NEW DELHI: Medical devices such as stents and orthopaedic implants may soon come under stringent regulatory scanner. The health ministry has come up with draft medical devices rules proposing stricter norms for companies selling such medical devices to ensure quality.
The draft proposes a shelf life for all medical devices and makes it mandatory for such products to carry manufacturing and expiry dates. It also suggests that companies must seek approval for their products from the regulator before launching them in the market. The ministry released the aft rules through a gazette draft rules through a gazette notification earlier this week. The government has sought comments from all stakeholders within a month, after which the rules will be finalized.
The move comes in the wake of increasing use of critical medical devices like stents, catheters and implants. The draft rules also highlight the need for the government regulating the medical devices sector due to the inherent risk. Currently quality checks for medical devices are weak in the absence of specific rules, guidelines and norms.
The almost $7 billion medical devices industry in India is clubbed with medicines and is regulated under the same norms. While so far the industry has maintained the absence of a separate law and regulator poses a major challenge for the industry’s growth, the draft regulation does not seem to have gone well with domestic as well as multinational companies.
Industry officials said the rules are too stringent and proposes norms that are not even applicable globally.”The latest draft regulations are an assault on `Make in India’ program. The proposed regulations will legalize pse udo manufacturing, result in closure of domestic manufacturing and drive jobs out of India,” Rajiv Nath of Association of Indian Medical Devices Industry, an association representing domestic manufacturers said.
Multinational companies have also raised concerns over the proposed rules saying internationally regulators allow at least 10 years of shelf life and the suggested norms may push up prices of imported products as companies will have to customize packaging accordingly.
The rules also have specific definitions and classifications. For instance, it has categorized medical devices into four different classifications based on risk assessment.
The ones with higher risk such as stents and implants may also require clinical trials to seek approval.