A fresh lease of life for medical devices?

The government’s decision to move the medical devices industry out of the pharmaceutical sector is is one of the most significant policy shifts of this year. While the move is attracting accolades from the medical devices industry, certain elements are required to be streamlined to align it with the government’s ‘Make in India’ pitch. Finance Minister Arun Jaitley said that the new rules for the medical devices industry will be harmonised with international regulations to attract investment into this sector along with reducing the cost of medical devices. The new rules have been framed in conformity with the Global Harmonisation Task Force (GHTF) framework and conform to best international practices.

According to the government, the new rules seek to remove regulatory bottlenecks to ‘Make in India’ and facilitate ease of doing business while ensuring availability of better medical devices for patient care and safety Medical devices will now be classified under GHTF practices based on associated medical risks into Class A (low risk), Class B (low moderate risk), Class C (moderate high risk) and Class D (high risk). Importantly, the manufacturers of medical devices will be required to meet risk-proportionate regulatory requirements. To usher in the highest degree of professionalism in regulation of medical devices, a system of ‘Third Party Conformity Assessment and Certification’ through notified bodies accredited by the National Accreditation Board for Certification Bodies (NABCB) is envisaged.  

The provision of third party certification even for low risk medical devices such as wheelchairs and syringes may beat the idea to use these as a ‘Make in India’ enabler and ensure ‘Ease of Doing business’. Because high risk Indian medical device manufacturers will now not be covered under professional third party certification, the proposed regulations may result in closure of some domestic manufacturing units and drive jobs out of India as more manufacturers of high-risk high technology devices may switch to imports.

However, the rules also seek to evolve a culture of self-compliance by manufacturers of medical devices and, accordingly, the manufacturing licences for Class A medical devices will be granted without prior audit of the manufacturing site. The manufacturer will, in such a case, be required to do self-certification of compliance with the requirements and based on such certification, the licence will be issued. Manufacture of Class A and Class B medical devices will be licensed by the respective state licensing authorities after a Quality Management System (QMS) audit by an accredited notified body. But the manufacture of high risk Class C and Class D medical devices will be regulated by the Central Licensing Authority.

The Association of Indian Medical Device Manufacturers (AiMeD) is foreseeing that a provision for government to seek expert input for inspection may end up as a double whammy. The industry, recalling the experience of joint inspections by state and central teams from the Drugs Department, fears that the new regulations will lead to another ‘inspector raj’. The medical devices industry has consistently sought a voluntary compliance process backed by third party certification. The Quality Council of India (QCI) offers the Indian Certification for Medical Devices (ICMED), which is preferred by the industry as against the QMS Audit by the Central Drugs Standard Control Organisation. The AiMeD claims that that it has the support of the Ministry of Commerce and the Ministry of Electronics and Department of Science and Technology (DST) but the Union Health Ministry was not responding to their request to recognise the ICMED certification.

The government has said that the purpose of regulations is to filter access to unsafe products, ensure patient safety and consumer protection. Amid this back and forth, there is no provision to penalise pseudo-manufacturing by mandating the country of origin as a labelling requirement or a ban on second-hand imports of medical equipment to safeguard patients from non-calibrated equipments. With the regulatory structure for the medical devices industry expected to finalised by early-March 2017, the industry is heavily lobbying with officials for favourable rules. Considering that the Union Chemicals and Fertilizers Minister Ananth Kumar keeps claiming that the government is with the industry, their hopes are high.