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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 has directed all manufacturers of high-risk pharma-grade solvents to obtain or register their licences on the ONDLS portal and upload batch-wise details, including quantity, CoA, and vendor information. A list of high-risk solvents has been issued, and State Drug Regulators have been directed to ensure that no batch is sold without compliance to these directions.
Source: urli.info/1iJjN

2. Central Drugs Standard Control Organization (CDSCO) has clarified that manufacturers of risk Class A and B medical devices not listed in its risk classification list must obtain proper risk classification from CDSCO before applying for a manufacturing licence. Investigational medical device manufacturers must also secure prior CDSCO permission before the grant of manufacturing licence.
Source: urli.info/1dXH7

3. India’s Central Drugs Standard Control Organization (CDSCO) has issued a list of Class A non-sterile and non-measuring (NSNM) medical devices which are exempted from licensing requirements. Manufacturers and importers of the listed devices must obtain CDSCO registration as Class A NSNM medical devices under the Medical Devices Rules, 2017.
Source: urli.info/1dXHz

4. The National Company Law Appellate Tribunal has ruled that the Competition Commission of India lacks jurisdiction to investigate alleged anti-competitive conduct involving patented pharmaceutical products, emphasising that the Patents Act, 1970 prevails over the Competition Act, 2002 when the conduct in question arises from the exercise of patent rights.
Source: urli.info/1dXHI

5. The Delhi High Court has upheld the FSSAI’s directive prohibiting companies from using the term “ORS” (Oral Rehydration Solution) on product labels unless the formulation meets prescribed standards. The Court held that public health considerations override commercial claims and that products misleadingly labelled as “ORS” could endanger consumers. While the company may request FSSAI permission to re-label existing stock, the ban itself remains in force.
Source: urli.info/1iJkL

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 Central Drugs Standard Control Organization (CDSCO) has released a draft guidance document outlining regulatory pathways, quality standards, and risk management requirements for Software as a Medical Device (SaMD) and Software in a Medical Device (SiMD). Stakeholders are requested to submit feedback within 30 days.
Source: h7.cl/1iyvi

2. India’s Ministry of Consumer Affairs has amended the Legal Metrology (Packaged Commodities) Rules, 2011, to exempt medical devices from the standard packaging declaration requirements. Packages containing medical devices will adhere to the Medical Devices Rules for height and width of numerals and letters used in declarations. This amendment will ensure regulatory consistency and eliminate duplication of compliance requirements.
Source: h7.cl/1iyuq

3. The Health Ministry has issued draft amendments to the Drugs Rules, 1945, proposing that oral formulations with over 12% v/v ethyl alcohol and packed in bottles over 30 ml will be excluded from Schedule K and included in Schedule H1 for prescription-only sale. Stakeholders are requested to submit comments within 30 days.
Source: h7.cl/1dNdh

4. The Ministry of Environment, Forest & Climate Change (MoEF&CC) has amended the list of “White Category” of industries, which are exempted from air pollution consent requirements. Now the list includes 86 non-polluting sectors, such as food packaging, small bakeries, etc. to simplify compliance, especially for MSMEs.
Source: h7.cl/1dNcN

5. The Food Safety and Standards Authority of India (FSSAI) has recently issued an order introducing a dedicated “seasonal food business” registration category in the FoSCoS portal. Effective from August 01, 2025, the provision allows retailers and food vending agencies at fairs and festivals to register for up to three months by paying a ₹100 fee.
Source: h7.cl/1dNdx

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 Trade and Economic Partnership Agreement (TEPA) with the European Free Trade Association (EFTA), effective October 1, 2025, reportedly excludes medical devices and pharmaceuticals from duty concessions, keeping them protected to safeguard domestic industries. While 92.2% of EFTA and 82.7% of India’s tariff lines are liberalised, sensitive healthcare products will face phased tariff reductions over 5–10 years.
Source: https://short-url.org/1hoSo

2. Central drug regulator (CDSCO) is reportedly set to conduct nationwide inspections and audits of cough syrup manufacturing units after child deaths in Madhya Pradesh were linked to toxic syrups. States and union territories have been directed to submit lists of manufacturers for surveillance, aiming to strengthen quality control and prevent contamination-related tragedies.
Source: https://short-url.org/1cGQR

