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India has drafted the first regulatory guidelines for developing and evaluating nanopharmaceutical products for therapeutic use in the country. The new precepts, applicable to finished formulations and APIs, are expected to speed up commercialisation of nanotechnology-based medical innovations by establishing transparent and predictable regulatory procedures.
Nanopharmaceutical segment is an emerging field that combines nanotechnology with pharmaceutical and biomedical science to enable targeted drug delivery. Of late, the Central government has announced several initiatives to promote academia-industry collaborations and public-private partnerships in this area through its Nano Mission, an umbrella programme under the Department of Science and Technology. While the application of this technology has huge potential to improve the therapeutic efficacy of a drug, the nanocarriers could change the action of a conventional medication that is loaded in the nanosystems, causing additional toxicity risk. Considering the complexity of the nanomaterial behaviour in the biological environment, clear-cut guidelines are imperative to ensure treatment efficacy and patient safety.
Since there are no specific parameters for development of such medications in India at present, the comprehensive guidance document prepared by experts from the Department of Biotechnology (DBT) and Indian Society of Nanomedicine, once adopted, would come in handy for manufacturers, importers and other industry stakeholders involved in research and development of nanopharmaceuticals.
The draft guidelines were formulated after a series of meetings with various industry stakeholders. They were further revised following an inter-ministerial meeting held recently. Institutions and industry representatives can submit their observations and suggestions on the draft until March 10.
The 49-page guidance document, a copy of which has been reviewed by Pharmabiz, classifies nanopharmaceuticals on the basis of their degradability, organicity, function and approval status. Their safety studies should be conducted as per general guidelines specified in Schedule Y of Drugs and Cosmetics (D&C) Rules of 1945. However, the rules don’t apply to conventional drugs with incidental presence of nanoparticles or drug products containing microorganisms or proteins which are naturally present in the nanoscale range. They are also not applicable to medical devices, in-vitro diagnostics, tissue-engineered products using nanotechnology or nanoparticle-modified cell-based therapy.
The guidelines stipulate that all nanopharmaceutical preparations will be treated as investigational new drug (IND) permanently and may be subject to differential scrutiny. The requirements of quality, safety and efficacy data may vary depending on the approval status of the drug and the nanomaterial. For instance, if the drug is a new molecular entity but the nanocarrier system is already used for other nanopharmaceuticals, the product should be considered as an IND and the general requirement for quality, safety and efficacy will be same as specified in Schedule Y of D&C Rules of 1945. In such cases, independent studies for the carrier are not mandatory.
Stability testing of developmental nanopharmaceuticals must be done extensively and systematically. As the drug is loaded in the nanocarrier, the stability of the drug in an active form should be tested from time to time. The tests should focus on functionality, integrity, size of nanoparticles, carrier material stability, drug stability and degradation products. It should be ensured that the selected stability storage conditions are relevant for the specific product and studies are done in intended market packs.
According to researchers, the novel technology’s application in treatment of chronic conditions such as cancer could substantially reduce drug toxicity in chemotherapy patients. In a country like India, where the crude incidence rate of cancer increased by 28 per cent between 1990 and 2016 and the number of new cases touched 1.1 million, making use of nanotech-based therapies will have far-reaching positive effects. Last year, a team of scientists at Regional Centre for Biotechnology at Faridabad has validated a nanotech-based novel cancer drug delivery system for the first time. Unlike the drug delivery systems currently available in the country, the new technology ensured a fourfold enhancement in bioavailability, which meant three times higher drug concentration at tumour site.
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