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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.  The RBI’s revised draft for the Foreign Exchange Management (Export and Import of Goods and Services) Regulations, 2025, mandates repatriation of unutilized advances if imports aren’t completed within the contract period. If outstanding advances exceed Rs 25 crore, future imports must be secured with an irrevocable standby letter of credit or an international bank guarantee.
Source: bit.ly/4jrYGCl

2. Major global pharma companies are reportedly setting up Global Capability Centres (GCCs) in India, driven by the country’s tech talent amid the global economic slowdown. Experts predict that India’s GCC sector will surpass $100 billion by 2030, with significant growth in the Life Sciences and Healthcare sector.
Source: bit.ly/4j1ZZYO

3. The Gujarat Food and Drug Administration has reportedly assured the Indian medical device manufacturers that the differential pricing order for cardiac stents, implemented under the Ayushman Bharat scheme, will be repealed. Under this scheme, stents approved by the US FDA are priced at Rs 25,000, while those approved by the Indian regulator are priced at Rs 12,000.
Source: bit.ly/42lIV8K

4. India’s Department of Animal Husbandry and Dairying (DAHD) has mandated that all poultry farms across the country must register with their respective state animal husbandry departments within a month. This initiative is part of the Centre’s strategy to enforce strict biosecurity measures in response to the ongoing H5N1 avian influenza outbreak affecting multiple states.
Source: bit.ly/4251YFL

5. The Supreme Court of India reportedly rejected a plea to ban children under 13 from social media which was filed over concerns about mental health and addiction. It stated the issue is a policy matter for the government, not the judiciary, and advised approaching relevant authorities or Parliament.
Source: bit.ly/4cqw7Tx

Posted on

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. The Indian Government amended the definitions of micro, small, and medium enterprises (MSMEs) on March 21, raising investment and turnover limits.  This reclassification will move many medium-sized businesses to the small enterprise category, enabling access to benefits like public procurement, the GeM platform, and dispute resolution services.
Source: bit.ly/4iQlc7N

2. The Rajasthan High Court quashed a drug complaint, ruling that failing a dissolution test is a minor defect and not the ground for prosecution if the active pharmaceutical ingredient is within standard limits. The court held that slower dissolution doesn’t affect efficacy or make the drug spurious by itself.
Source: bit.ly/43DZJKO

3. The United States Food and Drug Administration (US FDA) has rejected in vitro studies conducted by an India-based contract research organization due to significant data integrity issues. Certain generics relying on bioequivalence data from the affected studies are marked with a “BX,” indicating insufficient evidence for therapeutic equivalence, thereby impacting their market status and sale.
Source: bit.ly/3FPn9mB

4. The Association of Indian Medical Device Industry (AiMED) has reportedly criticized Gujarat Government’s new pricing for drug-eluting stents, which sets USFDA-approved stents at double the price of domestic-approved ones. The association urged the state to reverse the decision, noting that such price disparities are not observed globally.
Source: bit.ly/4hXrfWM

5. According to a fact sheet issued by the White House after the US President’s announcement, pharmaceutical products are not yet subject to reciprocal taxes, providing relief to Indian pharmaceutical companies that earn significant revenues from exports to the United States.
Source: bit.ly/3YdSJAy

 

 

Posted on

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 Foreign Trade regulator, the Directorate General of Foreign Trade (DGFT) has recently issued a Trade Notice, cautioning exporters to no longer accept physical copy Certificate of Origin, and to only accept electronically issued Certificates of Origin since the deadline for using physical copies has passed on 31st December 2024.
Source: bit.ly/439cxs0
Source: bit.ly/439ayEk

2. In light of a recent international report regarding the misuse of drug combinations in various countries in the African continent, India’s Ministry of Health and Family Welfare has rescinded the export license and No Objection Certificate (NoC) of a manufacturer of the said combinations.
Source: bit.ly/4353Mzp

3. India’s Supreme Court, in its recent order has expressed that the medical educational institution admission guidelines, which requires that “both hands [should be] intact” for a person suffering from a disability to gain admission to a medical educational institution, is violative of disability rights and has no basis under law.
Source: bit.ly/3QyRKH0

4. In a recent order, the High Court of Kerala has instructed the State Government to issue a circular to all Doctors in the state, requiring the preservation of foetus in case of a Medical Termination of Pregnancy of a minor, and require permission from the State Government for the destruction of said foetus.
Source: bit.ly/4bblB1L

