Syllabus
GS Paper 2 – Issues Relating to Development and Management of Social Sector/Services relating to Health, Education, Human Resources.
Context
In India, patients often turn to unqualified medical shop sellers for guidance on purchasing medicines instead of consulting with doctors.
Introduction
A generic drug is a pharmaceutical product that contains precisely the same active ingredient as its brand name counterpart, producing an equivalent therapeutic effect. In terms of dosing, safety, strength, quality, administration, and usage, it mirrors the brand-name drug. Notably, the development of generic drugs does not necessitate the repetition of extensive clinical trials over the years, in contrast to brand-name drugs, which typically undergo a rigorous and prolonged research and development (R&D) process.
Branded Vs Generic Medicines:
| Aspect | Branded Drugs | Generic Drugs |
| Definition | Referred to as “Innovator drugs,” introduced as new chemical entities | Pharmaceutical drugs with the same chemical substance as a previously patented drug |
| Trade Name | Marketed under the manufacturer’s name | Not marketed under the manufacturer’s name |
| Affordability | Generally high cost | Generally low cost |
| Patent Protection | Produced by a company holding the patent | Available in the market after the patent expires |
| Animal and Clinical Study | Essential to conduct tests | Not required |
| Features | Company formulates the chemical composition, establishes dosage, strength, efficacy, administration, etc. | Active ingredients, dosage, efficacy, and administration are identical to branded drugs |
| Competition | Little competition due to patent protection | Heavy competition due to price variation |
Benefits of Generic Drugs:
- Diverse Manufacturing Opportunities: Small companies can enter the market, manufacturing generic drugs without the need for extensive resources or research and development.
- Reduced Dependence on Brand Names: Healthcare providers are not required to memorize various brand names of a pharmaceutical compound, reducing reliance on specific companies.
- Freedom from Promotional Influence: Healthcare decisions are not influenced by promotional activities of specific pharmaceutical companies, promoting unbiased prescribing practices.
- Choice in Drug Dispensation: Doctors have the flexibility to choose from various generic drug manufacturers, enabling selection based on quality and patient-specific needs.
- Cost Savings for Patients: Generic drugs generally have lower profit margins compared to branded drugs, resulting in reduced expenses for patients.
- Regulated Dosage Control: Easier regulation of individual drug dosages is possible with generic drugs, unlike Fixed Drug Combinations (FDCs) common in branded drugs. Government regulations also curb irrational FDCs.
- Government Expenditure Reduction: State and Central Governments spend less on medical expenditure reimbursement for employees entitled to medical care, such as CGHS, Railways, Defence, ESI, RSBY, leading to increased access and affordability of medical care, especially for the economically disadvantaged.
Challenges in Generic Medicines:
- Decision Authority: Decision-making authority for the brand of generic medicine lies with the salesperson, restricting doctors’ autonomy.
- Unethical Practices: Unethical practices arise from a questionable connection between pharmaceutical companies and doctors, leading to susceptibility to unethical marketing tactics or kick-backs.
- Counterfeit Marketing: Large pharmaceutical companies prioritize profits over quality, engaging in costly campaigns against generic medicines.
- Lack of Accountability: The lack of accountability raises uncertainty about the entity responsible for ensuring compliance with drug quality standards.
- NMC Directive: The National Medical Commission’s directive instructing registered medical practitioners to prescribe only generic medicines was temporarily suspended following protests.
- Poor Quality Impact: The prevalence of unauthentic and sub-standard medicines at 4.5% and 3.4% directly jeopardizes patients’ health.
- Lack of Essential Medicines: Essential medicines are scarce, with non-essential items like vitamin tonics and cough syrup dominating pharmacy shelves.
Steps Taken by India to Promote Generic Drugs:
- Pradhan Mantri Bhartiya Janaushadhi Pariyojana (PMBJP):
- Implemented by the Ministry of Chemicals and Fertilizers to offer quality generic medicines at affordable prices.
- Each drug batch undergoes testing in laboratories accredited by the National Accreditation Board for Testing and Calibration Laboratories (NABL).
- Pharmaceuticals and Medical Devices Bureau of India: Medicines are sourced exclusively from suppliers certified by the World Health Organization – Good Manufacturing Practices (WHO-GMP), ensuring quality.
- Janaushadhi Sugam: The initiative provides public information about the locations of Jan Aushadhi Kendras through a mobile application.
- Free Drug Initiative: Implemented as part of the National Health Mission (NHM) with the goal of supplying essential generic drugs free of charge in public health facilities.
- National Pharmaceutical Pricing Authority: This authority establishes the ceiling price for Scheduled medicines outlined in Schedule-I (essential medicines) of the Drugs (Prices Control) Order, 2013.
| India’s Pharmaceutical Industry |
| Renowned as the “pharmacy of the world,” India is acclaimed for the high quality and cost-effectiveness of its pharmaceuticals. Globally, the Indian pharmaceutical industry stands among the largest, recognized for its production of affordable vaccines and generic medications. As the largest producer of generic drugs worldwide, India holds a significant share, contributing to 13% of the global pharmaceutical market. According to a recent report from Asian Lite, India’s pharmaceutical industry is currently ranked 3rd globally in terms of production volume. The pharmaceutical sector is a substantial contributor to India’s economy, accounting for approximately 1.72% of the country’s Gross Domestic Product (GDP). |
Way forward:
- Ensuring Medicinal Quality: The government bears the responsibility of ensuring the quality of medicines within both its Universal Health Coverage system and the private healthcare network.
- Regulating Through Periodic Testing: Mandatory periodic quality tests should be conducted, and any medicines failing these tests must be banned, accompanied by punitive measures against the manufacturers.
- Establishing Standards for Generic Drugs: The government must guarantee that medicines available in the market meet standard quality criteria, instilling confidence in healthcare practitioners and patients regarding the efficacy of generic drugs.
- Effective Monitoring for Universal Health Care: While advocating for free medicines and diagnostics under Universal Health Care, diligent monitoring is essential to ensure the successful implementation and accessibility of affordable medicines for all.
- National Promotion of Generic Drugs: Drawing from the successful experiences of states like Rajasthan and Tamil Nadu, there is a national push to promote generic drugs, enriching the public health system and fostering confidence in the use of generic medications.
Mains Enricher Points:
- Hathi Committee in 1975 recommended for the gradual elimination of brand names.
- In India, annually, about 32 million people get pushed below poverty line because of expenditure on medical care.
Must Read: Generic Medicines
Source: The Hindu
Practice Question
In the realm of generic medicine, how is India contributing to the pharmaceutical sector as the acclaimed “pharmacy of the world,” known for its thriving industry and innovative approach in delivering cost-effective life-saving medications? (Answer in 250 words)