Industry

Rising Testing Time leads to increasing prices of Medical Gloves in India

This article explores the reasons behind the price surge, the impact on importers, and the concerns raised by industry associations.

The Health Master

May 25, 2023

166

Doctor Face mask gloves — Picture: Pixabay

Table of Contents

Last Updated on May 26, 2023 by The Health Master

Testing Time of Medical Gloves

The prolonged testing time for medical examination and surgical gloves at the designated lab of the Central Drugs Standard Control Organization (CDSCO) in Chennai has resulted in a significant increase in retail prices.

This article explores the reasons behind the price surge, the impact on importers, and the concerns raised by industry associations.

Testing Delays and Cost Burdens Plague Medical Glove Imports in India

Click for more articles on CDSCO

The Consequences of Testing Delays:

Longer Testing Duration: The CDSCO-designated lab in Chennai now requires 40 to 60 days for quality checks on imported medical gloves, causing delays in their availability in the market.

Escalation in Retail Prices: The extended testing time has pushed up the retail prices of medical examination and surgical gloves by nearly 40%.

Importers’ Financial Burden: Importers are shouldering the hefty testing charges, which amount to approximately Rs. 55 lakh per month for gloves imported from Malaysia and Thailand.

Click for more articles on DCGI

Challenges and Concerns Expressed by Industry Associations:

Lack of Authorized Laboratories: Only one or two laboratories authorized by the CDSCO can conduct quality tests on imported medical glove samples, resulting in a massive backlog.

Income Loss for Importers: The absence of a robust quality control mechanism and oversight in the country has led importers to suffer significant losses in their daily income.

Urgent Intervention Needed: The All Food and Drug License Holders Foundation (AFDLHF) has called upon the Union Health Ministry and the Drugs Controller General of India (DCGI) to urgently address the rampant production and sale of poor-quality medical gloves.

Unfair Disparity in Quality Checks:

Disproportionate Burden on Importers: While importers are required to test their glove batches mandatorily at government-notified and certified Bureau of Indian Standards (BIS) labs, domestic manufacturers have the liberty to do so voluntarily.

This unequal treatment undermines the law of the land, favoring manufacturers and creating a demand-supply gap that affects the ethical business and competitiveness of Indian manufacturers.

Appeals for Quality Assurance:

IRGMA’s Plea for Intervention: The Indian Rubber Gloves Manufacturers Association (IRGMA) has previously sought the intervention of the Commissioner of Customs General, Mundra Port, Gujarat, regarding the supply of poor-quality medical and surgical gloves to government hospitals.

Representations to Government Authorities: The IRGMA has made representations to the Union Ministry of Health, Central Drugs Standard Control Organisation, and the Directorate General Of Systems & Data Management, urging them to ensure compliance with the new Medical Device Rules (MDR)-2017 by forwarding bill of entries for medical devices to the Assistant Drug Controller (ADC) offices at ports.

Addressing Health and Safety Concerns:

Procurement without Registration/License: Currently, both government and private hospitals procure disposable medical and surgical gloves without any registration/license issued by CDSCO/BIS, leading to serious health and safety risks for healthcare professionals.

Encouraging Local Manufacturers: Industry officials emphasize that BIS-licensed manufacturers, capable of meeting the quality standards, can counter low-grade imported gloves effectively. Compliance with directives will contribute to the “Make in India” initiatives initiated by the Government of India (GoI).

Conclusion:

The prolonged testing time and cost burdens for quality checks on medical gloves have resulted in a substantial price increase, impacting importers and the competitiveness of Indian manufacturers.

Urgent interventions and a fair quality control mechanism are needed to ensure the availability of high-quality gloves that meet health and safety standards in India.

Must read

Procedure to obtain license for manufacturing of Medical Devices

Procedure for registration of Medical Devices: CDSCO

Registration for sale of Medical Devices: Procedure and conditions

Latest Notifications: Medical Devices

Classifications of Medical Devices under the provisions of MDR 2017

Notified Bodies for Medical Devices

Updated list of Notified Bodies for Medical Devices

Updated list of Medical Device Testing Laboratories (MDTLs)

Medical Device Alert: Lists

Forms: All types of Medical Devices

Schedules: All types of Medical Devices