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TOP 5 HEALTH LAWS AND POLICY UPDATES

Dear Readers, 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.

1. India’s Central Drug Standard Control Organization (CDSCO) has issued an updated draft list for the risk-based classification of medical devices. The new entries in the list include categories such as interventional radiology, radiotherapy, oncology, and Class A (non-sterile and non-measuring) devices. Stakeholders are required to submit their feedback within 30 days of the draft’s publication.
Source: bit.ly/422UCmg

2. India’s Ministry of Health and Family Welfare has issued a draft notification proposing an extension for small and medium manufacturers with an annual turnover of ₹250 crores or less to comply with the revised Schedule M of the Drugs Rules, 1945. Manufacturers eligible for this extension must submit an upgradation plan in Form A to the central licensing authority within three months. The proposed deadline for compliance is December 31, 2025. The Ministry has also invited objections and suggestions from stakeholders, which must be submitted within seven days of the notification’s publication.
Source: bit.ly/40mUugc

3. The U.S. Food and Drug Administration (FDA) has released draft guidance on using artificial intelligence (AI) to support regulatory decisions regarding the safety, effectiveness, or quality of drugs and biological products. This guidance proposes a framework to enhance the credibility of AI models in product submissions. The FDA invites public comments on the draft within 90 days.
Source: bit.ly/4fKHeXf

4. India’s new draft Digital Personal Data Protection Rules 2025 require companies transferring personal data of Indian users across international borders to comply with data localization norms. These provisions, which impose additional government restrictions on specific data transfers, are reportedly expected to complicate business operations.
Source: bit.ly/41ZXocd

5. The U.S. District Court recently dismissed negligence and strict liability claims against a non-profit that received an NIH grant and sub-granted part of it to a Wuhan lab allegedly linked to COVID-19. The court found no liability for contributing funding for research activities or basis for strict liability, emphasizing the weak causal connection and the risks of imposing unlimited liability on research funders.”
Source: bit.ly/4gJaS0v

Posted on

TOP 5 HEALTH LAWS AND POLICY UPDATES

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.

Body massagers cannot be ‘sex toys’ just because they can have alternative use: High Court

In a recent ruling, the Bombay High Court has held that body massagers cannot be treated as ‘sex toys’ merely because they can be used for alternative purposes. While coming to this conclusion, the Court observed that it would be incorrect to classify massagers
as items of objectionable description or as obscene figures in the absence of any substantial justification.

Source: bit.ly/3Vvxp9k

Homeopathy practitioners cannot present themselves as gynaecologist; amounts to medical negligence and deficiency in service: State Consumer Commission

The State Consumer Disputes Redressal Commission, Lucknow (SCDRC) has taken the view that cross-practicing of medicine by doctors trained in branches other than allopathy constitutes medical negligence and a deficiency in service. SCDRC imposed a compensation of Rs. 30 Lakhs on a city-based private nursing home and a homeopathy practitioner for medical negligence. The practitioner misrepresented herself as a gynaecologist, and prescribed allopathic medicines. The SCDRC held both the practitioner and the nursing home liable for their negligence and deficiency in service.

Source: bit.ly/3xavblG

A leading ayurvedic Indian FMCG company has tendered an unconditional apology for its misleading advertisement to Supreme Court

Following a contempt notice on misleading advertisements and the issue of summons, the co-founders of a major ayurvedic FMCG company have tendered an unconditional apology for the company’s misleading advertising practices. The Supreme Court had directed that the co-founders of the company appear personally before the Court on the date of the next hearing. 

Source: bit.ly/43vV5wj 

Government proposes ban on 23 dangerous dog breeds in India

The Indian Government proposed a ban on 23 dog breeds in the country that are deemed “dangerous for human life” in an effort to address the growing number of dog attack cases. Additionally, the government has urged state governments to desist from granting licenses or permits for the sale and breeding of these dog breeds. 

Source: bit.ly/43xEjgi 

Draft Resolution introduced by the UN General Assembly on Artificial Intelligence

The UN General Assembly adopted its first resolution on artificial intelligence (AI) to ensure the technology benefits all nations while respecting human rights and ensuring safety.
Co-sponsored by 123 states, the resolution was adopted by consensus without a vote. Recently, the European Parliament has also taken steps to adopt the Artificial Intelligence Act, considered the world’s first comprehensive legal framework for AI.

Source: bit.ly/490W88s