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. Indian courts have recognized copyright protection granting a temporary injunction against Indian pharmaceutical companies for unauthorized use of drug dossier. This occurred in a lawsuit where a pharmaceutical company accused a Canadian company of breaching a licensing agreement, misappropriating trade secrets, and sharing drug dossiers with Indian companies.
Source: bit.ly/3XvnzV7

2. The Ministry of Health & Family Welfare has made registration for Clinical Research Organisations (CROs) mandatory, effective April 1, 2025. CROs can now register online through the SUGAM portal by submitting their applications along with the required documents.
Source: bit.ly/3F6DKBX

3. Punjab’s Food and Drugs Administration has implemented stringent reporting obligations on manufacturers, C&FAs, wholesalers, and retailers, requiring them to submit monthly sales and distribution reports on every 7th day of the month to the state’s drug control offices to monitor the movement of seven Schedule H and H1 drugs or formulations prone to misuse for intoxication.
Source: bit.ly/3QKofC5

4. India’s Supreme Court has urged state authorities to frame guidelines to prevent exploitation by private hospitals, ensuring patients are not compelled to purchase overpriced medicines and medical devices. The Court also recognized that private hospitals are essential to addressing healthcare gaps until infrastructure is improved.
Source: bit.ly/3QLU8tY

5. The Delhi government’s social welfare department has urged the health department to fast-track the establishment of dedicated wards for transgenders in all government hospitals and designate a hospital for sex reassignment surgeries, aiming to ensure rights, dignity, and healthcare access.
Source: bit.ly/4i4dkiN

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.

India’s Central Food Regulator (FSSAI) has published draft of the certificate required to be procured by importer of vegan food, from regulatory authority of exporting authority, in order to import vegan food into India. Objections may be submitted by 30th April 2025.
Source: bit.ly/4hbimbQ

2. Karnataka State Government is reportedly working on a Not of Standard Quality (NSQ) drug recall policy. In addition to recall, if a batch of medicines is found spurious or NSQ, the manufacturing and distribution license may get suspended until corrective actions are taken.
Source: bit.ly/4ioKGc0

3. India’s Environment Ministry (MoEFCC) has issued an SOP which clarifies that white-category industries can be exempted from obtaining consent to establish (CTE) only when they submit a self-declaration of compliance with applicable environmental laws. White category industries are least polluting industries.
Source: bit.ly/43mS433

4. India’s Central Pollution Control Board (CPCB) has discovered major non-compliances during audit of plastic packaging waste recyclers such as the absence of production capacity relative to Extended Producer Responsibility (EPR) certificates issued and the absence of GST invoices for sales transactions. Brand owners should not buy EPR certificates from such recyclers.
Source: bit.ly/43fNDXY

5. India’s Supreme Court has clarified that for an activity to be construed as “manufacturing” process requiring license under Factories Act 1948, the activity need not transform goods or necessarily produce an entirely new product that is commercially recognized as different.
Source: bit.ly/43fNQdI

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 Madras High Court has refused to pass interim order staying the controversial gaming law in Tamil Nadu, which prohibits minors under 18 years from playing games and generally imposes restrictions on gaming between 12 am and 5 pm.
Source: bit.ly/43hwJYX

2. Andhra Pradesh’s Director of Medical Education has instructed government medical colleges and hospitals to ensure doctors prescribe drugs using generic names. The ethical guidelines applicable to doctors mandate prescription in generic names, and brand name may be used in addition.
Source: bit.ly/43nG6WS

3. India’s Department of Pharmaceuticals (DoP) has established a technical committee to devise strategies aimed at enhancing supply chain resilience and reducing reliance on China for pharmaceutical products. This initiative, part of the Indo-Pacific Economic Framework, aims to strengthen key industries like healthcare and chemicals.
Source: bit.ly/43aZ1UZ

4. India’s Central Food Regulator (FSSAI) will reportedly release new Maximum Residue Level (MRL) values for 98 spices, up from the current values for 18 spices. A SOP guidance to fix MRL for pesticides is expected to be published soon as well.
Source: bit.ly/4h19LZl
Source: bit.ly/41luW2f

5. Delhi High Court has remarked that the government should put in place a legal framework to tackle “e-infringement” of trademarks in e-commerce. Since multiple parties are involved in e-commerce, it is difficult to determine who is responsible for infringement.
Source: bit.ly/4hX8TpY

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 Karnataka health department has become the first state to implement the Supreme Court’s 2023 directive on a patient’s right to die with dignity. The government issued an order appointing medical experts to a secondary medical board to determine when life-sustaining treatment can be halted for terminally ill patients.
Source: bit.ly/3CEYPlX

