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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 Health Ministry (MoH&FW) is considering a proposal to amend the New Drugs and Clinical Trials (NDCT) Rules, 2019 with an aims to reduce animal usage and minimize sacrifices during drug testing procedures. The amendment aims to remove the requirement for applicants to submit sub-acute animal toxicity study data for intravenous infusions and injections when seeking permission to import or manufacture a new drug already approved in the country.
Source: bit.ly/4f88Plu

2. India’s National Accreditation Board for Hospitals and Healthcare Providers (NABH) has introduced its first edition of Care Home Accreditation Standards to enhance quality and safety in care homes centres nationwide. This initiative focuses on ensuring that even the most vulnerable populations receive top-tier care.
Source: bit.ly/40a4U3m

3. The Public Health Foundation of India (PHFI), along with Jamia Millia Islamia University and Jan Swasthya Sewa Sansthan, has launched a global initiative called Community Focused Oral Health Research for Equity (CORE). This program aims to address oral health problems and improve health systems so that high-quality oral health services are available, affordable, and accessible to all.
Source: bit.ly/3UbOOCm

4. In India, the pharmaceutical and nutraceutical sectors are increasingly using LipoDuo technology to improve product stability, shelf life, and formulation options. This technology, reportedly, is ideal for creating advanced products and supports ongoing innovations that lead to more effective and stable formulations.
Source: bit.ly/3NtR4Bb

5. India’s National Pharmaceutical Pricing Authority (NPPA) is recalculating the ceiling prices for three antibiotics based on a review application submitted by a major pharmaceutical company. The company had claimed that the pricing authority made errors in its calculations.
Source: bit.ly/4f88I9y

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 Health Ministry has notified the New Drugs and Clinical Trials (Amendment) Rules, 2024 which will take effect from1st April, 2025.These amended rules outlines the requirements for registration of the Clinical Research Organizations.
Source:  https://bit.ly/4ddpX81

2. India’s Central Food Regulator (FSSAI), has issued a show cause notice to a Tamil Nadu-based company that supplied ghee for making laddoos (prasadam) at the Tirupati Balaji temple, following the detection of animal fat in the laddoos. The company is required to respond to the charges by 23rd September, 2024, failing which appropriate action will be taken against them.
Source: https://bit.ly/3BheNln

3. The Government of India is reportedly planning to adopt a risk-based approach for monitoring the quality of imported consignments of medical devices at ports. This will involve random sampling of consignments of medical devices and testing of entire cargoes in case of critical diagnostic kits.
Source: https://bit.ly/3BhePtv

4. India’s central health regulator has declared five samples of drugs to be spurious based on the physical comparison and analytical tests done by the manufacturers and on the reports from State Licensing Authorities. The actual manufacturers, as claimed on the labels, have stated that they are not the actual manufacturers of these drugs and the drugs are spurious.
Source: https://bit.ly/3XTfUjP

5. India’s Directorate General of Foreign Trade (DGFT) has amended Chapter 5 of the Handbook of Procedures (HBP) 2023 under the Export Promotion Capital Goods (EPCG) Scheme. The EPCG Scheme, which allows pharma industry to import capital goods duty-free for producing quality goods and services to boost exports, has been updated to streamline its reporting requirements. The amendment eliminates the previous requirement for annual reporting of Export Obligation (EO) fulfilment and has been replaced with a periodic reporting system.
Source: https://bit.ly/4dkMUWC

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. Doctors can sell medicines to their patients without obtaining a separate license for selling drugs after complying with all the conditions specified under the Drugs Rules, 1945: Bombay High Court
Source: bit.ly/4cqy94s

2. Drugs which are approved in USA, UK, Japan, Australia, Canada and EU have been exempt from requirement to conduct clinical trials in India before securing a marketing approval, if they fall into the categories of Orphan Drugs for Rare Diseases, Gene and Cellular Therapy Products, New Drugs used in Pandemic Situations, New Drugs for Special Defense Purposes, and New Drugs that represent a significant therapeutic advance.
Source: bit.ly/4cmWZ4W

3. India’s Central Drug Regulator (CDSCO) has made it mandatory to follow WHO Technical Report Series (TRS) guidelines in so far as they relate to Good Manufacturing Practices, such as the “WHO Good Manufacturing Practices for Sterile Pharmaceutical Products.”
Source: bit.ly/3yyC4y6

