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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 Indian Pharmacopoeia Commission (IPC) and the Central Drugs Standard Control Organization (CDSCO) have released Version 2.0 of the “Pharmacovigilance Guidance Document for Marketing Authorization Holders (MAHs) of Pharmaceutical Products”. This document facilitates the submission of the safety profiles of drugs by MAHs (manufacturer, marketer, or importer of a drug) and outlines the timeline for the process.
Source: bit.ly/4dctGCs

2. India’s Central Drug Regulator (CDSCO) is reportedly considering a proposal to change the color of all antimicrobial drug strips to blue for safer usage and to visually differentiate these drugs to curb antimicrobial resistance (AMR). This proposal would apply to pharmaceutical drugs and medicines, including antibiotics, antivirals, anti-parasitics, and antifungal drugs.
Source: bit.ly/47BUL0P

3. India’s Department of Food and Public Distribution (DFPD) has asked the leading edible oil associations in India to maintain the maximum retail price (MRP) of edible oil until the stocks of the edible oil that are imported at 0% and 12.5% basic customs duty (BCD) are exhausted. The Government of India has increased the BCD on various edible oils, which is effective from 14th September 2024, to support domestic oilseed prices.
Source: bit.ly/4e9Gwmj

4. The International Organization for Standardization (ISO) has released the second edition of ISO 23500-1:2024, outlining requirements for the preparation and quality management of fluids used in hemodialysis and related therapies. This standard guides practitioners on handling dialysis and substitution fluids for advanced treatments like hemodiafiltration and hemofiltration.
Source: bit.ly/3Bjlzqt
Source: bit.ly/4gskk8H

5. India’s Maharashtra Food and Drugs Administration (FDA) has taken action against an Ayurvedic drug manufacturing company by seizing its products and prohibiting the further distribution of its Ayurvedic drugs due to improper labeling. The company has made false and misleading claims about the drugs and its treatment in its advertisements, which are prohibited under the Drugs and Magic Remedies (Objectionable Advertisement) Act, 1954, and Rules, 1955.
Source: bit.ly/3ZucKUU

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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 Central Pollution Control Board (CPCB) has issued Environmental Compensation (EC) Guidelines to address non-compliance with Extended Producer Responsibility (EPR) registration, labelling requirements, failure to fulfill EPR obligations, and non-filing of annual returns, among other violations under the Battery Waste Management Rules, 2022. The guidelines outline formulas for determining Environmental Compensation (EC) in different cases of non-compliance with the Battery Waste Management Rules, 2022.
Source: bit.ly/3ZkGVOe
Source: bit.ly/4ehqaI4

2. India’s Food Safety and Standards Authority of India (FSSAI)  has extended the availability of Instant (Tatkal) Food License and Registration nationwide, with the exception of Chandigarh, Himachal Pradesh, and Meghalaya. Previously, this provision was limited to few states and Union Territories. The Instant (Tatkal) Food License and Registration provision came into effect on 31st August, 2024.
Source: bit.ly/3XGxBDo

3. India’s Bureau of Indian Standards (BIS) has notified amendments to various products, including Disposable Baby Diapers, Absorbent Cotton Gauze, Cotton Bandage Cloth, Sanitary Napkins, and Disposable Baby Diapers. All products imported, sold, or marketed in India must comply with these revised standards by 22nd February, 2025.
Source: bit.ly/4dZsFz8

4. India’s Department of Pharmaceuticals (DoP) has issued a issued notification under Drug Price Control Order,2013 (DPCO) thereby extending the current ceiling price for orthopedic knee implant systems until 15th September, 2025.
Source: bit.ly/3Tn6ASI

5. India’s central drug regulator (CDSCO) has suspended the manufacturing and marketing license of a pharmaceutical company due to the false and misleading claims that its eye drops could augment near vision within 15 minutes and the company’s failure to address queries raised by the drug regulators concerning these claims.
Source: bit.ly/4e04yAn

6. India’s Supreme Court, while hearing a case on the ban of commercial surrogacy, observed that the interests of surrogate mothers must be safeguarded. The Court emphasized the need for a regulatory system like “surrogate banks” to ensure that surrogate mothers are not exploited and their rights are upheld.
Source: bit.ly/4gePgsS

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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 Ministry of Corporate Affairs (MCA) has set a Deal Value Threshold (DVT) of ₹2,000 crore for mergers and acquisitions under the Competition (Amendment) Act, 2023. Transactions wherein the target company having substantial business in India if exceeds the given threshold, will have to obtain prior approval from the Competition Commission of India (CCI).
Source: bit.ly/3MGohZM

