April 19, 2009

Medical device makers oppose quality norms

The extension of quality norms that govern the manufacturing process of drugs to medical devices in recent amendments to the country’s drug laws has left manufacturers of stents, catheters and orthopaedic implants nonplussed — and even angry.

Following the amendements to the Drugs and Cosmetics Act, state drug inspectors are insisting medical devices firms that make catheters and IV cannulae install facilities similar to the ones in a drug manufacturing company.

“State drug regulators are harassing us. They expect even orthopaedic implant factories to install refrigeration units, just because drug manufacturing units are mandated to do so,” said Hindustan Syringes & Medical Devices joint managing director Rajiv Nath.

“The requirements of a medical device manufacturing unit and a drug manufacturing unit are different. You cannot regulate both with the same yardstick,” added Mr Nath, who also heads the Association of Indian Medical Device Industry.

The Haryana drug regulator recently ordered medical devices firm Mecmann Healthcare to shut down, and one company official said a major reason for the regulator’s action was Mecmann’s failure to comply with the provisions for the manufacture of pharmaceutical products under the Drugs & Cosmetics Act.

For medical devices covered under the drug law, companies are required to take a licence from state regulatory authorities to manufacture and sell them in the country. While the licence is a mandatory to export medical devices to west Asia, south-east Asia, Africa and CIS, only ISO certification is sufficient to export to the US and Europe, Mr Nath explained.

According to medical device manufacturers, the industry is facing problems due to absence of clear regulations and necessary licences. The companies claim that they are bearing losses as they have been unable to export for six months now.

“Less than 2% of the 700 units have been registered in 20 years,” Mr Nath added.

To put an end to its woes, the industry has sought central government’s intervention to form separate guidelines for orthopaedic and ophthalmic devices. The country’s medical devices industry is estimated at $2.17 billion today, and is estimated to reach $4.97 billion by 2012 at a growth rate of 15% a year.

Link: Original Article

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