New Delhi: After India's automobile industry, it's now surgical manufacturers who have threatened to come to the street opposing Centre's new framework for regulating all the medical devices under the 'Drugs and Cosmetic Act 1940.'
The notification issued by the Union Health Ministry suggested combining both surgical devices and drugs under one Act.
"If it's happening there will be a disaster. The new policy will wipe 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," said Hardeep Singh, Joint Secretary of the Surgical Manufacturers and Traders Association (SMTA).
It is believed that more than 1 million people associated with medical device manufacturers industry will be affected. There are 2,00,000 units of small and medium medical device manufacturers in India.
The notification issued by the Health Ministry regulates BP Monitors, digital thermometers, glucometers and nebulizers under Drugs and Cosmetics Act which will come into effect from January 2020.
The association alleged that the new rules tend to charge a hefty fee for annual audits and compliance certification.
Hardeep Singh alleged that the initiative was taken just to woo some crony capitalists as well as getting rich countries to take over India's medical device industry.
Pradeep Chawla, a senior member of the Surgical Manufacturers and Traders Association (SMTA) said that Indian consumers will suffer a lot due to this new proposed law.
Interestingly, the association has already filed a writ petition in the Delhi High Court against the proposed law. The court has also sought for Centre's response on it. The next hearing on the matter will be held on December 11.
Read more:India Exclusion Report 2019 launched
