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TOP 5 HEALTH LAWS AND POLICY UPDATES

The new criminal code, Bharatiya Nyaya Sanhita (BNS) has replaced the Indian Penal Code (IPC) and introduced stricter penalties for medical negligence. Registered Medical Practitioners can now face up to two years in jail and fines for medical negligence. The new law will apply from July 1, 2024.
Source: bit.ly/3RXnx5t

The Central Pollution Control Board (CPCB) has extended the last date of filing of annual returns by the registered producers, importers, brand owners (PIBOs) and plastic waste processors for FY 2022-24 and FY 2023-24 respectively till September 2024. The earlier timeline to file the annual returns were June 30, 2024 and April 30, 2024 respectively.
Source: bit.ly/3XQtxAY

In an effort to decrease reliance on imports and to promote domestic production of medical devices, the Department of Pharmaceuticals (DoP) reportedly intends to launch a new program that will provide shared facilities for medical device parks or clusters that are formed with the exclusive financial assistance of the state governments.
Source: bit.ly/3xU6b2u

The Enforcement Directorate (ED) is investigating an alleged nationwide network of contraband dealers and has placed several pharmaceutical companies under scrutiny who are engaged in the production of drugs and opioids as a measure to prevent the creation of illicit distribution networks through fraudulent sale and supply bills.
Source: bit.ly/3VNzoEw

The United States Food and Drug Administration (USFDA) has published a draft guidance that removes the requirement of undertaking switching studies for applicants undertaking an approval for treating Biosimilars as interchangeable. The USFDA has now made switching studies optional for biosimilar approvals. Hence, persons applying for approval for Biosimilars may now use computer modelling based on the current acceptable analytical technologies to demonstrate the Biosimilars as interchangeable.
Source: bit.ly/4eQUudy

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TOP 5 HEALTH LAWS AND POLICY UPDATES

India’s Central Pollution Control Board has issued final warning to all Producers, Importers, Brand Owners and Plastic Waste Processors, to complete Extended Producer Responsibility (EPR) registration on dedicated EPR portal latest by June 30, 2024, or face punishment.
Source: bit.ly/4cgRsxK

India’s Health Ministry has published Guidelines for Ethical Use of Leftover De-identified/ Anonymous Samples for commercial purposes.
Source: bit.ly/3RIc0XE

The Committee on Energy and Commerce in Congress of the United States of America has sought reply from US Food and Drugs Administration (US FDA) about institutional weaknesses in US FDA’s foreign inspection program over variations in inspection outcomes from India and China.
Source: bit.ly/3RF3xEH

India’s Karnataka High Court has formed a sub-committee to draft rules for establishing Intellectual Property Division (IPD) in Karnataka High Court. IPD benches are established with specialised judges to cater to Intellectual Property Disputes.
Source: bit.ly/4bmOVR8

India’s Kerala High Court, in a recent case, has framed guidelines for prosecuting guardian of a minor, or the owner of a vehicle driven by a minor, for offences involving vehicle driven by the minor.
Source: bit.ly/3RHALDn

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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.

NOC for the manufacture of unapproved drugs meant for export will be issued by the Central Drug Regulator
India’s Central Drug Regulator (CDSCO) will be the competent authority to issue the No Objection Certificate (NOC) required by pharmaceutical companies for the manufacture of unapproved, new, or banned drugs for export purposes, starting from 15th May 2024. The NOC will be issued by the zonal offices of CDSCO. The application for NOC will have to be made online. Prior to CDSCO, it was the State Licensing Authorities that issued NOCs.
Source: bit.ly/4dkZO8u

Producers of Batteries can meet EPR Targets and file Annual Returns by June 30, 2024
The deadline for meeting Extended Producer Responsibility (EPR) targets and submitting annual returns by the producers of all types of batteries has been extended to June 30, 2024.
Source: bit.ly/4a0Uynx

Private hospitals demand payment of interests from the government on delay of reimbursement for treatment under Ayushman Bharat Scheme
India’s Association of Healthcare Providers (AHPI) has raised concerns over inordinate delay in receiving reimbursement for treatment provided to Ayushman Bharat beneficiaries, which impedes cash flow and poses serious operational issues for all hospitals. The Association has urged that the government pay 1 percent interest on payments delayed beyond one month under the Ayushman Bharat scheme, which is the Central Government’s flagship universal health coverage scheme, as well as change of package rate to allow beneficiaries to avail of continued benefits from the Ayushman Bharat Scheme
Source: bit.ly/3wimXHQ

