The Microbiology section is the national lead centre for microbial quality analysis of homoeopathic medicines. Homeopathic medicines are often prepared from a wide range plant materials (roots, stems, leaves, flowers, bark, pollen, lichen, moss, ferns and algae), microorganisms (fungi, bacteria, viruses) , animal origin (tissues, secretions and cell lines), human origin (tissues, secretions, hormones, and cell lines) and natural or synthetic sources (minerals and chemicals. The homeopathic stock or its potencies may consist of processed or unprocessed substances. Raw material used in homeopathic medicines are may have a higher level contamination with microorganisms (bioburden), toxins, insects, pesticides, agrochemical residues and heavy metals. Due to the faulty post harvesting methods, inaccurate storage condition the herbal drugs may be contaminated with saprophytic or pathogenic microorganisms. Cross contamination is also possible from extraneous materials such as plastics, glass and other materials which come in contact with herbal drugs. The therapeutic efficacy of herbal drugs depends on the active ingredients which are effective against the specific malady. In case of high microbial contamination in herbal drugs it may be feasible that active ingredients of drugs may deteriorate.
The quality of source material and the procedure is important in the manufacturing of homeopathic medicines. The Good Manufacturing Practices for Homoeopathic Drugs as described in Sub-Rule (2) of Rule 85E of Drugs & Cosmetics Rules, 1945 with conditions as specified in Schedule ‘MI‘ GMP are to ensure that:
- Raw materials used in the manufacture of drugs are authentic, of prescribed quality and are free from contamination;
- Adequate quality control measures are adopted;
- The manufactured drug which is released for sale is of acceptable quality;
- To achieve the objectives listed above, each licensee shall evolve methodology and procedures for following the prescribed process of manufacture of drugs which should be documented as a manual and kept for reference and inspection.
Microbiology is an essential section to carry out the quality control tests and standardization of the Homoeopathic Drugs. The microbiology section accomplishes the sterility test and microbial limit test (MLT) for Homoeopathic drugs as per Drugs & Cosmetic Act. The section is also focusing on the quality control and standardization of nosodes as per HPI. The microbiology laboratory is equipped with all essential laboratory instruments and equipments. The laboratory is designed in such a manner that the risk of contamination will be very low. The laboratory is categorized in to following different area to maintain the aseptic condition to carry out the quality control tests and standardization of the Homoeopathic Drugs:Sample receipt and holding area:
This part of the laboratory is dedicated to receive the samples and keeping their records.Media preparation area:
This area is specifically designed for maintaining and preparing the different culture media to carry out the quality control tests and standardization of the Homoeopathic Drugs. This area is equipped with:
- Electronic balance
- Top pan balance.
The media preparation area of the laboratory is maintaining the stocks of:
- Introduction Culture Media
- Complex culture media
- Enriched media
- Defined culture media
- Selective media
This area is specifically designed for cleaning and sterilizing the laboratory glassware, equipment and to decontaminate the used utensils during laboratory experiment. This area is equipped with highly specific sterilization device:
- Vertical Autoclave
- Hot air Oven
Microbial inoculation area:
This area is specifically designed to carry out the microbial culture experiments and inoculation of Drug samples under aseptic environment. This area is equipped with:
- Biosaftey cabinet
- Laminar air flow
Microbial culture incubation area:
This area is specifically designed for providing the suitable condition for observation of Microbial growth. This are of the laboratory is equipped with highly specific device:
- Biological oxygen demand Incubator (BOD)
- Rotary shaker
The test for sterility is carried out under aseptic conditions. In order to achieve such conditions, the test environment has to be adapted to the way in which the sterility test is performed. The precautions taken to avoid contamination are such that they do not affect any microorganisms which are to be revealed in the test. The working conditions in which the tests are performed are monitored regularly by appropriate sampling of the working area and by carrying out appropriate controls.
Apart from the contribution of microbiology section in quality control tests and standardization of the Homoeopathic Drugs, the section also provides hands on training on microbiological analysis of Homoeopathic Drugs to drugs inspectors, asst. drugs controllers, Govt. analyst, faculty and student of various colleges across the Nation.
- Dr. M. Ramesh, Scientific Officer (Microbiology), Head of the Section
- Dr. Akhilesh Tiwari, Scientific Assistant (Microbiology)