A medicine only helps if it is the right medicine, in the right dose, made the right way. A bad tablet or syrup can fail to cure. It can also poison. India is a huge maker and seller of medicines. So it must keep bad ones out of the market.
This lesson explains the legal terms, who polices quality, how big the problem is, and what has changed after the cough syrup deaths.
- Law: the Drugs and Cosmetics Act, 1940 sorts bad drugs into misbranded, adulterated and spurious.
- Not of standard quality (NSQ): a real drug that fails a lab test. It is a different thing from spurious.
- Penalty: since 2009, the worst cases carry 10 years to life in prison.
- Who polices: state drug controllers do most of the work. CDSCO sets standards and coordinates.
- Scale: a 2014-16 national survey found about 3% NSQ and a tiny share spurious.
- Warning sign: toxic cough syrups killed children in Gambia, Uzbekistan and Madhya Pradesh.
Key Words in One Line Each
What Does the Law Say About Bad Drugs?
What is the difference between spurious, adulterated, misbranded and NSQ?
People often use “fake” and “substandard” as if they meant the same. The law does not. Each term has its own section and its own punishment.
| Term | Section | What it means |
|---|---|---|
| Misbranded | 17 | The label is false or misleading, such as a wrong claim on the pack. |
| Adulterated | 17A | The drug is dirty, made in unclean conditions, or holds a harmful substance. |
| Spurious | 17B | The drug is an imitation, or it falsely names another maker or drug. |
| Not of standard quality | Act and Rules | A genuine drug that fails the set standard, such as less active ingredient than printed. |
Remember the order: 17 is misbranded, 17A is adulterated, 17B is spurious. Different law books may word the definitions a little differently. Read the Act’s own text for exam answers.
Sources: Indian Kanoon: Drugs and Cosmetics Act, 1940; Section 27, Drugs and Cosmetics Act (text).
Think it through. Why does the law treat a spurious drug more harshly than a drug that is merely NSQ?
Show the explanation
A spurious drug is a deliberate lie. Someone chose to copy or mislabel it. An NSQ failure may come from a bad batch or a weak process. The first is closer to fraud, so Parliament made the punishment heavier.
How tough is the punishment?
The Drugs and Cosmetics (Amendment) Act, 2008 raised the penalties. It came into force in 2009.
- Section 27(a): a spurious or adulterated drug that is likely to cause death or grievous hurt. Jail of 10 years up to life.
- Fine: at least ₹10 lakh, or three times the value of the drugs seized, whichever is more.
- Compensation: the fine is paid to the harmed person, or to the family if the person died.
- Lesser offences: adulterated or spurious drugs that are not so dangerous carry lighter terms. A plain NSQ failure usually draws a much lighter penalty.
Some offences under the Act are cognizable and not bailable.
Check 1
Under Section 27(a), a spurious drug likely to cause death can mean 10 years to life in prison.
Who Polices Drug Quality in India?
Is it the Centre or the states?
Both. But the split surprises many students. Most day-to-day policing is done by the states.
| Task | CDSCO | State |
|---|---|---|
| New drugs, trials | Yes | No |
| Imported drugs | Yes | No |
| Standards, advice to states | Yes | No |
| Most licences | Little | Yes |
| Vaccines, sera, blood, IV fluids | Shared | Shared |
| Inspections, samples | Some | Most of it |
| Prosecution | Some cases | Most cases |
CDSCO is the Central Drugs Standard Control Organisation. It works under the Directorate General of Health Services in the Health Ministry. Its head is the Drugs Controller General of India. Our article on Fixed-Dose Combinations: How India Regulates Medicines shows how CDSCO approves combination drugs.
Sources: CDSCO: about us and functions; Indian Kanoon: Drugs and Cosmetics Act, 1940.
Why do critics call this setup weak?
- Many regulators: there are dozens of state bodies. Quality of checks differs from state to state.
- Few inspectors: a small team must watch thousands of makers and lakhs of shops.
- Slow cases: trials take years. Offenders sometimes restart under a new name.
