• Over-stepping the definition of medical devices
• “more burden on patients and affordable healthcare’
• ‘Licensing fee is unnecessarily higher’
• ‘It will cut down the investment in medical device industry.’
• ‘We are going to meet Dr. Harsh Vardhan tomorrow ‘

‘The Surgical Manufacturers and Traders Association’ organized a press conference against the new framework for regulating all the medical devices under the ‘Drugs and Cosmetics Act 1940’ proposed by the government of India. 

The association expressed its grievances that the new policy will swipe out the entire Medical Device Trade and Industry. Regulating all medical devices under one ambit of ‘Drugs and Cosmetics Act’ is the actual bone of contention.  

The notification regulates B.P. Monitors, Digital Thermometer, Glucometer & Nebulizers and etc, under ‘Drugs & Cosmetics Act’ 1940 w.e.f. 1st of January, 2020. “They have over-stepped the definition of a medical device. The definition of medical devices is much broader than it is mentioned in the new act. The DCA rules proposed to sideline the notification process by mentioning all medical devices that may assist by such means for one or more of the specific purposes,” said Pradeep Chawla, President, SMTA.

The SMTA has further alleged that there are no stakeholders discussions in laying the foundation of medical device rule. 

The rules were applicable only to few notified devices, which were critical by nature, sterile or implantable, however, now the department intends to apply the MDR on all medical devices. 

The Secretary of SMTA, Shri Puneet Bhasin talking about the new act said, “There would be a drastic rise in the cost of licensing, compliance, testing, audit and surveillance charges. Eventually, it will drive the entire micro, medium and small enterprise out of business. It will also decrease the investment in the medical device industry. The importers too would require wholesale drug license from respective State licensing authority. The fee imposed for licensing by Central Drugs Standard Control Organization (CDSCO) on imported medical devices is unnecessarily higher in comparison to the locally produced devices. It is not just licensing fee but a ‘non-tariff barrier’ for which Ministry of Health has no official mandate of the Ministry of Finance/ Ministry of Commerce to decide tariffs. As such all medical devices including rehabilitation aids and personal health aids are subjected to custom duty/surcharge/GST at a time of import. The CDSCO will be the nodal authority.”

Hardeep Singh, Joint Secretary, SMTA, said, “This is a draconian move done without the consensus of the stakeholders. Today taxes are getting higher on medical devices. Why does a patient have to bear tax on thermometers of BP machines. Today, the tax on diamond is lesser than the tax on medical devices. Is this the sensitivity of the government?”

The SMTA is its joint statement said the manufacturers need to upgrade the manufacturing facilities as per ISO:13485 standards with huge financial requirements. The new rules intend to charge hefty fee for annual audits and compliance certification. Importing new products with cutting edge latest technology would not be a herculean task for the traders.

Rakesh Sawhney, Chairman, Trade Act Sub Committee said, “Indian consumers will suffer a lot due to this new proposed law. Usually, such notifications are issued one month before the final gazette notification in order to acknowledge the grievances of the stakeholders but they didn’t. It was brought in overnight like withdrawing the President’s Rule in Maharashtra. This is an adverse situation. We have to fight bit together.”

SMTA believes that this notification is not the in best interest of the public and Indian healthcare system. With the increase in the costing of medical devices, goes higher the humongous expense of the patients.

It also states that there are 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.”

The members of the association will be meeting Union Health Minister Dr. Harsh Vardhan in Delhi on Thursday. 

The association has filed a writ petition in the Delhi High Court against the proposed law. The court has sought the centre’s response on the plea; hearing will be on 11th December.