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Centre notifies new export norms for doxycycline 100 mg dispersible tablets
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Shardul Nautiyal, Mumbai
April 30 , 2025
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In a significant move to streamline and promote pharmaceutical exports, the Directorate General of Foreign Trade (DGFT) has issued Public Notice announcing the fixation of a new Standard Input Output Norm (SION) for doxycycline 100 mg dispersible tablets under the Chemical and Allied Products category (Product Code 'A').
Doxycycline is used to treat bacterial infections in many different parts of the body. It is also used to treat pimples and abscesses (usually on the face) that are caused by rosacea, also known as acne rosacea or adult acne.
Under the powers conferred by Paragraph 1.03 of the Foreign Trade Policy (FTP) 2023, as amended from time to time, the DGFT notified the introduction of a new SION entry bearing Serial Number A-3685. The newly introduced SION specifically relates to the export of "Doxycycline 100 mg dispersible tablets (equivalent to Anhydrous Doxycycline 100 mg)."
Details of the New SION (A-3685) specifies export product: Doxycycline 100 mg dispersible tablets with export quantity of one tablet. The input material allowed is doxycycline monohydrate USP/BP and input quantity permitted is 106.13 mg per tablet.
This fixation of input-output norms specifies the permissible quantity of raw material — Doxycycline monohydrate conforming to US Pharmacopoeia (USP) or British Pharmacopoeia (BP) standards — that exporters can import duty-free against the export obligation of dispersible doxycycline tablets.
The notification provides greater clarity and facilitation to pharmaceutical manufacturers and exporters by standardizing the material requirement for producing the widely used antibiotic in dispersible form. This move is expected to ease the procedural aspects for exporters while promoting greater competitiveness in international markets, especially for Indian pharmaceutical companies specializing in antibiotic formulations.
Given the growing global demand for affordable, high-quality antibiotics, particularly in developing and low-income countries, this regulatory update is poised to enhance India's standing as a major supplier of essential medicines.
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