Mumbai : The retail prices of medical examination and surgical gloves have shot up drastically by almost 40% due to longer testing time ranging between 40 and 60 days at the Central Drugs Standard Control Organization (CDSCO) designated lab in Chennai for quality checks. Hefty testing charges of approximately Rs. 55 lakh per month is being borne by the importers for gloves imported from Malaysia and Thailand for quality checks.
“Only one or two laboratories are authorised by the CDSCO to do quality tests of imported medical gloves samples leading to a huge backlog. Importers are losing their daily income due to the absence of a robust quality control mechanism and oversight in the country,” informs Abhay Pandey, president, All Food and Drug License Holders Foundation (AFDLHF).
The AFDLHF has also sought urgent intervention of the Union Health Ministry and the Drugs Controller General of India (DCGI) on the ongoing rampant production and sale of poor quality medical examination and surgical gloves in the country.
Another big dilemma facing the industry is that the DCGI has directed the importers a month back to test their batches of gloves in the government notified and certified Bureau of Indian Standards (BIS) labs for quality checks mandatorily but domestic manufacturers have been given the liberty to do so on a voluntary basis. This is ironic and reveals that manufacturers are being favoured and importers have to bear the compliance burden alone which is not in accordance with the law of the land. This is creating a big demand supply gap and is impacting the ethical business and competitiveness of Indian manufacturers hugely.
The Indian Rubber Gloves Manufacturers Association (IRGMA) had, two months back, also sought immediate intervention of the Commissioner of Customs General, Mundra Port, Gujarat with respect to the poor quality medical and surgical gloves being supplied to the government hospitals.
IRGMA had also made representation dated December 27, 2022, to Union ministry of health, Central Drugs Standard Control Organisation and dated January 9, 2023 requested Directorate General Of Systems & Data Management, Central Board of Indirect Taxes and Customs (CBIC), Department of Revenue, Ministry of Finance, Government of India to communicate their offices at different ports to forward the bill of entries of the medical devices to the concerned Assistant Drug Controller (ADC) (1) Office at the port for ensuring the compliance of the requirements for import the medical devices under the new Medical Device Rules (MDR)- 2017.
Currently, disposable medical and surgical gloves at all government and private hospitals are being procured without any registration/license issued by CDSCO/BIS. The imported gloves are of very low quality posing serious health and safety issues for the health professionals.
“The quality and specified standards, as specified by BIS, can be met by the BIS licensed manufacturers having the adequate capability to supply and they also have the capacity to counter the spurious low grade imported gloves. The directives will enable BIS certified gloves manufacturing units to add to the “Make in India ” initiatives started by Government of India (GoI),” according to industry officials.
