Medical Plastic Data Service Magazine



Our 29th Year of Publication
Page  1 of 2





Dr. A. Ramkishan,
Deputy Drugs Controller,
CDSCO, East Zone, Kolkata


Dr. A. Ramkishan, Deputy Drugs Controller (India),
Dr.Kamal Krishna Halder, Assistant Drugs Controller (India),
Ashok Kumar, Drugs Inspector, CDSCO, East Zone, Kolkata


Background information:


Biological products can be defined according to their source material and method of manufacture. The source materials and methods employed in the manufacture of biological products for human use therefore represent critical factors in shaping their appropriate regulatory control. Biological products are derived from cells, tissues or microorganisms and reflect the inherent variability characteristic of living materials. The active substances in biological products are often too complex to be fully characterized by utilizing physicochemical testing methods alone and may show a marked heterogeneity from one preparation and/or batch to the next. Consequently, special considerations are needed when manufacturing biological products in order to maintain consistency in product quality. Good manufacturing practices (GMP) for biological products were first published by WHO in 1992 (1). This current revision reflects subsequent developments that have taken place in science and technology, and in the application of risk-based approaches to GMP (2–14). The content of this document should be considered complementary to the general recommendations set out in the current WHO good manufacturing practices for pharmaceutical products: main principles (2) and in other WHO documents related specifically to the production and control of biological products.


The use of stem cells as medicines is a promising and upcoming area of research as they may be able to help the body to regenerate damaged or lost tissue in a host of diseases like Parkinson's, multiple sclerosis, heart disease, liver disease, spinal cord damage, cancer and many more. Translating basic stem cell research into routine therapies is a complex multi-step process which entails the challenge related to managing the expected therapeutic benefits with the potential risks while complying with the existing regulations and guidelines. While in the United States (US) and European Union (EU) regulations are in place, in India, we do not have a well-defined regulatory framework for "stem cell based products (SCBP)". There are several areas that need to be addressed as it is quite different from that of pharmaceuticals. These range from establishing batch consistency, product stability to product safety and efficacy through pre-clinical, clinical studies and marketing authorization. This review summarizes the existing regulations/guidelines in US, EU, India, and the associated challenges in developing SCBP with emphasis on clinical aspects. The regulatory requirements for stem cells in India are summarized as follows:


Definition of New Drugs as per NDCT Rules, 2019

  • a drug, including active pharmaceutical ingredient or phytopharmaceutical drug, which has not been used in the country to any significant extent, except in accordance with the provisions of the Act and the rules made thereunder, as per conditions specified in the labeling thereof and has not been approved as safe and efficacious by the Central Licensing Authority with respect to its claims;

  • a drug approved by the Central licensing Authority for certain claims and proposed to be marketed with modified or new claims including indication, route of administration, dosage and dosage form;

  • a vaccine, recombinant Deoxyribonucleic Acid (r-DNA) derived product, living modified organism, monoclonal anti-body, stem cell derived product, gene therapeutic product or xenografts, intended to be used as drug; “investigational new drug” means a new chemical or biological entity or substance that has not been approved for marketing as a drug in any country.

  • The clarification of the Stem cell derived product is:-

  • ‘Stem Cell Derived Product’ means a drug which has been derived from processed stem cells and which has been processed by means of substantial or more than minimal
    manipulation with the objective of propagation and / or differentiation of a cell or tissue, ”cell activation and production of a cell-line which includes pharmaceutical or chemical or enzymatic treatment, altering a biological characteristic, combining with a non-cellular component, manipulation by genetic engineering including gene editing & gene modification’.

  • a drug which has been derived from processed cells including cell or tissue which has been processed by means of substantial or more than minimal manipulation

  • with the objective of propagation and / or differentiation of a cell or tissue,' cell activation, and production of a cell-line,

  • which includes pharmaceutical or chemical or enzymatic treatment, altering a biological characteristic, ü combining with a non-cellular component,

  • manipulation by genetic engineering including gene editing & gene

  • Substantial or more than minimal manipulation means ex-vivo alteration in the cell population (T-Cell depletion, cancer cell depletion), expansion, which is expected to result in alteration of function.

  • The isolation of tissue, washing, centrifugation, suspension in acceptable medium, cutting, grinding, shaping, overnight culturing without biological and chemical treatment, disintegration of tissue, separation of cells, isolation of a specific cell, treatment with antibiotics, sterilization by washing or gamma irradiation, freezing, thawing and such similar procedures, regarded as minimal manipulations and are not considered as processing by means of substantial or more than minimal manipulation.

  • Human cells or tissues removed from an individual for implantation of such cells or tissues only into the same individual for use during the same surgical procedure should not undergo processing steps beyond rinsing, cleaning or sizing and these steps shall not be considered as processing.

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