5. The recent decision of the United State Government to terminate employment of several employees of the United States Food and Drug Administration (FDA) has the possibility to cause delay in obtaining approvals and licenses from the FDA by members of the Medical Device industry.
Source: bit.ly/4hRolDN

Posted on

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 Regulator has notified that the application process for issuance of permission for import of additional variant of approved cosmetics into the country, will henceforth be conducted through additional module which will be activated on the SUGAM portal from the 22nd February 2025.
Source: bit.ly/3CQu6m2

2. The National Chemists’ Association has sought a meeting with India’s drug price regulator the National Pharmaceutical Pricing Authority (NPPA) to highlight concerns that the obligation on chemists to publicly display the prices of all drugs being sold, may be a very heavy burden for the industry.
Source: bit.ly/3QfYFor

3. The Pune Municipal Corporation (PMC) has issued show-cause notices to 97 private nursing homes and hospitals for violations of the Bombay Nursing Home Registration Act and Maharashtra Nursing Home Registration Rules. Key breaches include non-compliance with fire safety regulations, lack of patient complaint mechanisms, inadequate staffing, and failure to meet other legal standards like displaying contact information and maintaining proper treatment tariffs.
Source: bit.ly/41bya9P

4. In a recently published guideline, the United States Food and Drug Administration has expanded the applicability of Predetermined Change Control Plans (PCCPs) scheme, now requiring manufacturers to notify any post-market changes made to devices, which operate using Artificial Intelligence and not just those devices that use Machine Learning.
Source: bit.ly/4aZ3D2i

5. A Federal Court in the United States has recently dismissed the petition of a prominent drug manufacturer claiming “unfair business practices” by a pharmacy selling compounded versions of a patented drug, on the ground that the pharmacy has ceased to market and sell the compounded version of the drug.
Source: bit.ly/4aYtVSa

Posted on

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 advertising self-regulation body, the Advertising Standards Council of India (ASCI), has issued a report analyzing the conduct of the country’s leading online influencers. Notably, the report reveals that only 29% of the influencers have even made appropriate disclosures of material connection with brands/companies their content.
Source: bit.ly/4k649jp
Source: bit.ly/40NSywt

2. In pursuance of the Central government’s BioE3 policy, which was announced in November 2024, the Central Government Minister for Science and Technology has urged State Governments to set up BioE3 Cells to promote Center-state partnership in pursuance of the BioE3 policy aims.
Source: bit.ly/4jTZjW4
Source: bit.ly/40UBchz

3. India’s Health Ministry has reportedly established an expert working group that will monitor adverse effects of medical devices and IVDs which are reported under Materiovigilance Programme of India (MvPI), and will recommend measures to improve patient safety to Indian’s medical device regulator, the Central Drugs Standards Control Organization (CDSCO).
Source: bit.ly/3ExgA7l

4. Earlier this year, The United States Food and Drug Administration has issued a proposed new rule which would have introduced a cap on the nicotine content in cigarettes and other tobacco products, in an effort to curb deaths from nicotine addiction in the country.
Source: bit.ly/3WVFdRr

5. In cases of insurance claim of medical treatment costs for chronic illness, insurance providers cannot deny a claim on technical ground of absence of in-patient treatment, if the treating Doctor had determined outpatient treatment was sufficient for the patient: High Court
Source: bit.ly/3CWwSpM

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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 Madhya Pradesh High Court has ruled that rape survivors can undergo medical termination of pregnancy up to 24 weeks without requiring a court order. For pregnancies up to 20 weeks, a registered medical practitioner can perform the termination. This decision aims to streamline the process for survivors, reducing delays in accessing abortion services.
Source: bit.ly/4gkA5xi

2. The Indian Council of Medical Research (ICMR) and the Central Drugs Standard Control Organisation (CDSCO) have released a draft standard evaluation protocol for the performance evaluation of Human Metapneumovirus (hMPV) real-time PCR kits. This protocol provides detailed procedures for testing, including preparation of hMPV RNA evaluation panels, RNA extraction, and guidelines for real-time PCR systems. It aims to ensure the quality and reliability of diagnostic kits for hMPV. Public comments are invited till March 15, 2025.
Source: bit.ly/3WGUcOW

