India's Union Health Ministry advanced amendments to the Medical Devices Rules, 2017, on Tuesday, proposing shorter statutory timelines for licensing applications as the consultation period on the draft notification drew to a close. The Central Drugs Standard Control Organisation in New Delhi issued the changes.

The draft amendments, published in late June, seek to compress the time regulators take to process manufacturing and import licences for medical devices. The Health Ministry said the measures were intended to ease the regulatory burden on domestic manufacturers and support the government's push to expand local production under its Make in India initiative.

The proposals follow sustained lobbying from industry bodies including the Association of Indian Medical Device Industry, which has argued that lengthy approval cycles deter investment and delay patient access to diagnostic and therapeutic equipment. The Central Drugs Standard Control Organisation invited written comments from manufacturers, importers and the public on the draft.

The revisions form part of a broader effort by the Health Ministry to overhaul the regulatory framework governing the roughly 14 billion dollar Indian medical device market, which remains heavily dependent on imports. Health Ministry officials have signalled that faster licensing would be paired with strengthened post-market surveillance to maintain safety standards.

Rajiv Nath, forum coordinator of the Association of Indian Medical Device Industry, welcomed the direction of the reforms but urged the ministry to ensure clarity on enforcement. "Predictable timelines are essential, but they must be matched by adequate regulatory capacity to make them meaningful," he said.