Companies also pointed out that the registration costs of USD 1,000 per medical device is too high, as the number of medical devices far exceeds the number of drugs; larger companies have as many as 10,000-15,000 different medical devices. In addition, certain devices, despite being crucial, do not accrue business amounting to USD 1,000. “Even though we would not want a patient to be denied of our catheters; some of which have no substitute; it will not make commercial sense for us to continue to import these, given the high registration fee,” says Choudhary.
Excess documentation adds to the task, as companies need to recruit additional administrative staff and industry specialists to cover all areas that require submission for each device. These are namely, device master file, quality assurance procedures, risk assessment, biocompatibility and toxicology data, manufacturing process, details of standards to which the device conform etc. The requirement for imported devices to conform to local labelling requirements creates a logistical bottleneck for supplies while increasing the cost of surgical products.
To compound the problem, the state authorities will not be able to process the amount of data submitted due to staff scarcity, consequently leading to delays in granting of licenses. Echoing similar concerns on infrastructure bottlenecks, Bose states, “We are extremely concerned as an industry. There is a very voluminous amount of work that needs to be done in the coming months.”
Such guidelines along with tax increase have hit the industry hard and may result in a 5-10 per cent increase in cost for most players. From a patient’s perspective, treatment costs are expected to rise as healthcare deliverers seek to cover additional costs. From a company perspective, margins are expected to shrink, as device companies have to accommodate the four per cent increase in custom duties, announced in the recent budget. According to Bose, “A 5-10 per cent increase in costs would definitely hit companies’ top and bottom lines and also result in resource reallocation.”
Some experts claim that India could lose some cost advantage as a healthcare destination, as medical devices constitute a major portion of total hospitalisation costs. However, Mishra states that, “A 5-10 per cent cost increase will not affect medical tourism much, as treatment itself is two to three times cheaper in India. In fact, it will be beneficial, as foreign patients will be able to avail of locally manufactured devices that are certified, expanding the domestic market significantly.”
In order to address these concerns, the CII has urged the Centre to amend the proposed medical device regulations. According to Choudhary, “We have brought these problems to the government’s attention and the government has assured us it is looking into all these areas and we feel it will help us circumventing these hurdles.”
One of the most pressing suggestions has been to permit the import of devices that are US FDA/CE certified, so that efforts can be focused on local manufacturers without licenses. According to Mishra, “US FDA and CE certifications are extremely robust and universally acclaimed. Efforts should be focussed on devices that have not gone through any quality control; those that are directly connected to patients’ safety.” Currently, the American Chamber of Commerce, Europe’s UCOMED, the CII and National Committee for Medical Equipment are in talks with the MOHFW to provide a list of medical devices that require central clearance prior to import, manufacture and marketing in the country. These dialogues also hope to ensure framing of guidelines for medical devices accreditation, in addition to establishment of required infrastructure to undertake product testing in India, certification and quality standard evaluation.
On the whole, industry officials have made it clear that they are not opposing the regulations, recognising the importance of patient safety. What remains a matter of concern are the issues related to this regulation, as a few clauses could affect a $1.5 billion market, consequently taking its toll on patients. In the interest of companies that are not aware of the new guidelines put forth by the DCGI, the media should publicise the CDSCO website, where they are posted. Says Mishra, “Regulations should not kill the indigenous industry, when it is picking up in India. We have to remember that it is this industry that will bring the costs down in the future.” Quality control should always be a priority and the government has industry’s support in this respect. Says Bose, “I must applaud the government for its efforts and good intention towards patients. I am proud to be an Indian and fully support the initiative to ensure quality and regulation of life saving devices in India.”
The writer is Mumbai-based research analyst.
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