Section 92A explained: this guide covers what it means, who it applies to, the step-by-step process, documents required, fees, due dates and penalties in India — so you can stay compliant with confidence and avoid costly mistakes.
Section 92A allows a compulsory licence to manufacture patented pharmaceutical products in India solely for export to a country that has insufficient or no manufacturing capacity in the pharmaceutical sector to address public health problems. The importing country must itself have granted a compulsory licence or must have allowed importation of the product from India, by notification or otherwise. The Controller grants the licence on application in the prescribed manner. If you are considering such a licence, our legal consultation team can walk you through the conditions.
A compulsory licence is available for manufacture and export of patented pharmaceutical products to a country with insufficient or no manufacturing capacity in the pharmaceutical sector for the product, to address public health problems, provided that country has granted a compulsory licence or has allowed importation from India by notification or otherwise. The Controller shall grant it on an application in the prescribed manner, solely for manufacture and export to that country, on terms specified and published by him.
Amendments to know
Section 92A was inserted by the Patents (Amendment) Act, 2005 (from 1 January 2005) and is printed in square brackets as an inserted section. The Tribunals Reforms Act, 2021 and the Jan Vishwas (Amendment of Provisions) Act, 2023 did not change it. The text itself does not name any treaty. The ordinary compulsory licence is section 84 (our post on compulsory licensing under section 84), the special route in a national emergency is section 92 (see our article on section 92), and section 92A is a third, separate route tied to export.
Sub-section (1): when a licence is available
"Compulsory licence shall be available for manufacture and export of patented pharmaceutical products to any country having insufficient or no manufacturing capacity in the pharmaceutical sector for the concerned product to address public health problems, provided compulsory licence has been granted by such country or such country has, by notification or otherwise, allowed importation of the patented pharmaceutical products from India."
Break it into conditions:
| Condition | Text |
|---|---|
| What is covered | Manufacture and export of patented pharmaceutical products |
| Destination | Any country having insufficient or no manufacturing capacity in the pharmaceutical sector for the concerned product |
| Purpose | To address public health problems |
| Importing country's step | Either (a) a compulsory licence has been granted by that country, or (b) that country has, by notification or otherwise, allowed importation of the patented pharmaceutical products from India |
The sub-section says a licence "shall be available". It does not say who certifies that a country has insufficient capacity or how the importing country's step is proved. The text does not require that the importing country be a particular kind of country.
Sub-section (2): the Controller's grant
"The Controller shall, on receipt of an application in the prescribed manner, grant a compulsory licence solely for manufacture and export of the concerned pharmaceutical product to such country under such terms and conditions as may be specified and published by him."
- Duty: the Controller "shall" grant on receipt of an application in the prescribed manner. The form and fee are in the Patents Rules, 2003, not covered here.
- Scope: "solely for manufacture and export" of the concerned product to the country in question. The licence is not for sale in India under this section.
- Terms: "such terms and conditions as may be specified and published by him". The Controller must specify and publish the terms. The text does not list the terms, and section 90 is not referred to in this section.
Sub-section (3): no prejudice to other export rules
"The provisions of sub-sections (1) and (2) shall be without prejudice to the extent to which pharmaceutical products produced under a compulsory licence can be exported under any other provision of this Act." Other provisions may permit export of products made under a compulsory licence, for example section 84(7)(a)(iii) on an export market not being supplied or developed and section 90(1)(vii) on export, if need be, under a section 84 licence. Section 92A does not cut those down.
Explanation: what "pharmaceutical products" means
"For the purposes of this section, 'pharmaceutical products' means any patented product, or product manufactured through a patented process, of the pharmaceutical sector needed to address public health problems and shall be inclusive of ingredients necessary for their manufacture and diagnostic kits required for their use."
So the term covers:
- any patented product of the pharmaceutical sector needed to address public health problems;
- a product manufactured through a patented process;
- the ingredients necessary for their manufacture; and
- diagnostic kits required for their use.
This is wider than finished medicines. The Explanation does not define "pharmaceutical sector" or "public health problems".
How section 92A differs from sections 84 and 92
| Feature | Section 84 | Section 92 | Section 92A |
|---|---|---|---|
| Purpose | Working in India, affordability, public requirements | National emergency, extreme urgency, public non-commercial use | Export of pharmaceutical products to a country with insufficient capacity |
| Who triggers | Any person interested after three years from grant | Central Government notification, then applicants | Applicant; importing country has granted a compulsory licence or allowed import from India |
| Procedure | Section 87 | Section 87 not applied in urgent cases | The text prescribes application and terms specified and published; no reference to section 87 |
| Scope of use | Working in India | Working the invention | "Solely for manufacture and export" |
Illustration (invented)
Harita Biologics Ltd. holds an Indian patent for an anti-tubercular combination. Country X has no manufacturing capacity for this product and has, by notification, allowed the importation of the patented pharmaceutical products from India. A generic manufacturer, Prakash Remedies Pvt. Ltd., applies to the Controller in the prescribed manner for a compulsory licence solely for manufacture and export of the product to Country X. The Controller grants the licence on terms that he specifies and publishes. Prakash may then manufacture the combination and export it to Country X only; the licence does not authorise sales in India under this section. If the application also covers an intermediate ingredient and a diagnostic kit required for use of the product, the Explanation brings them within "pharmaceutical products".
What the section does not say
- No definition of "insufficient manufacturing capacity" and no authority to certify it.
- No time limit for the Controller to decide.
- No statement about royalty; the Controller specifies and publishes the terms.
- No mention of any hearing of the patentee; the section does not refer to section 87.
- The section does not name any international treaty.
- It does not list any countries.
Need help with an export compulsory licence?
The two conditions about the importing country and the scope "solely for manufacture and export" are strict. Our legal consultation team can assess whether your product and the destination country fit the section, and prepare the application in the prescribed manner.
Key takeaways
- Section 92A makes a compulsory licence available for manufacture and export of patented pharmaceutical products to a country with insufficient or no manufacturing capacity, to address public health problems.
- The importing country must have granted a compulsory licence or allowed importation from India.
- The Controller shall grant the licence, solely for manufacture and export, on terms specified and published by him.
- "Pharmaceutical products" includes ingredients and diagnostic kits.
Read next
- Sections 93 and 94: licence as deed between parties and termination of compulsory licence
- Section 92: compulsory licence on Central Government notification
- Pharma patents in India: section 3(d) and TRIPS compliance
- Patent for chemical and pharma inventions: special rules
Disclaimer: Based on the Patents Act, 1970 as amended up to the Jan Vishwas (Amendment of Provisions) Act, 2023, as consulted on 1 October 2026. Forms, fees and time limits under the Patents Rules, 2003 change from time to time and are not covered here. This article is general information, not legal advice; check the official text before acting.