Parliamentary Panel Recommends DoP To Expedite Implementation Of TMR For Medical Devices

New Delhi : The Department-Related Parliamentary Standing Committee on Health and Family Welfare has recommended to the Department of Pharmaceuticals (DoP) to ensure expeditious implementation of the Trade Margin Rationalisation Policy for medical devices in the country.

The Committee’s recommendation comes following an action taken-report from the government said that the Department is actively considering the issue of Trade Margin Rationalisation in consultation with the stakeholders.

The Parliamentary panel, in its 146th report on the action taken by the government on its previous recommendations in the 138th report, said, “The Committee appreciates the Government’s move in this direction and recommends that DoP must ensure expeditious implementation of Trade Margin Regularisation Policy.”

In the previous report, the Committee recommended the Department to effectively implement the Trade Margin Rationalization policy to address the issue of arbitrary pricing by importers.

Considering the number of supply chain in a vast country like India, the Department needs to have consultation with all the stakeholders in the industry. The Committee believes that thorough consultation with all the stakeholders would help the Department in arriving at a justified trade margin by which not only the interests of consumers, suppliers and manufacturers would be taken care of but also the problem of irrational pricing would be resolved.

Effective implementation of Trade Margin Rationalisation (TMR) would result in lower out-of-pocket expenditure which ensures that families are not pushed below the poverty line due to the medical expenses, it added.

The Committee, in its 146th report, once again recommended that the Government may expeditiously provide logistic support for shared manufacturing facilities like Medtech Parks to reduce the capital expenditure of manufactures, which will give a boost to indigenous manufacturing of medical devices.

It expressed hope that to improve the efficiency and overall facilities of Mediparks, expeditious action on its suggestions would be taken by the Government. Necessary approval of the Department of Expenditure in this regard may also be expedited.

In the previous report, the Committee appreciated the Department for launching Scheme for Promotion of Medical Device Parks in India and opined that well-coordinated inter-ministerial and inter-governmental (Central and state) strategies aimed at offering manufacturers competitive advantage in manufacturing in India will result in importers finding it more profitable to manufacture in India than to import it.

“The Committee believes that logistical support in shared manufacturing facilities like Medtech parks would significantly reduce capital expenditure of manufacturers and thus giving a boost to manufacturing in India,” it added.

In the 138th report, it also recommended steps for improving the efficiency and overall facilities of Medtech Parks in India including that the Mediparks should have NABL (National Accreditation Board for Testing and Calibration Laboratories) approved medical device testing laboratories to reduce time required in manufacturing a product; each park should have dedicated office for skilled and unskilled labour force. This said office should maintain a registry of registered workers so as to maintain the continuous availability of workforce; to control pollution, each Medipark should have Effluent Treatment Plant (ETP); availability of subsidized power and water; and for promoting the Indian medical device market, Mediparks should organize-“Medical Device Exhibitions” and workshops.

In response, the DoP informed the Committee that the suggestions of the Committee for promotional activities by the four medical device parks, ETP and dedicated offices for HR will be shared with States. Further, DoP is proposing a scheme to increase the number of NABL approved Medical Devices Testing Labs in the Country and the scheme awaits in-principle approval of the Department of Expenditure (DoE). Post approval, actions will be initiated to bring out a schematic intervention.

In the latest report, the Committee also noted that despite provisions for regulatory mechanisms and its regular monitoring and surveillance, violations of norms are still being done by some manufacturers.

“Accordingly, the Committee recommends that the Government must ensure that the strict compliance of different provisions of existing laws/regulations are done by each and every manufacturer and penalty provisions are invoked,” added the Committee headed by Member of Rajya Sabha Bhubaneswar Kalita.

In the previous report, the Committee, noting that besides the factors like availability of technology and raw materials, the phenomenon of inflation in medical devices is due to unfair trade practices by certain entities, strongly recommended strict surveillance over entry of sub-standard Medical device into Indian Market so as to avoid hazardous impact on patients’ health.

The Committee listed various measures to provide a level playing field to the domestic medical device manufacturers and curb the artificial inflation in the prices of medical devices.

It said that certain MNCs (Multinational Companies) avoid printing of MRP on each unit of product, so that the buyer (large distributors and hospitals) can list such a price to derive high profits, resulting in unnecessary surge in prices of medical devices.

“The DoP, in coordination with the Ministry of Finance, must ensure strict adherence to the compliance of the rule, which necessarily mandates the printing of MRP on each product. The Department through the Ministry concerned should instruct the Port officials to check each medical device consignment for compliance of the said rule, so that the issue can be addressed at the origin,” said the Committee in the 138th report.

Besides, some manufacturers indulge in manufacturing of low-cost but substandard products that wholly disturbs the market for genuine manufacturers who comply with all the regulations and standards, it added.

The government in its action taken report said that as per Para 24&25 of DPCO, 2013, it is mandatory for every manufacturer to display MRP on the label of the container of formulation and the minimum pack thereof.

“Same is being monitored scrupulously,” informed the DoP.

Licenses are issued only after satisfactory compliance of regulatory requirements and unlicensed manufacturers are not allowed to sell their products in the market. Moreover, post market surveillance is in practice by regulatory authorities both at Center and State levels by means of routine inspections, sampling, and surveys. A comprehensive Materiovigilance Programme has also been put in place by DoHFW for the same, it added. It was considering this reply, the Committee made further recommendations for strong action.

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