Page 64 - The Indian Digital Edition September-October 2020

DCGI. There is no time-frame given Class A (low-risk) and Class B (low-
as of now for processing of the UNDER THE NEWLY medium risk) medical devices sold
application for registration by the NOTIFIED MEDICAL in India will have to compulsorily
DCGI. DEVICES (AMENDMENT) obtain a license before 11 August
RULES, MANUFACTURERS 2022. This includes optometry
In order to obtain registration OR IMPORTERS WILL practices and optical shops dealing
applicants have to be certified as BE REQUIRED TO in frames, lenses, contact lenses/
compliant with ISO-13485 (Medical COMPULSORILY REGISTER solutions and low vision devices.
Devices – Quality Management THEIR MEDICAL DEVICES, These items can’t be sold without
Systems – Requirements for INCLUDING SO FAR registration with the Drug Controller
Regulatory Purposes). A license is UNREGULATED MEDICAL and the Ministry of Health (MHA);
issued only after quality checks, DEVICES, FOR A LICENSE and they will undergo inspections
and the license holder’s business WITH THE DRUGS from time to time as per the latest
premises are subject to periodic CONTROLLER GENERAL Medical Devices Rules (MDR)
inspection. It is mandatory to OF INDIA (DCGI) BEFORE 1 Amendment.
maintain detailed records of sales OCTOBER 2021
and purchases of medical devices Importers and manufacturers,
and ensure traceability in the event prices and availability of medicines distributors, whole sellers and
of a quality or safety-related failure in the country under the Drugs retailers of presently unregulated
or complaint. (Prices Control) Order (DPCO), 1995, Class C (medium-high risk) and Class
the organisation is also entrusted D (high risk) medical devices sold
Under the regulation, the MRP in India will have to compulsorily
(maximum retail price) must be with the task of recovering amounts obtain a license before 11 August
if manufacturers overcharge
clearly mentioned on all products consumers for controlled drugs. The 2023. All the above classifications
classified as medical devices, NPPA also monitors the prices of under the MDR, 2017, are classified
including those supplied for decontrolled drugs in order to keep as per the Global Harmonisation
institutional use. This applies to them at reasonable levels. Task Force (GHTF) based on the
domestic manufacturers, importers associated risks.
and marketers. The said price must Effective the new gazette
be prefixed by the word ‘MRP’ and notification, all manufacturers and The entire optical industry is up
suffixed by the words ‘Inclusive of importers of medical devices sold in arms against the proposal and
taxes’. in India will not be permitted to feels that such stringent measures

The government’s National increase the MRP of their products, by the government during this
pandemic and period of utmost
Pharmaceutical Pricing Authority year-on-year, by more than 10 uncertainty will be catastrophic
(NPPA) has the power to fix ceiling per cent. They will have to make for the optical industry and trade.
prices/revise the prices of any drug periodic trade-related filings with The All India Optical Federation
and formulation under extraordinary the government authority. The filings (AIOF) in association with Calcutta
circumstances and in the public require submitting information such Optical Association, Madras Optical
interest. This means that the MRP has as the price of the products quoted Association, Ahmedabad Optical
to be equal to or below the ceiling to distributors, stockists and retailers. Association and Mumbai Optical
price. In most cases the NPPA also They will be obliged to follow the Association has written a letter to
fixes the margins that may be offered price fixed by the authorities for each the respected Drug Controller
to the companies in the supply chain item. of India against such a proposal.
and any breach will be dealt with by Importers, manufacturers, The cause has also been well
law.
distributors, whole sellers and supported by Vision 2020 and other
The NPPA can not only enforce retailers of presently unregulated stakeholders.

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