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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 Karnataka Health Department has proposed introducing QR codes on medicine strips and boxes to help visually impaired patients access key drug information via smartphone scanning under the IMPACT-VIP programme. Details such as dosage, composition, and expiry dates can be accessed, and the proposal may be sent to the Centre for wider implementation.
Source: h7.cl/1o2Wy

2. India’s central drugs regulatory authority (CDSCO) has released a draft guidance outlining regulatory requirements and online procedures for importing in-vitro diagnostic medical devices. The document aims to streamline approvals under Medical Devices Rules, 2017. Comments from stakeholders are invited within 15 days.
Source: h7.cl/1j0Wg

3. The Government of India has in the Union Budget 2026–27 announced measures to position India as a hub for medical tourism, biopharmaceutical manufacturing and traditional medicine. The government will establish five regional medical hubs, expand Ayurveda, Yoga, Unani, Siddha and Homeopathy infrastructure, and strengthen research, manufacturing capacity and employment across the healthcare value chain.
Source: h7.cl/1o2WE

4. The Government of India is planning to amend the Drugs and Cosmetics Act to tighten oversight of pharmaceutical opioids, proposing stricter penalties, higher fines, and enhanced monitoring of manufacturing and sales to curb misuse, diversion, and illegal distribution while strengthening regulatory enforcement.
Source: h7.cl/1j0Wr

5. Indian Pharmacopoeia Commission has issued a formal circular urging all Medical Device Marketing Authorisation Holders (MAHs) to strictly comply with adverse event reporting requirements under the Materiovigilance Programme of India (MvPI). The move is aimed at bolstering patient safety and enhancing the post-market surveillance ecosystem for medical devices across India.
Source: h7.cl/1o2WQ

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 Karnataka Health Department has proposed introducing QR codes on medicine strips and boxes to help visually impaired patients access key drug information via smartphone scanning under the IMPACT-VIP programme. Details such as dosage, composition, and expiry dates can be accessed, and the proposal may be sent to the Centre for wider implementation.
Source: h7.cl/1o2Wy

2. India’s central drugs regulatory authority (CDSCO) has released a draft guidance outlining regulatory requirements and online procedures for importing in-vitro diagnostic medical devices. The document aims to streamline approvals under Medical Devices Rules, 2017. Comments from stakeholders are invited within 15 days.
Source: h7.cl/1j0Wg

3. The Government of India has in the Union Budget 2026–27 announced measures to position India as a hub for medical tourism, biopharmaceutical manufacturing and traditional medicine. The government will establish five regional medical hubs, expand Ayurveda, Yoga, Unani, Siddha and Homeopathy infrastructure, and strengthen research, manufacturing capacity and employment across the healthcare value chain.
Source: h7.cl/1o2WE

4. The Government of India is planning to amend the Drugs and Cosmetics Act to tighten oversight of pharmaceutical opioids, proposing stricter penalties, higher fines, and enhanced monitoring of manufacturing and sales to curb misuse, diversion, and illegal distribution while strengthening regulatory enforcement.
Source: h7.cl/1j0Wr

5. Indian Pharmacopoeia Commission has issued a formal circular urging all Medical Device Marketing Authorisation Holders (MAHs) to strictly comply with adverse event reporting requirements under the Materiovigilance Programme of India (MvPI). The move is aimed at bolstering patient safety and enhancing the post-market surveillance ecosystem for medical devices across India.
Source: h7.cl/1o2WQ

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 Council for Research in Ayurvedic Sciences has launched SIDDHI 2.0, a national industry research interface platform, to accelerate scientifically validated Ayurvedic product development. The initiative brings together regulators, researchers, and manufacturers to promote quality, safety, regulatory compliance and global competitiveness of Ayurvedic pharmaceuticals.
Source: h7.cl/1fbDr

2. The Telangana Drugs Control Administration (DCA) has issued a circular requiring all licensed retail and wholesale pharmacies across the state to prominently display a QR code and toll-free number to report adverse drug reactions (ADRs). This step enforces compliance with Central Drugs Standard Control Organisation (CDSCO) guidelines, strengthening pharmacovigilance under the national Pharmacovigilance Programme of India (PvPI).
Source: h7.cl/1k1Ny

3. Karnataka Pharma Retailers & Distributors Organization (KPRDO) has reportedly urged the government to halt ten-minute medicine delivery services, warning that treating prescription drugs as fast-moving consumer goods violates drug safety laws. They argue that medicines require prescription verification and pharmacist oversight, and that instant access to antibiotics and addictive drugs could lead to misuse, antimicrobial resistance, and public-health risks.
Source: h7.cl/1fbDv

4. Public commenters are calling on the US Food and Drug Administration (FDA) to loosen clinical trial requirements, particularly for rare diseases and drug development. Commenters are urging the FDA to allow more flexible trial designs and reduced burden to accelerate access to therapies, especially for rare or underserved conditions like disseminated coccidioidomycosis.
Source: h7.cl/1k1NB

