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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 Foreign Trade regulator, the Directorate General of Foreign Trade (DGFT) has recently issued a Trade Notice, cautioning exporters to no longer accept physical copy Certificate of Origin, and to only accept electronically issued Certificates of Origin since the deadline for using physical copies has passed on 31st December 2024.
Source: bit.ly/439cxs0
Source: bit.ly/439ayEk

2. In light of a recent international report regarding the misuse of drug combinations in various countries in the African continent, India’s Ministry of Health and Family Welfare has rescinded the export license and No Objection Certificate (NoC) of a manufacturer of the said combinations.
Source: bit.ly/4353Mzp

3. India’s Supreme Court, in its recent order has expressed that the medical educational institution admission guidelines, which requires that “both hands [should be] intact” for a person suffering from a disability to gain admission to a medical educational institution, is violative of disability rights and has no basis under law.
Source: bit.ly/3QyRKH0

4. In a recent order, the High Court of Kerala has instructed the State Government to issue a circular to all Doctors in the state, requiring the preservation of foetus in case of a Medical Termination of Pregnancy of a minor, and require permission from the State Government for the destruction of said foetus.
Source: bit.ly/4bblB1L

5. The recent decision of the United State Government to terminate employment of several employees of the United States Food and Drug Administration (FDA) has the possibility to cause delay in obtaining approvals and licenses from the FDA by members of the Medical Device industry.
Source: bit.ly/4hRolDN

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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 level drug regulator the Central Drugs Standards Control Organization (CDSCO) has issued a correction to the list of Fixed Drug Combinations for which manufacturing licenses can be obtained directly from the state regulators. The updated list is available on the website of the CDSCO at the given link.
Source: bit.ly/4hnPvSI

2. India’s Nursing professional regulator, the Nursing Council of India has issued Regulations prescribing the institutional and educational standards required to conduct the Nurse Practitioner in Pediatric Nursing Program.
Source: bit.ly/40IkEsV

3. A district level Consumer Disputes Redressal Commission has recently held that insurance providers cannot deny claims of policy-holders, on grounds of a medical issue arising out of “pre-existing conditions” if the “pre-existing conditions” is not the sole cause of the medical condition for which claim as made.
Source: bit.ly/3Q7gbLs

4. India’s Ministry of Health and Family Welfare has recently notified the updated grievance redressal system, and new physical verification procedure for empanelled hospitals aimed at improving service offering under the government’s public healthcare scheme.
Source: bit.ly/3WMQbc7

5. Industry groups make a representation to the European Policymakers to withdraw its recent AI Public Liability Directive protocol which sought to introduce non-contractual civil liability rules to artificial intelligence used by service providers, claiming that the non-contractual nature of the civil liability will disrupt existing supply-chains based on contractual understanding between service providers and receivers.
Source: bit.ly/4hK9sTp
Source: bit.ly/4hKflzQ

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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 Parliamentary Standing Committee on Ministry of Chemicals and Fertilizers has made a recommendation to the country’s drug price regulation authority (the National Pharmaceutical Pricing Authority), to install and implement the Price Monitoring and Resource Units in all of States and Union Territories where they have not yet been set-up.
Source: bit.ly/4hBFqB8

2. The State Consumer Redressal Commission of the state of Delhi recently held that the obligation of a treating doctor to attend to a patient during an emergency situation, should supersede and mitigate his liability against any claim of negligence that may be levelled against him for his failure to refer the patient to a concerned specialist where such specialized treatment may be deemed necessary but for the emergency situation.
Source: bit.ly/4jAMHTG

3. India’s foreign trade regulator, the Directorate General of Foreign Trade has issued a Notification instructing Regional Authorities (Ras) to reduce the Export Obligations of exporters in sectors that have experienced a decline of more than 5% in volume. This now includes, among other product categories the export of Radioactive Isotopes from India.
Source: bit.ly/42zKAcB

4. India’s foreign trade regulator, the Directorate General of Foreign Trade has altered the procedure for obtaining a Certificate of Origin (CoO) by exporters. Notably, the Export Inspection Council (EIC) has been stripped of its previous authority to provide and print blank CoOs, and applicants will also now be required to make their applications on the online platform.
Source: bit.ly/4hALDxj
Source: bit.ly/3EpEjGm

