Every prescription medicine carries two names: the brand name chosen by the company selling it, and the name of the active ingredient, the substance that does the work, which pharmacists in India often call the salt or the molecule. A product sold under that second name is a generic. People searching for generic medicine online want a licensed product with the same active ingredient in the same strength as the branded version, made by a different company at a lower price.
What makes a medicine “generic”
When a medicine is new, the company that developed it holds exclusive rights for a set period. Once those lapse, other licensed manufacturers may make the same formulation. What they sell is a generic medicine: same active ingredient, same strength, same form, different maker, and a name taken from the chemistry rather than from marketing.
Generic vs branded medicine: what is actually different
The active ingredient and its strength stay constant. What may differ is the manufacturer, the price, the look of the tablet, and the inactive ingredients: the fillers, coatings and colours around it. The US Food and Drug Administration permits minor differences in appearance, and notes that inactive ingredients can affect tolerability or absorption in a minority of patients.
A generic contains the same active ingredient in the same strength, a narrower claim than calling it the same as the branded product.
What the regulator requires before a generic can be sold
In India this is the Central Drugs Standard Control Organisation’s remit, under the New Drugs and Clinical Trials Rules, 2019. Those rules define a bioequivalence study as one showing no statistically significant difference in how much of the active ingredient is absorbed, and how fast, against a reference formulation of the same ingredient. In plain words, the body takes up the same amount at the same speed.
The rules also govern who may run one. No such study may be conducted without permission from the Central Licencing Authority and approval from a registered ethics committee. The World Health Organization sets the bar the same way, holding that a generic product must satisfy the standards applied to the originator.
WHO-GMP is separate: Good Manufacturing Practices describe how a factory produces and controls medicines, and WHO’s guidance is the basis for inspecting those sites. The certificate describes the manufacturer’s production standard. It says nothing about how a medicine acts in one patient. Medkart states that its medicines come from WHO-GMP certified manufacturers.
Where the price difference comes from
Development accounts for much of it. The FDA explains that generic companies do not repeat the costly clinical trials that established the original medicine, showing therapeutic equivalence instead.
Price rules account for some of the rest. The National Pharmaceutical Pricing Authority sets ceiling prices for scheduled medicines under the Drugs (Prices Control) Order, 2013, and caps annual increases for the others.
The government has measured the gap that remains. Under the Pradhan Mantri Bhartiya Janaushadhi Pariyojana a medicine is priced at no more than half the average of the top three brands, and the Ministry of Chemicals and Fertilizers has told Parliament that scheme prices run 50 to 80 per cent below branded ones.
Where generics need more care
A small group of medicines has what clinicians call a narrow therapeutic index: the margin between too little and too much is slim, so small differences in absorption matter. The UK regulator, the MHRA, has sorted anti-epileptic medicines into three risk-based categories, and for the first it advises keeping a patient on one manufacturer’s product.
That judgement belongs to the prescriber. It is why no pharmacy should tell a patient that the cheaper pack in front of them can replace the one their doctor wrote down.
How to buy generic medicine online, and what to ask first
A licensed pharmacy asks to see the prescription before dispensing. The pack that arrives should state the same active ingredient and strength the prescription names, and where a doctor has specified a manufacturer, that instruction stands.
Medkart built its comparison tool for this step, placing a branded medicine beside its generic equivalent with both prices visible, the generic versus branded medicine comparison a patient would otherwise assemble at a counter. The company has run its own stores since 2014 and states its purpose as making sure every citizen is fully aware of generic medicines and free to choose. It says customers have saved up to 85 per cent, its own figure.
Before ordering
The argument for generics rests on what the regulator checks before a medicine reaches a shelf. Anyone weighing a change has two steps worth taking: compare a branded medicine with its generic equivalent and look at both prices, or ask a pharmacist which active ingredient the prescription names and whether the manufacturer should stay fixed. Buying generic medicine online is worth doing once that second question has an answer.
FAQ
Are generics as safe as branded medicines? Regulators apply the same standards. CDSCO requires bioequivalence data before approval, and WHO holds that a generic product must satisfy the standards applied to the originator. Questions about a specific medicine belong with a prescriber.
Why do generic medicines cost less? The FDA explains that generic manufacturers do not repeat the clinical trials that established the original medicine, so development costs are far lower. India’s price control rules bring the retail figure down.
Can any medicine be switched to its generic version? No. Medicines with a narrow therapeutic index, anti-epileptics among them, are treated more cautiously by regulators such as the MHRA. Whether a switch suits a patient is the prescriber’s decision.
How can a patient check what a pharmacy has supplied? Read the active ingredient and strength printed on the pack, then compare both against the prescription. If either differs, or the doctor named a manufacturer, the pharmacist should be asked first.
Disclaimer: This article is general information about generic medicines and how they are regulated. It is not a substitute for professional medical advice, diagnosis or treatment. No medicine should be started, stopped, substituted or changed in any way without the prescriber who wrote it. Anyone with a question about a specific prescription should speak to their doctor or a registered pharmacist .
References
- Central Drugs Standard Control Organisation, Ministry of Health and Family Welfare. The New Drugs and Clinical Trials Rules, 2019. Definition of a bioequivalence study, rule 2(1)(f); permission from the Central Licencing Authority and ethics committee approval for bioavailability and bioequivalence studies, rules 31 to 35. https://cdsco.gov.in/opencms/resources/UploadCDSCOWeb/2022/new_DC_rules/23NEW%20DRUGS%20AND%20CLINICAL%20TRIALS%20RULES,%202019.pdf
- World Health Organization, Prequalification of Medical Products. Bioequivalence. Multisource generic products must satisfy the same standards as those applied to the originator product. https://extranet.who.int/prequal/medicines/bioequivalence
- World Health Organization. TRS 986, Annex 2: WHO good manufacturing practices for pharmaceutical products, main principles. GMP as the standard used to justify GMP status and as a basis for the inspection of manufacturing facilities. https://www.who.int/publications/m/item/trs986-annex2
- US Food and Drug Administration. Generic Drugs: Questions and Answers. Non-repetition of clinical trials and lower development costs; permitted minor differences in appearance; inactive ingredients affecting tolerability or absorption in a minority of patients. https://www.fda.gov/drugs/generic-drugs/generic-drugs-questions-answers
- Medicines and Healthcare products Regulatory Agency, United Kingdom. Antiepileptic drugs: advice on switching between different manufacturers’ products for a particular drug. Drug Safety Update, updated November 2017. Narrow therapeutic index; three risk-based categories. https://www.gov.uk/drug-safety-update/antiepileptic-drugs-new-advice-on-switching-between-different-manufacturers-products-for-a-particular-drug
- Ministry of Chemicals and Fertilizers, Government of India. Gap in Price of Branded and Janaushadhi Medicine. Press Information Bureau, 11 February 2022. PMBJP pricing principle; NPPA ceiling prices under the Drugs (Prices Control) Order, 2013, and the cap on annual increases for non-scheduled medicines. https://www.pib.gov.in/PressReleaseIframePage.aspx?PRID=1797762®=48&lang=2
- Ministry of Chemicals and Fertilizers, Government of India. The Government launched the Pradhan Mantri Bhartiya Janaushadhi Pariyojana scheme to make quality generic medicines available at affordable prices to all. Press Information Bureau, 25 July 2025. Scheme prices about 50 to 80 per cent below branded prices. https://www.pib.gov.in/PressReleasePage.aspx?PRID=2148570
