All Medical Devices, Including Implants, to be Classified as Drugs

After the Johnson & Johnson faulty hip transplant controversy, the government has decided to bring all medical devices under the control of Central Drugs and Standard Control Organisation (COSCO). These devices include implants and contraceptives.

In a draft notification, the Ministry of Health and Family Welfare said that all medical devices will be defined as drugs under the Drugs and Cosmetics Act effective December 1st.

It has sought opinions of all stakeholders and given them 30 days to respond.

The notification will require import, manufacture and sale of all medical devices to be certified by CDSCO and manufacturers will have to get licences from Drug Controller General of India.

The recommendations were drafted by the Drugs Technical Advisory Board (DTAB) earlier this year.

Medical Device Industry Points to Loopholes

In a quote to FIT, Rajiv Nath, Forum Coordinator, Association of Indian Medical Device Industry (AiMeD) said,

“What’s missing in covering note of under secretary is a stated policy or an assured road map to a separate Medical Devices Law with a Defined Transition period and in a phased manner for technology categories, in addition to the voluntary registration as a temprary measure under the current drugs act.”

“In absense of such a written notification, ow can Indian Manufacturers accept to be regulated under drugs Act by pharmacists and cut their hands?,” he added.

He raised concerns about the time frame given to stakeholders for implementing the new norms.

Johnson and Johnson Faulty Hip Transplants

In 2018, the news of over 4,451 patients affected by Johnson & Johnson’s faulty hip implants in India first broke.

The implant made of cobalt and chromium was found to be leaking metals in the body of patients, leading to fluid accumulation and metal poisoning in some cases.

This happened globally, and the device was first recalled in 2009 in Australia. But a month later, the company applied for an import license to sell the same product in India, and the authorities readily complied without any due diligence. It was only three years later in 2013, that the device was officially recalled in the country.

The medical device industry in the country is estimated at $5.8 billion and is pegged to increase to $9.6 billion by 2022.

Also Read: An Unregulated Mess: Inside India’s Medical Device Industry

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