“New” Indian Regulatory Rules Mean Surgical Staplers Are Now Drugs

In a move that harks back to historical, pre Eu Medical Device Directive days, the Indian authorities have decided to regulate the surgical stapler as though it was a pharmaceutical.  In a Times of India feature, the Central Drugs Standard Control Organisation ( CDCO) has reportedly decided to consider the ‘stapler’ as a drug and regulate it strictly under the Drugs and Cosmetics Act. Until recently Staplers were considered as medical devices.

“The move is important as it will regulate the quality of staplers” …Hang-Gliding’s dangerous so lets make Hang-Gliders drugs then

“Considering its growing usages in various surgeries, its manufacture needs to be strictly monitored. That’s why it has been brought under the drug category. That means that it will be mandatory for a manufacturer to get a licence to make it. Earlier, needles and heart stents were brought under the drug category,” Sanjay Patil, joint commissioner (drugs), told TOI on Monday.

The Central Drugs Standard Control Organisation, in consultation with the Union ministry of health and family welfare, has decided to regulate the import, manufacture and sale of this class of products as drugs under the Drugs and Cosmetics Rules. The notification was issued on October 4.

According to the article; “Surgical staplers were developed in response to concerns about the healing of traditional sutures. Evidence seemed to suggest that sutures were more prone to leaks and separation, although further studies indicated that when placed properly, conventional sutures are perfectly safe. However, development of surgical stapler created a number of advantages, including speed, accuracy, and evenness of wound closure, which made it a useful operation room tool. Both stapling and suturing are taught to surgeons, and training about the appropriate settings for each technique is also provided.”

At Medlatest we’re asking ourselves why the Indian authorities would do this.  Surgical Staplers are absolutely commonplace in surgery across the world and it seems retrograde and somewhat out of kilter with current thinking to regulate the stapler in this way.  It’s not a new technology, doesn’t have any suggestion of a pharmaceutical effect and from a functional perspective performs the same tasks as sutures, so why do it?  The answer may be twofold.  Firstly staplers are expensive things compared with sutures, so putting some additional hurdles in place might slow down their adoption a little.  “It will be important to see that it does not attract additional import duty and make stapler usage more expensive. Already the price of staplers compared with conventional suture material is quite high.”

Secondly, one wonders whether this says more about the underregulation of medical devices in general than it does about staplers in particular. If the authorities are concerned about a lack of regulatory control in medical devices it’s not inconceivable that they may have targeted a complex device for special treatment, the only way of delivering this regulatory control being the pharmaceutical route.

Meanwhile the industry has made a representation seeking grant of a transitional period for regulation of staplers under the Drugs and Cosmetics Act.

“It has been decided in consultation with the Union ministry of health and family welfare that three months may be granted as transitional period for regulation of these products under the Drugs and Cosmetics Rules in respect of import, manufacture, sale and distribution,” the notification states.

“We will start monitoring its manufacture, sale and import only from February,” Patil said.

The import, manufacture, sale and distribution of staplers without proper permission and licences under the Drugs and Cosmetics Rules would be considered an offence under the said Act from February 1, 2012, the notification states.

The full Times of India article is here.

Source: medlatest staff, times of India