NEW DELHI : The Surgical Manufacturers and Traders Association (SMTA) has opposed the new policy of the Central Government to regulate all medical devices under the Drugs and Cosmetics Act. SMTA has said that this move will wipe out the entire Medical Device Trade and Industry.
The SMTA has filed a writ petition in the Delhi High Court against the proposed law. The HC has sought the centre’s response on the plea; hearing will be on December 11.
Recently, the union health ministry has come out with a draft notification, which said that all medical devices will be regulated under the Drugs and Cosmetics (D&C) Act.
The association addressed a press conference in New Delhi and pointed out that regulating all medical devices under the ambit of ‘Drugs and Cosmetics Act’ is the actual bone of contention.
"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 D&CA rules propose 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.
Mr Chawla has pointed out that there were no stakeholder discussions in laying the foundation of the 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, he said.
The Secretary of SMTA, Puneet Bhasin, 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 enterprises out of business. It will also decrease the investment in the medical device industry.”
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 or BP machines?"