2. Central government of India has published amended Water Pollution Guidelines to streamline the process of obtaining consent for industrial plants that may cause water pollution with an aim to simplify compliance and enhance ease of doing business for industries. The guidelines outline procedures for obtaining, renewing, and potentially losing consent to establish or operate such plants. These guidelines exempt certain category of project from obtaining the clearances. It also states that the projects that required the Environmental Clearance (EC) as per Environmental Impact Assessment (EIA) Notification, 2006 are exempted from obtaining the Consent to Establish (CTE) separately.
Source: bit.ly/3WOVyaK

3. India’s National Medical Commission (NMC) thereby upholding the patients’ rights is considering to authorize the patients to appeal against the orders of State Medical Commission (SMC). Earlier, only doctors were authorized to file an appeal against the decision of SMC.
Source: bit.ly/4grUoZq

4. The Indian Council of Medical Research (ICMR) and the Central Drugs Standard Control Organization (CDSCO) are working together to improve the accuracy of In-Vitro Diagnostic (IVD) tests in India. They have released a draft manual for Standard Performance Evaluation Protocols, inviting stakeholder comments. These protocols outline methods for evaluating the performance of IVDs used to diagnose diseases like Chikungunya, Dengue, and Zika. After the consultation period, ICMR and CDSCO will review the feedback and finalize the protocols for official adoption.
Source: bit.ly/3QhIAyF

5. Major drug manufacturer in India has received approval from the Subject Expert Committee (SEC) of Central Drugs Standard Control Organization (CDSCO) to import and market tislelizumab injection, a cancer treatment drug. SEC waived the local clinical trial requirement under certain conditions, recognizing the drug as an orphan drug for an unmet medical need in India. Noting its approval in the USA, Europe, UK, Australia, China, and other countries, the committee also advised the company to submit safety and efficacy data for Indian patients, ensuring patient rights are considered.
Source: bit.ly/4hHyKSi

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. A Public Interest Litigation (PIL) has been filed in the Madras High Court, alleging that transgender clinics in Tamil Nadu are engaging in unethical practices. These include the use of the banned two-finger test and violations of established health guidelines. The court has issued notices to the National Medical Council and the Tamil Nadu government, seeking their responses to these serious allegations.
Source: bit.ly/4fCPFnA

2. The Indian subsidiary of a major U.S. pharmaceutical company is under investigation for violating the Uniform Code for Pharmaceutical Marketing Practices (UCPMP) guidelines by sponsoring foreign trips for 30 doctors. The government may take action against the company and the executive who signed the self-declaration of compliance. If proven, the doctors involved could lose their medical licenses and be prohibited from practicing medicine.
Source: bit.ly/409I4s3

3. India’s Allahabad High Court has overturned a National Consumer Disputes Redressal Commission (NCDRC) order that had mandated a compensation of ₹93 lakh from a doctor and hospital owner for alleged medical negligence during a C-section procedure in 2005. The High Court identified procedural errors in the NCDRC’s decision-making process, thereby nullifying the earlier order for compensation to be paid by the medical professionals involved.
Source: bit.ly/409s4pQ

4. India’s Karnataka High Court has granted temporary relief to pharmaceutical companies by directing the government to refrain from taking action against pharmaceutical companies producing nutraceuticals in drug-licensed units. This follows a challenge to Schedule M, which restricts the manufacturing of non-drug products in drug-licensed facilities
Source: bit.ly/40bT34c

5. The Jammu and Kashmir Medical Supplies Corporation Limited (JKMSCL) has ordered an immediate halt to the use of Bupivacaine Hydrochloride in Dextrose Injection USP (0.5%), 5mg/ml, 4ml ampoule, Batch Number AA40222, manufactured by Aishwarya Healthcare Ltd. This action follows a reported Adverse Drug Reaction (ADR) associated with the batch, which was manufactured in April 2024 and expires in March 2026. Medical officers have been instructed to cease using the affected batch immediately.
Source: bit.ly/408meFg

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 Ministry of Textiles has further extended the timeline for the implementation of the Medical Textiles (Quality Control) Order, 2023. The new deadline is now 1st January 2025, for disposable baby diapers, sanitary napkins, reusable sanitary pads, and period panties. Earlier, the implementation date was 1st October, 2024.
Source: bit.ly/3Afz4rd

2. India’s Subject Expert Committee (SEC) has granted permission to a leading pharma company for importing and marketing the drug for a rare blood disorder, paroxysmal nocturnal hemoglobinuria (PNH), in India by waiving the requirement to conduct local clinical trials. The proposal was presented before SEC and SEC noted that the drug is approved in 35 countries including the US, European Union, Japan, and others and eventually agreed for a local clinical trial waiver.
Source: bit.ly/3BZ2MkU