3. India’s Andhra Pradesh Medical Council (APMC) has reportedly announced that permanent registrations for Foreign Medical Graduates (FMGs) will be granted only to those who comply with the National Medical Commission (NMC) guidelines. This includes verification of degrees through the respective Indian Embassies and additional internship requirements. A group of 25 FMGs has filed a writ petition in the Andhra Pradesh High Court regarding this matter.
Source: bit.ly/3WEXdzv

4. Representatives from several pharmaceutical industry groups are scheduled to meet with officials from the Central Drugs Standard Control Organisation (CDSCO). The agenda includes discussions on the implementation of Schedule M, which sets quality standards and good manufacturing practices for pharmaceutical companies. Industry representatives, particularly from MSME pharma manufacturers, are expected to request an extension of the implementation timelines for the revised Schedule M.
Source: bit.ly/3WJDVZU

5. The US FDA has identified cybersecurity vulnerabilities in certain patient monitors used in healthcare and home settings. These monitors display critical patient information such as temperature, heartbeat, and blood pressure. The FDA warns that these vulnerabilities could allow unauthorized individuals to access and potentially manipulate the monitors, leading to improper functioning. Additionally, connected networks may be compromised, and sensitive patient data, including personally identifiable and protected health information.
Source: bit.ly/3X53S6r

Posted on

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 regulator (CDSCO) has called for urgent input from the pharmaceutical industry on regulatory challenges and opportunities for innovation. Stakeholders in the pharmaceutical industry, including companies, researchers, and healthcare providers, are invited to share obstacles to drug approval, difficulties in meeting compliance requirements, and barriers to entering new markets and are encouraged to reach out to CDSCO through its official communication channels.
Source: bit.ly/3PNEUnW

2. The National Medical Commission (NMC) has proposed a draft regulation that grants a one-year senior residency exemption to doctors with foreign postgraduate medical qualifications from five English-speaking countries (United Kingdom, United States of America, Canada, Australia, and New Zealand) to join medical colleges as faculty.
Source: bit.ly/4hlIQZn

3. The Union Cabinet approved the continuation of the National Health Mission (NHM) for another five years, until 2030, which was scheduled to end in 2025. This decision comes after the NHM achieved significant milestones in the past decade, improving healthcare access and quality in India.
Source: bit.ly/4h2YEzV

4. The National Pharmaceutical Pricing Authority (NPPA) has asked pharmaceutical companies and marketing companies of Iohexol, a diagnostic agent to submit price and market data. This action follows a directive from the Department of Pharmaceuticals (DoP) to review the drug’s pricing.
Source: bit.ly/4h9DqR4

5. The U.S. Food and Drug Administration (FDA) has approved a nasal spray as a monotherapy for the treatment of adults with treatment-resistant depression. This marks a significant advancement in mental health treatment, as the nasal spray is the first and only medication approved for this purpose.
Source: bit.ly/40G1bdv

Posted on

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. The Supreme Court of India has warned States and Union Territories of initiating contempt proceedings for failing to take action against misleading advertisements. It emphasized that authorities must ensure strict enforcement of laws to prevent such advertisements. The Court’s remarks come in light of a petition filed by the Indian Medical Association against a leading Ayurveda product manufacturing company on grounds of misleading claims and advertisements.
Source: bit.ly/3C3w9D4

2. India’s Bombay High Court, in a recent ruling, emphasized that authorities must uphold basic human rights, particularly in medical negligence cases. It stated that failure to provide adequate healthcare can violate a patient’s right to life and dignity. The court called for greater accountability and stricter enforcement of healthcare standards.
Source: bit.ly/3DVQlqO

3. The Food Safety and Standards Authority of India (FSSAI) has issued an order on 3rd January, 2025, to promote ease of doing business. It has decided that any changes or amendments to the Food Safety Standards (Labelling and Display) Regulations 2020 will be enforced starting from 1st July each year. The enforcement date will always be 1st July, with a minimum of 180 days between the notification of amendments and their enforcement. This policy applies to both labelling regulation changes and other food safety standards related to labelling. This move is aimed at enhancing regulatory predictability for food business operators while also improving consumer knowledge and transparency.
Source: bit.ly/4h001PO

4. The Indian Prime Minister’s Office (PMO) has directed the Indian Health Ministry to take appropriate steps to label oxygen cylinders clearly, distinguishing between industrial oxygen and medical oxygen. This action follows lawmaker Ajeet Madhavrao Gopchade’s appeal, emphasizing the importance of such measures for patient safety.
Source: bit.ly/4ais9eB

