Case Study Dr. Narendran

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6 Prior to the implementation of statutory reservations (affirmative action) for Other Backward Classes (OBCs), IMC’s intake was 30. The six departments are Medicine, Special Medicine, Pediatrics, Diagnostics, Pharmacology and Toxicology.

7 By 2011, IMC had 107 staff—23 academic staff, 23 administrative staff and 61 hospital staff. Many of the hospital/ administrative staff worked on contracts.

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catered to an average of 1,100 patients a day. The IPD opened in June 2005 with 20 beds. By 2008, it had 120 beds divided among the six departments. The IPD was in great demand; it had an occupancy rate of 100%. Patients admitted to the IPD received free treatment and dietary services; however, special pay wards were also available. The medical care mandate had also resulted in weekly geriatric OP services, a yoga OP program and other special OP programs that were conducted as and when a need arose. For example, IMC conducted a special chikunguniya8 OP program from September 2006 to April 2007 for nearly 6,000 patients.

The development of the hospital had taken considerable effort, and Dr. Narendran was convinced that as a postgraduate teaching institute, IMC’s hospital was a key element in training its students and should be developed further. He observed, “Siddha education and providing Siddha medical care are key objectives of the institute; we need to set up additional facilities for these.” He also knew that the shortage of manpower, especially for external therapies, and the congested consultation rooms, were areas of growing concern.

RESEARCH ACTIVITIES AT IMC

Research activity at IMC began in 2008. The institute approved seven research studies in October 2008. New research guidelines issued by the government around this time made it mandatory for new formulations to be subjected to safety (preclinical) studies before clinical studies on humans could be undertaken. Since IMC did not have the necessary laboratory support to conduct preclinical studies, it entered into memoranda of understanding with two universities. The Research Committee of IMC ultimately approved four projects and secured INR 3 million from the government for these studies in May 2010. In addition, IMC decided to conduct observational studies on sastric preparations, as prescribed in the traditional texts of Siddha medicine, for which safety analysis was not needed.

Dr. Narendran recalled a discussion he had had in August 2010 with the heads of the six departments, in which the group had identified a few challenges in research capacity building. The group had unanimously agreed that textual authority had to be supplemented with research that validated the therapies and drugs used in Siddha as this would promote the acceptance of Siddha among other systems of medicine. It also noted that in the dominant mainstream medicine system, many doctors and pharmaceutical companies were involved in drug research. These drugs cost a lot of money to develop, and the companies were granted exclusive rights to exploit their discoveries commercially, through patents. Siddha and other parallel systems of medicine would have to learn from these developments and change the way they looked at drug development.

The group also felt that Siddha still had some way to go in developing globally-acceptable research designs and defining appropriate outcomes of treatment, which would convert a holistic treatment system like Siddha into objective and quantifiable end-points. Once this was done, other systems of medicine could examine what Siddha had to offer them. One department head pointed out that in the context of globalization, reliable and validated Siddha products were neither visible nor available to patients in other countries and doctors in other systems of

[pic 9]

8 An infection caused by a mosquito-borne virus leading to illness characterized by severe joint pain.

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medicine. How relevant were these concerns to the commercialization implied by Dr. Ramkumar’s request, Dr. Narendran wondered.

Dr. Narendran felt that research at IMC was geared towards validating sastric procedures and formulations, but, as he noted, “adding value to the work of good faculty members will definitely motivate them.” He recalled that two other faculty members were working on formulations to reduce aneurysm risk (localized widening of a blood vessel) and support the treatment of septal defects (defects in the walls of the heart). Both were similar to Dr. Ramkumar’s research in terms of their importance.

MARKET STUDY

In order to better understand Dr. Ramkumar’s request, Dr. Narendran had asked a friend who was associated with a management education institute to study what Dr. Ramkumar’s idea meant in terms of commercialization. The report, prepared by a pair of students, was now in his hands. It said that IMC’s first step should be to patent and register the formulation with the state’s Food and Drug Administration. A patent would give IMC a monopoly right over the exclusive commercial use of the formulation for the time period specified by the patent. The patent was also an asset that could be sold during the exclusivity period. IMC could also grant a license to another party to use the patent, thereby earning income from it. The patenting process required full disclosure of the formulation; in return, IMC retained the right to exploit it commercially for a specified period of time. By not patenting the formulation, IMC ran the risk that another researcher might discover a similar formulation and patent it, thus preventing IMC from using its own formulation. The chances of this happening were not that remote, Dr. Narendran thought, since it would be difficult to keep the composition secret. A research institute was expected to share the outputs of its research through journals and newsletters. Any entrepreneur could borrow these results, make suitable modifications to derive an invention, and then go through the patenting process. However, Dr. Narendran intuitively felt that this would not prevent IMC from continuing to use its original formulation on its own patients.

The report stated that IMC could take one of three routes as far as licensing out was concerned. Outright transfer to a third party for a one-time license fee paid at the time of transfer was the first option. The second option was that IMC could use a registered