Section 92A of the Patents Act, 1970
Compulsory licence for export of patented pharmaceutical products in certain exceptional circumstances
Allows a compulsory licence to make and export patented medicines to countries that cannot manufacture them for their own public health needs.
Official legal text
The verbatim statutory text of this provision is reproduced from the official source and checked by our legal reviewer before it is published here. Until that check is complete for this page, read the exact wording directly from the official source linked below — it is the only version that governs.
This explanation is written for clarity, not for citation. The official statutory text and any Gazette notification in force on your date govern, and they prevail over anything said here.
What this section says, in plain language
Section 92A answers a problem that the rest of the chapter does not reach. A country facing a health crisis may issue a compulsory licence of its own, and still have no factory able to make the medicine. India, with large pharmaceutical manufacturing capacity, can fill that gap. This section was inserted by the Patents (Amendment) Act, 2005 to give effect to the international arrangement agreed at the World Trade Organization after the Doha Declaration on TRIPS and Public Health.
The licence it allows is export-facing. It is available for the manufacture and export of patented pharmaceutical products to any country that has insufficient or no manufacturing capacity in the pharmaceutical sector for the product concerned, where the export is to address a public health problem in that country.
There is a condition on the importing country's side. That country must either have granted a compulsory licence for the product itself, or must have allowed importation of the patented pharmaceutical product from India by notification or otherwise. India does not decide on its own that another country needs the medicine; the importing country has to open the door.
The Controller grants the licence on an application made in the prescribed manner, using Form 17 under Rule 96 with the fee prescribed in the First Schedule, and settles the terms and conditions, which are published. Terms in practice deal with the quantity to be made, the identity of the importing country, distinctive packaging or marking so the goods are not diverted, and the remuneration to be paid to the patentee.
The Act defines pharmaceutical products broadly for this purpose. It covers any patented product, or product made through a patented process, of the pharmaceutical sector that is needed to address public health problems, and it expressly includes ingredients necessary for their manufacture as well as diagnostic kits. So the route is not limited to finished tablets.
Why this section matters
Indian pharmaceutical manufacturers, importing countries with no manufacturing capacity, global health procurement agencies, and patentees of medicines and diagnostics.
When an importing country has issued its own compulsory licence or allowed import, and an Indian manufacturer is ready to supply.
A statutory route to a compulsory licence limited to manufacture and export, on terms the Controller specifies and publishes.
Exporting a patented medicine without such a licence is infringement in India, whatever the humanitarian need in the destination country.
How it works in practice
Supplying a paediatric medicine to a country with no plant
A country in East Africa faces a sharp rise in a treatable childhood infection. The medicine is patented there and in India, and the country has no facility able to make it. Its government issues a compulsory licence under its own law and notifies that it will import the product from India. Aarogya Formulations Pvt Ltd of Hyderabad applies to the Controller under Section 92A on Form 17, attaching the importing country's notification, its own manufacturing and quality approvals, and the quantities requested. The Controller grants a licence limited to manufacture for export to that country, and settles terms: the quantity permitted, distinct packaging and colouring so the product cannot be diverted into the Indian market, record keeping and reporting, and the remuneration payable to the patentee. The terms are published. Aarogya may not sell the product in India under this order, because the licence exists only for the export purpose the section describes.
Simplified illustration only. Actual legal outcomes depend on the facts.
Key points to remember
- Inserted in 2005 to implement India's obligations under the WTO arrangement following the Doha Declaration on TRIPS and public health.
- The licence is for manufacture and export only, not for the Indian market.
- The importing country must have insufficient or no manufacturing capacity for that product.
- That country must itself have granted a compulsory licence or otherwise allowed import from India.
- Pharmaceutical products are defined widely and include ingredients and diagnostic kits.
- The Controller settles and publishes the terms; the application goes on Form 17 under Rule 96.
Common mistakes and misunderstandings
- Assuming an Indian licence alone is enough. Without the importing country's compulsory licence or import permission, the route is not available.
- Treating the licence as general. Quantities, destination and packaging conditions are usually fixed, and diversion into other markets breaches the order.
- Thinking only finished medicines qualify. The definition also covers active ingredients needed to make them and diagnostic kits.
- Believing the patentee is not paid. Remuneration forms part of the terms the Controller settles.
Connected provisions
The Patents Act sets the requirement; the Patents Rules, 2003 set the procedure that carries it out. Parliament passes the Act and the Central Government makes the Rules, so the two are separate instruments. We list the connected rules here to take you from the principle to the paperwork.
Forms, deadlines and fees
Forms are not set out in the Act. They are prescribed in the Second Schedule to the Patents Rules and are revised from time to time, so obtain the current version from the official website before filing.
Any official fee connected with this provision is fixed by the First Schedule to the Patents Rules, not by the provision itself. The amount depends on who the applicant is and on whether the filing is made online or on paper, so no figures are reproduced here. How Indian patent fees work.
Amendment history
What changed in this provision, newest first. Read the footnotes in the official consolidated text for the full record.
- 2005The Patents (Amendment) Act, 2005The section was inserted. It allows a compulsory licence to make and export a patented pharmaceutical product to a country with little or no manufacturing capacity in the pharmaceutical sector, where that country has permitted the import.
Compiled from official consolidated texts and Gazette notifications. See the site-wide change log.
Related judgments
This part of the page is reserved for summaries of decided cases. They are added one at a time, after review by a person qualified to confirm that the summary matches the judgment. Nothing has been cleared for this provision so far, so there is nothing to show. How case notes are prepared.
Questions people ask about Section 92A
Which countries can receive medicines under Section 92A?
Countries that have insufficient or no manufacturing capacity in the pharmaceutical sector for the particular product, and that need it to address a public health problem. The section does not list countries. What matters is the factual position for that product and the step the importing country has taken: it must have granted a compulsory licence for the product itself, or have allowed importation of the patented product from India by notification or otherwise. Evidence of both capacity and permission normally accompanies the application to the Controller.
Can the medicine made under this licence be sold in India?
No. The licence exists for manufacture and export to the identified country, so domestic sale is outside it. Orders under this section commonly carry practical anti-diversion conditions, such as distinctive packaging, labelling or colouring, batch records, and reporting of quantities shipped. A manufacturer that sells the product into the Indian market under cover of such a licence would be acting outside the order and would be exposed to an infringement claim by the patentee.
Does Section 92A apply to medical devices or diagnostics?
The section is about pharmaceutical products, but the Act defines that term broadly for this purpose. It covers any patented product, or product manufactured through a patented process, of the pharmaceutical sector needed to address public health problems, and it expressly includes ingredients necessary for their manufacture and diagnostic kits. So diagnostic kits are within scope. General medical equipment that is not of the pharmaceutical sector would need to be considered under the ordinary compulsory licence provisions instead.
Exporting a patented medicine to a country in need?
MYCrave prepares Section 92A applications, importing-country evidence and the anti-diversion terms the Controller expects to see.
You will be speaking with MYCrave Consultancy & Services, the firm that operates this platform. General questions are answered free; matter‑specific work is quoted before anything is done.