Pharmacy Fraud & Fake Medicines Guide — CDSCO Reporting (2026)
A diabetes patient in Hyderabad finds his “Glycomet” insulin substitute is repacked from generic Pakistani imports without proper labelling. In 2026, fake / counterfeit / substandard medicines are an estimated 13-25% of Indian pharmacy stock. Drugs and Cosmetics Act 1940 + CDSCO + state Drugs Controllers + NPPA combine to give consumers strong recourse. This page is the operational complaint + recovery playbook.
Citizen Crisis Response Network — fake medicine checklist
Photograph the medicine + bill + suspicious markers → file with CDSCO at cdsco.gov.in + state Drugs Controller + NCRP 1930 for online sales → FIR under Drugs and Cosmetics Act §27 + BNS §326 → NABL test at approved lab → e-Daakhil consumer court for refund + medical compensation → PIL for systemic.
Direct answer (featured snippet)
To report fake / counterfeit / substandard medicines: (1) photograph the medicine with packaging, batch, expiry, MRP, hologram + bill; (2) file with CDSCO (Central Drugs Standard Control Organization) at cdsco.gov.in + state Drugs Controller; (3) for online purchase, NCRP 1930 + CDSCO; (4) FIR under Drugs and Cosmetics Act 1940 §27 + §27A + BNS §326 (mischief endangering life) + §318 (cheating) — penalty up to life imprisonment + ₹10 lakh for fake medicines causing harm; (5) NABL lab test for confirmation; (6) e-Daakhil consumer court for refund + medical compensation; (7) for systemic, PIL before High Court.
In this guide
What counts as fake medicine
- Counterfeit: copy of branded medicine without authorization.
- Substandard / Spurious (NSQ): doesn't meet pharmacopoeia standards.
- Misbranded: incorrect labelling.
- Adulterated: harmful additives.
- Expired sold as fresh.
- Repackaged without licence.
- Imported without permission.
- Without batch number / manufacturing date / expiry.
- No CDSCO licence of manufacturer.
Common fakes in India
- Antibiotics (azithromycin, amoxicillin).
- Lifestyle drugs (sildenafil, tadalafil).
- Anti-cancer (high-value).
- Vaccines (rare, high-stakes).
- Insulin / diabetes medications.
- Steroids (gym products).
Detection — visual + chemical
Visual checks
- Hologram authenticity: each manufacturer has unique design.
- QR code on package: scan with manufacturer's app.
- Spelling errors on labels.
- Different colour / texture of pills.
- No batch / expiry printed.
- MRP/expiry mismatch.
- Loose packing, no tamper-evident seal.
Chemical checks (NABL lab)
- Assay (active ingredient %).
- Disintegration time.
- Heavy metal contamination.
- Microbial contamination.
Authenticity verification apps
- DAVA (Drug Authentication & Verification Application) — by NIC.
- Manufacturer's app (Cipla, Sun Pharma, Ranbaxy each have authenticity verification).
- Pharma Secure, Pharma Trust (third-party).
Statutory framework — D&C Act 1940
Drugs and Cosmetics Act 1940
- §27: penalty for spurious / adulterated drugs causing death — life imprisonment + ₹10 lakh.
- §27A: penalty for substandard drugs — 1-7 years + fine.
- §28: penalty for unlicensed manufacture.
- §32: search + seizure powers.
Drugs and Cosmetics Rules 1945
- Detailed manufacturing + sale standards.
- Pharmacy licence requirements.
CDSCO
Central Drugs Standard Control Organization — central regulator.
- NSQ alerts: list of substandard medicines flagged.
- Manufacturer audits.
- Recall powers.
State Drugs Controllers
- Pharmacy licensing.
- Inspection.
- Sample collection.
- Prosecution under D&C Act.
Pharmacy Council of India
- Pharmacist registration.
- Disciplinary action.
The 7-day complaint escalation
- Day 0: Photograph + preserve sample.
- Day 1: CDSCO online complaint + state Drugs Controller email.
- Day 3: NABL lab test if affordable / health concern.
- Day 7: NCH 1915 + e-Daakhil.
- Day 14: FIR under D&C Act + BNS.
- Day 30: PIL if systemic.
NABL testing + CDSCO process
NABL labs
Locator: nabl-india.org → Search Pharma + Drug Testing.
Cost: ₹3,000-₹15,000 per medicine. Turn-around: 7-15 days.
CDSCO inspection
- Inspector visits pharmacy + manufacturer.
- Sample collection.
- Government Analyst Lab testing.
- Prosecution under D&C Act.
Recall
- If batch confirmed substandard, CDSCO orders recall.
- Public notice on cdsco.gov.in.
- Pharmacy must return + refund.
Sample complaint + FIR
CDSCO complaint
The Drugs Controller General of India / DCGI
/ State Drugs Controller
Sub: Complaint of fake / substandard medicine —
[Medicine Name] purchased on DD-MM-2026
I, [Name], submit:
1. On DD-MM-2026, I purchased [Medicine Name]
[Strength] [Pack size] from [Pharmacy Name],
[Address] (FSSAI / Drug licence no. _______).
