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 Food regulator, the Food Safety Standards Authority of India, now requires linking of new licenses with the Permanent Account Number (PAN) of the applicants, additionally existing Food Business Operators have been requested to keep their PAN data up-to-date.
Source: bit.ly/48QImab

2. The Telangana Drugs Control Authority has issued notices to private hospitals in Hyderabad and Telangana, requiring stricter compliance with purchasing requirements for Narcotics Drugs, under the Narcotic Drugs and Psychotropic Substances Act, 1985 (NDPS).
Source: bit.ly/4hJQoWf

3.  The Ministry of Environment, Forest and Climate Change has relaxed penalties under the E-Waste Rules, 2022 and the Hazardous and Other Wastes (Management and Transboundary Movement) Rules, 2016. From hereon, the contravention of any provision of these Rules shall not give rise to environmental compensation.
Source: bit.ly/4fqrp8W

4. In pursuance of an ongoing process for recovery of sums on account of a judgment of the Court for misleading conduct by the Respondent, the Supreme Court has issued an Order to auction the Trade Mark of a prominent Indian Hospital chain, while at the same time refusing to make provision for valuating the same.
Source: bit.ly/3Z1rcDf

5. European Union Drug Regulator considering proposal to reduce the duration of regulatory data protection available to companies.
Source: bit.ly/4hGEvQZ

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. 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

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 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

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 Drugs Technical Advisory Body, in its 91st meeting, has recommended the exemption of several chemical contraceptives at specific dosage values, from the labelling requirements under Schedule H which would have limited sale by prescription only.
Source: bit.ly/3ZWiqqU

2. The Directorate General of Foreign Trade has amended the export policy for cough Syrup, amending an earlier notification, exempting the requirement for pre-export testing for jurisdictions including the USA, EU, and South Korea which may already have granted approval.
Source: bit.ly/3YfvOVP
Source: bit.ly/3YeH6tI

3. The Ministry of Environment Forest and Climate change has notified the Liquid Waste Management Rules, 2024 set to come into force from 1st October; which govern the treatment and management of liquid effluents arising from domestic and industrial activities including treatment of wastewater, sludge generated during treatment of wastewater and reuse/reutilization of any wastewater or sludge generated.
Source: bit.ly/3YhCpzl

4. In a recent public notice, the Central Government Ministry of Ayurveda, Yoga and Naturopathy, Unani, Siddha and Homeopathy (AYUSH) has clarified that it does not license or ratify any AYUSH products or medicines, and warned against the advertising of AYUSH products as “Miracle Cures”. This comes in the light of the Ministry of AYUSH having repealed Rule 170 of the Drugs Rules, 1945, which regulated AYSUH advertising.
Source: bit.ly/4dzToBi
Source: bit.ly/3XXf9Fi

5. The European Commission’s Medical Device Coordination Group (MDCG) has issued a voluntary document to supplement its earlier Designation, re-assessment and notification of conformity assessment bodies and notified bodies, which is intended to guide notified bodies to impose corrective and preventative action.
Source: bit.ly/4eYr4JJ

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. In the most recent 91st Meeting of the Drugs Technical Advisory Board (DTAB) which advises the central government on drug regulatory policy matters, the DTAB has recommended the use of QR code to identify genuine anti-cancer medication, in recognition of recent cases of spurious drugs sale coming to light.
Source: bit.ly/3zP609I

2. The DTAB, has provided rationale for its decision to reject waiver of Clinical Performance Evaluation for IN-Vitro Devices (IVDs) which are already approved internationally. The DTAB expressed its opinion that the performance of IVDs are variable based on the population, and their performance and effectiveness cannot be taken for granted across demographic lines.
Source: bit.ly/3ZV6hT7

3. The Indian Ministry of Environment Forest and Climate Change has notified the new Ecomark Rules, aimed at replacing the erstwhile Ecomark Scheme, 1991. These rules specify criteria for approving ecomark for a product including: recyclability, reduction in pollution and use of non-recyclable resources, and sustainability of production process.
Source: bit.ly/3TXRP9a

4. The Bombay High Court clarified that any seized sample would have to be separated and the individual components of the Cannabis plant identified, because Ganja is defined under the Narcotic Drugs and Psychotropic Substances, Act 1985 only as the “flowering tops” of the Cannabis plant, and for that reason the seeds and leaves cannot be counted towards identifying whether an accused was carrying “commercial quantity” of Ganja.
Source: bit.ly/3NgyD2P

5. In a departure from government policy, the Drugs Consultative Commission (DCC) decided that including the International Nomenclature of Cosmetics Ingredients would be difficult to accommodate, and for that reason all cosmetics manufacturers should continue to adhere to the applicable standards set by the Bureau of Indian Standards (BIS) for their ingredients.
Source: bit.ly/3NduBbB

