Tough regulations, higher duties to cripple growth of medical devices industry

June 22, 2009 by · Leave a Comment
Filed under: Medical Devices 

Tough regulations, higher duties to cripple growth of medical devices industry
June 8, 2009, 0800 IST – Source:Pharmabiz.com

The stringent regulatory measures coupled with the high imports, customs duties imposed on the medical devices in the country may increase the burden on small scale companies and the cost of treatment, making the treatment unaffordable for patients without insurance coverage, alerts a latest report.

A sector analysis on medical devices, prepared by the National Institute of Pharmaceutical Education and Research (NIPER) – Ahmedabad, points out that the high cost of obtaining the required documentation for the regulatory submissions according to the recent amendment would lead to increase of prices for medical devices.

As per the regulation, the importer has to pay US$ 1500 towards the registration of the manufacturer from whom the domestic supplier is importing. Further, the importer has to pay a fee of US$ 1000 for registration of a single medical device, which may include variation in sizes or shape without any change in the material or method of use and an additional fee of US$ 1000 for each additional device. The report speculates that the high fee could become a burden for smaller manufacturers and also affect the available range of products in India as the sales per device are, normally, quite small.

“It is expected that the cost of devices is expected to rise primarily because of registration costs, which include the registration fee, salary of additional staff hired to follow registration process and paperwork and increase in countervailing duties to 4 per cent announced in the 2006-07 budget,” comments the draft report submitted to the Department of Pharmaceuticals lately. The financial burden will be passed down the value chain to patients, rendering devices more expensive and treatment unaffordable.

The increase in cost would be higher in larger devices such as stents, which constitutes almost 70 per cent of the total medical bill, as ay increase in cost of these products will increase the cost of treatment. The local labelling requirements for imported devices may create issue of logistics for supplies while increasing the cost of surgical products.

Further, the special additional duty of four per cent for medical devices and instruments in Union Budget 2006-07, along with the customs duty and the state level taxes will increase the cost on patient to 10 to 20 per cent in diagnostics, states the report. After the impost of special additional duty, medical instruments like CT Scanners, MRI machines, Cathlab and ventilators which were earlier under the five per cent customs duty slab now attracts nine per cent duty while ultrasound machines, patient monitors, defibrillators and blood cell counters will be charged under the 26.8 per cent customs duty category.

The duty exemption for diagnostic kits used to detect life threatening disease still apply only to basic techniques like the ELISA and CLIA tests though the methods are frequently replaced by newer and more precise methods like Polymerase Chain Reaction (PCR) test, which attracts 37 per cent duty per kit.

The tax measures mixed with huge customs tariff structure are expected to escalate the cost of treatments and finally restraint the delivery of modern healthcare. “Though increased cost of treatments will not affect the insured patients, but the coverage of health insurance which is less than 1 per cent then becomes a concern,” explains the report.

The tax measures will lead the margins to shrink for the medical devices companies, as they have to accommodate a four per cent increase in custom duties. As a country depending more on imports for medical devices supply, this will also lead India to loose its cost advantage in medical tourism.

Dependency on imports for supply of medical devices, low level of healthcare insurance and low levels of healthcare facilities and awareness especially in rural areas are the other factors which would cripple the medical devices industry in India, says the report.

 

Notification on new guidelines for medical devices sector soon

June 22, 2009 by · Leave a Comment
Filed under: Medical Devices 

Notification on new guidelines for medical devices sector soon June 22, 2009, 0800 IST -  Source : Pharmabiz News Letter (www.pharmabiz.com)

Decks have been cleared for formally implementing the comprehensive guidelines for the medical devices sector, with the Health Ministry is set to issue the notification in this regard very soon. The minutes of the Drug Technical Advisory Board (DTAB) which was held sometime back and suggested the guidelines have been finally approved and sent to the Health Ministry for issuing notification, which may come anytime now, sources said. Though the draft guidelines, prepared by the expert panel, were approved by the DCC and DTAB, the matter was pending due to the delay in the approval of DTAB minutes which were sent again to its members as desired by the health ministry. The guidelines, finalised in consultation with the industry, seeks to give a regulatory framework to the largely unregulated sector by placing the medical devices as a separate category with new definition, instead of treating in line with drug definitions. The DCGI office has already issued several notices in the recent past to streamline the sector by asking the industry to go strict on medical devices. Besides, the office also had expanded the list of medical devices, by including 19 more items to the list already in force since 2005. “As there were not many suggestions from the DTAB members with regard to the minutes of the last meeting, we have already passed it on to the health ministry for issuing necessary notification. It can be announced very soon,” sources said. The Drug Controller General of India (DCGI) had set up a committee involving representatives of trade bodies including FICCI and CII to draft the guidelines and have gathered inputs from the industry as whole also by inviting public opinion on the same. Besides, the WHO and the United State Food and Drug Administration (US FDA) have been assisting the DCGI office to float the new guidelines and train the staff at the headquarters. The DCGI office already has a separate wing to deal with the applications, monitoring and other related tasks about medical devices.

Regulatory system for manufacturing, distribution of medical devices soon

April 21, 2009 by · Leave a Comment
Filed under: Medical Devices 

April 21, 2009, 0800 IST -Source : ePharmail of Pharmabiz.com. For more info, visit http://www.pharmabiz.com.

A comprehensive regulatory framework for the medical devices sector is being planned with the authorities set to issue a new set guideline to treat medical devices as a separate category and to put in place new definition for the same. The sector has remained unregulated for several years due to many factors including lack of clarity in policies.

 

The draft guidelines, finalised in consultation with the industry through a series of meetings in the past, have already been approved by the DTAB recently and will be issued soon by the health ministry. The guidelines mainly seek to keep the medical devices separate from the new drugs and to be placed under stricter monitoring by the DCGI office. The guidelines will be binding on both the manufacturing and import of medical devices, it is learnt.

The DCGI office has already issued several notices in the recent past to streamline the sector by asking the industry to go strict on medical devices. Besides, the office also had expanded the list of medical devices, by including 19 more items to the list already in force since 2005.

Spinal needles, insulin syringes, three-way stop cock as an accessory of IV cannula/catheter/perfusion set, endotracheal tubes, introducer sheath, annuloplasty righ, cardiac patch, cochlear implant, extension tube, close wound drainage set, trachestomy tube with or without cuff, AV fistula needle, extension line as an accessory of infusion set, ANGO kit/cath lab kit, heart lung pack, measure volume set, flow regulator, haemodialysis tubing set and dialysis catheter were thus brought under the purview of the Act recently. Cardiac stents, drug eluting stents, catheters, intra ocular lenses, IV cannulae, bone cements, heart valves, scalp vein set, orthopaedic implants, and internal prosthetic replacements had been brought under the purview of Drugs and Cosmetics Act, making it mandatory to get licence for manufacture for sale and distribution in 2005.

The DCGI had set up a committee involving representatives of trade bodies including FICCI and CII to draft the guidelines and have gathered inputs from the industry as whole also by inviting public opinion on the same. Besides, the WHO and the US FDA have been assisting the DCGI office to float the new guidelines and train the staff at the headquarters. The DCGI office already has a separate wing to deal with the applications, monitoring and other related tasks about medical devices.

 

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