Government Amends MD Rules to Remove Regulatory Hurdle

The approval process for in-vitro diagnostic (IVD) devices will soon enter the fast track as the Central government has done away with a regulatory bottleneck and allows all NABL-accredited laboratories and institutes specified by respective state licensing authorities to issue performance evaluation report (PER) on such products. According to top officials at the Central Drugs Standard Control Organization (CDSCO), the health ministry has amended relevant provisions in the Fourth Schedule of the Medical Devices (MD) Rules to this effect after weighing up suggestions from various industry stakeholders. The proposal was backed by the Drugs Technical Advisory Board (DTAB), the country’s highest drug advisory body on technical matters, in May. IVDs include all blood testing techniques and test kits that can detect major diseases or infections including Human Immunodeficiency Virus (HIV) and viral hepatitis.
“The amendment will facilitate ease of doing business as a manufacturer can now obtain the PER from any accredited laboratory in the country,” Dr Ravi Kanth Sharma, Assistant Drug Controller, CDSCO, told.

As per the MD Rules 2017, it is mandatory for an applicant to submit a PER to obtain approval for a product. In June, almost six months after notifying the rules, the government named five laboratories in the public sector to evaluate medical devices and the Noida-based National Institute of Biologicals (NIB) was designated as the apex institution to test IVD devices for HIV, Hepatitis B surface antigen, Hepatitis C virus, blood grouping sera, glucose test strip and analyzer-based glucose reagent. However, there was no designated laboratory for many other IVDs, including those for malaria, dengue, chikungunya, syphilis, typhoid, tuberculosis or cancer markers. With the new amendment, a manufacturer can approach any NABL-approved lab or healthcare facility approved by National Accreditation Board for Hospitals and Healthcare Providers and obtain a PER.

Industry representatives have cheered the move as a step in the right direction. “This will help manufacturers get products tested nearer to their facility and is a welcome move for ease of doing business. Earlier they had to get products tested at NIB and if there was any dispute it was difficult to resolve as the tests were done by the highest decision maker in hierarchy of regulations for IVD testing. Now these accredited labs will be the safe middle ground and disputes can be referred to the higher hierarchy of NIB for retest of batch and settlement. Industry is hopeful that this initiative will greatly reduce the time taken for issuing the manufacturing licenses as currently it’s taking 6-9 months against 3-4 months earlier, and we were hopeful that, with an online application system, the process will hasten the process than earlier and not make it lengthier,” Forum Coordinator of Association of Indian Medical Device Industry Rajiv Nath said.

Of late, the government has been adopting various measures to ensure the quality of medical devices sold in the country. Recently, an extensive set of safety and performance guidelines was formulated by the ministry. These norms are applicable to all medical devices including IVDs. In the coming days, the government may also remove the clinical trial clause for IVDs which have been marketed for a minimum of two years in countries such as the UK, the US and Canada to increase their availability in the domestic market. The DTAB has already agreed to this proposal, the minutes of its meeting show. Currently, India imports around 80 percent of its medical devices’ requirement and a fourth of that comes from the US. The overall medical devices market in the country is estimated to be ₹640 billion. – PharmaBiz