4. India’s Central Government is reportedly planning to introduce a separate marketing practices code for medical devices. The proposed code aims to establish a voluntary framework to regulate marketing practices within the medical devices industry.
Source: bit.ly/4dvF6BY

5. Indian Government has revised hazardous residue standards for fruits and vegetables meant for domestic consumption and introduced new hazardous residue standards for fruits and vegetables meant for export purposes. Fruits and vegetables meant for export should comply with standards set by the Codex Alimentarius Commission or the importing country’s requirements.
Source: bit.ly/4fDKLYM

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TOP 5 HEALTH LAWS AND POLICY UPDATES

1. India’s Central Food Regulator the Food Safety Standards Authority, has introduced registration process for direct sellers to differentiate from Retailers, and make it easier to preserve exemption granted from regulation to direct sellers.

Source: bit.ly/4feuedl

 

2. The Kerala High Court in following with a recent decision of the Punjab High Court has held that the newly enforced Criminal Procedure (The Bharatiya Nagrik Suraksha Sanhita, 2024) will apply to all criminal appeals filed on or after 1st July 2024, the day of enforcement of the  new law. The court held that while the substantial right to appeal is preserved under the repealed statute, the procedural right will transfer over as per Sec. 531 of the new Code.

Source: bit.ly/4bQpMi4

 

3. Exports of Drugs and Pharmaceuticals have reportedly increased by 9.5% in the first quarter of FY 2024-25 year-on-year.

Source: bit.ly/4d3x3Nb

 

4. In response to recent reports that India has the 2nd highest number of unvaccinated children, the Indian government has clarified in a press release that, this statistic is misleading as such children only constitute a minute 0.11% of the nation’s population of children.

Source: bit.ly/3zQzFPw

 

5. The United States Food and Drug Administration has published Guidance for Human radiolabeled mass balanced studies, prescribing the information that sponsors need to submit, most notably now requiring a minimum of 6 participants for such studies as against the accepted variance between 4-6 participants.

Source: bit.ly/3y2UEy8

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.

Corporate hospitals may soon have to comply with advertisement norms applicable to doctors

India’s National Medical Commission (NMC), which regulates the conduct of medical practitioners (doctors), has endorsed the position that all hospitals should comply with the same standards of ethics as are applicable to doctors under the NMC Registered Medical Practitioner (Professional Conduct) Regulations, 2023. The operation of 2023 Regulations is currently under suspension.
Source: bit.ly/3vpJ7aV

High Court imposes damages of 244 crores in Standard Essential Patents case

India’s Delhi High Court has reportedly imposed damages amounting to INR 244 Crores on an Indian smartphone manufacturer. The Court found smartphone manufacturer guilty of infringing seven patents on 2G, EDGE, and 3G technology granted to a global telecom company. The order is expected to be out soon.
Source: bit.ly/3TxOXyI

Drug Manufacturers will have to upload all product details on Government portal soon

The Drugs Consultative Committee (DCC), a committee comprising State-level Drug Regulators, has recommended that the Central Drugs Regulator, Central Drugs Standard Control Organization (CDSCO), should set a deadline for manufacturers of drugs to upload list of drugs manufactured on an online portal called SUGAM.
Source: bit.ly/3TxP0uo

Ban on trade of ferocious dog breeds has been stayed in various States in India

India’s Kerala High Court, Karnataka High Court and Kolkata High Court has stayed a controversial circular of the Central Government which prohibited import, trading and selling of 23 breeds of dogs identified as ferocious in the circular. The circular also mandated sterilization of dogs from further breeding as pets. The circular has been challenged on the ground that it is unscientific, not based on evidence and has been issued without consultation with relevant stakeholders.
Source: bit.ly/3TVZcyi

European Medicines Agency urges sponsors of clinical trials to register on new portal before January 2025 deadline

The European Medicines Agency (EMA) has strongly advised sponsors of clinical trials that have been approved before 31 January 2023 to submit application to move the clinical trials to the new Clinical Trials Information System (CTIS) as soon as possible, considering it will take EMA up to three months to review and authorize the application. As of now, only 20% of clinical trials have been moved to the new platform.
Source: bit.ly/3TZRzHl

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.

