The Union government recently released Guidelines for Evaluation of Nanopharmaceuticals in India to provide transparent regulatory pathways for nanopharmaceuticals in India, ensuring“Affordable Health Care for All”.
About the guidelines
- The Guidelines are developed by the Department of Biotechnology (DBT), Ministry of Science and Technology, Indian Council of Medical Research (ICMR) and Central Drugs Standard Control Organization (CDSCO), Ministry of Health.
- They apply to the nanopharmaceuticals in the form of finished formulation as well as Active Pharmaceutical Ingredient (API) of a new molecule or an already approved molecule with altered nanoscale dimensions intended to be used for treatment or prevention of diseases.
Central Drugs Standard Control Organization (CDSCO)
- It is the Central Drug Authority for discharging functions assigned to the Central Government under the Drugs and Cosmetics Act.
- CDSCO has six zonal offices, four sub-zonal offices, 13 port offices and seven laboratories under its control.
- Regulatory control over the import of drugs
- Approval of new drugs and clinical trials
- Meetings of Drugs Consultative Committee (DCC) and Drugs Technical Advisory Board (DTAB),
- Approval of certain licenses as Central License Approving Authority is exercised by the CDSCO headquarters.
- They are a relatively new class of therapeutic-containing nanomaterials that often have unique " nano properties" (physicochemical properties) due to their
- Small size (compared with their bulk-phase counterparts)
- A high surface-to-volume ratio
- And the possibility of modulating their properties.
The nanomaterial is generally defined as material having particle size in the range of 1 to 100 nm in at least one dimension.
Active pharmaceutical ingredient (API)
It is the term used to refer to the biologically active component of a drug product (e.g. tablet, capsule).
Drug products are usually composed of several components.
The aforementioned API is the primary ingredient.
Other ingredients are commonly known as "excipients" and these substances are always required to be biologically safe, often making up a variable fraction of the drug product.