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 Pollution Control Board (CPCB) has clarified that producers of plastic packaging in the micro & small category do not have to EPR fulfill obligations with effect from Financial Year 2023-24. However, they will have to file annual returns for the financial year 2023-24.
Source: bit.ly/3JqZRBH

2. India’s Directorate General of Trade Remedies (DGTR) has initiated an anti-dumping probe into Vietnamese imports of calcium carbonate filler masterbatch to determine how these imports affect the nation’s domestic industry. The medical sector uses this product for pouches, blister packaging, and individual-wrap containers. The DGTR will examine market patterns, injury claims, alleged dumping tactics and anti-dumping measures necessary to shield local manufacturers from unfair competition.
Source: bit.ly/3AF2Vtc

3. India’s Ministry of AYUSH has notified the Drugs (Fifth Amendment) Rules, 2024, which revise licensing procedures for homoeopathic medicines. The requirement for renewing manufacturing and loan licenses has been removed, making it valid in perpetuity subject to submission of self declaration.
Source: bit.ly/3YT6BBc

4. The State Drug Controller of Tamil Nadu has reportedly clarified that there is no legal provision for issuing separate licenses for pharmaceutical marketing companies or marketers. Pharmaceutical marketers and other stakeholders have been advocating for an amendment to the Drugs and Cosmetics Act (D&C Act) to include a provision for granting separate licenses for pharmaceutical marketers.
Source: bit.ly/3CbsZNh

5. In an effort to reduce exaggerated health claims made by supplement manufacturers about illness treatment or risk reduction, the government panel have proposed to transfer power from the Food Safety and Standards Authority of India (FSSAI) to a drugs regulator. The expert group was initially formed to examine how to handle the challenges that overlap between drugs and nutraceuticals.
Source: bit.ly/3YSrjRG

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 government has expanded the definition of Homeopathic medicine, to include all drugs except those drugs “which is administered by injectable route”.
Source: bit.ly/48C6E7n

2. The government has given more powers to Adjudicating Officers under the food laws. In addition to existing power, they have now been granted the additional power to investigate cases of supply of false information as well as unlicensed operation of food business.
Source: bit.ly/3NPfCVw

3. India’s drug price regulator the National Pharmaceutical Pricing Authority (NPPA) has issued a price-control notification requiring a proportional reduction in price of the drugs resulting from the reduction in the Customs Duty and GST.
Source: bit.ly/3YPz7Du

4. The Indian Medical Association has taken objection to the proposal of the Central Government to introducing category of “Geriatric Nursing Practitioners”, and the designation of these nurses as Medical Practitioners, stating that this conflicts with qualification requirements under the National Medical Council Guidelines.
Source: bit.ly/4fu2IrI

5. Several industry associations representing the Homeopathic industry in the United States, have filed a lawsuit challenging the power of the United States Food and Drug Administration’s (US FDA) power to require New-Drug Approvals, and further the USFDA power to prosecute and penalize violations.
Source: bit.ly/3YuZxJz

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. 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. India’s Department of Consumer Affairs has requested comments from stakeholders regarding the declaration of units of measurement for the net quantity of food wrapping paper and aluminum foils used for carrying food products. The proposal suggests including both “weight” and dimensions (length x breadth), i.e., kg and meters x meters (or cm x cm), rather than only weight or dimensions. This proposal aims to inform consumers about the actual quantity of packing material delivered.
Source: bit.ly/3Yld47H

2. The Indian Pharmacopoeia Commission (IPC), under India’s Health Ministry, has released an updated Medical Device Adverse Event Reporting Form for the reporting of Medical Device Adverse Events (MDAEs). The form states that reporting any MDAE will not have any legal implications for the reporter, and the reporter’s identity will be protected and kept strictly confidential.
Source: bit.ly/3XYGbwc

3. India’s Ministry of Health and Family Welfare (MoH&FW) is considering a proposal to amend the timelines for conducting audits and verifying compliance for grant of manufacturing license for medical devices in India. Currently, the Medical Devices Rules, 2017, do not specify these timelines, leading to delays in Quality Management System (QMS) inspections and the subsequent compliance verification processes.
Source: bit.ly/3ZXbr12

4. India’s Ministry of Health and Family Welfare (MoH&FW) is considering a proposal to restrict the eligibility requirements for qualifying as a competent person for obtaining a wholesale license for the sale, stocking, exhibition, or distribution of drugs in India to those with a pharmacy background, specifically D. Pharmacy, B. Pharmacy, M. Pharmacy, Pharm D, or individuals who are Registered Pharmacists.
Source: bit.ly/3ZXbr12

5. The Ministry of Health and Family Welfare (MoH&FW) is considering a proposal to ensure mandatory reporting of Serious Adverse Events (SAE) related to medical devices, including In-Vitro Diagnostic Medical Devices, by the manufacturer or importer of these devices in India. Currently, under the Medical Devices Rules 2017, there is no mandatory requirement for reporting such events by the license holder.
Source: bit.ly/3ZXbr12

