Guidelines Released for Evaluation of Nano-pharmaceuticals

The Minister for Science and Technology, Earth Sciences and Health and Family Welfare, today released guidelines for evaluation of nano-pharmaceuticals, which are emerging as more potent tools for treating various diseases.

The document, which covers all the aspects of evaluation from the definition and categorization of Nanopharmaceuticals to pharmacovigilance of the new set of therapeutics, has been prepared as a joint project by the Department of Biotechnology in the Ministry of Science and Technology, and Indian Council of Medical Research and Central Drugs Standard Control Organization in the Ministry of Health and Family Welfare.

Nano-pharmaceuticals, which are derived by the application of nanotechnology in medical therapeutics are expected to bring about a revolution in treatment strategies as they would enable target-specific delivery of drugs and therapeutic molecules and thus offer higher efficacy and lower toxicity in many disease conditions. They are expected to be great use, particularly in cancer treatment.

Every year several new nano-pharmaceuticals are being developed and marketed across the world. India too has a sizable pool of nano-scientists generating a large number of scientific publications in this domain. However, regulatory approval is the most important factor for translating laboratory research into bedside medicine. The new set of guidelines is designed to facilitate this process.

Noting that the document has been prepared by domain experts in consultation with representatives of the industry, Dr. Harsh Vardhan expressed confidence that it will give a big boost to innovators and drug manufacturers to optimize their research and come out with medicines that would be safer and more affordable.

Dr. Harsh Vardhan also announced that a three-day international conference will be organized by Department of Biotechnology and Confederation of Indian Industry here from November 21 to 23 in collaboration with the Association of Biotech-Led Enterprises (ABLE) and Biotechnology Industry Research Assistance Council (BIRAC), which is a public sector undertaking under DBT to showcase India’s prowess in the area of biotechnology and help build new partnerships and investment opportunities.

Titled Global Bio-India 2019, the meet will deliberate on opportunities and challenges in the areas of bio-agriculture, bio-industry, bio-energy, bio-services, and biopharma sectors. It will have several components including policy dialogues, an investor round table, a meeting of regulators across the world and an exhibition.

Secretary, Department of Biotechnology, Dr. Renu Swarup, Secretary, Department of Health Research and Director General, Indian Council of Medical Research, and Dr. Balram Bhargava, and Drugs Controller General of India, Dr.V.G.Somani, hoped that the Indian pharmaceutical sector would make the best use of the guidelines in their work.

Sunderarajan Padmanabhan

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