CSIR-Indian Institute of Chemical Technology, Hyderabad, announced on 12 August 2026 an IND-ready phytopharmaceutical drug candidate for diabetic foot ulcers, developed from the medicinal plant Gymnema sylvestre.
The institute signed a technology transfer agreement with Viridis Biopharma Pvt Ltd, Mumbai, which will take the candidate through regulatory submissions to the CDSCO and the US FDA and into clinical evaluation.
The work was carried out by CSIR-IICT's Department of Applied Biology under Dr Anthony Addlagatta, with Dr Srigiridhar Kotamraju and Dr Aruna Jangam among the key researchers.
The candidate was developed under Phase III of the CSIR Phytopharmaceutical Mission and holds patent protection in India and in international jurisdictions.
Researchers have linked the therapy to other chronic wounds and inflammatory skin disorders beyond diabetic foot ulcers.
Under the Drugs and Cosmetics Rules, 1945, a phytopharmaceutical drug is a purified and standardised fraction of an extract of a medicinal plant or its part, containing a defined minimum of four bio-active or phytochemical compounds assessed both qualitatively and quantitatively, meant for internal or external use in humans or animals - but excluding administration by the parenteral route. The category was created by a 2015 amendment to the rules (notification GSR 918(E)), which added Appendix I-B to Schedule Y setting out the data required for approval. It is regulated by the Central Drugs Standard Control Organisation (CDSCO), not by the AYUSH framework that governs Ayurvedic, Siddha and Unani medicines.
Simple Analogy: A traditional herbal preparation is like a home-cooked dish whose recipe varies with the cook; a phytopharmaceutical is the same dish standardised to a fixed formula, with every ingredient measured, so that each batch behaves identically and can be tested like any modern medicine.
An Investigational New Drug application seeks permission to begin human trials; a New Drug Application seeks permission to market the drug after trials succeed. IND-ready means the first of these, not approval to sell.
A quality system for non-clinical safety studies. Regulators worldwide accept preclinical safety data only if generated in GLP-compliant facilities.
CSIR licenses laboratory-developed technologies to industry for commercialisation; this converts publicly funded research into products and generates royalty income for the laboratory.
India's Traditional Knowledge Digital Library was created to stop patenting of known traditional remedies abroad; phytopharmaceutical development is the constructive counterpart, generating fresh, patentable science on Indian plants.
GS Paper 3 > Science and Technology - indigenous technology, developments in biotechnology
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A medicinal plant of the Indian tradition, known as Gurmar or Podapatri, long associated with the management of blood sugar.
A stage at which a drug candidate has completed all preclinical work required before an application to begin human clinical trials.
A quality management system governing non-clinical safety studies on medicines and chemicals.
Central Drugs Standard Control Organisation, India's central drug regulator under the Ministry of Health and Family Welfare, headed by the Drugs Controller General of India.