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 the Central Drugs Standards Control Organization (CDSCO) has been made an affiliate member of the International Medical Device Regulators Forum (IMDRF). The application submitted by the Indian Government has been accepted contingent on the adoption of comprehensive regulation of Medical Devices in alignment with the existing international standards.
Source: bit.ly/3TQ1GOb

2. India’s Ministry of Health and Family Welfare has introduced Guidelines for Withdrawal of Life Support in Terminally Ill Patients, which sets out the institutional oversight requirements to facilitate ethical and informed decision-making in this regard.
Source: bit.ly/4eReyf6

3. The Supreme Court has held that in case of criminal suits which have an overwhelming civil quality, i.e. are based on private wrongs, where the parties to such criminal suits have already settled with each other, High Courts should exercise their powers under Sec. 482 of the CrPC and quash the underlying criminal proceedings.
Source: bit.ly/4dyF1wQ

4. India’s Central Drugs regulatory authority the Central Drugs Standards Control Organization (CDSCO) has decided that it will initiate action against a manufacturer of eye-drops, which had recently made social-media posts and conducted conferences regarding its new product, which had come under scrutiny for the claim that it would manage near-sightedness, and in pursuance of that, forwarded the matter to the State Drug Regulator of the state of Gujarat where the company is based.
Source: bit.ly/4dtuYJL

5. A prominent US based medical systems and medical devices manufacturer which has suffered a data-breach of its systems leading to the leak of sensitive personal and medical information of its patients, is currently facing a class-action lawsuit on grounds that the breach was caused due to non-adherence to industry standard practices in data storage and security.
Source: bit.ly/3BHdjRl

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

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. Application process for (1) Manufacture/ import a New Drug/ formulation, or conduct clinical trial, (2) Manufacture/ import of new bulk drug substance, and (3) Import of finished formulation of a new drug will henceforth exclusively take place online on the SUGAM portal, and processing of offline application has been retroactively paused from 16th August 2024.
Source: bit.ly/3z9EX92 

2. All registered Doctors are required to re-register their MBBS qualifications on the newly operationalized National Medical Register Portal and shall be provided a Unique Identification Number.
Source: bit.ly/3TyGpsl
Source: bit.ly/3zy4PLE3. The central drugs regulator of India, the Drugs Controller General of India has issued a revised Guidelines and checklists for Zonal, Sub-Zonal and Port-officers of the State Drug Authorities providing updated policy on how to conduct their duties.
Source: bit.ly/3TuM2b3

4. The Indian Pharmacopoeia Commission has clarified that in the event of a conflict of interpretation between the newly released digital version of the Indian Pharmacopoeia 2022, and the print version the print version shall win out.
Source: bit.ly/4gqZ2IA

5. In addition to requiring audio-visual warnings during presentation of films, the Central government will require all online curated content publishers to display a non-skippable anti-tobacco audio-visual advertisement, as well as place a static message for the duration of display of use of tobacco and tobacco products in the curated content. This requirement shall be effective form March 2025.
Source: bit.ly/3XMqTvq

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 Supreme Court has stayed the repeal of Sec. 170 of the Drugs, Rules 1945 which regulated Advertisement of AYUSH products by the AYUSH Ministry, to address the ultra-vires nature its policy regarding AYUSH advertisement.
Source: bit.ly/4e4qOZz
Source: bit.ly/4dDnIvK

2. The National Commission for the Indian System of Medicine has restated its position, as it has taken in an advisory issued earlier on 16th July, that practitioners of AYUSH medicine should not represent themselves as “Cannabis experts” as it may constitute a “Misrepresentation of qualification” under Regulation 27 of the National Commission for Indian System of Medicine (Ethics and Registration) Regulation, 2023.
Source: bit.ly/3APXRls
Source: bit.ly/4cLHaFl

3. The Supreme Court has issued a Notice to the Central and State Governments and their departments, seeking a response on policy position regarding braille accessibility and integration into (1) Medical packaging, (2) Consumer Goods packaging, and (3) Implementation of braille in all aspects of public and private sectors.
Source: bit.ly/3AHLUOP

4. The office of Director General of Foreign Trade has issued draft modalities for setting up E-commerce Export Hubs which will support infrastructure for cross-border e-commerce trade, and has requested for submission of detailed proposals for set-up of E-commerce Export Hubs.
Source: bit.ly/3ASWEd6

5. The Drug Enforcement Administration, part of the United States Department of Justice has issued a notice that it will be holding hearings regarding the subject-matter of a Federal level reclassification of Cannabis from a Schedule I to Schedule III substance.
Source: bit.ly/4dCiQXN