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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.

Guidance for making regulatory applications for biological and biotechnology products such vaccines may be revised soon
India’s central drug regulator, Central Drugs Standards Control Organization (CDSCO), has issued draft of revised guidance which seeks to align the online regulatory application process with applicable law i.e. The New Drugs and Clinical Trial Rules, 2019. Recently, the CDSCO has started accepting regulatory applications through NSWS portal. All stakeholders have time until April 25, 2024 to submit their suggestions/comments.
Source: bit.ly/3JlwIrU

Indian Pharma industry has sought clarity from Government on ethics of sponsoring foreign trips of doctors to attend scientific and training programs outside India.
An industry group representing multinational pharma companies has reportedly approached the Indian Government for seeking clarity on the issue of Indian doctors being sponsored by pharma companies for attending medical events outside India. A recent guidance issued by Department of Pharmaceuticals called Uniform Code for Pharmaceutical Marketing Practices, 2024 (UCPMP) has stated that pharma companies will not sponsor travel and hospitality of Doctors unless they are speaking in medical events.
Source: bit.ly/3JklqnG

New Guidance document for generation and transfer of EPR Certificate under E-Waste Management Rules issued
India’s Central Pollution Control Board has issued a guidance document which explains steps to be taken by recyclers, recycling facilities under the E-Waste (Management) Rules, 2022 for generation of EPR Certificate. It has been clarified that EPR Certificate will have validity of 2 years. All importers and manufacturers of electric and electronic equipment including medical devices are required to procure EPR Certificates from registered recyclers to discharge their respective Extended Producer Responsibility obligations.
Source: bit.ly/44242Oc

Nestle wins class action suit filed by Government in the infamous Maggie Noodles case
The National Consumer Disputes Redressal Commission (NCDRC) has dismissed the Indian government’s 2015 complaint against Nestlé India over the safety of its Maggi noodle products. The Indian government had accused Nestlé of engaging in unfair trade practices by adding a ‘No added MSG’ label and claimed that the instant noodle product contained impermissible lead levels. However, NCDRC has noted in its order that the lead content in the tested instant noodle products was within permissible limits and that the Food Regulator itself had permitted brands to carry No Added MSG label if MSG was not deliberately added by manufacturer during the manufacturing process.
Source: bit.ly/3vIR1MJ

US based telehealth companies penalised for selling personal information
The United States Federal Trade Commission has reportedly taken action against an alcohol addiction telehealth company, for sharing health information to third parties including some major social media companies and search engines. A proposed order to settle the allegations will prevent the company from disclosing sensitive data for advertising purposes, among other penalties.
Source: bit.ly/43ZfoCi

Posted on

Top 5 Health Laws & 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.

Innovator Pharma Company questions biosimilar trial on ground of non-procurement of comparator drug from authorized sources
A multinational pharmaceutical company has questioned the veracity of a biosimilar drug trial before India’s clinical trial regulator, The Drugs Controller General of India (DCGI), on grounds that the comparator drug, a biologic, was not procured from authorized sources, thereby putting clinical trial subjects at risk and casting shadow over appropriateness of the clinical trial.
Source: bit.ly/49tJmjj

Indian IPR regime well-equipped to handle AI generated works and there is no proposal to amend the law in context of AI generated content: Ministry of Commerce & Industry
India’s Minister of Commerce & Industry, while replying to a question in India’s parliament, has clarified that user of Generative AI should obtain permissions of owner of original copyrighted work processed by Generative AI technology before using the AI generated content for commercial purposes. The Minister further clarified that there is neither any proposal to create any separate right nor to amend the law in the context of AI-generated content.
Source: bit.ly/48cK4R8

Guidelines to distinguish nutraceuticals and drugs which have same or similar composition soon
The Indian Government has reportedly formed a high-level committee to address complaints that products which have identical or similar compositions are being approved as nutraceuticals, drugs or ayurvedic formulations, depending on the regulatory pathway chosen by the manufacturer. Under the current law, nutraceuticals are not permitted to make claims of treatment or cure on the label, however there are reports of non-compliance with this requirement.
Source: bit.ly/49bvaMb

Preparing a list of unvaccinated employees does not amount to violation of privacy: Madras High Court
India’s Madras High Court has held that the action of preparation of list of employees who have not received COVID-19 vaccinations and subsequent circulation of such list amongst employees of company would not amount to violation of privacy. The High Court was hearing a criminal complaint filed by an employee of the Company under Information Technology Act, 2000 on grounds that the Company had breached the said law sharing his personal information as part of list of unvaccinated employees.
Source: bit.ly/42yExmP

Couples seeking surrogacy on medical grounds are able to use donor sperm or egg, in spite of law to the contrary, by approaching a High Court
Following the precedent set by Supreme Court, the Bombay High Court has permitted two couples to use donor eggs for surrogacy owing to medical issues faced by the Couple. The development is important because The Surrogacy (Regulation) Rules, 2022 explicitly prohibits the use of donor gametes for surrogacy. In the past, Karnataka High Court has also granted similar reliefs to a couple facing medical challenges to conceive using own gametes while seeking a surrogate to deliver the baby.
Source: bit.ly/42yczHP