THE RECENT EVOLUTION OF MANUFACTURING POLICIES FOR VENTILATORS

With the onset of covid-19, the GOI has streamlined the policies for medical device manufacturing. The article discusses the policy in action before covid-19, what it was updated to during covid and what more needs to be done.

- Ashok Patel

Lately, the government of India has made earnest attempts to streamline policies and regulations to give that much needed thrust to the medical device sector. This was even before Covid-19 came as an unprecedented public health challenge. With ventilators constituting a critical weapon in the fight against Covid-19, the role of a policy framework guiding the manufacturing of ventilators became even more relevant. How has the policy landscape for manufacturing ventilators evolved in the country in recent years?

CDSCO, THE REGULATORY AUTHORITY

The Central Drug Standard Control Organisation (CDSCO) is the pivotal regulatory body for medical devices, including ventilators. The regulation is carried out either through the listing or registration of devices.

MEDICAL DEVICE RULES 2017, THE GUIDING REGULATORY FRAMEWORK

With the introduction of The Medical Device Rules 2017, which came into effect in January 2018, the stage has been paved for simplifying and streamlining the regulatory framework set out rules and norms for obtaining registration and licenses by manufacturers and importers of medical devices. And this would also apply to ventilator manufacturers. Very importantly, the intent was to treat medical devices as distinguished from drugs for regulation for the first time since the Drugs and Cosmetics Act, 1940 came about.[1] Yet, as of today, practically speaking, medical devices, including ventilators, continue to be treated as drugs for regulatory purposes.

A RISK-BASED CLASSIFICATION SYSTEM