3. Department of Pharmaceuticals has launched sensitisation programmes to guide pharmaceutical and medical technology companies on the amended Promotion of Research and Innovation in Pharma-MedTech Sector scheme. The sessions will help companies to understand the revised guidelines, and digital application process to ensure smooth participation.
Source: https://short-url.org/1cGR3

4. India’s Central food authority has issued a draft amendment to Packaging regulations 2018 to restrict the use of Poly- and perfluoroalkyl substances (PFAs) in food contact materials. It also states that food materials made with polycarbonate and epoxy resins must be free from Bisphenol A (BPA) and its derivatives. Objections / suggestions are awaited from the industry stakeholders for a period of 60 days from the date of publication.
Source: https://short-url.org/1hoTb

5. State drug inspectors are reportedly seeking enforceable powers to arrest and detain offenders, aiming to curb the growing menace of spurious drugs. The demand follows the recent incident involving contaminated cough syrup sold to paediatric patients, which resulted in multiple child deaths.
Source: https://short-url.org/1hoTt

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 authority has mandated manufacturers of pharmaceuticals to comply with strict testing of raw materials and excipients of every batch and each batch of final product and maintaining records. During inspections, State and UT Drug Controllers will inspect the licensee’s batch release records, ensure there is a robust vendor qualification system, and confirm that raw materials are sourced only from approved vendors.
Source: https://short-url.org/1csET

2. Central Drugs Standard Control Organization (CDSCO) has launched a 100-day awareness campaign on the Goods and Services Tax reduction on medicines and medical devices. Chemists and druggists associations are directed to encourage their members to display awareness posters at pharmacies. Compilation of photographs of the activities undertaken are to be submitted to CDSCO’s headquarter.
Source: https://short-url.org/1csHq

3. The Department of Consumer Affairs has granted three-month permit to leading FMCG, personal care, and medical device firms to use preprinted packaging despite labelling errors. Corrections such as unit sale price, company name, or customer care information must be declared using stamping, stickers, or online printing.
Source: https://short-url.org/1csCZ

4. India has notified its first binding Green House Gas (GHG) emission intensity targets for aluminium, cement, chlor-alkali, and pulp & paper sectors under the GHG Emission Intensity Target Rules, 2025. Industries must reduce emissions per output unit, trade carbon credits, and face penalties for non-compliance, boosting market-driven decarbonization.
Source: https://short-url.org/1habB

5. India’s Central Drug Regulator, CDSCO, has issued a notice inviting stakeholder comments to address disparities in new drug approvals. While the first applicant must conduct full local clinical trials and bioequivalence studies, subsequent applicants gain approval based solely on chemical, pharmaceutical, and bioequivalence data. This creates inequality in regulatory burden and costs. CDSCO seeks feedback by November 7, 2025, to develop fairer drug approval policies.
Source: https://short-url.org/1csDm

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 authority has released guidance to identify spurious drugs under the Drugs Rules, 1945. Earlier, the rules mandated QR codes on all APIs from January 2023 and barcodes or QR codes on the top 300 drug brands from August 2023. The authority has now issued a process flow to verify drug authenticity.
Source : https://short-url.org/1gVQq

2. India’s Central Drug Regulator has allowed manufacturers to apply for Certificate of Pharmaceutical Product/World Health Organization – Good Manufacturing Practices (COPP/WHO-GMP) certificates while product license applications are under review by the State Licensing Authority. Final COPP/WHO-GMP certificate will be issued after product approval.
Source: https://short-url.org/1gVUB

3. India’s central government has proposed the Assistive Technology (Standards and Accessibility) Rules, 2025, requiring all assistive devices to meet Bureau of Indian Standards quality standards. The draft ensures transparent procurement, financial aid, repair support, and a toll-free helpline, with an online Assistive Technology Portal for device certification, supply tracking, and grievance redressal.
Source: https://short-url.org/1ceKb

4. The Food Safety and Standards Authority of India has kept the spice enforcement drive (whole & powder) in abeyance until further orders. All state food safety commissioners and regional directors have been instructed not to initiate any action under the earlier directive until further instructions.
Source:
https://short-url.org/1ceKS
https://short-url.org/1gVSp

5. The US Food and Drug Administration (FDA) is seeking public input on evaluating AI-enabled medical devices, including generative AI tools. The aim is to enhance patient outcomes, public health, and accelerate medical innovation, while regulating these advanced technologies
Source: https://short-url.org/1ceLs

