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TOP 5 HEALTH LAWS AND POLICY UPDATES

Dear Reader, 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.

Manufacturers of Ayurvedic Drugs cannot claim “Certified by” or “Approved by”: Ministry of AYUSH
India’s AYUSH Ministry has reportedly issued a warning to all ayurveda, siddha, unani and homeopathic drug makers, against the use of any misleading, unsubstantiated claims and false advertisements such as a green logo or false statements like “the product is approved or certified by the ministry”. The Ministry also clarified that it has no role in issuing manufacturing licences or approvals. This warning comes in the backdrop of a misleading advertisements case against a major Ayurvedic drugs and products manufacturer in the Supreme Court of India.
Source: bit.ly/3UF32fP

After Hong Kong, US Food Regulator is probing Indian spices due to reports of contamination
The US Food and Drug Administration has reportedly initiated a probe against two Indian spice manufacturers for their spice mixes which allegedly contain hazardous cancer-causing pesticides. The two manufacturers who are facing similar controversies in Hong Kong and Singapore have refuted the allegations. India’s spice regulator, the Spice Board of India, has taken cognizance of matter and is working closely with the two manufacturers to ascertain the root cause of such allegations.
Source: bit.ly/3UB8q3r

India extends the approval for use of drones for spraying approved pesticides till April 18, 2025
India’s Agriculture Ministry has extended its interim approval by one year, i.e., until April 18, 2025, for drone-based application of already approved pesticides formulations including insecticides, fungicides and plant growth regulators which were earlier permitted to be only sprayed manually by knapsack sprayers. The earlier approval was valid till April 18, 2024.
Source: bit.ly/4bf9MX7

Indian FMCG companies are reclassifying popular health drinks as functional nutritional drinks to comply with the recent government directions
Days after India’s Ministry of Commerce and Industry issued a directive to all e-commerce sites instructing not to list malt drink mixes and other similar products under the category of health drinks, Indian manufacturers have started reclassifying their products. A major manufacturer of food products has classified its malt drink mix as “Functional Nutritional Drink”. India’s food regulator had clarified earlier this month that there is no category called “health drink” under which it grants manufacturing license.
Source: bit.ly/4dbOpb7

India’s Madras High Court denies relief to doctors for violating bond conditions; directs them to undertake Bond Service in Government Medical College and Hospitals
India’s Madras High Court has upheld the validity of bond service conditions based on bond agreements signed by doctors. The instant case related to temporary appointment of three doctors to the post of Assistant Surgeon in compliance with bond agreement. The doctors claimed that they had served during COVID-19 pandemic period and urged their service be calculated basis two years of service as stipulated in the bond. The High Court stated that the period of COVID duty done by Medical Officers after completion of their PG courses alone will be treated as Bond Service and services rendered by the Postgraduates during their courses would be considered as study period only.
Source: bit.ly/44opFYX

 

Posted on

TOP 5 HEALTH LAWS AND POLICY UPDATES

Dear Reader, 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.

Draft Guidance on Vaccine Approval and Quality Monitoring at port of Import published by Central Drug Regulator for Public Commect
The Central Government has recently published a draft of guidance on (1) regulatory framework for conducting vaccine related clinical trials, marketing approval, manufacture, import/ export and post marketing assessment and (2) Risk Based Approach for monitoring quality of imported drugs, medical devices and IVDs at customs ports. Public Comment is sought on these above Guidance Notes, within 30 days of publication i.e. by 10th May 2024.
Source: bit.ly/3xIoiIv
Source: bit.ly/4cVOpvL

Merchants Association Request Central Government Intervention to Stabilize trade of Medicines and Medical Devices with Africa
The Federation of Pharmaceutical and Allied Products Merchant Exporters, an industry association of small and medium sized importers and exporters, has advocated for fiscal and trade policy intervention including continued efforts to stabilize Rupee value, by the Government to stabilize the export of Medicine and Medical Products to Africa, which has seen a sharp decline due to rising shipping tariffs caused by ongoing geopolitical conflicts.
Source: bit.ly/3Q8qlvT

Threefold Increase in FDI in Healthcare and Medical Device Sector in India during latter half of FY 2023-2024
Foreign Direct Investment (FDI) into the Hospital and Diagnostic Sectors in the country has increased by about 90% in the last quarter of 2023-24, as compared to the same quarter the previous year. Moreover, the Medical and Surgical Implements Sector has also seen a nearly 1/3rd growth by proportion during the same time. The total FDI received in hospital and medical devices sector stood at USD 462 Million.
Source: bit.ly/3U6Km70

Modern medicine Doctor body Expresses Concerns regarding Introduction of Integraded School of Medicine as Treatment
The Indian Medical Association, a professional representative body of Doctors, has expressed its concerns regarding the proposal of the Central Government to institute Integrated Medicine, which would offer treatments which are a mix of allopathic, homeopathic and traditional medicine. The Council expressed concern that due to the vast gulf in the manner of training, specialization and expertise between the various schools of medicine means that integration and cross practice treatment may pose severe risk to patient.
Source: bit.ly/3U6yi5E

EU and Japan harmonize Pharmacopoeia for ease of doing Business and regulatory Burden
The European Directorate for the Quality of Medicine and Healthcare, and the Japanese Ministry of Health, Labour and Welfare have entered into a Memorandum of Cooperation and Confidentiality, to coordinate efforts to harmonize the European and Japanese Pharmacopoeia, a move that would reduce the regulatory burden on manufacturers operating in the twin jurisdictions, with respect to carrying out compendial tests and IP approval.
Source: bit.ly/3UmRBJo

Posted on

TOP 5 HEALTH LAWS AND POLICY UPDATES

Dear Reader, 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.

