India's central government has announced plans to bring all medical devices under the definition of drugs in order to regulate its manufacture and trade.
This announcement could threaten the Indian medical device industry, which is reportedly currently worth $5.2 billion, with the potential to increase up to $50 billion, according to Invest India.
The draft notification has been issued by the health ministry and aims to bring all medical devices under the purview of the Drugs and Cosmetics Act 1950. This will mean that all devices including instruments, apparatus, appliances, implants, material or other articles, whether used alone or in combination, including software or an accessory, for purposes of diagnosis, prevention, monitoring, treatment, investigation, disinfection will now come under this proposed regulation.
The first medical devices to be regulated under this drugs Act from 1st January 2020 will be digital thermometers, nebulisers, blood pressure monitoring devices and glucometers.
Puneet Bhasin, secretary, Surgical Manufacturers and Traders Association (SMTA) said: "By bringing these devices under the drugs Act, very onerous licensing norms would be applicable on their sale, import and manufacture and stock. Even if you have to sell a digital thermometer, a retail shop will now have to hire a pharmacist.
“Such requirements are quite baseless as pharmacists have no experience or technical knowhow about these electro-mechanical medical equipment. Moreover, 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 will monopolise trade and sound the death knell for lakhs of standalone surgical shops."
Pradeep Chawla, president of SMTA believes that as much as 90 percent of medical device suppliers within Asia’s largest wholesale market will find it impossible to comply with these regulations. Chawla commented: “Thousands of small and micro units will have to shut down, and imports will become multiple times costlier, turning medical devices expensive for consumers."
Associated leaders have also expressed serious concerns about this Act: "A separate medical devices Act should have been brought in first to regulate 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 which would be forced to bear the high cost of compliance. This is more likely to benefit large corporates that have the wherewithal to manage licences, huge manpower costs and deep pockets to sustain losses."
SMTA has approached the Delhi High Court. The court will hear the petition on 11th December 2020.