority healthcare needs and must be accessible, affordable, and effective for public health. It also highlights the issue of counterfeit medicines in India, detailing the prevalence, causes, and statistics related to counterfeit drugs, emphasizing the need for stricter regulations and enforcement. Prevention strategies include public awareness, authentication technologies, and global cooperation to combat the counterfeit medicine crisis.

1.  Dr. Deepak Kumar
 Associate Professor
 Department of Community Medicine
ESSENTIAL MEDICINES and
COUNTERFEIT MEDICINES

2. Specific Learning
Objectives
 Definition, essential criterion of essential
medicine
 Essential Medicines and their role in primary
health care
 Counterfeit Medicines and its prevention

3. Improving Access, Quality, and
Sustainability in Healthcare
Essential medicine

4. ESSENTIAL MEDICINES
• Satisfy the priority health care
needs
population.
• Essential medicines are intended to
be
of the
available
within the context of functioning health systems at
all times
adequate amounts,
appropriate dosage forms,
assured quality, and
at a price the individual and the community can afford.

5. Key Facts about Essential
medicines
• Satisfy the priority health care needs of a population.
• Selected with regard to disease prevalence, safety,
efficacy, and comparative cost effectiveness.
‐
• Over 350 medicines to treat priority conditions (WHO Model
List ).
• Listed by their International Non p
‐ roprietary Name (INN)
or generic name, without specifying a manufacturer.
• Updated every two years, using a transparent evidence based
‐
process. By WHO
• The WHO Model List can be used by countries as a guide for
the development of their own national essential medicines list.

6. 1. Medicine should be approved in India.
2. Medicine should be used in disease which is public
health problem in India.
3. It should have proven safety and efficacy record.
4. It should be cost effective.
5. Price of total treatment should be considered and
not the unit price.
Criteria for essential list in India

7.  6. It should be aligned with current treatment guideline
 7. It should be stable under storage condition in India.
 8. FDC are generally not included unless
unequivocally proven advantage.
 9. List of essential medicine is based according to level
of health care i.e. primary, secondary and tertiary care.
Criteria for essential list in India

8. Categories of Essential Medicines
1. Antibiotics (e.g., Amoxicillin, Ciprofloxacin)
2. Antiviral Medicines (e.g., Oseltamivir, Zidovudine)
3. Antipyretics & Pain Relievers (e.g., Paracetamol,
Ibuprofen)
4. Anti-Tuberculosis Drugs (e.g., Rifampicin,
Isoniazid)
5. Antimalarials (e.g., Chloroquine, Artemether +
Lumefantrine)
6. Antidiabetic Drugs (e.g., Metformin, Insulin)
7. Antihypertensives (e.g., Amlodipine, Enalapril)

9. Other Essential Medicines
8. Cardiovascular Medicines (e.g., Aspirin,
Atorvastatin)
9. Vaccines (e.g., BCG, Polio, Hepatitis B)
10. Anesthetic Agents (e.g., Lidocaine, Ketamine)
11. Antifungal Drugs (e.g., Fluconazole, Amphotericin
B)
12. Gastrointestinal Medicines (e.g., Omeprazole,
ORS)
13. Antiemetic Drugs (e.g., Ondansetron)
14. Contraceptives (e.g., Levonorgestrel, Copper-T
IUD)

10. Key Roles of Essential Medicines in
PHC
1. Ensuring Access to Treatment
2. Promoting Rational Use of Medicines
3. Improving Public Health Outcomes
4. Cost-Effectiveness and Sustainability
5. Supporting Universal Health Coverage (UHC)
6. Combating Global Health Threats

11. Counterfeit Medicine in
India: A Growing Concern

12. What Are Counterfeit Medicines?
Definition: Counterfeit medicines are drugs that are
mislabeled with respect to identity or source.
Examples
• During the COVID-19 pandemic especially fake
versions of remdesivir, favipiravir, and even
counterfeit vaccines.
• Multiple cases of counterfeit cancer medications
• In some areas, up to 20% of antibiotics sold were
found to be substandard or fake.
• lifestyle drugs (e.g., erectile dysfunction pills) and
painkillers.

13.  According to the (WHO), 10-25% of medicines
are either counterfeit or substandard.
 Estimated market value over $200 billion
annually.
 States with higher incidences: Maharashtra,
Gujarat, Uttar Pradesh, and Delhi
 A recent report indicated that 1 in 10 drugs
sold via e-commerce platforms in India could
be counterfeit.
Statistics on Counterfeit Medicine in
India

14. Causes of Counterfeit Medicine
Proliferation
Loose Regulations: Gaps in monitoring
supply chains.
High Demand for Low-Cost Drugs: Fosters
counterfeit market.
Weak Enforcement: Limited policing of
counterfeiting.
Online Sales: E-commerce facilitating
distribution.

15.  Stringent Enforcement of Laws:
India has the Drugs and Cosmetics Act, 1940, which
needs stricter enforcement. Amendments to increase
penalties for offenders
 Central Drugs Standard Control Organization
(CDSCO):
Strengthening the CDSCO to monitor and regulate the
production and distribution of medicines nationwide is
key.
 Increasing the number of inspections and audits can
help curb the circulation of counterfeit drugs.
Prevention and Control Strategies

16. 2. Public Awareness and Education
3. Pharmaceutical Authentication
Technologies
 Barcode and QR Code Systems
 Track-and-Trace system,
4. Global Cooperation and Law Enforcement
5. Good Manufacturing and Distribution
Practices
6. Improving Access to Affordable Medicines

17. Thank you