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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 Central Drugs Standard Control Organization (CDSCO), has enabled online submission of Post-Approval Changes (PAC) for Marketing Authorization related to r-DNA biological products through the CDSCO online portal. Offline submissions of PAC applications will be discontinued from March 5, 2026.
Source: short-url.org/1qFRp

2. The Indian government reportedly plans to train 100,000 allied health professionals over five years and expand caregiver training programmes to strengthen the healthcare workforce. The initiative will upgrade institutions, standardize training across disciplines and improve healthcare access and service quality nationwide.
Source: short-url.org/1qFRF

3. European Union has introduced a new Detergents and Surfactants Regulation requiring stricter biodegradability standards and a mandatory Digital Product Passport (DPP) for products sold in the EU. The regulations also restrict phosphates, update labeling requirements, regulate microorganism-based detergents, and ban animal testing to improve environmental protection and product transparency.
Source: short-url.org/1lwJ9

4. Delhi Drugs Control Department reportedly seized insulin stocks worth over ₹20 lakh from four wholesalers during a special enforcement drive. Inspections revealed violations of the Drugs and Cosmetics Act, 1940, including insulin meant for government supply being diverted, lack of purchase records, and storage of insulin at room temperature instead of required cold chain conditions.
Source: short-url.org/1qFRN

5. Delhi’s Central Procurement Agency (CPA) has reportedly issued a directive instructing government hospitals and allied institutions to stop issuing independent tenders for medical equipment and supplies. The notice reiterates that all procurement activities must be routed through the CPA to ensure centralized purchasing and maintain uniform pricing across hospitals. Hospitals have been warned against conducting separate tendering processes without CPA approval.
Source: short-url.org/1qFRR

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 (CDSCO) has issued a clarification stating that only Indian-issued manufacturing, import, and sale licenses from the Central or State Licensing Authorities as applicable are mandatory for all medical devices in India. Procurement agencies and hospitals must require these licenses in technical bids. Any foreign certifications may be added but cannot replace mandatory Indian approval.
Source: h7.cl/1jTDc

2. India’s pharmaceutical industry is reportedly upgrading quality systems, regulatory alignment and scientific rigour as the Central Drugs Standard Control Organization (CDSCO) as tightens requirements for bioavailability and bioequivalence of oral drugs. Post-approval changes now require stronger data, dissolution studies, and risk-based evaluation. The move aligns India with global regulatory expectations and aims to enhance drug reliability, consistency, and overall patient safety.
Source: h7.cl/1jTDs

3. MNC drugmakers are urging CDSCO to grant 10-year regulatory data exclusivity for novel drugs, arguing it will protect first-mover clinical trial data, boost innovation, and attract R&D investment. This follows CDSCO’s sought industry feedback on rules that require the first applicant to conduct clinical trials and bioequivalence studies, while the subsequent filers could skip the trials.
Source: h7.cl/1jTDC

4. Raids by the Kerala Drugs Control Department in Kozhikode, Thrissur and Thiruvananthapuram revealed that discount pharmacies are stocking a wide array of counterfeit and poor-quality medicines, facilitated by weak inspection and unregulated distribution networks. Stakeholders are now urging Central Drugs Standard Control Organization (CDSCO) intervention.
Source: h7.cl/1jTDY

5. The National Accreditation Board for Testing and Calibration Laboratories has issued a guidance document to strengthen quality at medical laboratory sample collection centres, outlining requirements, hygiene and transport protocols, temperature control measures, and strict oversight to ensure integrity and reliability of patient test results across all facilities.
Source: h7.cl/1jTEn

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 NPPA’s Multidisciplinary Committee, in its recent meeting has reportedly decided to co-opt experts from AIIMS, MAMC, SIC Safdarjung and NIPER to evaluate industry requests for a distinct ceiling price on cementless knee implants. Under Drugs Price Control Order, 2013, manufacturers may petition for separate pricing if their product shows innovation or superiority over existing variants.
Source: bit.ly/3HQpizr

2. The Bureau of Indian Standards (BIS) has introduced two important standards, IS/IEC 63203-201-1:2022 which outlines the standards for measurement methods for basic properties of conductive yarns used in wearable electronic textiles and, IS 19173 (Part 1):2025 which is aligned with IEC/TR 80002-1:2009, offers guidance on applying ISO 14971 to medical device software, strengthening risk management practices.
Source: bit.ly/4ejatBw

3. The National Human Rights Commission has reportedly directed AIIMS Delhi to submit a report within 15 days following allegations that neuroradiology doctors bypassed institutional procurement norms, referring patients to buy flow-diverter brain implants from a private vendor. The complaint highlights significant cost burden and potential human rights violations.
Source: bit.ly/4kY4PqY

4. The Customs, Excise, and Service Tax Appellate Tribunal (CESTAT), New Delhi Bench, ruled that packing or repacking parts of Vibratory Compactors and Wheeled Tractor Loader Backhoes does not constitute “manufacture” under Central Excise Act, so no excise duty is payable.
Source: bit.ly/4eispvP

5. The Sikkim High Court has ordered the State Government to conduct the periodic inspections of all industries including pharmaceutical companies to verify that no effluents are being discharged into rivers. The court also noted groundwater extraction and urged timely completion of the Sikkim Springs & Groundwater Regulation Bill, 2025.
Source: bit.ly/4k5z1yW

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 Health Ministry has notified the Drugs and Cosmetics (Compounding of Offences) Rules, 2025, enabling compounding of minor offences related to the manufacture, import, sale, or distribution of drugs, cosmetics, and medical devices. The move aims to simplify compliance and reduce the burden on the judiciary.
Source: bit.ly/3YVqxTl

2. India’s Central Drug Regulator has exempted orphan drugs from mandatory port testing. Importers must submit a legal undertaking to provide test results within 15 days of receipt from labs. This decision aims to address challenges like small volumes, high costs, and lack of specialized testing infrastructure.
Source: bit.ly/3S8NM8K

3. The Orissa High Court has held that doctors cannot be criminally liable for prescribing an expensive drug unless it is hazardous, sub-standard, or restricted. The Court also stated that government cannot compel patients to use cheaper, less effective drugs, especially if they are paying for treatment themselves.
Source: bit.ly/4jR6Eoq

4. The Supreme Court of India will examine whether excluding divorced and single men from availing surrogacy violates constitutional rights. A divorced man has challenged this exclusion, arguing it discriminates based on gender and marital status, infringing on fundamental rights.
Source: bit.ly/4jLJtMm

5. The Chhattisgarh Anti-Corruption Bureau (ACB) and Economic Offences Wing (EOW) have reportedly filed a chargesheet against six individuals involved in a ₹550 crore medical procurement scam. The accused inflated prices for medical supplies and used to procure medical supplies without verifying the actual requirements of health centers, causing major losses to the state exchequer.
Source: bit.ly/4iHo5XR