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 Indian Pharmacopoeia Commission (IPC), traditionally responsible for preparing standards for medicines, is now reportedly expanding its role to prepare standards for medical devices in collaboration with the Bureau of Indian Standards (BIS). It has also begun auditing medical device companies and is developing monographs which will outline standards and specifications for medical equipment. This initiative aims to enhance India’s credibility in medical device manufacturing and support export growth.
Source: short-url.org/1c9pE

2. The Telangana High Court set aside a blanket injunction order in a trade secret dispute, holding that confidential information and trade secrets must be clearly identified and proven. It ruled that the trial court erred by granting a blanket restraint and directed a fresh hearing in accordance with law.
Source: short-url.org/1gQnE

3. The Indian government has amended the export policy for rice (both Basmati and non-Basmati) to non-EU European countries, removing the requirement for Export Inspection Council (EIC) certification until April 2, 2026. The EIC certification will, however, remain mandatory for exports to the EU, the UK, Iceland, Liechtenstein, Norway, and Switzerland.
Source: short-url.org/1gQlT

4. The Pharmaceuticals Export Promotion Council (Pharmexcil) has asked pharma exporters to submit cases of delayed or non-payment by overseas buyers to help frame a Standard Operating Procedure (SOP). This SOP aims to streamline the process of addressing payment-related grievances and Pharmexcil’s timely intervention.
Source: short-url.org/1c9p-

5. Tamil Nadu Food and Drugs Administration (FDA) is investigating the license of a local cough syrup manufacturer following child deaths in Madhya Pradesh linked to contaminated cough syrup produced by the company. The scrutiny in Tamil Nadu began after a formal request from the Madhya Pradesh Drugs Control Authority and the state drug regulator. In response to these incidents, India’s Union Health Ministry has issued an advisory urging the rational use of pediatric cough syrups banning them for children under two years, advising caution for older children, and promoting rest and hydration as preferred treatments.
Source: short-url.org/1gQng
Source: short-url.org/1c9qC

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 Indian Central Government has eased GST rate revision compliance for manufacturers and importers allowing them to voluntarily affix revised price stickers on unsold stock manufactured before September 22, 2025, without obscuring the original price. Mandatory newspaper advertisements have been waived and only circulars to dealers and retailers are needed. Old packaging can be used until March 31, 2026, with price corrections allowed.
Source: short-url.org/1fjNU

2. Food Safety and Standards Authority of India (FSSAI) will be conducting a nationwide enforcement drive in October 2025 targeting 13 whole and powdered spices after a 2024–25 surveillance found substandard quality, contaminants, and labelling lapses. Only manufacturing units will be inspected, with samples tested in NABL-accredited labs. States authorities are required to submit reports by 20 November 2025.
Source: short-url.org/1aHQi

3. The Drugs Control Department of Delhi has directed all manufacturers and marketers of drugs, formulations, and medical devices to revise MRPs as per reduced Goods and Services Tax (GST) rates effective 22 September 2025. Revised price lists must reach retailers, and billing systems must be updated to reflect new GST rates.
Source: short-url.org/1fjO6

4. The Bangalore District Chemists and Druggists Association has warned that Goods and Services Tax 2.0 will force pharmacy retailers to absorb losses as they sell old stock at reduced maximum retail prices without input tax credit. It urged authorities to assure no penalties during the transition until December 31, 2025.
Source: short-url.org/1aHQy

5. India’s Federation of Pharmaceutical Merchant Exporters (FPME) has urged exporters to share feedback on the challenges faced with the new dual-use No Objection Certificate (NOC) system introduced by CDSCO via the Sugam portal. Reportedly, The new process has caused delays and increased documentation requirements, impacting export efficiency. FPME has urged Pharmexcil to address these issues with regulatory authorities to streamline export compliance.
Source: short-url.org/1fjOk

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 Consumer Affairs Ministry has permitted manufacturers, packers, and importers to revise MRPs on unsold pre-packaged goods post-GST changes, reflecting only the tax difference. Original MRP must remain visible. Revisions via stickers or stamping are allowed. Conditions include newspaper ads, dealer notifications, and apply until December 31, 2025, or stock exhaustion which ever is earlier.
Source: short-url.org/1dU94

2. The Department of Consumer Affairs has proposed an amendment to the Legal Metrology (Approval of Models) Rules, 2011, introducing a validity period of 10 years for domestic and 5 years for imported model approvals. Public comments are invited before October 9, 2025 through emails.
Source: shorturl.at/7wExv

