Govt sitting on Bill for four years.
Consider this: Of the more than 140 plus orthopaedic implant manufacturers in the country, only a few have the drug regulator’s licence to produce such devices. Only 14 of the 2,000 odd medical devices available in the domestic market have been notified under the Drugs and Cosmetics Act, and hence, require mandatory regulatory approval.
An increasing number of medical device makers are now turning into traders, owing to the difficulty in sourcing raw materials for domestic production. Inordinate delays in legislation to regulate the Rs 15,000-crore medical device industry are hurting both business interests, as well as consumers’ rights to safe medical devices.
Last month, Union health minister Ghulam Nabi Azad said the government was yet to decide on a four-year-old Bill aimed at implementing specific laws to regulate medical devices.
“We have asked the health ministry to promulgate an ordinance to take medical device regulation out of drug laws,” said Rajiv Nath, coordinator, Association of Indian Medical Device Industry (AIMD).
AIMD says the crux of the problem lies in the government’s attempt to regulate medical device through the definition of drugs. “The two are entirely different sets of products. The government has realised this, as is evident from the draft Bill prepared a long time back. The attempt was to set up a specialised regulatory body for medical devices and introduce a four-tier licensing structure, depending on the critical nature of the device,” Nath said.
Despite the Bill clearing the Parliamentary panel’s scrutiny, the government has not been able to pass it. “In the absence of a specific law, the government is trying to regulate medical devices under the Drugs and Cosmetics Act. This has led to a situation in which drug authorities are seeking the same kind of data from medical device makers, as well as drug manufacturers,” he said.
The inability to fulfil the requirement is delaying the grant of licences and marketing approvals and, a practice similar to that followed by orthopedic manufacturers, the medical devices industry is seeking a legal recourse to continuing production without obtaining licences from drug authorities.
Regulatory officials admitted the government had not added any new product to the list of 14 medical devices. “USA de-linked medical devices regulation from drugs 35 years ago. It requires different treatment. Unfortunately, the government seems to be ignoring the sector. Even the ones that were added a few years ago, were because of a court directive,” said an expert on medical devices.
Although the medical devices, diagnostics and equipment industry is only a fraction of the $35-billion domestic healthcare sector, its growth potential is immense, since high-end medical electronics and the imaging industry would also be regulated under this category, once the Bill turns a law.