US government likely to ease restrictions on regulation of Marijuana
The U.S. Drug Enforcement Administration (DEA) is likely to reclassify marijuana as a less dangerous drug by moving it from a tightly regulated class to a less tightly regulated class. Although the DEA’s proposal would highlight the medical benefits of cannabis, it would not allow its use for recreational purposes. The White House Office of Management and Budget is reportedly still in the process of reviewing the idea.
Source: bit.ly/4a2osrm

Form 483 notice need not to be responded by manufacturers of medical devices within 15 days: US Medical device experts
According to US Food and Drug Administration (FDA) officials, a medical device manufacturing company is not required to respond to a Form 483 notice (Notice of Inspectional Observations) within 15 days. The 15-day deadline for response applies to warning letters and not to Form 483 notices, though the FDA advises that if the manufacturer wishes to respond to a Form 483 notice, then it should do so within 15 days of the notice.
Source: bit.ly/44FHVxn

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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.

Manufacturers of tobacco products required to register their packing machine(s) with tax authorities
India’s Central Board of Indirect Taxes and Customs (CBIC) has postponed the timeline for manufacturers of tobacco products such as pan-masala, chewing tobacco, smoking mixtures, etc. to report their production capacity. CBIC had in January this year announced that producers must register their filling and packing machines and report these details. The measure was set to be implemented from 1st April 2024. However, the new effective date for implementation of the timeline is now 15th May 2024.
Source: bit.ly/3xz7400

NPPA releases draft ceiling price calculation sheets of seven scheduled formulations
The National Pharmaceutical Pricing Authority (NPPA) has published a preliminary calculation of ceiling prices for seven drug and vaccine formulations, inviting feedback from stakeholders within a ten-day period. These ceiling prices have been adjusted to reflect the minimum and maximum market prices of the products, in accordance with the updated Schedule I of the Drugs (Prices Control) Order, 2013, aligning with the National List of Essential Medicines (NLEM), 2022. The move shall be affecting major pharmaceutical giants in the business of ORS, vaccines and more.
Source: bit.ly/3UhjK4J

High Courts should interfere only when the case in lower court was decided by fraud or collusion: Supreme Court of India
While deciding an appeal against the order of the High Court, the Supreme Court of India observed that the High Court should apply care and caution while entertaining the petitions under Article 226 of the Constitution. The Court further explained that, in case of an already available alternative statutory remedy, the High Court should interfere in the matter only when the case is decided by fraud or collusion, otherwise an order in the same matter by the High Court will mean reopening the issues that have achieved finality.
Source: bit.ly/4cNGwIJ

Goa FDA to get the status of “US FDA observer” amid surge in increase in retail and wholesale licenses
The Goa Food and Drug Administration (FDA) has been extended the invitation to participate as “FDA observer” for inspections conducted by the USFDA India Office. This development came as a result of increase in retail and wholesale licenses issued by Goa FDA and their familiarity with the US FDA’s inspection process.
Source: bit.ly/3UfqIHq

Rejecting apology of the Directors of a Company for misleading advertisements, the Supreme Court sets caution for FMCG companies
Observing caution for fast-moving consumer good (FMCG) companies, the Supreme Court of India has refused to accept an apology from a major Indian Ayurvedic medicine manufacturer for misleading advertisements regarding its products in contravention of an undertaking provided to the Court. The Supreme Court stated that misleading advertisements by FMCG companies result in deceiving innocent consumers and play with public health.
Source: bit.ly/3PYqoKq

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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.

