ASU drug licensing

The primary function of this laboratory is to test the quality of statutory samples lifted and sent by the Drug Inspectors/District Siddha Medical Officers in discharging of their statutory function under section 33G of Drugs and Cosmetics Act, 1940. 

State Drugs Testing laboratory (Indian Medicine) consists of Chemistry, Pharmacognosy, Microbiology and Siddha, Ayurveda and Unani divisions to ensure quality of Siddha, Ayurveda, Unani and Homoeopathy Drugs in terms of identity, purity and strength as per ASU Pharmacopoeias and other standard books.

The Chemistry section is equipped with Hi-Tech Instrument viz. High Performance Thin Layer Chromatography (HPTLC), High Performance Liquid Chromatography (HPLC), Gas Chromatography (GC) and Atomic Absorption Spectroscopy (AAS), to estimate the Active Constituents present in the ASU Medicinal drugs, Any Adulterants present in raw drugs, steroids detection and determination of heavy metals being evaluated for Qualitative and Quantitative analysis.  

In AYUSH section, Siddha, Ayurveda, Unani and Homoeopathy drugs are analyzed through  the Physio-chemical parameters such as Total Ash, Acid insoluble ash, water soluble extractive, Moisture test, acid value, iodine value, refractive index, Reducing sugar, Phenol compounds by using Digital Refractometer, digital Polarimeter, UV-VIS spectrophotometer, KF titrator

In Pharmacognosy, plant drugs are authenticate by Macroscopic and Microscopic Examination as per ASU pharmacopoeia specification. Trinocular Microscope with image processor is being used for microscopic examination of Root, Stem, leaf and Powder of raw drugs and prepared medicines in pharmacognostic evaluation. 

In Microbiology, Microbial Load of the plant drugs, total microbial count, Total Yeast, Mould and identifying the specific pathogenic organism like staphylococcus aureus, salmonella, and Pseudomonas aeruginosa microbial test are done as per pharmacopoeia specification.

The Quality of Drugs is beyond understanding the common man, It is a responsibility of ensure the availability of quality drugs to the public and market is free from counterfeit, Spurious and Substandard Drugs. Analyzing correct ingredients or with the wrong ingredients, without active ingredients, with insufficient or too much active ingredient, or with fake packaging. State Drugs Testing Laboratory (Indian Medicine) being statutory body the organization performance very important role in supporting Health Care Service Regulation and enhancing consumer confidence. As a Statutory body the Laboratory distinguish the massive challenges posed by Not of standard quality Drugs, Spurious, Adulterated and Misbranded drugs by some manufactures and dealers.

State Drug Licensing Authority for Indian Medicine:

• In Tamil Nadu, Office of the State Drug Licensing Authority (IM) has started functioning from 29.11.2007 for granting license to manufacture of Siddha, Ayurveda and Unani drugs as per Drugs and Cosmetics Act, 1940 and Rules, 1945.
• The State Drug Licensing Authority (Indian Medicine) is the Appropriate Authority for granting Licence to Drug Test Laboratories for testing the Drugs of Siddha, Ayurveda and Unani System of Medicines.
• The Director of Indian Medicine and Homoeopathy, Chennai is the Controlling Authority of State Drug Licensing Authority (Indian Medicine) and the Drug Inspectors (Indian Medicine) in the state of Tamil Nadu. The role of Controlling Authority is to give directions to State Drug Licensing Authority (Indian Medicine) and the Drug Inspectors (Indian Medicine) for enforcement action against the manufacturers of Ayurveda, Siddha and Unani Drugs who
  violates the provisions of the Drugs and Cosmetics Act, 1940.
• As per the Sub-section (1) of Section 8 of the Drugs and Magic Remedies (Objectionable Advertisements) Act, 1954 the District Siddha Medical Officers, shall be the authorized Gazetted Officer with effect from 11.01.2018, for monitoring the advertisements in Print, electronic, internet and audio-visual media of Siddha, Ayurveda and Unani drugs for the areas within their respective jurisdiction.

Achievements:

• The total license granted for manufacturing sale of Siddha, Ayurveda and Unani Drugs is 529 till December 2023. Based on the 4 th Amendment made in Rule 156(1) of the Drugs (4 th Amendment) Rules, 2021 the State Drug Licensing Authority (IM) has granted 269 perpetual licenses to manufactures and sellers of Siddha, Ayurveda and Unani Drugs from November 2021 to December 2023.
• An exclusive website for office of the State Drug Licensing Authority has been established on 09.07.2020 with web address www.tnslaim.com through Tamil Nadu e-Governance Agency (TNeGA).