2. Ayurvedic businesses seeking to advertise ayurvedic drugs in Kerala must reportedly must secure permission from Kerala Drugs Control Department before making misleading and exaggerated claims via advertising. Advertisements made without approval will face legal repercussions.
Source: bit.ly/3AYOsbu

3. India’s Central Pollution Control Board (CPCB) has issued Environmental Compensation (EC) guidelines to address non-compliance with Extended Producer Responsibility (EPR) registration requirements, non-fulfilment of EPR obligations, non-filing of annual returns, among other violations under the E-waste Management Rules, 2022. These guidelines also regulate the cost of EPR certificates for fulfilling EPR obligations.
Source: bit.ly/3B05aY8

4. India’s Goods and Services Tax (GST) Council has decided to reduce the tax rate on cancer drugs – Trastuzumab Deruxtecan, Osimertinib and Durvalumab to 5% from the previous tax rate of 12%. The Council is reportedly set to finalize reductions in tax rates for health and life insurance premiums in its next meeting in November 2024.
Source: bit.ly/3zd6NB2

5. Medical Colleges in India must reportedly meet the safety and security measures of women doctors, nurses and students to get recognition from the Medical Education Regulator, National Medical Commission.
Source: bit.ly/3XEGNrT 

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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 Government of India, reportedly plans to establish a distinct category for advanced coronary stents and increase its ceiling price. This change is intended to ensure that stent manufacturers launching next-generation devices in India are not affected by price control measures.
Source: bit.ly/4cOGnU4

2. India’s Department of Pharmaceuticals (DoP) is reportedly developing a ‘Disposal Policy’ for sound disposal of expired, leftover, substandard, spurious, and adulterated drugs from the sale premises and from the households to prevent environmental damage and curb antimicrobial resistance (AMR).
Source: bit.ly/47dCgQ2

3. The Karnataka High Court has directed the Drug Controller General of India to establish an efficient online system whereby the drug samples which are sent for test/analysis are expeditiously tested and analysed by the Government Analyst within 60 days and the reports sent by them are available online on a real-time basis.
Source: bit.ly/3Te2Umc

4. India’s Department of Telecommunications (DoT) has advised all unregistered Machine to Machine Service Providers (M2M SPs) and WPAN/WLAN Connectivity Providers for M2M services to register with the DoT by September 30, 2024, to prevent any disruption to their services. Failure to comply may result in the withdrawal of telecom resources from authorized telecom licensees.
Source: bit.ly/3Xeknft

5. The Indian Council of Medical Research (ICMR) is reportedly developing evidence-based guidelines for the empirical use of antibiotics to address antimicrobial resistance (AMR), which is a significant public health challenge in India
Source: bit.ly/4cROOhl

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. Due to a recent spike in cases, the Karnataka Government has declared dengue as an “epidemic” and to that effect has issued a notification under the Karnataka Epidemic Diseases Regulations, 2020. As part of the notification, the government has empowered Municipal Corporations across the state to carry out inspections of sites for compliance with mosquito prevention measures.
Source: bit.ly/3ThmkGK

2. Industry associations of manufacturers of Drugs and Medical Devices have called for an amendment of the Drugs (Prices Control) Order, 2013 to make pricing guidelines uniform for both Scheduled and non-scheduled formulations.
Source: bit.ly/3AJuTUn

3. India’s Central food regulator, the Food Safety and Standards Authority of India has issued a notification to re-operationalize The Food Safety Standards (Health Supplements, Nutraceuticals, Food for Special Dietary Use, Food for Special Medical Purpose and Prebiotic and Probiotic Food) Regulations, 2022, in the interim of formulating new regulations.
Source: bit.ly/3ASeVYj

4. It is reported that IT’s upcoming meeting scheduled for 9th September, the Goods and Services Tax Council may take a decision on removing the existing 18% Goods and Services Tax on health insurance policies.
Source: bit.ly/3TjjrWa

5. In pursuance of its larger and long-term project of fighting and reducing anti-microbial resistance, the World Health Organization has issued a guidance directing management of “antibiotic waste” generated by manufacturers, which contributes to rising levels of anti-microbial resistance.
Source: bit.ly/4g922t1

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) is set to develop guidelines for the safe disposal of pharmaceutical waste which are expired and unused drugs and medicines, to curb antimicrobial resistance (AMR).
Source: bit.ly/3yOlfPY

2. The Indian Health Ministry has reportedly stated that 156 fixed dose combination (FDC) drugs recently banned were licensed by the State Licensing Authorities (SLA) without prior approval from the Drug Controller General of India (DCGI).
Source: bit.ly/3Xl6Xj7

3. Bureau of Indian Standards (BIS) certification will be mandatory for medical textile products covered by Quality Control Order from 1st October 2024. The products that will require certification and BIS mark are sanitary napkins, reusable sanitary pads/sanitary napkins, period panties, baby diapers, hospital bed linens, pillow covers, dental bibs and shoe covers intended for medical use.
Source: bit.ly/4e3FI1U

