Makers or importers will get more 6 months licence validity for 7 Medical Devices-GOI

New Regulatory Regime for 8 Medical Items under Drugs and Cosmetics Act

Transition time of 6 months allowed for ensuring supply chain continuity and access while implementing their regulatory order under Medical Devices Rules (2017)

DATE 18 APR 2021

Adopting a proactive and sensitive approach to address the needs of the Indian Industry, the Union Ministry of Health & Family Welfare has taken a significant decision for ensuring continued access of eight regulated medical devices today.

The Ministry had earlier notified the following medical items to be regulated under the Drugs and Cosmetics Act which was to come into effect from 1st April, 2021 (as per S.O. 775(E) dated 08th February, 2019 under Medical Devices Rules 2017):

All Implantable Medical Devices;

CT scan equipment;
MRI equipment;
Defibrillators;
PET Equipment;
Dialysis Machine;
X-Ray Machine; and
Bone marrow cell separator.

Accordingly, as per the said order the importers/manufacturers are required to take import/manufacturing licence from Central Licencing Authority or State Licencing Authority, as the case may be, for import/manufacture of above devices, w.e.f. 1st April, 2021.

In order to ensure supply chain continuity and access to these Medical Devices, while implementing smooth transition into the new regulatory regime, Union Ministry of Health and Family Welfare has now decided that in case an existing importer/manufacturer who is already importing /manufacturing any of these devices, has submitted application to Central Licencing Authority or State Licencing Authority, as the case may be, for grant of import /manufacturing licence in respect of the said device(s) under the provisions of MDR, 2017, the said application shall be deemed valid and the importer/manufacturer can continue to import /manufacture the said device(s) up to 6 months from issue of this order or till the time, the Central Licencing Authority or State Licencing Authority, as the case may be, takes a decision on the said application, whichever is earlier.

Order in this regard has been issued by Drugs Controller General (India) on 18th April 2021 through The Central Drugs Standard Control Organisation website.

Under the Drugs and Cosmetics Act, CDSCO is responsible for approval of Drugs, Conduct of Clinical Trials, laying down the standards for Drugs, control over the quality of imported Drugs in the country and coordination of the activities of State Drug Control Organizations by providing expert advice with a view of bring about the uniformity in the enforcement of the Drugs and Cosmetics Act.

CURRENT SUPREME COURT JUDGMENTS

Somesh Chaurasia Vs. State of Madhya Pradesh & Anr-22/07/21 - There are distinct doctrinal concepts in criminal law namely (i) the grant of bail before trial or, what is described as the 'pre-conviction' stage; (ii) setting aside an order granting bail when the principles which must weigh in the decision on whether bail should be granted have been overlooked or wrongly applied; (iii) the post- conviction suspension of sentence under the provisions of Section 389(1); and (iv) the cancellation of bail on the ground of supervening events, such as the conduct of the accused during the period of bail, vitiating the continuance of bail.
Union of India Vs. Rajendra N. Shah & Anr-20/07/21 - These appeals raise an important question as to the vires of the Constitution (Ninety Seventh Amendment) Act, 2011 [the "Constitution 97th Amendment Act"] which inter alia introduced Part IXB under the chapter heading 'The Co-operative Societies'. The Constitution 97th Amendment Act was passed by the requisite majority of the Lok Sabha on 27.12.2011 and the Rajya Sabha on 28.12.2011.
K.P. Natarajan & Anr. Vs. Muthalammal & Ors-16/07/2021 - There is no dispute on facts and there is no escape from the conclusion that the respondents have been grossly negligent in defending the suit as well as the execution proceedings. But the fact remains that while the parties can afford to remain negligent, the Court cannot. The High Court has found, after summoning the records from the trial Court that as a matter of fact, the trial Court failed to appoint a guardian for the third respondent/minor in a manner prescribed by law.
Sachin Kashyap & Ors. Vs. Sushil Chandra Srivastava & Ors-15/07/2021 - Writ Petition having been filed for a particular cause and with a particular prayer cannot be expanded to cover within its ambit all the issues which may be of general or public importance without there being any pleadings or prayer with regard to a particular issue.

EXECUTIVE ORDERS

Executive Order on Promoting Competition in the American Economy-09/07/2021 - The American information technology sector has long been an engine of innovation and growth, but today a small number of dominant Internet platforms use their power to exclude market entrants, to extract monopoly profits, and to gather intimate personal information that they can exploit for their own advantage.
Blocking Property and Suspending Entry Into USA of Certain Persons Contributing to Destabilizing Situation in Western Balkans-EO-08/06/21 - All property and interests in property that are in the United States, that hereafter come within the United States, or that are or hereafter come within the possession or control of any United States person of the following persons are blocked and may not be transferred, paid, exported, withdrawn, or otherwise dealt in: any person determined by the Secretary of the Treasury, in consultation with the Secretary of State
Threat posed by military Industry of China- Biden Issued Executive Order-03/06/2021 - I find that the use of Chinese surveillance technology outside the PRC and the development or use of Chinese surveillance technology to facilitate repression or serious human rights abuse constitute unusual and extraordinary threats, which have their source in whole or substantial part outside the United States, to the national security, foreign policy, and economy of the United States, and I hereby expand the scope of the national emergency declared in Executive Order 13959 to address those threats.
Improving the Nation’s Cybersecurity-EO 12/05/2021 - The United States faces persistent and increasingly sophisticated malicious cyber campaigns that threaten the public sector, the private sector, and ultimately the American people’s security and privacy. The Federal Government must improve its efforts to identify, deter, protect against, detect, and respond to these actions and actors. The Federal Government must also carefully examine what occurred during any major cyber incident and apply lessons learned. But cybersecurity requires more than government action.

© Advocatetanmoy Law Library

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