QUALITY CONTROL & QUALITY ASSURANCE LABORATORY
IASST with partial financial support from DBT, Govt. of India has established a quality control/quality assurance laboratory (QCQA) for testing herbal and medicinal plant material/extract. The state-of-the-art laboratory facility is first of its kind in NE India, for testing of herbal and phytopharmaceutical products having received drug testing license under State Drug Control (AYUSH) as per rule 160-A vide file no. AYUSH/LA/20/2022/1386 dated 2nd September, 2022. The laboratory has also applied for NABL accreditation for 16 test scopes (NABL Lab ID: T-7354).
Vision:
To be the NER Nodal Agency in establishing Quality standards for drugs of Indian Systems of Medicine and Phytopharmaceuticals as per national pharmacopeia standards.
Objectives:
1. To act as State Drug testing laboratory (AYUSH)
2. Identification and authentication of raw drugs and their parts used in ASU&H drugs as per pharmcopeal standards.
3. To maintain an authentic Reference Raw Materials (RRM) repository of plant materials used in AYUSH and Phytopharmaceuticals for North Eastern Region (NER).
4. Development of TLC/HPTLC fingerprint profile of selected herbals as per Indian Pharmcopea/Ayurvedic pharmcopea of India.
5. Maintenance of Botanical Reference Standards (BRS) and Chemical Reference Markers (CRM) procured from Indian Pharmacopoeia Commission (IPC), Ghaziabad.
6. To perform Botanical authentication, Physiochemical tests and Toxicity tests [Sterility test, Microbial Limit Test (MLT), detection of aflatoxins] as per phamcopeal standards.
Beneficiaries:
Interested farmers/cultivators, suppliers and manufacturers of plant based products can obtain Certificate of Analysis for their tested samples along with necessary technical guidance for preparation of Herbal products as pharmacopeal standards.
QCQA laboratory Sections:
Pharmacognosy/Taxonomy:
Plant origin drug substances being a major component of the raw materials used in ASU&H medicines, a dedicated Botanical Reference Standards (BRS) repository is being developed and maintained for stake holders as reference standards. Along with this raw drug samples which are collected /received are stored in the museum in dried form. QCQA, IASST also houses a herbarium of medicinal plants (of about 21 high value plant species of NER) which are used in the traditional system of medicine at NER. The plant specimens for herbarium are collected from various agro-climatic zones of NER during the survey cum collection tours. These herbariums are used for identification and reference purposes which are verified at Botanical Survey of India (BSI), Shillong.
Chemistry:
The main focus of the chemistry section is to verify and validate the Pharmacopoeial Quality Standard methods. For this, the section generates data of
standardization through multiple experimental evidences before applying for enhancement of scope under NABL accreditation.
Microbiology:
To analyze the microbial contamination in herbals, the laboratory is equipped with all essential instruments and equipments. The laboratory is designed in such a manner that the risk of contamination is 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 ASU&H drugs and other herbals:
1) Sample receipt and holding area
2) Media preparation area
3) Sterilization area
4) Microbial inoculation area
5) Microbial culture incubation area
In addition to analytical testing areas, the facility has dedicated Waiting Room, Sample receiving room, Storage room, QA documentation room, Library, Sitting cubicles, Chemical and solvent storage room etc.
Current Available Test Parameters:
Botanical Parameters
a) Botanical Authentication (macroscopic)
b) Estimation of Foreign Matter
Physiochemcial Parameters
a) Determination of Moisture Content
b) Determination of alcohol soluble and water soluble extractive
c) Quantitative estimation of plant biomarker by HPLC.
d) Determination of total ash content
Food Safety and Standards Authority of India (FSSAI) test parameters
Qualitative tests for analysis of food and spices as per FSSAI manual of methods like detection of added colour, starch, dye, lead chromate etc.
People:
Prof. Asish Kr. Mukherjee
Dr. Jagat C. Borah
Dr. Asim Kr. Dutta
Mr. Dipumani Barman
Contact Us:
Reception Director IASST
Phone: +91-361-270095 Email: dir.iasst[at]nic[dot]in
Phone: 0361-2912073
QCQA laboratory Email: qaqciasst[at]gmail[dot]com