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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 National Pharmaceutical Pricing Authority has announced that all applications for retail price fixation of new drugs in Form I must be submitted through the dedicated online portal, Integrated Pharmaceutical Database Management System (IPDMS 2.0) from April 1, 2025. At present, Form I applications for the retail price fixation of new drugs are being submitted via email.
Source: bit.ly/4i4aKJw

2. India’s small retailers are facing challenges as quick-commerce giants are allegedly engaged in deep discounting  for the products sold through their platform. The All India Consumer Products Distributors Federation has urged the Competition Commission of India to investigate these discounting pricing practices.
Source: bit.ly/4ixzqtB

3. The Information Technology Industry Council (ITI) urges the government to delay children’s data processing rules under the Digital Personal Data Protection (DPDP) Rules, 2025, as global tech firms are facing operational challenges. They recommend aligning age verification with international standards.
Source: bit.ly/3QQV1l0

4. The Indian Council of Medical Research’s new guidelines exempt Ayush-approved medicines from additional safety evidence from animal studies or phase I/II human clinical trials in integrative research. However, non-codified traditional medicines must undergo full regulatory approval and adhere to applicable regulations.
Source: bit.ly/3QQWkAq

5. The Competition Commission of India (CCI) has ruled that a hospital’s intentional misleading of consumers, involving the misrepresentation of its surgeon’s qualifications and false advertising, does not raise any concerns under the provisions of the Competition Act 2002 and is outside CCI’s jurisdiction.
Source: bit.ly/3Fbvl05

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 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

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 Council of Medical Research (ICMR) has issued an Expression of Interest (EoI) for organizations, companies, and manufacturers to develop and produce a lateral flow-based point-of-care device for serum ferritin quantification. Serum ferritin is an important biomarker for diagnosing iron deficiency or anemia. The deadline for submitting the EoI is February 28, 2025.
Source: bit.ly/4jCmvrJ

2. The Pharmacy Council of India (PCI) has requested pharmacists facing registration issues on the DIGI-PHARMed portal due to existing identity proof in the system, to submit their details along with a declaration. This initiative is part of the Council’s efforts to eliminate fake or incorrect data by blocking incomplete entries and asking affected pharmacists to create new profiles with valid information.
Source: bit.ly/3Ee0e3q

3. The Federation of Pharma Entrepreneurs (FOPE) is urging the Union government to address GST rationalization due to challenges like low liquidity and increasing compliance burdens in the pharmaceutical industry. FOPE highlighted that the current GST structure has created an inverted duty structure, causing significant working capital blockages and operational inefficiencies, which impacts the critical role of the Indian pharma sector in healthcare, employment, and exports.
Source: bit.ly/3WC6Nmu

4. The National Medical Commission (NMC) is investigating around 30 doctors who took foreign trips to Monaco and Paris, sponsored by a drug manufacturer under the pretext of a dermatology conference. The doctors may face censure or suspension from the Indian Medical Register for three months to over a year, depending on the severity of the violation. This follows a reprimand from the Department of Pharmaceuticals (DoP) over the drug company’s sponsorship of the Rs 1.91 crore trips.
Source: bit.ly/4aCPis9

5. India’s Chhattisgarh High Court has ruled that when determining whether a mixture of narcotic drugs or psychotropic substances constitutes a “small quantity” or “commercial quantity,” both the quantity of the offending drug and the neutral substance mixed with it should be considered.
Source: bit.ly/4jAW8Ti

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 Drugs Technical Advisory Board (DTAB) has approved a proposal to amend the New Drugs and Clinical Trials (ND&CT) Rules, 2019 to eliminate the two-step certificate issuance process for biomedical and health research ethics committee registration. Now, a system for reviewing and examining all ethics committee documents has been put in place at Department of Health Research (DHR). This process allows for the removal of redundant work and resource use, and only final certificates can be directly issued to ethics committees.
Source: bit.ly/3A8haGQ

2. To improve India’s whole digital healthcare infrastructure, a new certification program for hospital information systems (HIS) and electronic medical records (EMR) has been introduced by the National Accreditation Board for Hospitals and Healthcare Providers (NABH). The program offers Basic and Advanced maturity levels that are valid for two years. The NABH portal will open for registration on December 1, 2024.
Source: bit.ly/3UjzcN7

3. The Drugs Controller General of India (DCGI) plans to amend the Medical Devices Rules, 2017, to include quality control provisions for non-sterile, non-invasive Class A medical devices like thermometers and stethoscopes. Currently exempt from licensing, these devices will now require manufacturers to comply with a quality management system.
Source: bit.ly/3NApDpw

4. The Madras High Court has ruled that Siddha practitioners are permitted to practice modern medicine but are prohibited from storing allopathic drugs without a valid license under the Drugs and Cosmetics Act, 1940.
Source: bit.ly/4hs9VKT

5. The World Health Organization (WHO) has prepared a draft guideline for food packaging to include health impact labels on the front, emphasizing the need for clearer consumer information regarding potential health risks associated with food contact materials. The draft received public comments till October 11, 2024 and will release the final guidelines in 2025.
Source: bit.ly/3BQlKKm