RESEARCH AND DEVELOPMENT ACTIVITIES UNDERTAKEN BY THE LABORATORY ARE :

The laboratory follows Good Laboratory Practices in its working. It was awarded "Good Laboratory Practice award '99", by the Indian Drug Manufacturers Association Murnbai. The entire Laboratory setup satisfies all the requirements laid down in the proposed international guidelines for biomedical research involving human subjects issued by the World Health Organisation and the Council for International Organisation of medical Sciences in 1982, and the policy statement on ethical considerations involved in research on human subjects issued by the Indian Council of Medical Research in 1980.

Dr. R. T. Sane who was the founder principal investigator for bioavailibility and bioequivalence studies is recognized by the Drug Controller General of India (DCGI). New Delhi, India, He was awarded the "Eminent Pharmaceutical Analyst Award", awarded by the Indian Drug Manufacturers Association, Mumbai in the year 1999. Currently the laboratory is headed by Dr. Sasikumar Menon and he coordinates and conducts all projects as the Principal Investigator.

QUALITY POLICY

The Therapeutic Drug Monitoring Laboratory is totally dedicated to the task of providing quality testing services that can facilitate accurate assessments of raw materials, drug intermediates and pharmaceutical formulations; it has a sophisticated infrastructure to ensure that the bioavailability / bioequivalence studies it conducts are of the finest order and assure the best in client satisfaction. To ensure unrelenting "adherence to considerations of quality in the accomplishment of its aims, the TDML places considerable emphasis on the following factors:

QUALITY AUDITS

Audits are conducted at regular intervals. The audit programme features both horizontal and vertical audits. Additional audits are carried out on any quality-system related topics whenever there is any reason to doubt the efficacy of the quality system that is used.

ADHERENCE TO NORMS

All activity at the TDML is conditioned by the belief that 'Quality is the key to success.' Stringent operating procedures, coupled with the integration of multiple-stage quality-control measures, ensure data accuracy and integrity. Our clients know very well that the data they receive from the laboratory will be absolutely accurate and reliable.

Our insistence on quality is matched by our paramount concern for the safety of our volunteers. All our trials are conducted in accordance with the Helsinki Declaration under the supervision of known medical practitioners and measure up to the most exacting standards.

INSTITUTIONAL ETHICS COMMITTEE

All trials are reviewed and approved by an Institutional Ethics Committee which ensures that the study is carried out as per scientific and ethical norms. The Institutional Ethics Committee is composed of 12 voting members and 6 non –voting members. These are clinical pharmacologists, consulting physicians, social workers, educationists, legal experts and individuals of known standing as the members of the committee. The committee ensures the general well-being of volunteers during the conduct of a study.

EXACTING STANDARDS

The Therapeutic Drug Monitoring Laboratory offers facilities for monitoring the bioavailability, comparative bioavailability and bioequivalance of therapeutic drugs. In so far as bioavailability is the amount of the drug that is available in the blood over a particular period of time, it is a determinant of the drug's safety If two products have statistically similar bioavailability; they are said to be 'bioequivalent': and can be substituted for each other in therapeutics. The laboratory also has facilities for the analysis of synthetic drugs and drug intermediates from pharmaceutical preparations by chemical, instrumental, microbiological and biological methods. Healthy volunteers who help in the assessment of the efficacy and safety of new drugs are drawn from various localities, colleges and universities; they are carefully screened and assessed by experts to ensure that they meet all requisite criteria. The entire laboratory setup satisfies all the requirements laid down in the proposed international guidelines for biomedical research involving human subjects issued by the World Health Organization and the Council for International Organization of Medical Sciences in 1982. It adheres to the policy statement on ethical considerations involved in research on human subjects issued by the Indian Council of Medical Research in 2000. It also adheres to the Guidelines for Good Clinical Practice, 1996, set forth by the International Conference on Harmonization (lCH) of Technical Requirements for Registration of Pharmaceuticals for Human Use. The laboratory has well-equipped facilities for proteomics and genomics; and it provides DNA and RNA evaluations for plant materials. Recombinant DNA technology is provided for metabolites of therapuetic importance.

ACCREDITATION AND AFFILATIONS

In recognition of its adherence to accepted norms, the Indian Drug Manufacturer's Association (lDMA) gave its Good Laboratory Practice Award '99 to the TDML. The laboratory has been assessed and approved as a center for bioequivalence studies by

INFRASTRUCTURE

The laboratory is housed in a two-storey building. A cold-storage room, a library cum seminar room, a documentation room, a accounts office, a gas-cylinder room, and the offices of the director, assistant director, technical manager, quality manager and the assistant technical manager are all located on the ground floor. The first floor houses the analytical complex which comprises two instrumental laboratories, a microbiological laboratory, a sample-preparation room, a wet chemistry laboratory and a distillation unit room. A pantry and 32 bedded clinical pharmacology unit are accommodated on the second floor.

TDML also accommodates a spacious library which houses an excellent collection of specialized reference books.

It is adequately stocked with chromatography-related interactive software and statistical software like SAS. Augmenting the TDML's valuable stock of information are extensive volunteer data bases that play a very important role in the studies it conducts. LC/MS/MS facilities and all allied supports for genomics and proteomics studies are also housed here.

EQUIPMENT

The laboratory is adequately furnished with equipment and reference materials required for the effective performance of various complex tests. All measuring and testing equipment is calibrated before being put to use. In fact, the laboratory has a special programme for the calibration of the equipment it uses. The laboratory uses specified reference standards for measuring and calibration.

AREAS OF SPECIAL INTEREST

Research and development activities undertaken by the TDML include :

ORGANIZATIONAL SETUP

The top slots in the hierarchical ladder are occupied by the Director, the Assistant Director, the Quality Manager and the Technical Manager who playa key role in the general administration and functioning of the TDML. In addition to these, the laboratory has a highly competent managerial staff invested with the authority and resources that are needed to encourage its performance at the highest levels of efficiency.Dr. Sasikumar Menon (Ph.D., Mumbai)

HUMAN RESOURCES AND TRAINING

Employee-training is an integral part of a laboratory's commitment to quality and to consistency in its performance. A dedicated team of highly qualified professionals formulates and offers perceptive instructional programmes that enhance the competence and efficiency of the laboratory's personnel.