Are Domestically Manufactured Medical Devices Safe - ACRI India

1. Are Domestically Manufactured Medical Devices Safe? Shri Narendra Modi has introduced the “Make in India” initiative, a Swadeshi movement covering 25 sectors of the economy, on 25th September 2014, in order to encourage companies to manufacture their products in India, rather than import the same from abroad. But, when this initiative was extended to the medical industry, there was a swarm of medical device manufacturers claiming to be on par with global brands under the Make in India banner. But, the matter of concern has been whether these locally manufactured medical devices are actually safe and up to the standards. Why are clinical trials important for determining standards of medical devices? Many Indian brands launched cardiac stents, which were compared to some gold standard stents in the global market. But, how true is it that these stents were safe and reliable? Only robust clinical trials can help decide the safety and efficacy of such devices. It needs to be understood that different patients have different needs. Choosing only one stent for every patient is not right. Every individual patient requires individual devices and individual quality of care, depending upon his or her condition. This is why rigorous clinical trials are important so that the stent (or any other medical device for that matter) is tested on a group of patients, belong to various categories and conditions, to determine its safety and efficacy. It is important to use the best available clinical evidence from systematic research before coming up to a decision of approval. Until domestic players are able to meet the global standards in every

2. aspect, their entry into the market should be barred. What India needs most of all are medical companies with high quality infrastructure and a strong product pipeline of research-based products. The Indian Government takes steps to strengthen policies Taking all of the above into account, the government has taken steps to strengthen the regulatory and policy framework, and encourage local R&D and skill development. Developing any medical device depends upon the science, research, and technology invested in manufacturing it; and the first significant step in this direction is clinical data. Clinical trials for every device, no matter what, must be conducted on thousands of patients to undoubtedly establish its success rate. With so many people suffering from so many diseases and disorders today, there is a need for better and better healthcare facilities, and a range of sophisticated medical devices and equipment. Patient safety should be a first for every doctor and healthcare practitioner. If there is any doubt in the quality of a device, it should be considered inappropriate, in order to not put the patient’s life at risk. You can see how important clinical trials are for not only medicines, injections, and other drugs, but also medical devices. To be able to identify if every element going into the medical industry is perfect for use, so that the health status of your country is improved, you can put in your efforts by joining the clinical research team of India. And for this, you can always join a reputed clinical research virtual learning center Bangalore, one like Avigna Clinical Research Institute. ALSO READ: Are Indian Stents At Par With Globally Available Variants?