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TOP 5 HEALTH LAWS AND POLICY UPDATES

1. The Central Government is mulling including non-prescription Neutraceuticals currently regulated by the Central government food regulator the Food Safety Standards Authority of India, under the price control regime similar to Drug price regulation under the Drugs (Prices control) Order, 2013.
Source: bit.ly/4cRZVb7

2. The Supreme Court in continuation of prior orders issued acknowledging the concerns raised in a petition seeking to address the shortage of life saving Antiretroviral Drugs in the country, has granted the request of the petitioner to discuss the access of quality Antiretroviral Drugs to persons dealing with HIV.
Source: bit.ly/4cAATg9

3. The Central Government has issued a Draft Notification proposing amendment to the Drugs Rules, 1945, mainly intending to introduce restriction on advertising Drugs listed in Schedule G of the Rules.
Source: bit.ly/3Whm0Ke
Source: bit.ly/3VZZ0Or

4. Then United States Federal Trade Commission is set to take action against Drug supply middlemen and major pharmacy chains for use of anticompetitive tactics in negotiating Drug prices.
Source: bit.ly/3WgtAom

5. The World Health Organization has issued a new and updated list of pathogens, to reorient the prioritization in combating Antimicrobial Resistance.
Source: bit.ly/4czZdiw

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.

Drug manufacturing facility cannot manufacture food products: Central Drugs Regulator
India’s Central Drug Regulator, The Drugs Controller General of India (DCGI), has directed the state drug licensing authorities to take action against the drug manufacturers who are also manufacturing nutraceuticals and health supplements in the same facility. Under Indian law, a drug manufacturing facility cannot be used to manufacture food products. Nutraceuticals and health supplements are regulated as food products in India.
Source: bit.ly/4bUWpwg

Methodology to calculate Green Credit against Tree Plantations notified
India’s Ministry of Environment, Climate and Forest Change, has notified the methodology for calculating green credit in respect of tree plantation under Green Credit Rules, 2023 which were notified under The Environment Protection Act, 1986. A person desirous of purchasing green credits will have to make an application to the Administrator. 1 tree planted will be equal to 1 green credit.
Source: bit.ly/3wGJgqo

A person cannot be prosecuted for food related offence under Food Safety Law and Indian Penal Code simultaneously: Supreme Court
The Supreme Court of India has held that, since The Food Safety and Standards Act, 2006 (FSSA) has effect notwithstanding any other law, a food related offence will have to be pursued under FSSA and not under a general law such as the Indian Penal Code, 1860 (IPC).
Source: bit.ly/48whOZJ

Period Safety Update Reports (PSURs) of new drugs will have to be submitted online, physical submissions will not be accepted
The Indian Central Drug Regulator, Central Drugs Standard Control Organization (CDSCO), will accept PSURs of new drugs, subsequent new drugs (SND), fixed dose combinations (FDC), biologicals and veterinary drugs only through online medium from 11th March 2024. A PSUR is required to be submitted for a period of four years after receipt of marketing permission.
Source: bit.ly/3wDqZKE

Indian Government is incentivizing domestic drug manufacturers to develop cost effective treatment for rare health conditions
India’s medical research body, Indian Council of Medical Research (ICMR), has reportedly invited domestic drug companies to develop localized treatments for “priority rare genetic disorders” and has offered assistance in pre-clinical, clinical research and regulatory approvals. The aim for this initiative is to encourage domestic drug companies to develop cost-effective treatments for rare health conditions by offering assistance in clinical research.
Source: bit.ly/4bQQ3y4

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.

Drug manufacturing facility cannot manufacture food products: Central Drugs Regulator
India’s Central Drug Regulator, The Drugs Controller General of India (DCGI), has directed the state drug licensing authorities to take action against the drug manufacturers who are also manufacturing nutraceuticals and health supplements in the same facility. Under Indian law, a drug manufacturing facility cannot be used to manufacture food products. Nutraceuticals and health supplements are regulated as food products in India.
Source: bit.ly/4bUWpwg

Methodology to calculate Green Credit against Tree Plantations notified
India’s Ministry of Environment, Climate and Forest Change, has notified the methodology for calculating green credit in respect of tree plantation under Green Credit Rules, 2023 which were notified under The Environment Protection Act, 1986. A person desirous of purchasing green credits will have to make an application to the Administrator. 1 tree planted will be equal to 1 green credit.
Source: bit.ly/3wGJgqo

A person cannot be prosecuted for food related offence under Food Safety Law and Indian Penal Code simultaneously: Supreme Court
The Supreme Court of India has held that, since The Food Safety and Standards Act, 2006 (FSSA) has effect notwithstanding any other law, a food related offence will have to be pursued under FSSA and not under a general law such as the Indian Penal Code, 1860 (IPC).
Source: bit.ly/48whOZJ

Period Safety Update Reports (PSURs) of new drugs will have to be submitted online, physical submissions will not be accepted
The Indian Central Drug Regulator, Central Drugs Standard Control Organization (CDSCO), will accept PSURs of new drugs, subsequent new drugs (SND), fixed dose combinations (FDC), biologicals and veterinary drugs only through online medium from 11th March 2024. A PSUR is required to be submitted for a period of four years after receipt of marketing permission.
Source: bit.ly/3wDqZKE

Indian Government is incentivizing domestic drug manufacturers to develop cost effective treatment for rare health conditions
India’s medical research body, Indian Council of Medical Research (ICMR), has reportedly invited domestic drug companies to develop localized treatments for “priority rare genetic disorders” and has offered assistance in pre-clinical, clinical research and regulatory approvals. The aim for this initiative is to encourage domestic drug companies to develop cost-effective treatments for rare health conditions by offering assistance in clinical research.
Source: bit.ly/4bQQ3y4

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