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. India’s National Consumer Disputes Redressal Commission (NCDRC) has directed one of the medical device company to pay ₹35 lakh to a consumer as compensation for medical complications arising from the inherently defective design of hip replacement device.
Source: bit.ly/3XP4bla

2. India’s Ministry of Environment, Forest and Climate Change has issued the Ecomark Rules, 2024, detailing the criteria for granting the “Ecomark”. These rules intend to promote environmentally friendly products and support green industries.
Source: bit.ly/47PY0ly

3. India’s District Consumer Dispute Redressal Commission (DCDRC) of North East Delhi, has ordered a leading hospital to pay compensation for negligence to a patient who had met with a road accident on the ground of deficiencies in the services and failure to meet medical obligations.
Source: bit.ly/3ByeP8E

4. India’s Bombay High Court has issued a restraining order in a trademark infringement case against five juice center outlets in Kerala for unauthorized use of the Haji Ali trademark. The court observed the outlets continued using the name, trademark, and logo of Mumbai’s iconic Haji Ali Juice Centre despite the termination of their franchise agreement.
Source: bit.ly/3XP4RXK

5. The Indian Pharmacopoeia Commission (IPC), under India’s Health Ministry, has issued a drug alert regarding the rampant use of “Tetracycline.” The commission advises both doctors and patients to exercise caution while prescribing this medication, as it may cause adverse reactions, specifically Fixed Drug Eruption (FDE).
Source: bit.ly/3Yb5nkp

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 identified 59 drug samples as Not of Standard Quality (NSQ) in August, including products from major pharmaceutical manufacturers. The action has come after several states and union territories failed to report NSQ data, prompting the CDSCO to emphasize the need for timely submissions to enhance drug safety oversight.
Source: bit.ly/4drUUFz
Source: bit.ly/3zCDmJ0

2. The District Consumer Disputes Redressal Commission-II in Visakhapatnam has awarded a compensation of Rs. 15 lakhs in a medical negligence case and has found the private eye institute, its director, and two ophthalmologists guilty as they failed to meet their medical obligations by neglecting the crucial pre-surgery test of the patient leading to a loss of eyesight of the patient.
Source: bit.ly/3N6HST2

3. The Punjab and Haryana High Court has ordered the attachment of the salaries of several health officials, including the state health secretary for a potential diversion and unauthorised use of funds. The court held that the state cannot withhold the amount released by the central government due to hospitals under the Ayushman Bharat scheme and has asked for a detailed explanation from the state in the matter.
Source: bit.ly/3zCDt7o

4. India’s health ministry has issued draft regulations amending the Food Safety and Standards (Contaminants, Toxins and Residues) Regulations, 2011 to limit the Maximum Residue Limits (MRL) of pesticides/insecticides in each food community. The notification invites objections and suggestions from stakeholders regarding the proposed changes till November 17, 2024.
Source: bit.ly/47MlQOV

5. The Indian government has released a notification to include Acupuncture under the category “Other Care Professionals” in the schedule of the National Commission for Allied and Healthcare Professions Act, 2021.
Source: bit.ly/3ZJqXNO

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 government is planning to launch the Trinetra portal to register complaints against Ayurvedic product advertisements making exaggerated, misleading or deceptive claims, concealing important details, or showing deceptive images that can misguide consumers, influence their decisions and result in unfair practices. The portal will enable speedy redressal of complaints through a central registry system and an AI-based redressal mechanism.
Source: bit.ly/3ZGp1pp

2. The government has notified draft rules to amend the Cigarettes and other Tobacco Products (Prohibition of Advertisement and Regulation of Trade and Commerce, Production, Supply and Distribution) Rules, 2004. The draft rules aim to mandate the display of non-skippable anti-tobacco health spots and disclaimers about the harmful effects of tobacco use for films and online curated content platforms.
Source: bit.ly/3MWfUt8

3. The Union Health Ministry has announced that the National Medical Register (NMR) has received 20,000 applications, linking doctor registration to Aadhaar for authenticity. The National Medical Commission has further been asked to initiate efforts for increasing medical seats to add 75,000 more undergraduate and postgraduate seats for aspiring medical professionals.
Source: bit.ly/3XCGcpe

4. India’s Narcotics Commissioner has extended the deadline for companies dealing with psychotropic substances to register themselves on the CBN Online Portal to December 31, 2024. Earlier, this deadline was September 30, 2024. Any failure to register by the revised date will result in the cancellation of registrations, while companies are advised to continue submitting quarterly returns as previously required.
Source: bit.ly/3TDTSPC

5. The High Court of Jammu and Kashmir has recommended proper training for officials of the Drug Controller department to address the high rate of technical defects in prosecutions related to substandard drugs. The court highlighted that many cases fail due to procedural non-compliance, urging the Health and Medical Education Department to implement corrective measures to prevent premature quashing of complaints under the Drugs and Cosmetics Act, 1940.
Source: bit.ly/4etb82g

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