Why this site names no medicine
India’s marketing code counts information from a manufacturer as promotion and forbids promotion before marketing approval. What that means for a site like this one.
Medicines made outside India
Importing a medicine into India, form by form
Indian law gives every step a numbered form. Form 40 puts the foreign factory and its drug on the register, Form 8 asks for the import licence, Form 19 for the licence to sell by wholesale. This guide follows each one to the rule that creates it.
This site presents no medicine. Why
The route
The route, in order
Five steps between a factory abroad and a wholesaler in India. The third applies only to a new drug.
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Form 19 to Form 20B or 21B
Wholesale licence
The Indian agent or importer
A State licence to sell or distribute drugs by wholesale. It is what qualifies the Indian party to act for the manufacturer.
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Form 40 to Form 41
Registration Certificate
The manufacturer abroad
Registers the foreign factory and each drug made there. Applied for through the authorised agent in India.
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Form CT‑18 to Form CT‑20
New drug permission
The importer, if the drug is new in India
Needed only for a new drug. Granted or refused with reasons within 90 working days.
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Form 8 + Form 9 to Form 10
Import licence
The importer in India
Applied for with the manufacturer’s undertaking and a copy of the Registration Certificate.
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Rule 43A
Port of entry
The consignment
Drugs enter India only through a listed seaport, airport, inland container depot or land station.
The parties
Who holds what
In the usual route each licence belongs to a different party: the Registration Certificate is issued for the manufacturer abroad and its premises, the import licence to the importer in India.
| Document | Held by | Issued by | Applied for in |
|---|---|---|---|
| Wholesale licence (Form 20B or 21B) | The Indian agent or importer | The State licensing authority | Form 19 |
| Registration Certificate (Form 41) | The manufacturer abroad | The licensing authority under rule 21 | Form 40, through the authorised agent |
| New drug permission (Form CT‑20) | The importer of a new drug | The Central Licencing Authority | Form CT‑18 |
| Import licence (Form 10) | The importer in India | The licensing authority under rule 21 | Form 8, with the undertaking in Form 9 |
| Test licence (Form 11) | The institution or firm doing the testing | The licensing authority under rule 21 | Form 12 |
Drugs Rules, 1945, rules 21, 24, 24A, 33, 34, 59 and 61; New Drugs and Clinical Trials Rules, 2019, rules 75 and 76
Promotion
No marketing approval, no promotion
Indian law limits what may be said about a medicine, both before it is approved and once it is. The rules apply to material for doctors as well as to the general public.
Read the note- UCPMP 2024, clause 1.2A drug must not be promoted before its marketing approval, and promotion must stay within the terms of that approval.
- Drugs and Cosmetics Act, section 18(c)Selling, stocking, exhibiting or offering a drug for sale needs a licence.
- Drugs Rules, rule 106No drug may claim to prevent or cure any of the 51 diseases and ailments in Schedule J.
- Magic Remedies Act, sections 3 and 14Advertisements suggesting a drug for the conditions in its Schedule are prohibited; the exemption for doctors covers material sent confidentially to a registered medical practitioner only.
To read
Notes
Three points on the route, explained with the text of the rules.
When is a medicine a new drug in India?
A medicine approved for years abroad can still be a new drug in India. The definition in the New Drugs and Clinical Trials Rules, 2019, and what follows from it.
Schedule J: the claims no medicine may make in India
Rule 106 of the Drugs Rules lists 51 diseases and ailments that no drug may claim to prevent or cure. The list, and the 54 conditions of the Magic Remedies Act beside it.
For businesses and professionals in the health sector
A question about the route?
The form is open to manufacturers, importers, authorised agents, wholesalers, pharmacies, doctors and hospitals. Write your organisation’s details and your question; the reply comes by email.
Go to the form