4. India’s major pharma companies have requested the Delhi High Court to quash the government’s recent notification banning 156 fixed-dose combination (FDC) drugs. They have also sought interim relief in their petitions to exhaust the stock that was manufactured before the notification came into effect, prohibiting any coercive measures against retailers and stockists until the stock is exhausted.
Source: bit.ly/3yUZFcw

5. India’s Central Pollution Control Board has issued a show cause notice to producers, importers, and brand owners (PIBOs) of plastic packaging, requiring them to file annual reports and fulfill Extended Producer Responsibility (EPR) obligations for the financial year 2022-2023 by September 1, 2024. Failure to comply will result in the imposition of environmental compensation (EC) and additional penalties.
Source: bit.ly/3XmQ5bF
Source: bit.ly/3XmQc75
Source: bit.ly/3yUZAWg

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. India’s Health Minister has reportedly confirmed that Central Drugs Standard Control Organization (CDSCO) will be the sole regulator of veterinary medicines in India and there is no proposals to establish a separate regulatory body for veterinary medicines in India.
Source: bit.ly/4cbgTQe

2. India’s Food regulator (FSSAI) has warned against use of unapproved non-specified ingredients, such as “Deionized apple juice concentrate,” in fruit juices.
Source: bit.ly/46swOZq

3. The State Drug Regulator (FDA) of Maharashtra is reportedly going to start an inspection drive to identify doctors and hospitals which are running an open shop for medicines without holding a valid pharmacy license.
Source: bit.ly/46rtHAZ

4. The Principal Bench and State Benches of Goods and Services Tax Appellate Tribunal (GSAT) have been established with effect from 1st September 2023.
Source: bit.ly/3A86tDM

5. The US Food & Drugs Administration (FDA) has warned a pharmaceutical company for sponsoring a celebrity paid promotion campaign on social media, in which the influencer promoted a drug but did not disclose essential risk information. The FDA found the post to be misleading.
Source: bit.ly/46rtI81

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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.

NOC for the manufacture of unapproved drugs meant for export will be issued by the Central Drug Regulator
India’s Central Drug Regulator (CDSCO) will be the competent authority to issue the No Objection Certificate (NOC) required by pharmaceutical companies for the manufacture of unapproved, new, or banned drugs for export purposes, starting from 15th May 2024. The NOC will be issued by the zonal offices of CDSCO. The application for NOC will have to be made online. Prior to CDSCO, it was the State Licensing Authorities that issued NOCs.
Source: bit.ly/4dkZO8u

Producers of Batteries can meet EPR Targets and file Annual Returns by June 30, 2024
The deadline for meeting Extended Producer Responsibility (EPR) targets and submitting annual returns by the producers of all types of batteries has been extended to June 30, 2024.
Source: bit.ly/4a0Uynx

Private hospitals demand payment of interests from the government on delay of reimbursement for treatment under Ayushman Bharat Scheme
India’s Association of Healthcare Providers (AHPI) has raised concerns over inordinate delay in receiving reimbursement for treatment provided to Ayushman Bharat beneficiaries, which impedes cash flow and poses serious operational issues for all hospitals. The Association has urged that the government pay 1 percent interest on payments delayed beyond one month under the Ayushman Bharat scheme, which is the Central Government’s flagship universal health coverage scheme, as well as change of package rate to allow beneficiaries to avail of continued benefits from the Ayushman Bharat Scheme
Source: bit.ly/3wimXHQ

US government likely to ease restrictions on regulation of Marijuana
The U.S. Drug Enforcement Administration (DEA) is likely to reclassify marijuana as a less dangerous drug by moving it from a tightly regulated class to a less tightly regulated class. Although the DEA’s proposal would highlight the medical benefits of cannabis, it would not allow its use for recreational purposes. The White House Office of Management and Budget is reportedly still in the process of reviewing the idea.
Source: bit.ly/4a2osrm

Form 483 notice need not to be responded by manufacturers of medical devices within 15 days: US Medical device experts
According to US Food and Drug Administration (FDA) officials, a medical device manufacturing company is not required to respond to a Form 483 notice (Notice of Inspectional Observations) within 15 days. The 15-day deadline for response applies to warning letters and not to Form 483 notices, though the FDA advises that if the manufacturer wishes to respond to a Form 483 notice, then it should do so within 15 days of the notice.
Source: bit.ly/44FHVxn

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.