5. A major US retail chain has recalled several bottles of saline nasal spray after US Food and Drug Administration (FDA) tests detected contamination with Pseudomonas lactis. The Class II recall covers two production lots with 2027 expiry dates. While the risk is considered medically reversible, regulators advise consumers to stop using the affected batches immediately.
Source: h7.cl/1k1NE

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 CDSCO via a circular has directed all licensing authorities to ensure that retail and wholesale pharmacy stores prominently display the designated Pharmacovigilance Programme of India (PVPI) QR code and toll-free number. This initiative aims to facilitate easy and seamless reporting of adverse drug reactions (ADR) by the public, strengthening drug safety monitoring.
Source: h7.cl/1jLf0

2. FSSAI has issued an advisory for dairy units selling milk/milk products via vending machines and kiosks, directing them to maintain approved rapid-test kits on-site for detecting common adulterants. The machines must display usage instructions, enable consumer self-tests or staff-demonstrations, retain usage records, and ensure kit validity and proper storage.
Source: h7.cl/1jLfi

3. The Food Safety and Standards Authority of India (FSSAI) has reportedly directed immediate removal of fruit-based beverages, R-T-S drinks and energy drinks labelled with the term “ORS” from retail and e-commerce platforms, reaffirming that only formulations meeting WHO oral-rehydration-solution standards may use “ORS”.
Source: h7.cl/1jLft

4. Indian Government reportedly plans to amend the Drugs and Cosmetics Act by adding sale licensing conditions a per which advertising of high-risk drugs in Schedules G, H, H1 and X will be explicitly banned, including via e-commerce and digital platforms, in order to curb self-medication, misleading claims an misuse of potent medicines.
Source: h7.cl/1jLfQ

5. Indian Government is reportedly framing a broader medical-device manufacturing policy aimed at cutting the country’s heavy import dependence. The plan focuses on boosting domestic production, introducing quality standards for thousands of devices, promoting zero-defect manufacturing, and strengthening India’s global competitiveness in the healthcare technology sector.
Source: h7.cl/1eWCg

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 Regulator has reiterated that import of drugs, will be permitted only through notified ports under Rule 43-A of the Drugs Rules, 1945. The designated entry points have been mapped with customs’ ICEGATE system to ensure regulatory oversight and streamline import clearances.
Source: https://short-url.org/1h02u

2. India’s Directorate General of Trade Remedies has initiated an anti-dumping probe into imports of harming domestic producers. The investigation will assess the extent of dumping and its impact for need of anti-dumping duties under Indian laws.
Source: https://short-url.org/1gZMy

3. The National Human Rights Commission has reportedly issued notices to several state governments over multiple child deaths allegedly caused by contaminated cough syrup. It has also directed the drug regulator and Health Ministry to investigate spurious drug supply. Recently, similar action was taken over a gas leak in Maharashtra.
Source: https://short-url.org/1ciNX
https://short-url.org/1ciLx

4. Indian government have reportedly assured Jan Aushadhi Kendra retailers that it will review the newly introduced zero-distance policy, which removed the 1 km minimum distance requirement between outlets in cities with populations of over one million. Retailers are seeking rollback, citing significant losses in sales and profitability due to increased competition.
Source: https://short-url.org/1ciMf

5. The All India Organization of Chemists and Druggists (AIOCD) has reportedly incorporated its first pharmaceutical Limited Liability Partnership (LLP) in Kerala, marking a significant step in empowering local wholesalers to compete with corporate and foreign players. This initiative aims to consolidate traditional distributors into corporate entities, enhancing efficiency and resource pooling.
Source: https://short-url.org/1ciLM

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 of India has reduced GST to NIL on 36 lifesaving drugs and cut GST on key medical devices and supplies from 18%/12% to 5%, effective September 22, 2025. Pharma and medical device companies must revise MRPs accordingly and comply with pricing norms under The Drugs Price Control Order and anti-profiteering provisions.
Source: shorturl.at/dRaT8

2. CDSCO has announced that Institutional Biosafety Committee (IBSC) approvals will now be sufficient for biopharma companies seeking CT-10 permissions to manufacture test items from Category I and II genetic engineering experiments.
Source: shorturl.at/ACkQm

3. Maharashtra’s Medical Education Department has instructed the Maharashtra Medical Council (MMC) to begin registering homeopathic practitioners who’ve completed the one-year Certificate Course in Modern Pharmacology (CCMP) under a separate registry. The Indian Medical Association (IMA) has strongly opposed the move deeming it risky to public health, and plans to escalate the matter to the Bombay High Court.
Source: shorturl.at/Ge5OT

4. India’s GST Council has reduced the goods and services tax on diagnostic kits, reagents, and medical devices from 12–18% to 5%, effective September 22, 2025. While this lowers the cost base for labs, experts caution that reagent expenses account for only ~20% of diagnostic test costs, so the actual price drop for patients may be a modest 2–5%, depending on providers’ pricing strategies.
Source: shorturl.at/WvZHI

5. CDSCO has introduced a dedicated “Not of Standard Quality” (NSQ) alerts portal on its official website, enabling Industry experts to access real-time updates on substandard drug batches.
Source 1: shorturl.at/oMBXn
Source 2: shorturl.at/J7Pma

