The Advanced Medical Technology Association (AdvaMed) has demanded that the regulations governing the medical devices industry in India must be separated from the Drugs and Cosmetic Act and should be categorised separately specific to medical devices.

According to Sanjay Banerjee, chairman of India working group, AdvaMed, there are 14000 medical technology devices among which government of India has categorised about 14 sets of medical devices such as catheters, surgical sutures, orthopedic implants and cardiac stents, pace makers, bone cements, etc as drugs, and are being regulated under the same rules as drugs and medicines.

“Medical devices are completely different entities and have no similarity with the chemical compounds used in drugs. Based on the provisions of Drugs and Cosmetic Act, government had categorised 14 sets of medical devices as drugs and because of which the manufacturers and suppliers are facing challenges and problems to get product registration for marketing and sales licenses. It is high time that the government should realize this and come out with a separate framework for regulating medical devices industry,” said Sanjay Banerjee.

As the medical devices industry in India is still at a nascent stage and it accounts for only about 6 per cent of the total healthcare industry, the government should come out with clear regulatory framework that should be more transparent, predictable, internationally harmonized and risk based, so that more investors will come and set up their manufacturing bases, which in turn not only help enable improve the quality of healthcare but also enhance employment and economy of the country.

At present, the medical technology industry in India is roughly estimated to be around 4 billion dollars where as the whole healthcare industry in India is about 70 billion dollars. According to an estimate, the medical devices industry is severely under penetrated in India due to lack of awareness, unpredictable regulations and lack of access to healthcare facilities. “Effectively out of 100 dollars spent on total healthcare only 6 dollars are spent on medical devices. About 18-20 dollars are spent on pharma industry, while the rest is spent for healthcare and insurance services in the country. This shows medical devices industry needs a big push for better growth in the future,” Banerjee opined.

According to a recent study done by Boston Consulting Group (BCS) along with CII, it is forecast that the Indian medical devices industry has a great potential to grow. It is estimated that the industry will grow 8 folds to about 50 billion dollars by 2025. For that to achieve India needs to not only streamline its regulatory procedures, but also has to take proactive steps to attract more investments on the lines of ‘Make in India’ campaign coined by Narendra Modi government. In addition to that, there is also a need to improve the healthcare facilities like increasing hospital beds, employ trained surgeons, paramedical personnel and create an ecosystem to get easy access to funding mechanism for industry and hospitals.

Moreover, the medical devices industry which is still coming under the same framework of clinical research regulations should be separated as it does not fit regulations governing the drugs and medicines. “Research for new molecules and clearing clinical trials for its effectiveness in pharma industry takes years together along with huge investment, while it is not same for the medical devices industry. It is more like an automotive industry and every day new things are added. So this industry needs an incremental regulation and should not be governed by same regulations as that of drugs except for safety and efficacy,” stressed Banerjee.