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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. In a new Amendment to the Food Safety and Standards (Prohibition and Restrictions on Sales) Regulations, 2011, the Food Safety and Standards Authority of India (FSSAI) has clarified that BIS standards mark requirement may no longer be necessarily applicable for manufacture and sale of infant milk food, infant formula and milk cereal based weaning food etc. as well as Condensed milk sweetened, condensed skimmed milk sweetened, milk powder, skimmed milk powder, partly skimmed milk powder and partly skimmed sweetened.
Source: bit.ly/4hkwSPN
Source: bit.ly/3BXUuK4

2. In a recent amendment to the  Food Safety and Standards (Contaminants, toxins and Residues) First Regulations, 2011, which shall come into force from 1st April 2025 the Food Safety and Standards Authority of India (FSSAI)has: (1) Simplified and reduced the number of prohibited use Antimicrobials including chloroform, stilbenes and other steroids, (2) Increased the permissible concentration for Antimicrobials in Honey, (3) reduced the concentration of antimicrobials in cattle.
Source: bit.ly/3AdyXMN

3. The Rajasthan Authority for Advance Rulings held that the vanilla mix being sold by a major manufacturer of consumer food products in the country would not be classified as an “ice-cream” for the purpose of taxation under the Goods and Services Act, 2017 (GST Act) due to sugar being the major ingredient at about 65%. This decision in contrast to the Supreme Court’s decision on similar grounds.
Source: bit.ly/3BW78sY
Source: bit.ly/3BQh9I0

4. The Supreme Court quashed a criminal case which had been filed against a major Indian bank for non-compliance with an order of the authority under the Income Tax Act, holding that an allegation of mens rea cannot be made against a juristic person such as the bank and that the intention of the officers and functionaries cannot be construed to be that of the juristic person itself.
Source: bit.ly/3C5fH4y

5. The Therapeutic Goods Administration (TGA), Australia’s regulator for Medical Devices has clarified some queries concerning its updated Essential Principles, which are necessary compliances for getting approval for devices in Australia. In this new update to the checklist, the TGA has reiterated its existing commitment to recognizing foreign approval standards, and has placed obligation on Sponsors to update the TGA if their Manufacturer Evidence may be expiring in 50 days, among other things.
Source: bit.ly/48jlWxM
Source: bit.ly/4eSYR7P

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.

1. Mere title of a person within an organization such as Managing Director/ CEO does not automatically make the person criminally liable for offence committed by Company under Drug Laws. In order to make a person holding a managerial position in the company criminally liable, the complaint should have specific averments against such person which indicates that the person was in charge of and responsible for the conduct of the business of the company so far as it relates to the manufacture of the drug: High Court of Jammu and Kashmir
Source: bit.ly/4cYU4Rl

2. The Government of India is reportedly considering whether to stop marketing of look-alike and sound-alike drug brands in public interest. Under the current proposal, the brand names which were approved first by the drug regulator will be permitted to be marketed, and look-alike or sound-alike drug brands will be prohibited from being marketed.
Source: bit.ly/3SvoDFN

3. The Indian Government is reportedly considering whether to exempt Medical Devices which have been approved and sold in the European Union for two years from requirement of conducting clinical investigation in India prior to marketing authorization.
Source: bit.ly/4d3sJgC

4. The Delhi High Court has ordered an Ayurvedic medicine manufacturer to delete from all websites on the internet and social-media platforms claims which were beyond the scope of license and implied that the medicine it marketed could treat COVID-19.
Source: bit.ly/3WFxEyG

5. A prominent US based health savings account administrator has reported that it has suffered a data breach which has led to the loss of sensitive employee and customer information.
Source: bit.ly/4dkt525