Separate Norms For Medical Devices Soon
The government has decided to bring separate quality
guidelines for medical devices such as stents, catheters, orthopaedic implants
and heart valves by end of May. The guidelines would make it mandatory for both
domestic as well as global medical device makers such as Siemens, Phillips,
General Electric (GE) and LG Electronics to get their products certified by
notified bodies like ISO and Bureau of Indian Standards (BIS) before selling
them in the Indian market. It would also classify medical devices based on the
“The DCGI has finalised the guidelines for regulating medical devices and have
submitted them to the Drug Technical Advisory Board for an approval. The
guidelines are likely to be notified by the end of May,” an official in the
health ministry said.
At present, medical devices are treated like drugs and are regulated by state
drug regulators under the drug law - Drugs and Cosmetics Act. Medical device
manufacturers, who require a free sale licence from the government of India to
export their products, were facing problems in the absence of the clear
regulations and necessary licences. “Other than US and Europe, in most of the
countries we require a free sales licence form India to export our products.
However, we are not readily getting the licence from the government as there are
no specific rules for the industry,” Hindustan Syringes & Medical Devices joint
managing director and head of Association of Indian Medical Device Industry
Rajiv Nath said.
Europe, Middle East, Africa and North America are prime export markets for
Indian medical device makers. However, India imports a huge volume from other
countries. According to Mr. Nath, even as the Indian Manufacturers produce
medical devices worth $2.5 billion, the domestic supply is very low. Out of $2.5
billion, export accounts for more than $1.5 billion. To cater to its domestic
demand, India imports medical devices around $1.5 billion.
“This gap is because of a clear discrimination between the indigenous
manufacturers and multinational companies. While the state drug regulators
expect even orthopaedic implant factories to install refrigeration units just
because drug companies are mandated to do so, there is no means to inspect the
facilities of those who are importing their products. Besides, their imports are
fast tracked if they have Conformite Eurropeenne (CE) certificate from the
European authorities or have an ISO labeling,” Mr. Nath said.
The government move comes in the wake of the industry protesting against the
present norms and delay in issuance of licence to domestic manufacturers. The
idea is not just to provide uniform norms but also to ensure manufacture and
sale of safe medical devices in the country. The domestic medical device
industry is estimated to be around $2.17 billion, growing 15% a year. According
to estimates, it is expected to reach $4.97 billion by 2012.
(Ref: The Economic Times Dated April 30, 2009)