3. The Soybean Processors Association of India has reportedly objected to FSSAI’s ‘Eat Right India’ post promoting olive oil, calling it elitist and biased. They argue it undermines public confidence in affordable, nutritious local oils like soybean and mustard, and urge its withdrawal to protect consumer trust and national interests.
Source: shorturl.at/zkeaL

4. The FSSAI has constituted a committee to modernize India’s organic-food and agricultural products’ regulatory framework by revising certification rules, usage of the India Organic label, and aligning standards with global benchmarks. While the scope spans organic agricultural products, the authority has not provided a timeline for rollout.
Source: shorturl.at/AQnA5

5. The Retail Distribution Chemist Alliance (RDCA) has cautioned that the shift reducing GST on most medicines from 12% to 5%, effective September 22, 2025, is financially unviable for pharmacies due to unrecoverable input tax credit, risking severe medicine shortages without urgent relief.
Source: shorturl.at/oAEhB

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 Food Safety and Standards Authority of India has classified packaged drinking water as a high-risk category, mandating pre-licence inspections of packaging facilities and annual risk-based audits for existing licence holders. This move aims to ensure hygiene and quality standards, aligning bottled water regulation with stricter public health norms.
Source: short-link.me/17nQx

2. Big private hospitals in India are opposing the General Insurance Council’s common empanelment proposal, arguing it lacks clarity on tariffs, timely claim settlements, and dispute resolution for short payments. They demand wider consultation and revisions before acceptance, stressing the framework must address operational challenges while ensuring insurers’ goal of streamlined empanelment and policyholder access.
Source: short-link.me/1bQ13

3. The GST Group of Ministers (GoM) has reportedly proposed eliminating the current 18% GST on individual life and health insurance premiums. The constituted panel will present recommendations by October 2025 and the final will be taken by GST Council.
Source: short-link.me/17nQT

4. The Pharmaceuticals Export Promotion Council of India is reportedly collaborating with stakeholders to launch an online logistics platform to integrate exporters, importers, service providers, and regulators. The tool aims to centralise compliance, bidding, warehousing, insurance, routing, digital documentation, tracking and feedback.
Source: short-link.me/1bQ1l

5. India’s central drug regulator has recently mandated that exported drugs must retain at least 60% of their shelf life, prompting pharmaceutical companies to discard older inventory and incur significant financial losses. Industry stakeholders caution that the rule introduces substantial economic and logistical strain without offering adequate flexibility.
Source: short-link.me/1bQ1u

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 Ministry of Commerce & Industry introduced the Jan Vishwas (Amendment of Provisions) Bill, 2025 in Lok Sabha to decriminalise 288 minor offences under 16 central laws, including the Drugs and Cosmetics Act. It proposes replacing imprisonment with monetary penalties and improvement notices to ease compliance, boost business confidence, and cut litigation. The Bill now awaits Parliamentary committee review.
Source 1: short-link.me/1bGZT
Source 2: short-link.me/1bGZX

2. India’s Central Pollution Control Board (CPCB) has introduced an automated alerts protocol for OCEMS (Online Continuous Emission/Effluent Monitoring Systems). Compliance issues now trigger tiered warnings: Yellow (Level I), Orange (Level II), and Red (Level III), requiring escalating actions from record-keeping to immediate shutdowns and detailed incident reporting.
Source: short-link.me/1bH01

3. The Health Ministry has reversed the requirement for doctors to register on the National Medical Register just months after making it mandatory. The change comes after fewer than 1 percent of doctors enrolled, facing a process tangled with Aadhaar mismatches and affidavit demands, leaving most applications unapproved.
Source: short-link.me/1bH03

4. Delhi’s Drug Control Administration issued a strict advisory to chemist associations, mandating the immediate cessation of over-the-counter sales of pregabalin and tapentadol due to rising misuse for intoxication and addiction. The directive demands accurate stock records under the Drugs Rules, 1945, and warns of strict penalties for non-compliance.
Source: short-link.me/17f6F

5. The Food Safety and Standards Authority of India has reportedly formed a committee to evaluate whether added sugar should be permitted in infant food. This follows criticism for major manufacturer of infant food for adding sugar in infant food sold in India. Current food regulations allow limited sucrose/fructose only if essential, capped at 20% of total carbohydrates.
Source: short-link.me/17f6L