Medical Device Makers Get Relief as Government Removes QCOs on Crucial Inputs

The industry is greatly relieved that the Indian government has revoked a number of Quality Control Orders (QCOs) pertaining to essential inputs used in the production of medical devices. Manufacturers who had trouble obtaining necessary materials like polypropylene and polycarbonate stand to gain the most from this action. Long-standing industry concerns have been addressed with the removal of certain medical device QCOs, which is a positive move for local production.

What are Medical Device QCOs?

Legal orders requiring particular criteria for goods are known as quality control orders. Although the goal of QCOs is to guarantee consumer safety and product quality, their application to primary and intermediate raw materials frequently resulted in operational complications. Mandatory Bureau of Indian Standards (BIS) certification for certain raw materials used to be a problem for medical device manufacturers, affecting supply chains and driving up costs.

Industry associations have often pointed out that India's local supply base does not reliably generate a large number of specialised materials and high-grade polymers to international standards. As a result, in order to guarantee product performance, safety, and export readiness, access to internationally approved imported grades became crucial. As a result, many people believed that the previous QCO framework unintentionally restricted imports, which hurt the industry's ability to compete.

Why Govt. Decided to Rollback QCOs?

Following a thorough assessment by Niti Aayog, the government decided to remove the QCOs. The operational challenges faced by the industry in locating primary and intermediate resources necessary for the production of final items were severely highlighted in this paper. Numerous QCOs for a variety of sectors were described by Niti Aayog, including those for polypropylene and polycarbonate, which are essential for products including surgical instruments, lenses, dialysis filter cartridges, and specimen bottles.

How Crucial it is for Indian Medical Device Sector?

The Indian medical device industry is anticipated to benefit in a number of ways from the withdrawal of these QCOs. First and foremost, it guarantees continuous raw material availability, which is essential for reliable production. Second, the action reduces input costs and import restrictions for manufacturers, particularly Micro, Small, and Medium-Sized Businesses (MSMEs).

Manufacturers will have the freedom to utilise internationally certified materials and won't have to rely just on a small number of domestic suppliers who have been recognised by the BIS. This policy change comes after the Rajiv Gauba Committee of NITI Aayog received numerous submissions from industry stakeholders, including the Association of Indian Medical Device Industry (AiMeD). Mandatory BIS criteria for raw materials frequently served as inadvertent import limitations, according to AiMeD. In the end, this project has the potential to boost global competitiveness, increase operational efficiency, and assist the "Make in India" movement in the medical technology sector.