Inspector raj gets booster shot with medical device regulation in coma

This incongruous interpretation of the law results from the lack of separate standards for medical devices in many states like Haryana. The result is often a bizarre hark back to the inspector raj of pre-liberalised India, such as drug inspectors insisting that orthopedic implant factories install refrigeration units, just because pharma units are mandated to do so.

Naturally, entrepreneurs are left in the lurch by this dichotomy. Mann claims he received no show-cause notices or communiqu?s, nor did the drug regulator seek any explanation before he was asked to down his shutters for, among other things, manufacturing medical devices without the required licence.

?This was more than a month after the drug controller general of India?s (DCGI?s) office had assured us in a February meeting that in the transitory period until an exclusive policy for medical devices is notified, companies with the relevant ISO or BIS certificates would be given interim relief,? said Rajiv Nath, joint managing director, Hindustan Syringes & Medical Devices.

Mecmann has obtained both ISO 9001: 2000 and ISO 13485: 2003 (meant specifically for medical devices), and the company?s products are also CE marked for export to Europe. Mecmann has been manufacturing IV cannulae since 2003, two years before they were notified in the list of devices brought under licensing. Mann applied for a license to the state drug regulator in 2006, after which the first formal inspection took place in March 2009.

Now, newly formed medical devices industry body Aimed and Mecmann are threatening to sue the state drug controller. Earlier, the orthopedic industry in Mumbai and Delhi sought a high court stay order on similar grounds to continue running their businesses.

The $2.5-billion medical devices industry has been pleading for separate policies and regulation for over several years now. Ironically, the Drugs & Cosmetics Act, the principal legislation that governs the country?s drugs and devices sectors, does not even contain an exclusive definition of medical devices. However, that anomaly will be corrected through an amendment to the Act that is currently under review.

Manufacturers of devices such as IV cannulae that have been notified under the drugs classification require a specific licence under the Drugs & Cosmetics Act. Although the DCGI is the final licence approving authority for notified devices, state drug controllers also play a pivotal role in the registration process. Under the prevailing law, a license to manufacture notified devices requires compliance with Schedule M and Schedule M-III of the Drugs & Cosmetics Act.

?Is it not ironical that this unit of Mecmann, which has been in operation since 2003 and obtained ISO 13485 certification, a CE mark in 2004 and meets the stringent regulatory requirements of advanced countries in Europe failed to satisfy domestic standards, while India freely allows the import of medical devices from foreign companies that have the CE mark and IS0 13485 without undergoing inspection. We deserve a level playing field,? said Nath, who is also the forum coordinator for Aimed.

On Thursday, however, there was light at the end of the tunnel for industry players like Mann. At a meeting in the DCGI office, the central drug controller again assured them that the first formal inspection according to law should have been a joint one with representatives from both the DCGI office and state drug controller?s office, unlike in the case of Mecmann, where the state drug controller conducted the inspection individually, claimed participants at the meeting. They said the DCGI office assured them that flaws in the process would be rectified soon. But that?s cold comfort for Mann, who still awaits word on when he can reopen his factory.