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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. Drugs Technical Advisory Board (DTAB) has proposed to mandate the immediate suspension of licenses for drugs classified as Not of Standard Quality (NSQ) in the public interest. Such suspensions would remain in effect unless the concerned manufacturers submit a satisfactory Corrective and Preventive Action (CAPA) plan. The proposal also includes corresponding amendments to the Drugs Rules.
Source: bit.ly/3EFg5Zx

2. Drugs Technical Advisory Board (DTAB) has proposed to classify all antimicrobials as “New Drugs” under the New Drugs and Clinical Trials Rules, 2019. This move aims to facilitate stricter regulatory oversight in light of growing concerns over antimicrobial resistance.
Source: bit.ly/3EFg5Zx

3. Drugs Technical Advisory Board (DTAB) has proposed that manufacturers of medical devices with a valid manufacturing or loan license need not apply for a sterilization loan license. Instead, they can submit documentary evidence in support of proper sterilization when applying for a manufacturing license, provided the sterilization site’s license number is included on the device label.
Source: bit.ly/3EFg5Zx

4. Drugs Technical Advisory Board (DTAB) has proposed amendments to the Medical Devices Rules, 2017, to include clear definitions for “registration certificate” and “registration certificate holder.”  This change aims to provide better regulatory clarity in the medical device industry.
Source: bit.ly/3EFg5Zx

5. The Indian Government is finalizing revised biosimilar guidelines to align with global standards. The updated ‘Guidelines on Similar Biologics’ focus on stricter quality standards, reducing animal testing, and promoting in-vitro studies, while adhering to the 3R principles (Replace, Reduce, Refine). The aim is to streamline approvals and ensure patient safety.
Source: bit.ly/3GFiunq

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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 Food Safety and Standards Authority of India (FSSAI) has proposed halting new registrations and the renewal of existing registrations for the manufacturing of certain high-risk foods, such as dairy products and infant nutrition. They have also proposed permitting only state or central licenses and implementing pre-license inspections for manufacturers in these categories. They have sought public feedback on these proposed changes by 30th May, 2025.
Source: bit.ly/3RRy4Po

2. The Bombay High Court directed the state government to consider a separate registration facility for patients who are not yet on dialysis but will soon need an organ transplant. This came after a CKD Stage-V patient was denied registration. The Court said such denial violates the right to life.
Source: bit.ly/3RM4xqh

3. India’s ministry of commerce and industry has prohibited the use of specified antibiotics, antivirals, and antimicrobial medicinal products in fish, shrimp, hatchery operations or any manufacturing, pre-processing and processing unit to prevent antimicrobial resistance and safeguard export quality.
Source: bit.ly/44ZamIz

4. India’s Central Drugs Standard Control Organization (CDSCO) has released the guidelines for the safe disposal of expired and unused medicines by hospitals and the general public. The initiative is aimed at addressing the growing concerns of antimicrobial resistance and minimizing environmental hazards. 
Source: bit.ly/4iOmj7d
Source: bit.ly/4d3ywnf

5. Under the Stockholm Convention, 40 nations worldwide have agreed to phase out the use of chlorpyrifos, a hazardous pesticide on food crops. However, India secured a five-year exemption for its use on 12 essential crops to manage certain pests and termites, as well as the lack of immediate alternatives.
Source: bit.ly/4iL0q8M

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 Rajasthan High Court has ruled that retesting or resampling of Narcotic and Psychotropic drugs should not be a routine and must be allowed in exceptional circumstances. Applications must be made within 15 days of receiving the test report from Forensic Science Laboratory.
Source: bit.ly/4lDwRZu

2. The Supreme Court of India has ruled that dealing with substances listed in the Schedule of the Narcotic Drugs and Psychotropic Substances (NDPS) Act, 1985, even if not listed in Schedule I of the NDPS Rules, is still an offence.
Source: bit.ly/4jGg0TY

3. A preliminary inquiry reportedly revealed that eight doctors and an associate professor at a Ahmedabad Municipal Corporation (AMC) college conducted unauthorized drug trials on patients with 50+ pharma companies since 2021. Payments were deposited into the doctor’s personal accounts. AMC has suspended the staff involved.
Source: bit.ly/4jGg1Y2

4. The Central Board of Indirect Taxes and Customs has issued instructions to the officers processing GST registration to request only specified documents and avoid raising notices for minor issues. The move is intended to minimize delays and improve ease of doing business.
Source: bit.ly/4jglvJf

5. The Patna High Court has upheld Rule 6 of the Bihar Pharmacist Cadre Rules, 2014, stating that a D. Pharm is mandatory for pharmacist posts in the Bihar Health Department, even for candidates holding higher qualifications like B. Pharm or M. Pharm.
Source: bit.ly/3RteFnB

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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. Indian courts have recognized copyright protection granting a temporary injunction against Indian pharmaceutical companies for unauthorized use of drug dossier. This occurred in a lawsuit where a pharmaceutical company accused a Canadian company of breaching a licensing agreement, misappropriating trade secrets, and sharing drug dossiers with Indian companies.
Source: bit.ly/3XvnzV7