5. The Parliamentary Standing Committee on Ministry of Chemicals and Fertilisers has recommended in its recent report, that various State Licensing Authorities should be sensitized on the best practices and procedures for the issue of license for Class A & B Medical Devices.
Source: bit.ly/4az0Lch

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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 AYUSH has notified an amendment to the Drugs Rules, 1945, inserting Schedule TB, which specifies the standards for the delivery mechanism, preservatives, and excipients that must be complied with in order to obtain a license for the manufacture of Ayurveda, Siddha, Unani, or other traditional medicines that use a nasal spray as a delivery mechanism.
Source: bit.ly/4j9pCHs

2. India’s Directorate General of Foreign Trade (DGFT) has notified the revised Schedule II (Export Policy) whereby, the terms of export have been updated in conformity with the Finance Act, 2024.
Source: bit.ly/4jss5x0

3. India’s indirect tax regulator has issued a circular clarifying the conditions for eligibility for the interest waiver scheme introduced by the GST Council late last year. In addition to submitting applications and filing Forms GST SPL-01 and GST SPL-02, applicants are also required to withdraw any appeal application filed against demand orders, notices, or statements for which the interest waiver is being sought.
Source: bit.ly/40ohfzs

4. India’s Parliamentary Standing Committee on Chemicals and Fertilizers, in its most recent report, has expressed concern that the low number of IVD manufacturers selected under the PLI incentive scheme may not be sufficient to meet the country’s domestic requirements
Source: bit.ly/42a7zuM

5. The United States Federal Trade Commission (US FTC) has alleged that several of the country’s largest insurance companies entered into vertical arrangements with benefit managers to mark up the prices of common and essential prescription medicines, totalling USD 7.3 billion between 2017 and 2022.
Source: bit.ly/4fXStMi

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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 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

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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 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

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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. To combat antimicrobial-resistance the Drugs Consultative Committee, which advises the Central and State Governments on conduct of Drug regulation in the country, has, in its 64th meeting recommended amendment to the Drug Rules to regulate sale of antibiotic Drugs to manufacturers who may not have a license under the Drug regulations.
Source: bit.ly/4evHfhA

2. The Punjab and Haryana High Court upheld the position that under the Narcotic Drugs and Psychotropic Substances Act, 1985, upon seizure, the entirety of the bulk of the seized substance need not be sent to the Forensic Laboratory, rather merely a select homogenized sample thereof would be sufficient.
Source: bit.ly/4gx15uL

3. The Supreme Court has ordered the Central Government Ministry of Health and Family welfare, and the Government of Kerala to file counter-affidavits explaining the delayed action in setting up a special committee to study the effectiveness of the Rabies vaccine.
Source: bit.ly/3MXwwAE

4. The High Court of Bombay has struck down the insertion of Rule 3 of Information Technology (Intermediary Guidelines and Digital Media Ethics Code) Amendment Rules, 2023, which empowered the government to set up fact-check units on the ground that this violated the fundamental right to equality and to carry on trade and business.
Source: bit.ly/4diYthg

5. The United States Federal Trade Commission has formally initiated litigation against Pharmacy Benefit Managers which act as middlemen between Drug Companies and Insurers, for deliberately driving the price of insulin higher for consumers and receiving rebates from manufacturers in the process.
Source: bit.ly/3zrNfcq

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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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India’s Food Regulator FSSAI Introduces Instant License and Registration for Food Businesses with Some Exceptions

India’s Food Regulator Introduces Instant License and Registration for Food Businesses with Some Exceptions_1

India’s central food regulator, the Food Safety and Standards Authority of India (FSSAI), has made a policy decision to issue instant registrations and licenses to food businesses in India. The instant registration or license will be valid for one year and may be renewed in a regular course.

Background

All food businesses in India require either a registration or license to operate. Whether a food business will require a registration or license depends on (a) the scale of the business (b) the nature of the business and (c) the number of States in India in which the business will operate. A registration will be typically granted by the State-level Food Regulators, and license may be granted either by State-level or Central Food Regulator (FSSAI).

As per current timelines prescribed in the Food Safety and Standards (Licensing and Registration of Food Businesses) Regulations, 2011, the food regulators may take anywhere between seven days and a month to grant a registration, and up to two months to grant a license. These timelines are sometimes compounded if, during the pre-registration / pre-license inspection, the inspector directs the applicant to make improvements before the registration/license may be granted.

