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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 ministry of environment, forest and climate change has recently issued an office memorandum stating a revised list of high end and high value used / refurbished medical equipment for import. MRI, CT and radiography devices are some of the new inclusions in the list. This may lead to unchecked import of refurbished medical devices in India, and potentially risk patient safety. This will also negatively impact Make in India Initiatives. (Order attached).
Source: bit.ly/4hqd4ea

2. The Central Consumer Protection Authority (CCPA) has given the quick e-commerce companies a notice of 15 days for violations related to packaged product disclosures mandated under the Legal Metrology Act, which mandates online and offline retailers to display key product information, maximum retail price, expiration date, weight, manufacturer details, etc on packaged goods. This re-emphasises regulatory stance on consumer safety and disclosure requirements.
Source: bit.ly/3YEp5oF

3. The Central Board of Indirect Taxes and Customs (CBIC ) under the aegis of Ministry of Finance has issued Notification No. 69/2024-Customs (N.T.) dated October 23, 2024, updating the tariff values for imported commodities such as that of edible oils such as Palm Oil and Soya, brass scrap, gold, silver etc (Notification attached).
Source: bit.ly/3BUSmm7

4. Institutions of the Council of Scientific and Industrial Research (CSIR) has designed ‘FluoriPCR’, a device which will help test for food adulteration and presence of bacteria, viruses and fungi etc in food items, increasing the affordability to conduct such tests.
Source: bit.ly/3YqBBah

5. Medical Device Coordination Group (MDCG) has updated the guidance on the application of MDR requirements to ‘legacy devices’ and ‘old’ devices, taking into account the amendments to Regulation (EU) 2017/745 on medical devices (MDR) has been amended by Regulation (EU) 2023/607
Source: bit.ly/3YGoCm7

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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 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

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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. In a new Amendment to the Food Safety and Standards (Prohibition and Restrictions on Sales) Regulations, 2011, the Food Safety and Standards Authority of India (FSSAI) has clarified that BIS standards mark requirement may no longer be necessarily applicable for manufacture and sale of infant milk food, infant formula and milk cereal based weaning food etc. as well as Condensed milk sweetened, condensed skimmed milk sweetened, milk powder, skimmed milk powder, partly skimmed milk powder and partly skimmed sweetened.
Source: bit.ly/4hkwSPN
Source: bit.ly/3BXUuK4

2. In a recent amendment to the  Food Safety and Standards (Contaminants, toxins and Residues) First Regulations, 2011, which shall come into force from 1st April 2025 the Food Safety and Standards Authority of India (FSSAI)has: (1) Simplified and reduced the number of prohibited use Antimicrobials including chloroform, stilbenes and other steroids, (2) Increased the permissible concentration for Antimicrobials in Honey, (3) reduced the concentration of antimicrobials in cattle.
Source: bit.ly/3AdyXMN

3. The Rajasthan Authority for Advance Rulings held that the vanilla mix being sold by a major manufacturer of consumer food products in the country would not be classified as an “ice-cream” for the purpose of taxation under the Goods and Services Act, 2017 (GST Act) due to sugar being the major ingredient at about 65%. This decision in contrast to the Supreme Court’s decision on similar grounds.
Source: bit.ly/3BW78sY
Source: bit.ly/3BQh9I0

4. The Supreme Court quashed a criminal case which had been filed against a major Indian bank for non-compliance with an order of the authority under the Income Tax Act, holding that an allegation of mens rea cannot be made against a juristic person such as the bank and that the intention of the officers and functionaries cannot be construed to be that of the juristic person itself.
Source: bit.ly/3C5fH4y

5. The Therapeutic Goods Administration (TGA), Australia’s regulator for Medical Devices has clarified some queries concerning its updated Essential Principles, which are necessary compliances for getting approval for devices in Australia. In this new update to the checklist, the TGA has reiterated its existing commitment to recognizing foreign approval standards, and has placed obligation on Sponsors to update the TGA if their Manufacturer Evidence may be expiring in 50 days, among other things.
Source: bit.ly/48jlWxM
Source: bit.ly/4eSYR7P

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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. 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

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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 Drugs Technical Advisory Board (DTAB) has approved a proposal to amend the New Drugs and Clinical Trials (ND&CT) Rules, 2019 to eliminate the two-step certificate issuance process for biomedical and health research ethics committee registration. Now, a system for reviewing and examining all ethics committee documents has been put in place at Department of Health Research (DHR). This process allows for the removal of redundant work and resource use, and only final certificates can be directly issued to ethics committees.
Source: bit.ly/3A8haGQ

2. To improve India’s whole digital healthcare infrastructure, a new certification program for hospital information systems (HIS) and electronic medical records (EMR) has been introduced by the National Accreditation Board for Hospitals and Healthcare Providers (NABH). The program offers Basic and Advanced maturity levels that are valid for two years. The NABH portal will open for registration on December 1, 2024.
Source: bit.ly/3UjzcN7

3. The Drugs Controller General of India (DCGI) plans to amend the Medical Devices Rules, 2017, to include quality control provisions for non-sterile, non-invasive Class A medical devices like thermometers and stethoscopes. Currently exempt from licensing, these devices will now require manufacturers to comply with a quality management system.
Source: bit.ly/3NApDpw

4. The Madras High Court has ruled that Siddha practitioners are permitted to practice modern medicine but are prohibited from storing allopathic drugs without a valid license under the Drugs and Cosmetics Act, 1940.
Source: bit.ly/4hs9VKT

