Indian regulators have decided to abandon a proposed law that would have amended parts of India’s Drugs and Cosmetic Act of 1940, to pursue more extensive revisions to create a separate device regulation.
India’s Ministry of Health & Family Welfare has already prepared separate rules for medical devices under the existing act, and has begun drafting separate laws for regulating medical devices, drugs and cosmetics. Draft legislation is expected later this year as the ministry continues to seek input from industry.
“This ushers in times of change and hopefully for the better,” said Rajiv Nath, forum coordinator for the Association of Indian Medical Device Industry (AIMED). He told IDDM that the association has long asked for separate regulations for devices.
Some of the changes that AIMED had asked for include quality management system requirements that are aligned with ISO 13485 standards, as well as third-party certification bodies to conduct inspections.
The regulator has proposed third party certification bodies, similar to the EU, and is currently considering four tiered risk-based regulations. The government said it was willing to consider third-party certification for low-risk devices but plans on using medical officers for all other device categories.
Nath said the proposed regulatory framework may require changes once complete but the structure would ensure devices are regulated all at once as opposed to being rolled out in stages on a product-by-product basis as was originally proposed.
The most contentious issue is the current definition of manufacturer. CDSCO defines a manufacturer as a person who himself manufactures a medical device and includes any other person who undertakes such manufacturing activity on his behalf.
Nath said this definition could be applied to pseudo-manufacturers, traders, and marketing companies that could be misconstrued as a manufacturer.
AIMED proposed manufacturers be defined as a “person, an enterprise, or an entity who himself makes a product through a process involving raw materials, components, or subassemblies, usually on a large mass production scale with different operations divided among different workers.”
He said the issue is important because how legal manufacturers were defined in Europe has hurt its domestic industry as complete products have been farmed out to manufacturers in countries such as China, India and Malaysia and are claimed to be made by European companies.
For this reason, AIMED proposed using Japan’s model for defining manufacturers to protect domestic manufacturing and the “Make in India” initiative.
Industry can expect drafted rules within the next six months after which public comments will be integrated into final rules.