Supreme Court clarifies when a patient’s negligence may be reduced due to pre-existing conditions
India’s Supreme Court has laid down the situations in which a patient’s claim for compensation due to medical negligence may be reduced on the grounds of pre-existing conditions. These are: First, when a latent condition of the patient has been unearthed; Second, when the negligence on the part of the wrongdoer re-activates a patient’s pre-existing condition that had subsided due to treatment; Third, wrongdoer’s actions aggravate known, pre-existing conditions, that have not yet received medical attention; and Fourth, when the wrongdoer’s actions accelerate an inevitable disability or loss of life due to a condition possessed by the patient even when the eventuality would have occurred with time, in the absence of the wrongdoer’s actions. This rule is commonly referred to as the ‘egg-shell skull’ rule.
Revised penalty will apply, even if the offence took place before the penalty is revised: Supreme Court
India’s Supreme Court has held that a repealed provision will cease to operate from the date of repeal and the substituted provision will commence to operate from the date of its substitution. The Court was dealing with a matter involving the determination of penalty for loss of liquor in transit. The unamended rule, which existed at the time when the breach happened, provided for a penalty of four times the duty payable on liquor.  The amended rule provided for a penalty equal to the duty payable on liquor. Since no additional guidance for the application of the amended rule was prescribed, the Supreme Court held that the amended penalty provision would apply.
Proceedings related to alcohol content in drugs under excise laws and drug laws can run concurrently: High Court
India’s Gujarat High Court has clarified that action under the Drugs & Cosmetics Act does not exempt an individual from prosecution if a case is made out under the Gujarat Prohibition Act, 1949. In this case, a pharmaceutical manufacturer had allegedly violated the State’s prohibition law by selling intoxicating substances as ayurvedic medicine and, therefore, was facing action against the excise laws as well as drug laws.
Limits on the import of Isopropyl alcohol relaxed
India’s Directorate General of Foreign Trade (DGFT) has notified the discontinuation of safeguard measures on the import of isopropyl alcohol (IPA) through a trade notice. Earlier, country-wise quantitative restrictions (QR) were imposed on the import of IPA into India.
Used imported medical devices with a minimum shelf life of 5 years are not waste: Tribunal
India’s Hyderabad Bench of Customs, Excise, and Service Tax Appellate Tribunal (CESTAT) has held that used medical devices with a minimum residual life of 5 years or more are not e-waste or hazardous waste. In this matter, a hospital had imported used medical equipment for internal use but the Customs had seized the capital equipment on grounds that the used medical equipment qualified as hazardous waste under the Hazardous and Other Wastes (Management and Transboundary Movement) Rules, 2016
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.

Strict quality checks to be done by the food regulatory authority of powdered spices in India
Food Safety and Standards Authority of India (FSSAI) has announced plans to conduct comprehensive quality checks of different brands of powdered spices following an import ban by Hong Kong and Singapore on certain packaged powdered spices manufactured two popular Indian brands. The ban was ordered due to alleged discovery of a cancer-causing pesticide, ethylene oxide, which is also prohibited for use in food products by FSSAI in India.
Source: bit.ly/4b8aiWU

India too may soon allow sale of drugs without license
A Committee chaired by India’s Directorate General of Health Services will reportedly publish a list of drugs which can be sold over the counter (OTC) at retail stores, which are not druggists and chemists store. Unlike other countries like US, UK or China, India does not currently have any rule that allows sale of drugs over the counter.
Source: bit.ly/3UellH0

New voluntary standards for allopathic clinics to be implemented from June
India’s National Accreditation Board for Hospitals & Healthcare Providers (NABH) has published Accreditation Standards for Allopathic Clinics (2nd Edition). NABH will start issuing accreditations as per this standard from 1st July, 2024. New applications or renewal applications as per the 1st Edition Standards will not be accepted after 30th June, 2024.
Source: bit.ly/3xKLMwx

Indian Pharma Companies need to implement differential pricing strategies to leverage patent cliff: DOP study
A study conducted by India’s Department of Pharmaceuticals (DOP) states that pharmaceutical companies should come up with competitive pricing strategies and investigate differential pricing models based on regional economic factors and healthcare systems to ensure affordability and improve accessibility to capitalize on patent cliff opportunities. The report states that over 20 drugs with a combined sales value of $251 billion are expected to go off-patent in the current decade.
Source: bit.ly/4dbsCAg

World Health Organization outlines ten fundamental patients’ rights in its Patient Safety Rights Charter
The World Health Organization has launched the Patient Safety Rights Charter. This first-ever charter identifies ten fundamental patients’ rights in the context of safety and provides healthcare workers, leaders, and governments with the tools they need to build patient-centered healthcare systems, enhancing patient safety and lowering the risk of harm. WHO has recognized increasing patient safety through systemic and systematic action as a global priority.
Source: bit.ly/3WcsnPg