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 Health and Family Welfare has amended the Cosmetics Rules, 2020 introducing clearer expiry labelling, redefining terms, updating recordkeeping norms, and empowering authorities to suspend or cancel licences. Notable changes include labelling for exports, new batch record rules, and designation of the Central Cosmetics Laboratory.
Source: short-link.me/1aoFG

2. In order to enhance ease of doing business, India’s central drug authority (CDSCO) has streamlined the process of issuance of Dual Use NOC through Sugam Portal for importing bulk drugs for non-medicinal use. Further to reduce the compliance burden, CDSCO has initiated issue of 1 year NOC, subject to prescribed conditions for such drugs. The new online Dual use system will be effective from 31st August 2025.
Source: short-link.me/1aoEr

3. The Food Safety and Standards Authority of India (FSSAI) has mandated all food business operators such as restaurants, cafes, dhabas and cloud kitchens to display their licence or registration along with a QR code linking to the Food Safety Connect app. This helps consumers access details, lodge complaints and provide feedback, promoting transparency and accountability.
Source: short-link.me/1aoOH

4. The Indian government enacted the Vegetable Oil Products, Production and Availability (VOPPA) Regulation Order, 2025, replacing the 2011 framework. It mandates mandatory registration for all vegetable oil producers, monthly online reporting of production, stocks, sales, and pricing, and grants authorities inspection and enforcement powers to boost market transparency and curb hoarding.
Source: short-link.me/1aoEM

5. Karnataka’s Health & Family Welfare Department has filed 29 legal cases under the Drugs & Cosmetics Act, and has served show-cause notices to 231 pharmacies for dispensing prescription drugs without prescriptions; simultaneously, authorities have flagged food vendors using synthetic colors and have issued warnings.
Source: short-link.me/1aoEW

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 Department of Pharmaceuticals has extended the application deadline for Round V of its Production-Linked Incentive (PLI) scheme to 21 June 2025, giving pharma companies additional time to apply. Applications can only be made online through the given link in the circular.
Source: bit.ly/4kn1e4J

2. The Delhi High Court has barred a leading Ayurvedic manufacturer from airing advertisements claiming superiority of its Chyawanprash, ruling that freedom of commercial speech doesn’t justify misleading claims for regulated drugs. It has further emphasized stricter scrutiny on drug-related marketing to prevent false efficacy claims and consumer deception.
Source: bit.ly/4kqs63F

3. The Madras High Court has clarified that importing Ayurvedic drugs into India does not require an import license, provided the products conform to the standards set for domestically manufactured equivalents. This precedent emphasizes regulatory alignment with Indian pharmacopoeia standards and could facilitate smoother market entry for Ayurvedic importers while ensuring consistent quality.
Source: bit.ly/4lgEXH2

4. The National Pharmaceutical Pricing Authority (NPPA) will change its official website from nppaindia.nic.in to nppa.gov.in effective 15 July 2025. The new domain will host all notifications, pricing orders, data systems, and circulars. Stakeholders are advised to update their records and bookmarks to ensure uninterrupted access to NPPA services during the transition phase. The old domain will temporarily redirect users.
Source: bit.ly/44AXWF9

5. The National Pharmaceutical Pricing Authority (NPPA) has issued an Order thereby fixing the ceiling prices for I.V. fluids (non-glass with special features). Now the product I.V. fluids (non-glass with special features) cannot be sold beyond the fixed prices.
Source: bit.ly/44gE4rR

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 Health and Family Welfare mandates all WHO-GMP (COPP) certificate applications to be submitted exclusively through the ONDS Portal from June 15, 2025. Hard copy submissions will not be accepted. A step-by-step procedure and contact details for support have also been provided.
Source: bit.ly/3HWGXWd

2. CDSCO has informed all states and union territories that a loan license is no longer required for outsourcing sterilization of medical devices, provided the sterilization facility is licensed under MDR-2017. Manufacturers must submit documentation and include the sterilization site’s license number on labels of the device.
Source: bit.ly/44nGKCX

3. The Bombay High Court has issued an interim injunction restraining a company from using packaging, labels, bottles, and trade dress that closely resemble those of an established hair-oil brand. The court found that the packaging was “slavishly copied,” potentially misleading consumers and amounting to trademark infringement and unfair competition.
Source: bit.ly/4kd5DXM

4. The Andhra Pradesh High Court has ruled that under the Narcotic Drugs and Psychotropic Substances Act, 1985, “Ganja” refers only to the flowering or fruiting tops of the cannabis plant, explicitly excluding seeds and leaves when not accompanied by the tops.
Source: bit.ly/4ls1iRl

5. India’s Central Board of Indirect Taxes and Customs (CBIC), following DGTR recommendations, has slapped anti dumping duties for five years on four key chemicals from China—PEDA, acetonitrile, Vitamin A palmitate and insoluble sulfur—to shield domestic pharma, agro and rubber industries, signalling a strategic push to rebalance imports and promote local manufacturing.
Source: bit.ly/4lNeEYX