Tatkal (Instant) System of Food License

To improve the ease of doing business for businesses, the FSSAI has streamlined the process for granting license such that the registration/license for food businesses could be made available instantly without inspection. Of course, the registered/licensed food business will be subject to future inspection and requirements to comply with inspection related improvements.

The said ‘Tatkal’ (instant) license facility will be made available to the following categories of food businesses: importers, wholesalers, distributors, retailers, transporters, non-atmospheric-controlled storage providers, food vending agencies, direct sellers, merchant exporters, petty retailers such as snack and tea shops, and mobile food vendors (hawkers).

However, this Tatkal registration or license will not be issued to food business operators dealing in milk, meat, and fish. Also, the applicant should not have had their registration or license suspended or cancelled in the prior three months before the date of application.

Before applying, every food business should thoroughly evaluate their application. Providing incorrect information regarding the Kind of Business or failing to meet eligibility requirements can result in fines of up to Rs. 10 lakhs.

Conclusion

The decision to issue tatkal (instant) registrations and licenses is a very pragmatic step taken by the Indian Government to improve the ease of doing business for food business operators. The facility will be initially available only for individuals who own food businesses (proprietors) and be rolled out in Assam, Delhi, Gujarat, Jammu & Kashmir, and Kerala. It is expected to be eventually extended to partnerships/registered firms and be available to businesses in other States and Union Territories as well.

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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.

All manufacturers, importers and brand owners of products using plastic packaging must register by 31st March 2024 with Pollution Control Board

India’s Pollution Control Board has given a final opportunity to manufacturers, importers and brand owners of products which use plastic packaging, to register with appropriate Pollution Control Board under provisions of Plastic Waste Management Rules, 2016. Such entities are required to register and discharge Extended Producer Responsibility (EPR) by buying EPR Credits from registered recyclers of plastic packaging waste.

Source: bit.ly/3PGd79b

 Central Consumer watchdog and Industry Regulators of Advertisements enter into collaboration to curb misleading advertisements

India’s Central Consumer Protection Authority (CCPA) has announced a collaboration with the industry’s self-regulatory advertisement body called Advertisements Standards Council of India (ASCI). Under the collaboration, ASCI will forward details of advertisement found to be in breach of its own misleading advertisement guidelines to the CCPA since such advertisements may also be violative of the law on misleading advertisement in India.

Source: bit.ly/3Q1U3CL

Imported devices containing foreign embedded SIM for use in M2M communication have to mandatorily shift to services provided by Indian telecom providers within six months

India’s telecommunication regulator, Telecom Regulatory Authority of India (TRAI), has issued specifications and licensure requirements for the implementation of use of embedded Sim technology in Machine-to-Machine (M2M) communication, which is seeing more and more use for remote diagnosis and monitoring in healthcare sector, since launch of 5g sim technology in the country. All communication profiles on any M2M eSIM fitted in an imported device on international roaming in India should be mandatorily converted/reconfigured into communication profiles of Indian telecom service providers (TSPs) within a period of six months from the date of activation of international roaming on such M2M e-SIM or on change of ownership of the device, whichever is earlier.

Source: bit.ly/4cyHEPZ

US FDA’s scientific authority to regulate drugs under challenge

A suit before the United States Supreme Court is challenging the decision of the United States Food and Drug Administration (FDA) in 2016 to expand scope of prescription of Mifepristone 2000, a drug that is commonly used to carry out medicated abortion procedures, and permit its prescription via telemedicine. Ex-Commissioners of US FDA have expressed concern that a decision in favour of the petitioners may lead to an environment of uncertainty where any US FDA approval granted to a drug could be challenged in future on scientific grounds even if it was approved by the US FDA.

Source: bit.ly/49dk4p2 

New reserve sample retention quantity requirements for BA and BE studies in US

The United States Federal Food and Drug Administration (US FDA) has published the final version of a guidance document that prescribes new reserve sample retention requirements for Bioavailability (BA) and Bioequivalence (BE) Studies. In the Guidance Document, US FDA has prescribed retention of 30 Single Dose, and 3 Multi Dose samples (with at least 1 unit in original container) across all sites carrying out In-Vivo studies, and 30 Single Dose, and 3 Multi Dose samples in original container for In-Vitro studies.

Source: bit.ly/3xeLrC7