The Central Government is planning to set up a medical devices regulatory authority to sanction and monitor the clinical trials of new surgical procedures and medical devices in the country. The proposal for the establishment of the authority, tentatively named as Indian Medical Devices Regulatory Authority (IMDRA), has already been drafted by the Society of Biomedical Technology (SBMT) set up under the Defence Research Development Organisation (DRDO), it is learnt.
The revised Schedule Y guideline under the Drugs and Cosmetics Act 1940 that is under the final scrutiny of the Health Ministry is expected to have a mention of the proposed authority as the competent body to sanctions all such clinical trials and marketing approvals.
As an interim arrangement, the government is to constitute specific committees to deal with the sanctions of clinical trails with biomedical devices and approvals are to be given on case-to-case basis. The committees are to function until the guidelines are formulated and implemented by the new regulatory authority.
The concept of regulations governing investigations involving biomedical devices is new to the country. At present, except for needles and syringes, the Drugs and Cosmetics Act, 1940, do not cover such investigations.
The only evaluation currently done on these devices before they reach the market is by the Central Excise authorities. Since this exercise is done for the taxation purpose, nowhere the entrepreneurs are undergoing a quality check. The government has felt that the situation discourages entrepreneurs to venture in this area with quality products especially when they do not come under the strict purview of the existing regulatory bodies like ISI, Bureau of Indian Standards (BIS) and Drug Controller General of India (DCGI). It should be noted that India has very low number of patents or propriety medical equipments manufactured and produced in the country.
The Union Health Ministry points out that biomedical technology has made considerable progress in the conceptualisation and designing of bio-equipments. It has felt that only proper maintenance of good manufacturing practices (GMP) can accelerate the growth of quality products in this segment.
It is known that several medical devices and critical care equipment have been developed and many more are in various stages of development in the country. As the capacity of the country in this area is improving day by day the need for a regulatory mechanism/ authority is also on the rise. The ministry is to come out with the interim arrangement for control of clinical trials on medical devices soon.
Medical devices market in India is estimated to be of $1,250 million worth and is growing at a rate of around 25% for the last few years. There are about 120 domestic manufacturers in the country. However due to absence of quality checks and GMP norms, demand for imported devices are more and imported goods constitute almost 50% of the domestic market. Indian makers of diagnostic kits and medical devices include Hindustan Syringes & Medical Devices, Hindustan latex, Dr Reddy's Lab, Cadila Pharma, Lupin Laboratories, J Mitra & Co., XyCton, Bharat Biotech etc. The DCGI had recently embarked on the task of preparing a comprehensive list of all medical devices and diagnostic equipment available in India and is known to have sought the help of the BIS to come out with standards and specifications for each of these products.