Surgical Traders and Manufacturers oppose classification of popular devices as Drugs, write to Health Minister

New Delhi: The recent decision of the government to classify 4 common healthcare devices namely nebulizer, blood pressure, digital thermometer, glucometer in the category of drugs, has met strong opposition from industry body, which has pointed that the policy would be a death knell to the livelihood of small and medium enterprises

The Surgical Manufacturers and Traders Association (SMTA) has strongly opposed to Health Ministry already notifying 4 common healthcare devices namely nebulizer, blood pressure, digital thermometer, glucometer as DRUGS, stating that decision would lead to disastrous consequences for the local manufacturers and traders who would be unable to produce/stock/sale under the stringent conditions of the DRUG Act.

Earlier this year, the Government, through a Gazette, notified eight medical equipment, including all implantable devices, as “drugs” under Section 3 of the Drugs and Cosmetics Act, effective from April 1, 2020.

Also Read: Eight medical devices including CT, MRI, X-ray notified as DRUGS by the health ministry

However, the move was severely condemned by medical device makers who saw red and under the ambit of SMTA held a conference against the new framework for regulating medical devices that hit the trade of these manufacturers.

Further, SMTA also wrote to Dr Harsh Vardhan, Union Health Minister, seeking to look into this matter and issue relevant instructions to the Ministry of Health, to safeguard the interest of not just the MSME sector but the entire Medical Device sector which would be devastated by the proposed changes.

In its letter, SMTA had pointed out various drawbacks that established the proposed draft notification to regulate medical devices as gross irrational and unjustified. The key highlight of the grievances put forth the ministry that alleged flaws in the process of CDSCO.

“The entire process of approval of the product of CDCSO licensing is grossly flawed requiring re-registration of any manufacturing site, of the same product, for different importers, causing colossus waste of manpower, time, resource, which in turn will not yield any health benefit to the nation, ” read the letter.

Also Read: All medical devices sold in India to be CDSCO certified: What it Means

Speaking to Medical dialogues, Puneet Bhasin, Secretary, SMTA stated that by bringing the devices as medical devices under the Drug act very onerous licensing norms would be applicable on sale, import, manufacture, stock thereby restricting the shops/outlets from where these goods can be sold to customers /patients. This, in a nutshell, means that to sell even a digital thermometer a retail shop has to hire a pharmacist!

SMTA further pointed out that the move would also lead to increasing of product prices for final customers as the cost of compliance would spiral in terms of product registration fees, annual testing and licensing fees along with regular inspections by state drug control departments. It would also lead to monopolizing of a trade by a few large pharmaceutical companies who have the wherewithal to comply with the provisions of drug act.

"India imports 80-90% of medical devices and the CDSCO licensing fees for imported medical devices is 28 to 140 times at least of the locally produced devices This would greatly enhance the healthcare costs in the country. This is obvious that this isn’t just a licensing fee but a non tariff barrier for which Health ministry has no official mandate as it is the domain of the Ministry of Finance/commerce to decide on tariffs or non tariff barriers for imported medical devices which are in any case being subjected to customs duty/surcharge/GST at time of import," SMTA further added,

The Association demanded that a separate medical devices act should have been brought in first which could provide the correct ecosystem for regulating this medical equipment as most of these devices are neither invasive nor sterile nor implantable.

"Regulating these products in the same manner as that of medicinal drugs would not be in the right spirit and would cause unnecessary burden and hardship to manufacturers and traders and also to the general public who would be forced to bear the high cost of compliance to the drug act. This is more likely to benefit large corporates who have the wherewithal to manage licenses, huge manpower costs and deep pockets to sustain losses," it stated