The Mashelkar Committee studied this in 2003. It urged a stronger central drug regulator and more funds for state drug bodies. It also wanted tougher penalties, non-bailable offences and special courts for spurious drugs. The 2008 amendment took up the penalty ideas. Reports differ on how far the rest was carried out.
Sources: Mashelkar Committee report (Dept of Pharmaceuticals); CDSCO: about us and functions.
How Does a Drug Sample Get Tested?
What are the steps from shop to court?
A drug inspector takes the sample under the Act. The sample is divided so that the seller and the court can have a part. A government lab then gives a report. Every month CDSCO puts out a list of drugs that failed. The list names the batch, the maker and the lab.
Sources: CDSCO: about us and functions; Indian Kanoon: Drugs and Cosmetics Act, 1940.
Check 2
A drug that fails a lab test is always called spurious.
How Big Is the Problem?
What did the national drug survey find?
The Health Ministry ran its biggest drug quality survey in 2014-16. The National Institute of Biologicals did the work.
- Samples: about 47,000 samples tested, covering 224 drug molecules.
- NSQ: around 3.2% of samples failed. The PIB release gave 1,850 NSQ samples.
- Spurious: only 13 samples, a tiny share.
- Government supply chain: reports said about 10% of samples from government sources were NSQ. That is higher than in shops.
The percentages in different reports do not match perfectly with the raw counts. Treat them as rough pictures, not exact scores.
Sources: PIB: national drug survey, Health Ministry; Down To Earth: 10% of drugs in government supply chain below standard.
What does the WHO say about the world?
In 2017 WHO said about 1 in 10 medical products in low- and middle-income countries is substandard or falsified. A companion study put the failure rate at 10.5%. It looked at more than 100 papers from 88 countries, covering around 48,000 samples.
WHO calls these figures an indication of scale, not an exact count.
Sources: WHO: 1 in 10 medical products is substandard or falsified (2017); WHO fact sheet: substandard and falsified medical products.
What do the monthly alerts show in 2026?
CDSCO publishes a monthly alert of drugs that failed. A failure applies only to the tested batch, not to the whole brand.
| Month 2026 | NSQ batches | Spurious |
|---|---|---|
| May | 159 (46 central, 113 state) | 1 (Assam) |
| June | 159 (27 central, 132 state) | None noted |
| July | 280 (40 central, 240 state) | 1 (Bihar) |
| August | 220 (29 central, 191 state) | 1 (Delhi) |
Note that state labs find many more failures than central labs. That is because states test far more samples.
Sources: Daily Pioneer: August 2026 drug alert.
Think it through. Does a high number of NSQ alerts mean Indian medicine is getting worse?
Show the explanation
Not necessarily. More testing finds more failures. A state that tests many samples will report many. Compare the number of failures with the number of samples tested before you decide.
Why Did Cough Syrups Kill Children?
What went wrong in the cough syrup cases?
Some syrups use propylene glycol as a safe solvent. Diethylene glycol (DEG) and ethylene glycol are cheap look-alikes. They are poisons that damage the kidneys. If a maker uses them, or the raw material is mixed up, children can die of kidney failure.
- Gambia, 2022: WHO issued an alert on four syrups made by Maiden Pharmaceuticals in Haryana. It linked them to kidney injury and 66 child deaths. Some reports give higher counts, and India disputed the link.
- Uzbekistan, 2022-23: WHO warned about syrups made by Marion Biotech. Reports said at least 19 to 20 children died. Indian lab tests later found many samples adulterated and spurious, and some employees were arrested.
- Madhya Pradesh, 2025: children in Chhindwara and nearby areas died after taking Coldrif syrup, made by Sresan Pharma in Tamil Nadu. The toll is reported as 23 or more, and reports differ. Lab tests found DEG far above the 0.1% limit. The maker’s licence was cancelled and its owner was arrested.
Many reports blame tainted raw material for the DEG. Whether the maker tested its raw material is a key question in each case.
Sources: WHO Medical Product Alert 6/2022; Al Jazeera: Gambia deaths and WHO; Chemistry World: Indian children’s deaths and cough syrup; CNN: WHO warning on contaminated cough syrup in India; DT Next: Sresan Pharma shut down; Tribune: ED on Coldrif maker.