3. India’s Ministry of Commerce and Industry is reportedly providing a significant boost to exporters through launch of new online portals like “Jan Sunwai” and “Enterprise Resource Planning (ERP).” These initiatives aim to reduce bureaucratic hurdles, enhance transparency, and facilitate smoother operations, ultimately leading to faster resolutions of trade issues.
Source: bit.ly/3Aeyl9N

4. The India Pharmacopoeia Commission (IPC), under the Ministry of Health and Family Welfare, attended a Joint Working Group Meeting with national regulatory authorities from Bhutan, Mauritius, Mozambique, Nepal, the Solomon Islands, and Sri Lanka. The meeting focused on strengthening pharmacopoeial cooperation and establishing an annual forum for ongoing cooperation.
Source: bit.ly/3A1eY43

5. India’s Department of Pharmaceuticals (DoP) has recently rejected the review applications from five major pharmaceutical companies, upholding the ceiling prices set for various strengths of the modified release (MR) formulations of the high blood pressure drug metoprolol. The companies argued that the pricing authority erred in its calculations by combining both the plain and modified release formulations of metoprolol 25 mg and 50 mg tablets. They pointed out that the National List of Essential Medicines (NLEM) 2022 does not include the modified release forms of metoprolol. However, the National Pharmaceutical Pricing Authority (NPPA) contended that in the absence of specific mention of any variant, these formulations can be considered alongside the conventional formulations.
Source: bit.ly/3AaMHYJ

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. Export samples of “Cough Syrup” under HSN code 3004 has been exempted from testing by the Directorate General of Foreign Trade (DGFT) provided they are being exported to or are manufactured at a plant/section which is approved by the regulatory agencies of USA, UK, Canada, European Union, Japan, Australia, Singapore, Republic of Korea and Switzerland.
Source: bit.ly/3YeH6tI

2. India’s Department of Pharmaceuticals (DoP) has recently rejected the review application of a leading pharmaceutical company and upheld the action of NPPA in fixing the ceiling price of the subject formulation. DoP stated that all modified release formulations of a drug that were mentioned in National List of Essential Medicine (NLEM) 2011 – Schedule I of Drugs Price Control Order, 2013 (DPCO, will be included in the NLEM 2015 – Schedule I of DPCO even though not specifically mentioned in NLEM 2015. It may be worth noting that, NLEM 2022 unlike NLEM 2015 specifically mentions that all modified release formulations of drugs specified in the NLEM list of 2022 will be regulated as scheduled formulations.
Source: bit.ly/3NzW73a

3. Goods and Service Tax (GST) on life and health insurance premiums by senior citizens may reportedly be exempted from GST irrespective of the coverage amount. Group of Ministers (GOM) to submit its report on the GST rates on life and health insurance premiums to the GST Council by October end of this year and final decision will be taken by the GST Council.
Source: bit.ly/3Nxr1cr

4. India’s pharmaceutical exporters are waiting for a government response to their request for an exemption from the onerous payment conditions prescribed under Section 43B (h) of the Income Tax (IT) Act, 1961. They are advocating for a minimum 60-day credit period, which is in line with global market standards where credit terms frequently extend up to 120 days. According to section 43B (h), payments for goods or services must be cleared within 45 days of acceptance. Failure to comply within this period creates financial burden and prevents businesses from claiming these payments as tax deductions.
Source: bit.ly/3Nx3dFD

5. To streamline and modernize pharmaceutical export-related procedures, the Directorate General of Foreign Trade (DGFT) has implemented an electronic Appendix 4H certificate filing system. The certificates which record the consumption and stock of duty-free imported or locally sourced raw materials under the Advance Authorization (AA) and Duty-Free Import Authorization (DFIA) schemes, are fully digitalized, as highlighted in Trade Notice No. 21/2024-25. Digital submission of these certificates is now mandatory for all pharma exporters.
Source: bit.ly/3YvCbES
Source: bit.ly/48fPe0g

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) has waived off the registration fees of hawkers for the grant of registration certificate and renewal of registration certificate with effect from 28th September 2024. The registration certificate will now be issued for five years only. Previously an option for selection of validity from one to five years was available to the applicant.
Source: bit.ly/4dy8EyA

2. Drug manufacturers submitting false or misleading information may reportedly face legal action from the Drugs Controller General of India (DCGI). As of now, the Drugs Rules, 1945 contains no provision addressing the problem of providing false, falsified, or misleading information for receiving regulatory approvals. As per the plan, the applicant may face debarment in addition to product suspension and cancellation for misleading the licensing authority.
Source: bit.ly/3Nh4D6V

