The loosely regulated Indian medical devices industry is bracing for two separate sets of laws, which manufacturers claim will lead to over-regulation, red tape and a multiplicity of reporting agencies.
Makers and sellers of medical devices, ranging from catheters to high-end scanning machines, are currently regulated only for those products that are implanted in people or for those that puncture the skin.
So far, just 16 such products, including syringes, cardiac stents and valves, require approval from the country’s drug quality regulator, the Drugs Controller General of India, or DCGI.
The ministry of health introduced a Bill in the recent session of Parliament to amend India’s main pharmaceuticals law, the Drugs and Cosmetics Act, 1940, to set up a Central Drug Authority (CDA) on the lines of the US Food and Drug Administration, an omnibus regulator for drugs, health-care and life sciences.
The CDA will expand the powers of the drugs controller and start departments that will monitor clinical trials, medical devices, vaccine and other drugs-related businesses.
Meanwhile, a draft law, called the Medical Devices Regulation Bill, is being finalized by the ministry of science and technology, which proposes setting up what is called a Medical Device Regulatory Authority of India.
This regulator will specify standards, and ensure compliance of quality and safety norms for medical devices.
The two Bills have considerable overlap.
The lack of clarity “could lead to a period of chaos,” predicts D. Raghavan, executive vice-president of Siemens Medical Solutions, a division of Siemens AG.
The stakes are high. A study done by consultant Ernst and Young for trade body Federation of Indian Chambers of Commerce and Industry (Ficci) estimates the market in India for medical devices and equipment will more than double to $4.98 billion (Rs19,621 crore) by 2012 from $2.18 billion in 2006.
Lobbies such as the Confederation of Indian Industry, Ficci and the American Chambers of Commerce have already weighed in on the CDA Bill to a parliamentary committee and to the science ministry, which has invited comments.
On Friday, the CII said in a statement that “it is very important to ensure that there is no regulatory overlap for the medical devices industry.”
“We are discussing the Bills with both the ministries but we are not clear about which ministry is taking the lead and who will regulate what. The industry will look for simplicity in the (regulatory) mechanism,” says Anjan Bose, business head of medical systems at Philips Electronics India Ltd and chairman of Ficci’s medical equipment forum.
“There is a lot of confusion here,” adds Himanshu Baid, managing director of Poly Medicure Ltd, which makes spinal needles, catheters and blood bags.
DCGI M. Venkateswarlu said the science ministry’s Bill had not been officially brought to his notice yet and he could comment on a potential overlap with CDA only after he reviewed it. “If it interferes, we will give our opinion and information on the contradictions,” he said.
A senior official at the science ministry, who did not wish to be named, said he, too, was unaware of the CDA Bill and added, “We are getting reactions from people on (our) Bill and will synthesize them. Thereafter, it will be sent to various ministries for their suggestions before going to the cabinet,” the official said, without giving a timeline for it.
“We are not sure when the (science ministry’s) draft Bill might be considered for introduction.
“Therefore, it is premature to point out if the ministries are working at cross purposes,” said C.V. Madhukar, director with research body PRS Legislative Research.
Maneka Gandhi, a member of the standing committee of Parliament on health and family welfare, said she, too, was unaware of the overlap in two legislations and promised to bring it up at the next meeting of the lawmaker panel.