The Indian Pharma Paradox

THE INDIAN PHARMA PARADOX: GENERIC VS BRANDED GENERIC

 Background

India has over 60,000+ branded generic drugs. These are essentially off-patent molecules sold under brand names (e.g., Paracetamol as Crocin, Calpol, P-650, etc.). The active pharmaceutical ingredient (API) is the same, but the branding creates a perception of trust, quality, or superiority.

When the Supreme Court or government regulators push for prescriptions by salt/generic name only, the stated objective is:

    • Reduce drug prices

    • Eliminate unethical promotions

    • Ensure wider access

But the ground reality paints a more complicated picture.

 CORE ISSUES WITH GENERIC-ONLY PRESCRIPTIONS IN INDIA

1. Quality Variability

    • Anyone with a license and a basic facility can manufacture generics.

    • WHO GMP compliance is not uniform across the industry.

    • Substandard or bio-inequivalent drugs may enter the market, especially at low prices.

    • Patients may suffer from therapeutic failure despite receiving the “right salt.”

2. Distribution Power Shift

    • If doctors prescribe just the molecule, chemists decide the brand.

    • This creates a power shift:

        ◦ From Pharma companies bribing doctors

        ◦ To companies bribing chemists/distributors/retailers to push their products

Result? The same corruption cycle continues — only the players change.

3. Lack of Regulation & Oversight

    • CDSCO and State FDAs are underfunded, understaffed, and inconsistent.

    • Very few random quality checks on generics at the retail level.

    • Lack of a centralized drug quality database for prescribers and patients.

4. Patient Confidence and Compliance

    • Patients often associate branded drugs with effectiveness.

    • Generic-only prescriptions confuse patients, especially in rural areas.

    • Chemists may exploit this by dispensing high-margin, low-quality drugs.

5. Impact on MNCs

    • In India, patent enforcement is weak, and process patents can be bypassed.

    • MNCs cannot recoup R&D investments unless it's a niche or protected molecule.

    • Their presence shrinks unless:

        ◦ They license to Indian companies

        ◦ Enter into PPP models

        ◦ Focus on orphan drugs, oncology, biologics (harder to replicate)

 POSSIBLE SOLUTIONS & ALTERNATIVES

Let’s look beyond just “generic prescriptions” and propose a multi-layered approach:

1. Regulated Generic Prescription with Manufacturer Tagging

Doctors prescribe using:

    • Salt name

    • Plus 2-3 manufacturer options (all WHO GMP compliant)

Example:

Drug: Telmisartan 40 mg

Manufacturers: Cipla / Ajanta / Medley

Benefits:

    • Retains doctor’s clinical discretion

    • Prevents low-quality generics at chemist level

    • Encourages quality-based competition, not just price

2. Generic Drug Certification Portal

Launch a government-managed portal/app with:

    • All WHO-GMP certified manufacturers

    • Test results of batches

    • Red/Green/Amber rating based on quality and recall history

Doctors and patients can verify before prescribing or purchasing.

3. Two-Tier Prescription Model

    • Tier 1: Essential Medicines List (EML) – prescribed by salt name only

    • Tier 2: Other drugs – choice between branded or generic

Benefits:

    • Balances cost control with quality assurance

    • Reduces risk of poor-quality substitutes for critical medicines

4. Digitize and Monitor Prescription Trends

Create a Doctor Prescribing Dashboard linked to pharmacy data:

    • Track % of generic vs branded prescriptions

    • Highlight unusual concentration of a single brand

    • Reward doctors for diverse, ethical prescription behavior

5. Reform Retail Pharmacy Practices

    • Make it mandatory for pharmacies to stock top 3 generics of every essential drug

    • Enforce label clarity: Manufacturer, batch number, manufacturing location

    • Penalize pharmacists for pushing one company excessively

6. Strengthen Jan Aushadhi Stores & Expand Role

    • Increase number and reach of Jan Aushadhi Kendras

    • Introduce blockchain-based track & trace for public trust

    • Partner with reputed Indian pharma manufacturers

THE FATE OF MNCS IN INDIA

You are spot-on — the future of MNCs in India hangs on:

    • New molecule pipeline (hard to replicate)

    • Innovative formulations (e.g., slow-release, depot, inhalation)

    • Biologics & biosimilars (difficult and expensive to copy)

    • Partnerships with Indian companies (Sun, Dr. Reddy’s, etc.)

Without patents, traditional blockbusters become commodities within months.

 POLICY SUGGESTIONS TO GO FORWARD

Policy Tool Impact Risk if Ignored

Manufacturer-tagged generics Assures quality, retains doctor role Patient harm from poor generics

Central quality registry Transparency in drug quality Black box for prescribers & patients

Pharmacy behavior regulation Breaks corruption at chemist level Bribe cycle continues

E-prescription tracking Early warning for unethical behavior Difficult to prove pharma malpractice

Tiered generic-branded system Balances affordability and choice Pushback from both industry & doctors

CLOSING THOUGHT

Prescribing by salt name alone may appear to be pro-poor, but in practice, without regulatory safeguards, it can open the door to unregulated chaos, poor-quality medicines, and patient distrust.

Instead of binary decisions (branded vs generic), the solution lies in:

    • Transparency

    • Accountability

    • Incentivizing ethical behavior

    • Regulatory modernization

India doesn’t need to kill the branded system — it needs to reward quality, not marketing muscle.