Sri Chitra Institute’s big stride into the medical device sector

In 2008, Dr TV Anil Kumar started a peculiar Sunday routine. While most of the city slept peacefully, this Trivandrum native would embark on a solitary journey, steering his way through the predawn darkness towards the city’s lone pig butchery near Mar Ivanios College.

But his purpose was far from culinary pursuits; instead, it was a quest for a scientific breakthrough. Anil, as he is known among colleagues and friends, was pursuing a project he was involved in while doing post doctoral fellowship in Ireland.

He returned to India and the Sree Chitra Tirunal Institute for Medical Sciences & Technology (SCTIMST) in 2005 and after three years, managed to get a grant from the central government to pursue his work to develop a skin graft material from pig gallbladder membrane. That set off his early morning treks to the piggery.

“Pig slaughter was uncommon in Trivandrum those days and we had to grab every chance to get the raw materials. That meant my team and I ended up spending many Sundays cooped up in the lab as the pig slaughter took place only on that day,” recalls Anil.

Years of such relentless pursuit have now borne fruit as the SCTIMST has become the first institute in the country to develop a Class D medical device, one that needs to pass stringent measures. The Central Drug Standard Control Organisation has given approval for the device named Cholederm which can be used to quicken the healing process after severe injuries, burns and surgeries.

The discovery didn’t end there. The continued research on this by the Experimental Pathology division headed by Anil has now opened up possibilities that could radically change treatments for heart ailments and even a gateway to the billion-dollar global cosmetic market.

Known in medical parlance as graft scaffolding, Indian hospitals use imported ones and SCTIMST scientists say their product could bring down the price by 80 percent when locally produced.

The approval from the Indian drug controller also chips away at a myth that, unlike developed nations, India cannot develop animal-derived products to be used in sensitive processes like skin grafting.

The Sri Chithira Institute researchers have taken membrane from the pig gall bladder and turned into a scaffolding through a process called decellularisation, essentially getting rid of the cells that trigger rejection by the human body.

The membrane developed at the institute proved to be better in healing than similar stuff already in the global market as the process Anil developed to decellularise the raw material retained some of the bio components that encouraged healing.

“Necessity is the mother of all innovations and that was true in my case also. When I embarked on this project here, there was a scarcity of sophisticated equipment and I had to come up with a way to overcome this. I adopted a simpler method for decellularisation and that proved more effective than the conventional methods followed till then,” he says.

A technology transfer agreement to produce Cholederm was signed with a Trivandrum-based company called Alicorn Medical in 2017 and earlier this year a patent was obtained for the process. But queries to the firm about the progress went unanswered.

This is one of the first medical devices to be granted a licence after India adopted the Medical Device Rules that year.   

A 2022 report by the Indian Brand Equity Foundation says that the Indian medical device market is driven by 70-80 per cent imports from countries such as the US, China and Germany.  The Indian government in April this year approved a Medical Device policy to nurture an ecosystem to develop the medical device manufacturing sector domestically.

Meanwhile, Kerala officials argue that given the state’s healthcare achievements and the existence of research centres like STCMIST and Regional Cancer Centre, it is ideally positioned to be the gateway for an Indian expansion into the global market.

While the state government has taken some steps in this direction, still it has a fair distance to go to achieve such a target. As Anil pointed out at a press conference on Saturday, the state has no qualified lab to process the Cholederm membrane in Kerala and it has to be transported elsewhere, adding a cumbersome logistics process given the hygiene levels required. 

While Cholederm has crossed some major hurdles to become a commercially viable project, another product that Anil and his team developed from this graft scaffolding could potentially revolutionise coronary disease treatment.

Anil and his fellow researchers Dr KV Pratheesh and KS Praveen last week obtained a patent for an injectable gel made from this material.

The injectable form allows it to be delivered straight to the point of damage through a catheter and without surgery, KS Praveen told the local media.

Currently, the doctors attending to a coronary case have to assess the damage done to the heart muscles before they can start the surgical procedure for stent placement. The time element becomes crucial as scarring on the heart muscle cannot be reversed.

The use of this injectable gel could potentially save time as it can be administered quickly without surgery, reduce the scarring of the heart muscles and limit the damage. This could change the way heart attack cases are handled in future.

Head of the Biomedical Wing at the Institute, Dr PR Harikrishna Varma says the fact that this material is biocompatible – meaning the chances of the human body rejecting it is minimal – makes it versatile.  

This could be a blessing in the treatment of injuries of diabetic people but this will need more trials though experiments on animals had produced positive results.

Another lucrative spinoff from the gel could be the possible development of cosmetic skin creams, a billion-dollar industry globally.

The new medical device policy of India aims to incorporate divergent fields like veterinary science to atomic energy under one platform, boost medical device manufacturing and make the country a global player by 2030.

These SCIMST achievements indicate that such a thrust can be achieved if a proper ecosystem is established to overcome red tape and recognise the value of research in different fields beyond the hallowed medical labs.

Anil, who did PhD in Animal Pathology at the Imperial College of Science Technology and Medicine in London,  says his attention turned to this particular medical device after he came across research work done by US veterinarian and medical doctor Stephen Badylak. He had successfully generated graft assistance membranes from the small intestines of pigs and that have been used universally, including in India.

Anil’s focus as the head of the Experimental Pathology section of the SCIMST was to generate the same kind of material from the pig gall bladder as it was one part that was thrown away as waste by butcheries everywhere, making the raw material availability easier and cheaper. It took years of dogged persistence but Anil is quick to share the spoils with his team over the one and half decade of work.

The team which consisted of one scientific officer, six PhD scholars and two research fellows also stacked up 20 research publications, nine patents and a few awards including international ones during their work.

Given such hectic work, naturally, the question to ask was whether his trek to the Trivandrum piggery was still going on. “No,” he laughs it off. “We found a steady supply from the government-run Meat Products of India butchery in Kuthattukulam as they slaughter more pigs there.”

That unit located 180 kilometres from Trivandrum was disposing of the gallbladders as a waste till Anil and his team approached them. “Now they give it to us, charging 50 rupees per gall bladder that weighs around 40 grammes,” he says with a wry smile.

“So Cholederm could improve the financial health of some pig farmers also in future as gallbladders would be pricier than pork.”

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