2. The Ministry of Health & Family Welfare has made registration for Clinical Research Organisations (CROs) mandatory, effective April 1, 2025. CROs can now register online through the SUGAM portal by submitting their applications along with the required documents.
Source: bit.ly/3F6DKBX

3. Punjab’s Food and Drugs Administration has implemented stringent reporting obligations on manufacturers, C&FAs, wholesalers, and retailers, requiring them to submit monthly sales and distribution reports on every 7th day of the month to the state’s drug control offices to monitor the movement of seven Schedule H and H1 drugs or formulations prone to misuse for intoxication.
Source: bit.ly/3QKofC5

4. India’s Supreme Court has urged state authorities to frame guidelines to prevent exploitation by private hospitals, ensuring patients are not compelled to purchase overpriced medicines and medical devices. The Court also recognized that private hospitals are essential to addressing healthcare gaps until infrastructure is improved.
Source: bit.ly/3QLU8tY

5. The Delhi government’s social welfare department has urged the health department to fast-track the establishment of dedicated wards for transgenders in all government hospitals and designate a hospital for sex reassignment surgeries, aiming to ensure rights, dignity, and healthcare access.
Source: bit.ly/4i4dkiN

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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 regulator has issued a Notification extending the deadline to 31st December 2024, for submitting quarterly filings for the FY 2023-24 for all entities registered under the Hazardous and Other Wastes (Management and Transboundary Movement) Amendment Rules, 2022.
Source: bit.ly/49ahqlK

2. A District Consumer forum in the State of Maharashtra has held that the refusal of returns by a e-commerce service provider, under a blanket “no-returns” policy constituted a “unfair trade practice” and awarded compensation to consumer whose return of sub-standard product had been rejected.
Source: bit.ly/417xJxQ

3. In a recently published response to a query received by it under the Right to Information Act, 2005, the Delhi Medical Council clarified that, since only medical practitioners registered with the council and having recognized qualifications in Allopathic medicine are permitted to practice medicine in Delhi: Dentists, who are registered with the Dental Council are not licensed to perform aesthetic and cosmetic treatment which is not medically necessary.
Source: bit.ly/3ZbT0Ur

4. After considerable negotiation, India has signed the final act of the Riyadh Design Law Treaty which aims to establish protections for Industrial Design patents, the treaty specifies procedural guardrails which member states can adopt into their own local design patent protection regulations.
Source: bit.ly/3CXRxcH
Source: bit.ly/4f5AYJz

5. The United States Supreme Court has declined to hear petition by manufacturers of tobacco products, challenging the decision of the Federal Government of the United States to include graphic visual warnings on cigarette packets.
Source: bit.ly/415u1EU

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. 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/3zy4PLE

3. 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. 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

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. All medical practitioners (doctors) who practice modern medicine will have to mandatorily register on the new National Medical Register established by the National Medical Commission.
Source: bit.ly/3YYlPoE

2. The Indian Government is reportedly considering to ban 34 multivitamin drugs.
Source: bit.ly/4e0490u

3. The Indian Government is planning to publish a new policy for promoting bio-technology sector called BioE3 (Biotechnology for Economy, Environment and Employment) Policy.
Source: bit.ly/3MiPNfw

4. A leading e-commerce giant has set up rest areas facility for its delivery partners in India. The rest area will have facilities like air conditioning, seating areas, drinking water, and mobile charging stations as a measure to provide them better working conditions.
Source: bit.ly/3MkPYHl

5. Amid rising cases of mpox globally, the World Health Organization (WHO) has reportedly relaxed the rules for its health partners to hold commercial discussions on mpox vaccines. It has also declared that partners like GAVI and UNICEF can begin purchasing mpox vaccines before WHO approves them.
Source:  bit.ly/3Z0RWV0

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TOP 5 HEALTH LAWS AND POLICY UPDATES

1. India’s Central Food Regulator the Food Safety Standards Authority, has introduced registration process for direct sellers to differentiate from Retailers, and make it easier to preserve exemption granted from regulation to direct sellers.

Source: bit.ly/4feuedl

 

2. The Kerala High Court in following with a recent decision of the Punjab High Court has held that the newly enforced Criminal Procedure (The Bharatiya Nagrik Suraksha Sanhita, 2024) will apply to all criminal appeals filed on or after 1st July 2024, the day of enforcement of the  new law. The court held that while the substantial right to appeal is preserved under the repealed statute, the procedural right will transfer over as per Sec. 531 of the new Code.

Source: bit.ly/4bQpMi4

 

3. Exports of Drugs and Pharmaceuticals have reportedly increased by 9.5% in the first quarter of FY 2024-25 year-on-year.

Source: bit.ly/4d3x3Nb

 

4. In response to recent reports that India has the 2nd highest number of unvaccinated children, the Indian government has clarified in a press release that, this statistic is misleading as such children only constitute a minute 0.11% of the nation’s population of children.

Source: bit.ly/3zQzFPw

 

5. The United States Food and Drug Administration has published Guidance for Human radiolabeled mass balanced studies, prescribing the information that sponsors need to submit, most notably now requiring a minimum of 6 participants for such studies as against the accepted variance between 4-6 participants.

Source: bit.ly/3y2UEy8