5. The World Health Organization (WHO) has prepared a draft guideline for food packaging to include health impact labels on the front, emphasizing the need for clearer consumer information regarding potential health risks associated with food contact materials. The draft received public comments till October 11, 2024 and will release the final guidelines in 2025.
Source: bit.ly/3BQlKKm

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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

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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. A recent Right to Information filing before the Ministry of Health and Family welfare has brought to  attention that the Central government has not notified or published procedure in light of the  proposed 2022 Amendment to the National Medical Commission Act, 2019 which aimed to allow appeal against decisions of the State and National Medical Commission before the autonomous Ethics and Medical Review Board.
Source: bit.ly/486DMnN
Source: bit.ly/4h3sHaZ

2. The Jammu and Kashmir High Court held in a recent decision that the insurance company does not have the discretion to reduce the eligible claim amount solely on the basis that compensation has already been given to the claimant from the government.
Source: bit.ly/48a2Bz6

3. The Department of Consumer Affairs has issued the Guidelines for Prevention and Regulation of Greenwashing and Misleading Environmental Claims, 2024. These guidelines regulates the nature of technical terms that can be used in these claims, and prescribes requirements for substantiation of the claims.
Source: bit.ly/3A3vIYi

4. The National Accreditation Board for Testing and Calibration Laboratories, has proposed to initiate a program for accreditation of bio-banking facilities modelled after the international standards as prescribed under ISO 20367:2019.
Source: bit.ly/3BJfa8z

5. The United States Drug Administrative Science Board has recommended that the United States Food and Drug Administration (USFDA) set up an office to monitor alternatives to animal testing methods, and bring them within the quality control regime of the USFDA.
Source: bit.ly/3U7gW9N

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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 National Pharmaceutical Pricing Authority (NPPA) in public interest has approved 50% increase of ceiling price of eleven scheduled formulations of eight drugs from the current ceiling prices along with annual price increase as per the Wholesale Price Index (WPI) in April. This comes as a recommendation from the Inter-Ministerial Committee.
Source: bit.ly/3zOtSKV

2. Income Tax Appellate Tribunal (ITAT) of Ahmedabad has upheld the disallowance of amount claimed by a leading pharmaceutical company relating to promotional activities for doctors like accommodation, freebies etc and declared it as inadmissible for tax deductions. The activities were claimed as marketing tools rather than business necessities
Source: bit.ly/4eZ8fH7

3. India’s Central Drug Authority (CDSCO) along with National Regulatory Authority of India (NRA) and affiliated institutions after an evaluation by global experts have satisfied the WHO’s requirements for a functional vaccine regulatory system. Safety, efficacy, and quality are three basic parameters for the assessment of vaccines.
Source: bit.ly/4eJmn6S

4. The National Council for Clinical Establishments (NCCE) has recommended to allow the physiotherapists to own and run the clinics as per the amendment proposed in the Clinical Establishments (CE) Act, 2010. The decision comes as a relief to the physiotherapists and their organizations, which has been fighting legally to attain its right to own and run a clinic, which was not allowed as per the Act notified in 2010.
Source: bit.ly/3BMLs2s

5. The Directorate General of Foreign Trade (DGFT), under the Ministry of Commerce & Industry, has issued a Trade Notice to give clarification on the import and re-import provisions for “Exhibits and Samples” that are exported for display or exhibition purposes. This move is expected to support businesses and industries, including the pharmaceutical industry participating in both domestic and foreign exhibitions to facilitate effortless import or re-import of goods for exhibition or display without imposing further bureaucratic obstacles.
Source: bit.ly/4h7x9FD

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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 Union AYUSH Ministry has prohibited to advertise Ayurveda, Siddha, Unani, and Homeopathy drugs with claims of “miraculous or supernatural effects” in order to prevent misleading advertisements with unverified claims. The ministry instructed that such drugs should contain a caution to be taken under medical supervision on its label. Additionally, the ministry issued a public notice clarifying that it does not certify, grants license or approves any company for making ayurvedic drugs.
Source: bit.ly/4eXXjsL
2. India’s central drug regulator (CDSCO) is actively investigating social media influencers who promote false claims, quick fixes and misleading medical content.
Source: bit.ly/4eGfqDC 

3. The Pune division of the Food and Drug Administration (FDA) has taken action against three drug firms for violating the Drugs and Magic Remedies (Objectionable Advertisements) Act, 1954. The firms were found selling Ayurvedic medicines with misleading claims to cure diabetes, arthritis, and kidney ailments, leading to the seizure of products.
Source: bit.ly/3XUC5Fe

4. The Delhi High Court ruled that a mere fraction of a cause of action occurring in a jurisdiction is insufficient to invoke the court’s territorial jurisdiction. The decision of the court said that in order to raise the territorial jurisdiction of a specific court, there must be a significant link of the matter to the specified territory, reinforcing the standards for filing cases in the court.
Source: bit.ly/3ZXxPr1

5. The Medicines and Healthcare products Regulatory Agency (MHRA) in UK has unveiled its 2024/25 business plan, which prioritizes enhancing access to innovative healthcare technologies while optimizing service delivery. Key initiatives of the plan include the implementation of new IT systems and a commitment to public engagement and diversity in regulatory processes, aimed at reinforcing the UK’s position in life sciences and improving pandemic preparedness.
Source: bit.ly/3BES5Ux

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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 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