Last Updated on December 31, 2023 by The Health Master
Medical Devices
The Department-Related Parliamentary Standing Committee on Health and Family Welfare has urged swift action on the implementation of the Trade Margin Rationalization (TMR) Policy for medical devices in India.
This recommendation comes after the government’s report stated that discussions on TMR for medical devices are actively ongoing in consultation with relevant stakeholders.
Parliamentary Committee’s Call for Implementation:
In its 146th report, the Parliamentary Panel acknowledged the government’s efforts and proposed that the Department of Pharmaceuticals (DoP) ensure the speedy implementation of the TMR Policy.
This policy is essential to tackling the issue of arbitrary pricing imposed by importers.
The Committee emphasized the need for collaboration with all industry stakeholders due to India’s complex supply chain.
Consultation for a Balanced Trade Margin:
The Committee emphasized the significance of comprehensive consultation with industry stakeholders.
Such an approach would lead to a well-justified trade margin that takes into account the interests of consumers, suppliers, and manufacturers.
This effort is expected to resolve the problem of irrational pricing and ensure fair practices.
The effective implementation of the Trade Margin Rationalization (TMR) policy could alleviate out-of-pocket medical expenses, preventing families from falling below the poverty line.
Boosting Indigenous Manufacturing:
In its 146th report, the Committee reiterated its recommendation for the government to provide logistical support for shared manufacturing facilities like Medtech Parks.
This move aims to reduce manufacturers’ capital expenditure, thereby promoting domestic manufacturing of medical devices.
The Committee expressed optimism that prompt action would enhance the efficiency and facilities of Mediparks.
It also suggested expediting the necessary approvals from the Department of Expenditure to facilitate this endeavor.
Encouraging Domestic Production:
The Committee lauded the Department for launching the Scheme for Promotion of Medical Device Parks in India.
It emphasized the need for coordinated strategies between various ministries and government levels to provide manufacturers with a competitive edge for local production.
The Committee highlighted that logistical support in shared manufacturing facilities could significantly lower manufacturers’ capital costs, thus fostering a thriving manufacturing ecosystem in India.
Enhancing Medipark Facilities:
In its previous report, the Committee provided suggestions to improve the efficiency of Medtech Parks, including:
- Establishment of NABL-approved medical device testing laboratories (MDTL) within Mediparks to expedite product manufacturing.
- Dedicate offices within Mediparks for skilled and unskilled labor, maintaining a registry of registered workers to ensure a continuous workforce.
- Integration of Effluent Treatment Plants (ETPs) in Mediparks to control pollution.
- Provision of subsidized power and water to enhance cost efficiency.
- Organization of “Medical Device Exhibitions” and workshops to promote the Indian medical device market.
Also read: Updated list of Medical Device Testing Laboratories (MDTLs)
Government’s Response and Regulatory Vigilance:
The Department of Pharmaceuticals (DoP) informed the Committee that suggestions for promotional activities, ETPs, and dedicated offices will be shared with States.
Moreover, the DoP is proposing a scheme to increase the number of NABL-approved Medical Device Testing Labs (MDTL), awaiting approval from the Department of Expenditure (DoE).
The Committee also noted that, despite regulatory mechanisms, some manufacturers continue to violate norms.
It recommended strict enforcement of existing laws and regulations, invoking penalty provisions for non-compliance.
The Committee urged the government to ensure compliance to prevent hazardous impacts on patients’ health.
Preventing Inflation and Unfair Practices:
The Committee identified unfair trade practices as a source of inflation in medical device prices.
Certain Multinational Companies (MNCs) avoid printing the maximum retail price (MRP) on individual products, leading to inflated prices.
The Committee urged the Department of Pharmaceuticals (DoP) to collaborate with the Ministry of Finance to enforce the rule mandating MRP printing.
It also emphasized inspections at ports to verify compliance.
Additionally, the Committee highlighted the negative impact of substandard products on the market and genuine manufacturers.
The government clarified that licenses are only granted after regulatory compliance, and unlicensed manufacturers are prohibited from selling.
Regulatory authorities conduct post-market surveillance to ensure compliance, including routine inspections, sampling, and surveys.
Conclusion:
The recommendations of the Parliamentary Committee underscore the importance of expediting the Trade Margin Rationalization Policy’s implementation in India’s medical device industry.
Collaborative efforts among stakeholders, enhanced Medipark facilities, strict enforcement of regulations, and preventing unfair trade practices are pivotal steps toward fostering a thriving and ethical medical device market.
Disclaimer: This article contains information derived from the source mentioned below. Our team utilized an AI language model to rewrite and present the news or article in a unique format.
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