No significant hike in prices of essential medicines: Indian Government
India’s Ministry of Health and Family Welfare has issued a clarification in response to reports about the significant increase in medicine prices by an increase in the Wholesale Price Index (WPI) of 0.00551% for the FY 2023-2024. It has been clarified that the increase is a miniscule increase and will not have any substantial increase in the prices of medicines. WPI increase is the maximum increase permissible and the manufacturers may or may not avail this increase in price for the medicines.
Source: bit.ly/43I1OmR

Foreign medical graduates should receive same internship stipend as medical graduates who have completed education in India: Supreme Court
The Supreme Court of India has directed medical colleges to treat foreign medical graduates on par with Indian medical graduates in terms of stipends paid by the medical colleges during internship, on grounds of fairness and equity. The Court has also warned medical colleges of strict action if they discriminate against foreign medical graduates.
Source: bit.ly/3J3gAuX

Digital database for organ donation to be rolled out soon by Indian Government
India’s National Health Authority (NHA) and the Ministry of Health and Family Welfare are likely to roll out a National Digital Organ Donor Register which is aimed at building a comprehensive database of prospective organ donors to meet increasing demand for organ transplant and to regulate organ donation in the country. The digital register will reportedly maintain records of prospective donors and patients waiting for organ transplant in a confidential manner.
Source: bit.ly/3TGWrQh

Export of fresh fruit and vegetable to receive a boost from Indian Government
India’s Commerce Ministry is reportedly seeking to facilitate export of agricultural products, including fresh fruits and vegetables, to new markets such as US, European Union and African countries with an aim to double India’s agricultural exports, bring foreign exchange, and address the existing export-import imbalance due to ban on export of wheat and rice.
Source: bit.ly/43MOrSv

China relaxes regulations on Cross Border Data Transfer
The Cyberspace Administration of China (CAC) has introduced revised cross-border data transfer regulations. The revised regulations have reportedly eased compliance burdens on companies, which should facilitate more cross-border flow of data.
Source: bit.ly/3PMdlvq

Posted on

TOP 5 HEALTH LAWS AND POLICY UPDATES

Dear Reader, 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.

Indian government may reconsider its decision of prohibiting manufacture of drugs and nutraceuticals, health supplements in same facility
The Indian government is reportedly reconsidering its decision to act against pharmaceutical companies who are manufacturing nutraceuticals, health supplements and drugs in the same facility, due to objections raised by small scale manufacturers. The previous Good Manufacturing Practices (Schedule M) for drugs gave some concession to manufacturers of drugs to manufacture nutraceuticals and health supplements in the same facility. However, no such concession exists under revised Good Manufacturing Practices (Schedule M) published in December 2023.
Source: bit.ly/3x59lQo

Exporters of Indian farm produce are facing phytosanitary challenges
Indian agricultural exports, including fruits and vegetables, are reportedly finding it difficult to enter regions like Europe, Australia, and the US due to tough phytosanitary requirements and thresholds such as high pesticide content. In response, India’s Commerce Ministry is reportedly creating a data set on export consignments of agricultural exports that were refused by European countries and other nations on grounds of phytosanitary non-compliances, resulting in significant trade hurdles regardless of duty relaxations. A phytosanitary certificate is required for the export of agricultural products to ensure that the produce is pest-free, disease-free, and meets other health requirements such as traceability at the farm level.
Source: bit.ly/4ctvxnB

Indian government has established Fact Check Units to check spread of fake news
The Indian Ministry of Electronics and Information Technology has appointed the Press Information Bureau of the Ministry of Information and Broadcasting as Fact Check Unit to address fake and misleading news against Central Government. The fact check unit of the central government is expected to vet all the online content related to the business of the central government. Any content identified as fake by the unit will be taken down from the internet.
Source: bit.ly/3Px3Yj8

The Centre gives more time to states to establish Allied Healthcare Councils
India’s Ministry of Health and Family Welfare has extended the timeline for states to establish state allied and healthcare councils by six months. State Governments have to setup State Councils for Allied Healthcare by November 2024. The National Commission for Allied and Healthcare Professions Act 2021, which regulates quality of allied and other healthcare professionals in India, will be operationalized once the State Councils have been established.
Sourve : bit.ly/3PxeZ4d

Integrated Veterinary Health Certificates (VHC) mandatory after 30th June,2024 for import of milk and milk products into India
The Food Safety and Standards Authority of India (FSSAI) has extended the deadline for implementing its decision to require imported food consignment of milk and milk products to be supported by an integrated veterinary health certificate. The requirement will take effect on July 1, 2024. From that date, only those milk and milk products that are supported by integrated veterinary health certificates will be allowed importation into India. The Integrated Veterinary Health Certificate must demonstrate that imported milk and milk products meet both the FSSAI’s food safety standards and the Department of Animal Husbandry and Dairying’s (DAHD) sanitary criteria.
Source: bit.ly/3TIh53F