Dear Reader, We are happy to share the most interesting legal and policy updates concerning health industry that we read today. We hope you enjoy reading it.
Periodic Safety Update Reports for Medical Devices to be filed only through online portal of CDSCO
The Central Medical Devices Regulator of India (Central Drugs Standards Control Organization) has issued a circular, stating that starting on 1st April 2024 it will require and restrict all manufacturers of Medical Devices/ In-vitro Devices to make submission of Periodic Safety Update Reports, only on the online portal and that offline mode of submission of application will not be accepted going forward.
Source: bit.ly/3TEO74B
Absence of Regulation of Second-Hand Medical Devices being Imported into India flagged by Parliamentary Panel
The Department-related Parliamentary Standing Committee on Chemicals and Fertilisers, in a recent report, has highlighted that currently India’s Central Medical Device Regulations (Medical Devices Rules, 2017) do not regulate second-hand medical devices. The Committee has recommended framing policy to ensure its quality and safety, as well as introducing possible restrictions on import of second-hand or refurbished Medical Devices into India.
Source: bit.ly/3VsdCaQ
Supreme Court Orders Director of Company as well as Endorser of offending Advertisement to be present for Contempt Proceedings relating to misleading advertisements
As part of the ongoing action being taken against a major Indian Ayurvedic Medicine manufacturer for publication of misleading advertisements regarding its products in contravention of an undertaking provided to the Court, the Supreme Court, in pursuance of determining whether to pursue contempt proceedings against the manufacturer, has issued an order requiring the physical presence of the Director of the entity as well as a prominent Ayurvedic Yoga practitioner who had given his endorsement to the claims made in the offending advertisements of the Company.
Source: bit.ly/3vu45VQ
Delhi High Court orders suspension of accounts accused of impersonation of prominent investment group despite objection that no evidence of involvement is provided.
In pursuance of ongoing action against certain anonymous persons impersonating a prominent Investment group and misleading the general public, the Delhi High Court has issued a further order to messaging platform WhatsApp to take action to remove/ block access to certain accounts/ messaging groups, despite objection from the platform that the account/ messaging groups have been prove to neither violate T&Cs of WhatsApp, nor having carried out any illegal activity.
Source: bit.ly/3vkn7hu
EU Parliamentary Committee votes to present amendment to increase exclusivity period for orphan drugs and introduce extended regulatory data-protection period.
The European Parliamentary Committee on Environment, Public Health and Food Safety has voted in favour of introducing several amendments to the current EU Pharmaceutical Directive, including a controversial proposal to increase the exclusivity period for Orphan Drugs from 10 to 11 years, as well as an extended regulatory data-protection period of 9 years; both decisions that industry experts believe may have adverse consequences for competition in the EU Pharmaceutical Market.
Source: bit.ly/3Vr9zeK
