New Delhi: The Union ministry of health and family welfare has asked the department of science and technology, or DST, not to proceed with its proposed Bill for regulation of medical devices in the country, and set up an independent regulatory agency for the purpose as the plan would overlap with a new Bill currently before Parliament and lead to duplication of efforts.
The DST is yet to take a final call on whether it will pursue the Bill or abandon it, even as the issue seems to be escalating into a turf war between ministries. Medical device makers, largely unregulated until now, meanwhile, stay puzzled on how and by whom they will be regulated.
One regulator please: A surgery in progress at a hospital in New Delhi. Medical device makers, largely unregulated until now, don’t know how and by whom they will be regulated. (Photo: Madhu Kapparath/ Mint)
“We have written to DST as well as the cabinet secretary on this. We have warned them at the right stage,” said a senior health ministry official explaining that the letter asked the science ministry to “hold off because health ministry was already dealing with the issue under Drugs and Cosmetics Act (1940)”. With a Bill already before lawmakers since last year on setting up what is called Central Drugs Authority, or CDA, there was “no need for a separate Bill and authority from DST,” said the official, who wanted to remain unidentified. A separate division for medical devices is envisaged under CDA.
Mint had reported on 31 December that the text of the two Bills—DST’s proposed Medical Devices Regulation Bill and health ministry’s CDA Bill—showed considerable overlap in the area and manner of regulation they intended to impose.
Both spoke of setting up of a regulator, specifying standards as well as safety norms for medical devices and then ensuring compliance. Officials of both ministries had then said they were not aware of the other’s Bill then.
A DST official, who too did not want to be named, last week confirmed receiving the health ministry letter. “We are putting our inputs together and will submit it in. We haven’t taken a final call,” he said, adding the department’s key recommendations of having medical devices and implants tested and certified by an accredited laboratory were still relevant. The offices of the Drug Controller General of India, or DCGI, the country’s drug quality regulator, and state drug agencies are not equipped to deal with the technological advancements in medical devices, he said.
Currently, just 16 such products, including syringes, cardiac stents and valves, require approval from DCGI. The entire medical devices sector, according to a sector study by the Federation of Indian Chambers of Commerce and Industry and audit and consulting firm Ernst and Young, will grow at 15% yearly to increase to $4.98 billion (around Rs20,000 crore) by 2012 from $2.18 billion in 2006. The domestic manufacturing will also get a fillip from the government’s policy of setting up ‘Medical Parks’ in the country.
G.S. Bhuvaneshwar, a sector expert who helped DST frame its Bill, said he hopes the ministry doesn’t scrap it. Medical devices need risk-based classification and safety conformity assurance from third-party agencies and this is not best carried out by the health ministry, he added.
Although the industry acknowledges the need for regulation to ensure patient safety in a loosely regulated sector, one company executive said he was perplexed. “We want clarity. We want a single monitoring body and no multiplicity of control. Somewhere the two ministries have to sit together and sort it out,” said a regulatory affairs executive of a multinational device maker in India. In an earlier interview with Mint, D. Raghavan, executive vice-president of Siemens Medical Solutions, had said there were fears of over-regulation in the industry.