5. The U.S Food and Drug Administration (US FDA) has banned the use of Red No. 3 dye in food items and oral drugs due to potential links to cancer. The decision follows concerns raised by studies suggesting that the high exposure of dye could be carcinogenic.
Source: bit.ly/42f7YvR

Posted on

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. The Jharkhand High Court has quashed criminal proceedings against an MBBS doctor charged under Section 304A of the Indian Penal Code for causing death by negligence, following a patient’s death after gallbladder surgery at his clinic. The allegations included medical negligence and violations under the Scheduled Castes and Scheduled Tribes (Prevention of Atrocities) Act. The court found no evidence of malicious intent or negligence on the doctor’s part, leading to the dismissal of the charges.
Source: bit.ly/4jiLOzc

2. India’s Central Pollution Control Board (CPCB) has released guidelines for the transportation and storage of used oil under the Extended Producer Responsibility (EPR) framework, effective from April 1, 2024. These guidelines outline the roles and responsibilities of collection agents, who are tasked with safely collecting, storing, and transporting used oil while adhering to environmental regulations. The framework aims to ensure proper management of hazardous waste and facilitate a more sustainable approach to oil recycling.
Source: bit.ly/3DTNDSR

3. India’s Central Pollution Control Board (CPCB) has released a methodology for conducting a gap analysis on biomedical waste management, aimed at improving compliance with existing regulations. This initiative is part of the CPCB’s ongoing efforts to ensure better environmental and public health outcomes related to the disposal of hazardous waste.
Source: bit.ly/4fYFBFq
Source: bit.ly/3PyGXfq

4. The U.S. Food and Drug Administration has released updated guidance regarding the notification process for manufacturers concerning permanent discontinuances or interruptions in the manufacturing of medical devices, as mandated by Section 506J of the FD&C Act. This guidance aims to prevent or mitigate shortages of critical medical devices during public health emergencies by requiring timely notifications from manufacturers about potential supply disruptions. The document also includes a list of devices that fall under this requirement and outlines the necessary information that must be provided.
Source: bit.ly/4hh2XqP

5. The U.S. Food and Drug Administration has released draft guidance proposing major changes to the accelerated approval pathway for drugs. These changes aim to strengthen the evidence and procedures required for quickly approving new medications, ensuring they deliver real clinical benefits while maintaining safety and effectiveness. The updates reflect the FDA’s commitment to improving the approval process for important therapies and addressing concerns about how these drugs perform once they reach the market.
Source: bit.ly/4hf9N09

Posted on

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. The Food Safety and Standards Authority of India (FSSAI), in its 45th meeting, decided that the amendment to the Food Safety and Standards (Labelling and Display) Regulations, 2020, will be enforceable from 1st July 2025. This is subject to the condition that at least 180 days have passed from the date of notification of the amendment. Additionally, in cases of emergency, a separate decision may be taken regarding enforcement.
Source: bit.ly/3BPK9jH

2. The Supreme Court of India recently ruled that while courts have the authority to order the seizure of vehicles pending trial under the Narcotic Drugs and Psychotropic Substances Act, 1985 (NDPS Act), there is no provision in the Act that prohibits the return of seized vehicles. The Court emphasized that owners of such vehicles should be given an opportunity to be heard regarding the restoration of possession, particularly if they had no knowledge of the transport of narcotic or psychotropic substances,
Source: bit.ly/3DNibWg

3. The Rajasthan High Court, in a matter seeking to quash a petition against pathologists at a hospital accused of falsifying reports based on signature irregularities, held that cases of medical negligence must be subjected to a higher degree of scrutiny. The court further stated that mere irregularities in documents do not constitute falsification.
Source: bit.ly/3C2O64y

4. India’s Directorate General of Foreign Trade (DGFT) has issued a public notice regarding procedure for exporting certified organic products from the country. The new procedure requires that all ‘organic products’ intended for export should carry a Transaction Certificate issued by a National Accredited Body under the National Program for Organic Production (NPOP) and should be labelled in accordance with the NPOP. A revised NPOP will come into force from 5th July 2025
Source: bit.ly/4j48uD1

5. The US Food and Drug Administration has issued a finalized guidelines under the Advanced Manufacturing Technologies Designation Program, whereby manufacturers are able to obtain designation of the manufacturing process which may either reduce development time of drug or maintain supply of life-supporting, life-sustaining or critical drug.
Source: bit.ly/4j3H3Jr