Indian Drug Agency To Start Regulating Medical Devices
The Central Drugs Standard Control Organization (CDSCO) in India announced its plan to add medical devices to its regulatory jurisdiction, if its proposed legislative amendment passes. The move is expected to boost local manufacturing and India’s stake in the global medical device market.
While 14 categories of medical devices have been under the regulatory eye of CDSCO since 1940, experts complain that its scope is not large enough, and that it is inappropriate to regulate devices in the same way the organization regulates drugs, reports an article in The Business Standard.
Given advances in medical device technology and its prevalence in clinical care, the lack of official government regulatory oversight needs to be amended, a senior CDSCO official was quoted as saying in a Times of India article.
This same official went on to explain that regulation could provide both patients and clinicians protection from potential counterfeits and provide much needed quality control. Right now, many Indian doctors depend on rulings from foreign regulatory agencies in their clinical decision making.
Another significant advantage of local government oversight is the economic boost it would provide the medical device manufacturing sector. Earlier this year, an article in The Hindu Business Line (HBL) reported that 70 percent of medical devices sold in India are imported.
According to HBL, the amendment bill is enthusiastically embraced by local manufacturers, who also hope the government’s stamp of approval will encourage Indian doctors to use their products and subsequently increase production.
Until Indian local supply meets the demand, the Indian government will not be able to correct the inverted duty placed on manufacturing supplies. Under this inverted duty structure, importing foreign medical devices is cheaper than importing the raw materials necessary to manufacture them, explains G.S.K Velu, an Indian medical device manufacturing entrepreneur.
Vibhav Garg, vice-chair of the international manufacturer’s consortium for the Advanced Medical Technology Association (AdvaMed), told HBL that a well-structured regulatory environment would not only help India move away from imports, but would also encourage foreign investment and companies looking to manufacture abroad.
The Times Of India reports that CDSCO is currentlyhosting a five-day workshop for 75 drug control officials from around the country to discuss the details of the amendment bill. Subjects of conversation will include definition of medical devices, issues of quality control management, regularity of audits, and the effect of the proposed amendment on existing regulatory procedures.
Currently, India only represents a $4 billion market in the global medical device industry, but that is set to change. Sanjay Banerji, India Working group chair of AdvaMed, told The Business Standard, “Appropriate regulatory framework, aided with proper government policies could help the industry grow to a USD 25-30 billion in the next ten years."
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