Penalties on manufacturers of medical devices may go up by over 50% in case of failure of devices and non-compliance to norms. The government, in the upcoming Drugs and Cosmetics Act Amendment Bill 2015, has proposed the increase in penalties, which could take the quantum over Rs 1 lakh.
“While drafting the proposal the clear mandate was to align the bill with requirements of Make in India,” said an official from ministry of health and family welfare. “Harmonisation of medical devices standards and compliance with the international benchmarks is at the core of the bill (and section on medical devices).” The new section on medical devices will help bring the 14,000 odd devices under the ambit of the new law.
The government is planning to set up a medical device technology advisory board and recruit more medical device officers if the bill, first introduced in Rajya Sabha in 2013, gets passed.
According to industry estimates, failure of medical devices has spurted over 20% in last three years. Official figures do not exist because the country does not have a system to monitor and record failures. The government is thus also developing a surveillance system, which coupled with increased fines could see better regulation.
Another official involved in the making of proposals on the amendment bill, said the bill would propose new regulations and penalties related to clinical trials and misbranded drugs. “Penalties for misbranded drugs, which are damaged, labelled improperly or carry false claims, are likely to be double.” Currently, misbranded drugs attracts fine not be less than `3 lakh or three times the value of the drugs confiscated.
“The bill will grow domestic manufacturing capacity, allow domestic industry to compete globally, and incentivise Make in India,” said AdvaMed, an association of medical device manufacturers.