Supreme Court of India pulls up State Licensing Authority for failing to take action against misleading advertisements by leading ayurvedic manufacturer
India’s Central Ayush Ministry recently filed an affidavit in the Supreme Court of India to explain the steps it has taken against a leading manufacturer of Ayurvedic products after receiving several complaints against the manufacturer for making false and derogatory claims against modern medicine. The affidavit states that no action has been taken in the past two years by the State Licensing Authority, despite several orders from the Supreme Court, Right to Information (RTI’s), and directives from the Prime Minister’s Office (PMO). The Supreme Court has now asked the State Licensing Authority to issue its reply.
Source: bit.ly/4aDTxmc

Relaxation of penalties for certain offences involving drugs, medical devices and cosmetics to take effect from December 31, 2024
The Indian Government has decided to relax the penalties for offences relating to drugs, medical devices and cosmetics that are of the nature of violation of conditions of license or failure to label in the prescribed manner. These offences typically invited punishment of imprisonment and fine, but may now be compounded by the payment of a penalty both before or after institution of prosecution. The decision was notified under the Jan Vishwas (Amendment of Provisions) Act, 2023. The Government has now notified the date of coming into effect of the relaxation as December 31, 2024.
Source: bit.ly/3U0yhS4
Source: bit.ly/3THGUjd

Major technology company admits to collecting information from private browsing, agrees to destroy data as part of the settlement
A major technology company, known for operating a popular internet search engine, has agreed to destroy billions of data records to settle a lawsuit. The suit claimed that the search engine company was secretly tracking the internet use of people who thought that they were browsing privately. Under the settlement, the search engine will update disclosures about what it collects in “private” browsing and will also let the users block third party cookies for five years.
Source: bit.ly/3vIwHL9

Industry demands that US FDA should give prior notice before conducting remote regulatory assessments
The US Food and Drug Administration’s (USFDA’s) revised guidance for conducting remote regulatory assessments (RRAs) has received comments from the industry. A clear demand from the industry is that the US FDA should provide advance notice for mandatory assessments and discuss observations before taking any regulatory action.
Source: bit.ly/3xieXXJ

Written patient consent required for sensitive examinations on anesthetized patients in US
The United States Department of Health and Human Services has recently released a new guidance as per which hospitals have to mandatorily obtain written informed consent from anesthetized patients for breast, pelvic, prostate, and rectal exams performed on them for educational and training purposes. If hospitals do not obtain the explicit consent and violate the patient privacy rights, they may become ineligible for participation in the Medicare and Medicaid programs, as well as become liable for fines and investigations.
Source: bit.ly/3U1M8aX

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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.

Star-rating for energy efficiency on white goods to be under stricter government regulation

Indian Government may reportedly introduce rules for non-branded products to validate star rating for energy efficiency on white goods. White goods refer to household appliances of daily use such as air conditioners, refrigerators, television sets, etc. The National Test House (NTH), along with Bureau of Energy Efficiency (BEE), will conduct testing to help improve the quality of products and put a check on substandard products with a view to save energy.
Source: bit.ly/3TAWopa  

US FDA to train Indian drug regulators on cGMP inspection

The US FDA has invited drug regulators of the State of Gujarat, Telangana, Goa, and Karnataka to act as observers during checks and inspections of drug facilities in India, so that they develop a greater understanding of the US FDA inspection protocol.
Source: bit.ly/43FfvD9

GST officials should refrain from doing fishing inquiries: Government

The Directorate General of GST Intelligence (DGGI) has reportedly issued a new guideline for GST officials stating that they should refrain from “fishing inquiries” to check evasion of goods and service tax (GST). The Guidelines state that tax officers should clearly state the nature of the investigation in formal letters to designated company officials and avoid using ambiguous language in letters and summons. Terms like “GST enquiry,” “evasion of GST,” or “GST evasion,” among others, should not be used in a letter sent to an ordinary taxpayer.
Source: bit.ly/3IZO9Og  

Indian Courts will be slow to intervene in enforcement of foreign arbitral awards on grounds of bias: Supreme Court 

India’s Supreme Court has held that intervention in enforcement of a foreign arbitral award on the grounds of bias should be discouraged. Indian courts will be permitted to entertain a claim for arbitral bias in an enforcement proceeding only after the ground has been raised before the arbitral tribunal. In order to assess arbitral bias, the Courts will have to prioritize international standards above domestic ones, even while it permits the execution of a foreign arbitral award. 
Source: bit.ly/3J48bqR  

Chemicals used to decaffeinate coffee beans may be banned in US 

Consumer Health Groups have petitioned US Food and Drug Administration to ban methylene chloride, a chemical which is used as additive to decaffeinate coffee beans, because it has been proven to cause cancer in rodents.
Source: bit.ly/3vx2n6a

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.

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