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Guidelines on medical devices, bitter pill for manufacturers

The Drugs Controller General of India (DCGI) new medical device guidelines for sterile devices like stents, catheters, orthopaedical implants, etc., may give rise to an impending crisis for Indian patients.

While the new guidelines have caused severe alarm in the industry, industry practitioners say that these guidelines will adversely hit patients. Players like Johnson and Johnson, Vygon India, among others say that they may have to stop importing these medical devices into the country to comply with the legal situation that demands registration of each medical device within 60 days since March 1, 2006.

Since 80-90% of these devices are imported, non-import may lead to scarcity of these crucial life-saving devices.

Industry players also point out that the registration costs at $1000 per medical device is too high. They say that compared to drugs, the number of medical devices is much more.

For instance, Johnson & Johnson alone has about 10,000-15,000 different medical devices. Some of them do not even give business amounting to $1000.

Vygon India’s MD and Chairman of the European Business Healthcare Group Pavan Choudary, says, “We have above 40 categories of catheters that need to be registered. Some of these like pulmonary artery catheter, perineural catheter, pestonial catheter, etc do not give us beyond $500. Thus registering them at $1000 does not make sense for us.”

He points out that these devices perform crucial tasks in life-threatening situations. Even if they are used less, it does not take away from their importance.

Excess documentation adds to the task. An industry player says, “One will need to recruit a person to file these documents as they need a specialist’s attention.” There are requirements like device master file, quality assurance procedures, risk assessment, biocompatibility and toxicology data, manufacturing process, details of standards to which the device conform, etc., that a company will need to submit for each medical device.

Says Philips Medical Systems CEO and CII’s medical devices group chairman Anjan Bose, “Most people in the industry have not even heard of the term “master file” for medical devices. It is generally drugs that have a master file.”

He pointed out that the the state authorities will not be able to process the amount of data submitted due to staff scarcity. This will further lead to delay in the granting of licenses.

He said that these guidelines along with the tax increases for the medical device industry have served as a double whammy for the industry. This may result in a rise in costs of between 5% and 10% for most players.



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