3. An exemption has been granted for the generation of E-way bills for the transportation of job work, storage, and warehousing of goods, specifically turmeric, chilli (genus: Capsicum), and raisins, by the Maharashtra Government. This exemption applies on the condition that such goods are transported within the State of Maharashtra for a distance of up to fifty kilometers with no cap on consignment value.
Source: bit.ly/4dxlj4M

4. India’s Ministry of Health and Family Welfare (MoH&FW) is reportedly considering a proposal to classify all antibiotics as ‘new drugs’ under the New Drugs and Clinical Trials Rules, 2019. The aim is to regulate all antibiotics centrally through Central Licensing authority (CDSCO) rather than by State Licensing Authorities. The proposal also seeks to amend labelling requirements under the Drugs Rules, 1945, to address the rising concern over Antimicrobial Resistance (AMR), which has been highlighted as a global health priority.
Source: bit.ly/3ByExtw

5. Concerns over the potential harmful effects of hormonal contraceptives, particularly emergency contraceptive pills (ECP) or morning-after pills, have prompted India’s Central drug authority (CDSCO) to constitute an expert panel to discuss the possibility of requiring a doctor’s prescription before purchasing these drugs. The proposal to amend Drugs Rules is under examination by the three member committee constituted by CDSCO. As of now, hormonal contraceptives falling under Schedule K of the Drugs rules can be purchased without a prescription from a physician.
Source: bit.ly/4dFTXcT

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 Pharmacopoeia Commission (IPC) and India’s Central Drug Authority (CDSCO) have released Version 2.0 of the “Pharmacovigilance Guidance Document for Marketing Authorization Holders (MAHs) of Pharmaceutical Products” wherein they have extended the timelines to report non-serious adverse events within 90 calendar days from the previous proposed timelines of 30 days.
Source: bit.ly/4dctGCs

2. Drugs Consultative Committee (DCC), which advises the Central and State Governments on uniform implementation of drug laws in India, has reportedly advised all the State Licensing Authorities (SLA) to ensure that all applications are exclusively received and processed through the Online National Drugs License System (ONDLS) portal only.
Source: bit.ly/4ejO8Tr

3. The Federal Court of Australia has heavily penalized and ordered one of the leading manufacturers and suppliers of medical devices for unlawfully supplying Infuse Bone Graft Kit without LT Cage. The Australian Register of Therapeutic Goods (ARTG) prevents the supply of Infuse Bone Graft Kit without LT Cage.
Source: bit.ly/3XChUMd
Source: bit.ly/4dlv5H1

4. The World Health Organization (WHO) has released guidance on best practices for clinical trials to improve the design, conduct, and oversight of clinical trials in countries of all income levels. The guidance provides recommendations to the national health authorities, regulatory authorities, funders, and others on how to facilitate clinical trials to generate evidence on health interventions in addition to practical concerns.
Source: bit.ly/47Fc0hI
Source: bit.ly/4ezzQxN

5. India’s Central Drug Licensing Authority has reportedly introduced new guidelines to lower the frequency of drug testing for imports from nations like the US, Australia, Japan, Canada, and the European Union, to one sample from every two years’ worth of consignments or one sample out of every 20 consecutive consignments, whichever occurs first provided the drug samples maintain a clean record with no quality failures in the last five years.
Source: bit.ly/3Bgacjo

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 Director General of Foreign Trade has issued a Trade Notice, reducing the amount of export eligible for net-subvention to only Rs. 5 Crore for MSMEs till 30th September 2024, and Rs. 2.5 Crores for manufacturing exporters as calculated till 20th June 2024.
Source: bit.ly/3zsuYM8

2. The Supreme Court has issued Notices in connection with a Public Interest Litigation challenging the constitutionality of Rule 9(ii) of the Clinical Establishments Rules, which seek to introduce a price-control mechanism on the cost of healthcare treatment.
Source: bit.ly/3zqVx48

3. The Supreme Court has issued an Order recommending that the High Court of West Bengal may consider withdrawing the anticipatory Bail granted to an accused under the Narcotic Drugs and Psychotropic Substances Act, and expressed that it was highly concerning that such anticipatory bail was granted.
Source: bit.ly/3BfCUAY

4. The State Drugs Controller of the State of Karnataka has announced that it will be using emergency medical tracking functions first introduced during the COVID-19 pandemic, to keep track of analgesic medication to prevent their misuse.
Source: bit.ly/47DyH5Z

5. Starting from 19th September 2024, if the investigation of a complaint received by the Competition Commission has lead to it passing an order ex-parte, it shall be mandatory to give notice of said order and provide the impugned parties an opportunity to be heard.
Source: bit.ly/4e8jtIB