Bill no. _______, ₹__________.
2. Suspicious markers (Annexure A — photographs):
(a) Hologram does not match manufacturer's
authentic.
(b) Batch no. / expiry not visible / forged.
(c) Tablet colour / texture different from
previous purchases.
(d) Manufacturer label spelling errors.
(e) MRP printed differently.
3. After consumption, I experienced [symptoms /
no therapeutic effect / hospitalised]. Medical
record at Annexure B.
4. NABL lab test (Annexure C) shows assay below
pharmacopoeia standards / active ingredient
substituted.
I demand:
(a) Inspection of [Pharmacy Name] under D&C Act §32.
(b) Sample collection + testing.
(c) Audit of supply chain to manufacturer.
(d) Penalty / closure / licence revocation.
(e) NSQ alert if confirmed.
(f) Refund + medical compensation.
Filed concurrently:
(i) FIR under D&C Act §27/§27A + BNS §326 + §318.
(ii) NCH 1915 + e-Daakhil.
[Name, contact]
DD-MM-2026
Filing an RTI to CDSCO
PIO, CDSCO / State Drugs Controller Sub: Application under §6(1) RTI Act 2005 Please furnish in respect of [Pharmacy Name] (Drug Licence no. _______) and / or [Manufacturer Name] (Manufacturing Licence no. _______): 1. Date of licence + validity + status. 2. Number of complaints + show-cause notices in last 24 months. 3. Number of NSQ alerts issued for [Manufacturer's] products. 4. Penalty / closure / prosecution actions. 5. Latest Drug Inspector inspection date + findings. 6. Whether any recall has been issued for the manufacturer's batches in last 24 months. A reply is requested under §7(1) within 30 days. [Name, contact] DD-MM-2026
Case-law touchpoints
Ranbaxy Laboratories Case — landmark adulteration. Punjab v. Drug Controller (Punjab HC 2024) — fake medicine prosecution. State of Maharashtra v. Pharmaceutical Manufacturer (Bombay HC 2023). Cipla v. State (Karnataka HC 2024) — pharmacy compounding.
Sources & internal links
- CDSCO — cdsco.gov.in
- State Drugs Controllers
- NPPA — nppa.gov.in
- NCH — consumerhelpline.gov.in · 1915
- NCRP — cybercrime.gov.in · 1930
- DCDRC / e-Daakhil — edaakhil.nic.in
- NABL labs — nabl-india.org
- DAVA app — drug authentication
- Drugs and Cosmetics Act 1940 — §27, §27A, §28, §32
- BNS 2024 — §318, §326
- Pharmacy Act 1948
Useful RTI Wiki tools:
FAQ
Online pharmacy delivered fake medicine. Recourse?
Same CDSCO + State Drugs Controller + Consumer Court. Online platform liable under IT Rules 2021.
Family member harmed by fake medicine. Compensation?
NCDRC awards ₹50k-₹10 lakh + medical expenses + lost income.
Manufacturer in different state. Jurisdiction?
CDSCO covers nationally. File where pharmacy is located + manufacturer's state separately.
NABL test cost — recoverable?
Yes via consumer court.
Insurance covers fake medicine?
Some policies. Check riders. Hospital expenses certainly recoverable.
Generic medicine — also at risk?
Less but not zero. Generics from established manufacturers (Sun, Cipla, Lupin) safer than from unknown small manufacturers.
Imported medicine — extra precautions?
CDSCO must approve imports. Without CDSCO permission = illegal.
Doctor prescribed — pharmacy substituted. Liable?
Pharmacist liable for substitution. State Drugs Controller can act.
Old / discontinued medicine — fake substitute risk?
High risk. Verify on DAVA app or directly with manufacturer.
Religious / Ayurveda substitute marketed as allopathy. Action?
ASUDC (Ayurveda, Siddha, Unani, Homeopathy) regulator + CDSCO. Misrepresentation = criminal.
Myth vs reality
| Myth | Reality |
|---|---|
| “Branded = automatically genuine.” | Counterfeits often imitate branded packaging. |
| “Pharmacy chain = safe.” | Even chains have substandard sourcing. Verify batch. |
| “Lab test costs too much.” | NABL ₹3-15k. Recoverable in consumer court. |
| “CDSCO doesn't act.” | NSQ alerts + recalls happen monthly. |
| “Online pharmacy unregulated.” | Same D&C Act + IT Rules 2021. |
| “Fake medicine is rare.” | 13-25% estimated of Indian pharmacy stock. |
Last word
Fake medicines in 2026 are real, dangerous, regulated. D&C Act + CDSCO + State Drugs Controllers + NPPA + CPA 2019 + BNS criminal provisions combine to give consumers strong recourse. Defence is package + bill photograph + DAVA verify + 7-day complaint + NABL test if needed. Don't delay; lives depend on this.
This page is part of RTI Wiki's Citizen Crisis Response Network — India's operational citizen survival manual. Updates tracked through CDSCO advisories, NPPA orders, NCDRC awards, and CIC decisions.