The efficacy of the medicine (Levodopa) used to manage Parkinson's Disease will wear off after a time, in about 10-15 years. After this, Deep Brain Stimulation (DBS) is the best treatment for the progressive neurodegenerative disorder that impairs movement. For drug-resistant Parkinson's patients, the DBS surgery is the only way out. 

Still, it is only a minuscule number of Parkinson's patients who go for the DBS surgery. Reason: exorbitant cost. Even in Sree Chitra Tirunal Institute for Medical Sciences and Technology (SCTIMST), where the operation is the least costly in the country, the surgery costs ₹16 lakh. 

This has hindered accessibility. The first DBS surgery at the SCTIMST's Comprehensive Care Centre for Movement Disorders, which incidentally was also the first DBS surgery in Asia, was done in 1999. More than a quarter century later, the Centre has done fewer than 350 surgeries.

Now, the SCTIMST's Division of Medical Instrumentation has developed India's first indigenously built Deep Brain Stimulator (DBS), christened 'AnuChitra'. "It's a technological equivalent and a low-cost alternative to the DBS we use now," said Jithin Krishnan, the scientist who is part of the team that developed the 'Made in India' DBS. 

The SCTIMST team has valued the device at nearly  ₹1.5 lakh; a cost derived based on various factors like investment in the project, bill of materials and market demand.  

Ultimately, when the product hits the market in about three years after clinical trials, the cost is expected to be less than ₹5 lakh, a nearly 70 per cent cost advantage. Moreover, a cost of up to ₹5 lakh is covered under most of the insurance schemes joined by middle and low-income families, including MEDISEP for state government employees and pensioners.

The surgery involves drilling two holes on either side of the skull to implant ultrathin platinum electrodes deep inside carefully chosen areas of the brain that control movement. These electrodes are connected by a thin extension wire to a pacemaker-like electronic device called Implantable Pulse Generator (IPG) or neurotransmitter that is placed right beneath the skin on the upper chest. These IPG-powered electrodes stimulate the specific motor-function areas of the brain, dramatically improving movement.

The SCTIMST now uses the DBS of Ireland-based Medtronic, the global leader in DBS technology. "Its technology is completely hidden. We cannot even reverse engineer it to understand how it is works," Jithin said. So the team had to begin from scratch, right from understanding how an electric field works inside the brain.

The project to create a locally made DBS began in 2016, when Dr Asha Kishore was the director of the SCTIMST. It was Dr Kishore who introduced the DBS surgery in the SCTIMST, and by extension, the country, after she returned from higher studies in Canada. 

The team to develop AnuChitra is headed by senior SCTIMST scientist Muralidharan C V. However, fabricating the stimulator locally was too precision-driven and costly to be conducted in the SCTIMST labs alone. "It involved high-end micro machining processes that our labs could not support. Nor could the institute under the union government's Department of Science and Technology, afford the investment such a high-value but low-volume product necessitated," Jithin said.

So a partnership was struck with the Bhabha Atomic Research Centre (BARC). The name 'AnuChithra' was born out of this association. 'Anu' stands for atom, which denotes BARC, and Chitra for the institute. 

The SCTIMST-BARC team has taken the product development to the highest stage they can, up to trials on animals. The New Drugs and Clinical Trial Rules, 2019 (NDCT Rules) do not allow institutions to carry out human trials. Only companies can.

So, Expressions of Interests were invited, and companies have been shortlisted for technology transfer. The technology has already been transferred to one company, Indore-based Shree Pacetronics, for a fee. Since a non-exclusive clause exists, the technology will be sold to other manufacturers who are found fit, too.

"The company can register for a clinical trial within a year, and the trial period will last another two years. So in three years we can expect full commercial production," Jithin said.