Drug Testing Laboratory

INITIATIVES BY STATE DRUGS TESTING LABORATORY (I.M&H):

Quackery Eradication: 

Effective steps to adopt Eradication of Quackery medicine by analyzing substandard Siddha, Ayurveda, Unani and Homoeopathy Drugs available to public.

NABL Accreditation:

Follow NABL guidelines and get accredited as NABL in stipulated time – frame. 

Development of New standards:

Create new specification and certification of AYUSH medicines and development of new standards in collaboration with pharmacopoeia of India to uplifting the Indian system of Medicine.

Research Activity:

Join in network research programmes by the Research councils, NMPB and pharmacopoeia committee to invent evidence based medicine to Uplifting of Indian system of medicine.

State Drugs Testing Laboratory (Indian Medicine and Homoeopathy):

State Drugs Testing Laboratory (Indian Medicine and Homoeopathy) was established in 2003 under the control of Directorate of Indian Medicine and Homoeopathy. DTL ensures quality of Ayurveda, Siddha, Unani and Homoeopathy Drugs to strengthen the enforcement mechanism as in Chapter IV-A of Drugs and Cosmetics Act 1940 and Rules 1945. Its primary function is to test the quality of statutory samples collected by the Drug Inspectors/District Siddha Medical Officers in discharging of their statutory function under section 33G of Drugs and Cosmetics Act, 1940.

DTL ensures the drugs are not Adulterated, Spurious or Substandard. Analyzing the drugs for incorrect ingredients, like active substances in, insufficient or excessive annuls, forged packaging. This Laboratory plays a pivotal role in supporting Health Care Service Regulation and enhancing consumer confidence and also to overcome massive challenges posed by substandard, Spurious, Misbranded and Adulterated drugs by invoking Section 33E for Misbranded drugs, Section 33EE for Adulterated drugs, Section 33EEA for Spurious drugs under the Chapter IV-A of Drugs and Cosmetics Act 1940 and Rules 1945.

This laboratory comprises of Siddha, Ayurveda, Unani, Homoeopathy Chemistry, Pharmacognosy and Microbiology divisions for analysis of raw drugs, shastric and proprietary medicines. Raw drugs are tested for identity, purity and strength as per Siddha, Ayurveda, Unani & Homeopathy Pharmacopoeia of India, Indian pharmacopoeia and ISI standard books.

Hi-Tech Instruments viz. High-Performance Thin Layer Chromatography (HPTLC), High Performance Liquid Chromatography (HPLC), Gas Chromatography (GC) and Atomic Absorption Spectroscopy (AAS) have been installed in the laboratory for the purpose of accuracy in testing towards standardization and quality of Indian medicines. These Hi-Tech Instruments support to estimate the Active Principal Marker present in the Indian Medicinal Raw drugs, steroids detection and determination of heavy metals.

Other instruments viz., Digital Refractometer, UV-V is Spectrophotometer are being used to check the physio-chemical parameters such as Ash value, Acid value, Saponification value, Iodine value, Refractive sugar, Phenol compounds etc. Trinocular Microscope with image processor are being used for pharmacogenetic evaluation and plant drugs authentication. Laminar Air flow bench, BOD incubator, Hot air oven are used for Microbial limit test and detection of pathogens.

As per Memorandum of Understanding in the Government in G.O.(D).No.2117 Health & Family Welfare Department (I.M-2/2), dated: 18.12.2018, with Health Department of Andaman Nicobar Island (UT) it has been notified that the Government Analyst (ex-officio) & State Drug Testing laboratory (Indian Medicine and Homoeopathy) Tamil Nadu to discharge the statutory duties for Andaman Nicobar (UT) as per section 33F(2) of Drugs Cosmetics Act 1940. Five statutory samples were tested and reported in 2022-2023.

• 2385 samples have been tested for assessing statutory status by State Drugs Testing Laboratory (Indian Medicine & Homoeopathy), during April 2023 – December 2023.Whenever required the quality of raw drugs and medicines are also tested for Tampcol which is engaged in manufacturing of medicines.
• Govt. of India, Ministry of AYUSH, Drug policy section, has directed SDTL (IM&H) in Lr.No.-T-14020 /2 /2022-DCC, dated 21/07/2022 to carry out testing of Homoeopathic drugs at their respective State DTLs approved by Ministry of Ayush under Rule 160 B of D&C Rules 1945. 3 Homoeopathic statutory samples were received in 2023 for testing.
• Being a statutory body, State Drugs Testing laboratory (I.M&H) has been receiving and testing samples of Court of CBCID/Crime branch.
• This Laboratory has also been receiving samples from Customs and Excise for ensuring the quality of export medicines.
• This laboratory also trains the Post graduate students in the Government Indian System of Medicine Colleges.
• Special training is also given to candidates of private Indian System of Medical colleges and Science, Pharma students by collecting prescribed fees.
• Statutory Samples received by SDTL (I.M) which needs urgent and speedy action are analysed and reported on time.
• As per report of the Government of India, quality control of AYUSH drugs dated 02.08.2022, the State of Tamil Nadu has analysed highest number of Ayush drug and product samples tested in the last Five years to ensure the quality standard of drugs as per the respective pharmacopoeia.
• Government of India, Ministry of Ayush in its communication in File No. T-12020/9/2021-DCC-part (1), dated:20 th December, 2023 has confirmed its recommendation for providing Machinery and Equipment under AOGUSY Scheme for DTL at a cost of Rs. 47,17,062/- to achieve higher standards in its operation.

The tasks accomplished by Drug Testing Laboratory (I.M&H) are given below: