The Central government is likely to introduce a set of GMP norms for medical devices and diagnostic equipment manufacturing in the country. It is exploring the possibilities of coming out with a fresh set of rules that can control and monitor the manufacturing standards of medical devices manufactured and marketed in the country.
The government had recently organized a national workshop to gather suggestions from the medical devices manufacturing industry on how to lay down GMP norms for medical devices and inspection of medical devices manufacturing units. The workshop, organized by the Central Drug Standard Control Organization (CDSCO) had the presence of about 80 drugs control and CDSCO officials and officers from government testing laboratories of 11 states.
According to the participants of the workshop, the office of the DCGI would initiate the preparation of a comprehensive list of all medical devices and diagnostic equipment available in India and seek the help of the Bureau of Indian Standards (BIS) to come out with standards and specifications for each of these products.
This exercise is to help the authorities to have a clear idea of the current status of Indian medical equipment manufacturing sector.
The participants informed that there are more than 5,000 medical devices including various kinds of diagnostic kits that are available in international market. Though India''s production in this segment is limited to 1000 odd products, almost all devices are available in local market. While there are four categories of medical devices according to the internationally accepted norms, India has no clear distinction in this aspect. India should also categorize its medical equipment-manufacturing sector, based on the risk factor associated with each product, the participants said. They pointed out that many of the high-cost drug filled devices are being imported at present without any check or licenses.
Interestingly, the Indian arm of a multinational company that applied for a marketing license for its balloon expandable drug eluting stent system, had to be satisfied with a delayed reply from the authorities concerned that a license is not necessary as it is "not a drug".
The participants pointed out that proper regulation and standards have always helped the growth of domestic industry. "It will also lead to the reduction of prices as in the case of many other drugs," they said. Some of the cardiac stents are known to cost more than a lakh rupees for a single set. There are many devices that are going to remain inside the body for years together. Experts pointed out that orthopedic devices are often planted inside the body for very long period. As on date there are no restrictions or monitoring on the quality of these devices.
The workshop highlighted the need for proper testing facilities and recognized national standards for diagnostic products and medical devices. They said that unless such systems are in place, there is no point in bringing in GMP guidelines for the sector as no authority would be competent enough to inspect the facilities and identify the ills. These were said to be some of the major problems that are hindering the growth of medical device manufacturing sector of the country.