Good Distribution Practices may be implemented in India for pharmaceutical products soon
India’s Drugs Consultative Committee (DCC) has recommended that draft of revised Good Distribution Practices (GDP) guidelines for pharmaceutical products should be made mandatory soon. The DCC is of the view that there is a gap in the law which requires owners of premises such as warehouses to ensure appropriate storage condition for drugs, but no such requirement exists for transporters who transport the drugs, and this affects the quality of drugs.
Source: bit.ly/49cMPCk

TB vaccine clinical trials begins in India
A Hyderabad based biotechnology company has started Phase 3 clinical trials of tuberculosis (TB) vaccine called MTBVAC among the adults in India. The vaccine is the first live attenuated vaccine of Mycobacterium tuberculosis isolated from human strain, unlike the BCG vaccine.
Source: bit.ly/495Zuak

Medical and Sales Representatives’ body says new Pharma Marketing Code lacks teeth
The Federation of Medical and Sales Representatives’ Associations of India (FMRAI) has criticized the newly notified Uniform Code for Pharmaceuticals Marketing Practices (UCPMP), describing it as a futile effort. It stated that the new code lacks statutory enforcement and contains no explicit penal provisions against unethical marketing by pharmaceutical and medical device companies.
Source: bit.ly/495ZAic

Fire safety in hospitals should be evaluated by Government before Summer Season: Disaster Management Body
India’s Union Health Ministry and National Disaster Management Authority (NDMA) have jointly issued an advisory to all States and Union Territories (UT’s) to take proactive measures to check fire safety compliance of all hospitals before the incoming summer season.
Source: bit.ly/4akq9Bg

No change in surrender value norms for life insurance policies: Insurance Regulator
The Insurance Regulatory and Development Authority of India (IRDAI) has decided to retain the current surrender value requirements for life insurance policies due to concerns over higher surrender value expressed by the industry. Surrender value in life insurance is an amount paid by the insurer to the policyholder when the policy is terminated prior to the policy’s maturity date.
Source: bit.ly/43zOkcL

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.

Panel of auditors to audit the promotional expenses of pharma and medical device companies will be appointed soon: Government
The Secretary, Department of Pharmaceuticals, has reportedly said that the government will appoint a panel of auditors who can undertake risk-based audits from time to time, to evaluate whether the promotional expenses, especially towards conferences and workshops, have been incurred in an ethical manner as per the Uniform Code for Pharmaceutical Marketing Practices 2024. Any discrepancy will be reported to the appropriate government agency or authority.
Source: bit.ly/49SNs5f

Industry welcomes the new Uniform Code for Pharmaceutical Marketing Practices
The pharmaceutical industry has reportedly welcomed the new Uniform Code for Pharmaceutical Marketing Practices (UCPMP). According to news reports, the industry feels that the new code is a step ahead towards the advancement of the industry as it ensures ethical and healthy engagement between the pharmaceutical industry and medical professionals.
Source: bit.ly/4a6SZWd

Nutraceutical and food supplement regulations are to be tightened further
The Food Safety and Standards Authority of India (FSSAI) is in the process of tightening the regulations for nutraceuticals and health supplements. This move was prompted by the receipt of several complaints by the FSSAI about the presence of non-compliant health supplements on the market and the fact that the over-the-counter availability of nutraceuticals and health supplements is resulting in people consuming supplements along with drugs, which increases the risk of adverse effects.
Source: bit.ly/3wXMsOU

A major e-commerce entity was fined Rs 25 lakh due to its inaction to remove counterfeit products from the marketplace
A State Consumer Commission in India has imposed a fine of Rs. 25 lakhs on a major e-commerce entity on the grounds that the e-commerce entity failed to correct the listing of a product, which it was aware was a counterfeit product. By failing to remove the listing, the Commission held that the e-commerce entity had engaged in dark patterns and unjust enrichment.
Source: bit.ly/3IBUsaH

EU to extend regulatory data protection for innovator drugs to 7.5 years
The European Union is set to extend regulatory data protection for innovator drugs to 7.5 years, with one extra year of incentives if the drug meets an unmet medical need and clinical trials are conducted in the EU. There is a proposal to grant an additional 3 years of protection from generics, taking the total protection to a maximum of 11.5 years.
Source: bit.ly/3IxEIWl