Check 3
Diethylene glycol is a poisonous substitute that can damage the kidneys of children who take a contaminated syrup.
What Has India Changed?
What is the revised Schedule M?
Schedule M of the Drugs Rules sets Good Manufacturing Practices. A revised version was notified in December 2023. It asks makers to test raw materials, keep records and run a quality system.
- Large firms: had about 6 months to comply.
- MSMEs: firms with turnover up to ₹250 crore got extra time if they applied. The extended date was 31 December 2025.
- Since January 2026: CDSCO asked states to inspect units that did not apply or did not comply. Reports on any further extension conflict, so check the latest notice.
Small units are the weak link. They make a large share of India’s medicines but often lack money for upgrades.
Sources: Business Standard: CDSCO asks states to inspect under Schedule M; BW Healthcare World: Schedule M extension for MSMEs.
What is track and trace?
A QR or barcode on the pack lets anyone scan it and see whether it is genuine. It also helps recall bad batches faster.
- 2022: a new Schedule H2 was added to the Drugs Rules.
- 1 August 2023: QR or barcode became mandatory for the top 300 drug brands.
- June 2026: the Health Ministry extended it to vaccines, narcotic and psychotropic drugs and anti-cancer drugs by 1 July 2027. Antimicrobials follow by 1 July 2028.
What other steps followed the 2025 deaths?
Tamil Nadu banned Coldrif and shut the maker down. The Centre also amended Schedule K of the Drugs Rules and removed “syrup” from one of its cough-preparation exemptions. Check the notification text for the exact wording.
Sources: CNN: WHO warning on contaminated cough syrup in India; DT Next: Sresan Pharma shut down.
Quality also depends on price and supply. Cheap generics from Jan Aushadhi Scheme: Affordable Generic Medicines in India only work if they are tested. For the link between standards and prices, see Essential Medicines in India: NLEM, DPCO and Drug Price Control. The body that writes the standards is described in Indian Pharmacopoeia Commission.
What Is Happening Now?
What are the latest developments in 2026?
- Monthly alerts continue: the August 2026 list, published in September, showed 220 NSQ batches and one spurious sample from Delhi.
- QR codes widen: the June 2026 notification adds more drug groups with dates in 2027 and 2028.
- Schedule M: small firms face inspections. Some reports say industry wants more time.
- Policy talk: the call for one stronger national regulator keeps returning after each scandal.
Dates and counts in live news change often. Check CDSCO’s notices for the latest.
Sources: Daily Pioneer: August 2026 drug alert; RAPS: India expands QR codes for traceability; Business Standard: CDSCO asks states to inspect under Schedule M.
What Is the Debate?
What do people argue about?
- Stronger centre: some experts want one national drug regulator with direct control over quality.
- States’ role: others say drugs are a state subject in practice, and states know local shops best.
- Tough penalties versus workable law: heavy jail terms deter fakes. But critics fear honest small makers may be punished for minor lapses.
- Cost of compliance: better factories raise costs, which may hurt MSMEs and cheap generics.
- Testing at source: testing every batch of raw material helps most, but needs money and trained staff.
Sources: The Bureau of Investigative Journalism: toxic cough syrup; Chemistry World: Indian children’s deaths and cough syrup.
Exam Angle
- Section 17 is misbranded, 17A adulterated, 17B spurious. NSQ is a separate quality failure.
- Section 27(a): 10 years to life, fine at least ₹10 lakh or three times the value of the drugs.
- The 2008 amendment came into force in 2009. The Mashelkar Committee reported in 2003.
- CDSCO works under DGHS. States license most manufacturers and shops.
- 2014-16 survey: roughly 3% NSQ and a tiny share spurious. WHO: about 1 in 10 in low- and middle-income countries.
- Cough syrup cases involve DEG. Know Gambia 2022, Uzbekistan 2022-23 and Madhya Pradesh 2025.
- Track and trace: QR code on the top 300 brands since 1 August 2023.
MCQ on Spurious and Substandard Drugs
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