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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. Export samples of “Cough Syrup” under HSN code 3004 has been exempted from testing by the Directorate General of Foreign Trade (DGFT) provided they are being exported to or are manufactured at a plant/section which is approved by the regulatory agencies of USA, UK, Canada, European Union, Japan, Australia, Singapore, Republic of Korea and Switzerland.
Source: bit.ly/3YeH6tI

2. India’s Department of Pharmaceuticals (DoP) has recently rejected the review application of a leading pharmaceutical company and upheld the action of NPPA in fixing the ceiling price of the subject formulation. DoP stated that all modified release formulations of a drug that were mentioned in National List of Essential Medicine (NLEM) 2011 – Schedule I of Drugs Price Control Order, 2013 (DPCO, will be included in the NLEM 2015 – Schedule I of DPCO even though not specifically mentioned in NLEM 2015. It may be worth noting that, NLEM 2022 unlike NLEM 2015 specifically mentions that all modified release formulations of drugs specified in the NLEM list of 2022 will be regulated as scheduled formulations.
Source: bit.ly/3NzW73a

3. Goods and Service Tax (GST) on life and health insurance premiums by senior citizens may reportedly be exempted from GST irrespective of the coverage amount. Group of Ministers (GOM) to submit its report on the GST rates on life and health insurance premiums to the GST Council by October end of this year and final decision will be taken by the GST Council.
Source: bit.ly/3Nxr1cr

4. India’s pharmaceutical exporters are waiting for a government response to their request for an exemption from the onerous payment conditions prescribed under Section 43B (h) of the Income Tax (IT) Act, 1961. They are advocating for a minimum 60-day credit period, which is in line with global market standards where credit terms frequently extend up to 120 days. According to section 43B (h), payments for goods or services must be cleared within 45 days of acceptance. Failure to comply within this period creates financial burden and prevents businesses from claiming these payments as tax deductions.
Source: bit.ly/3Nx3dFD

5. To streamline and modernize pharmaceutical export-related procedures, the Directorate General of Foreign Trade (DGFT) has implemented an electronic Appendix 4H certificate filing system. The certificates which record the consumption and stock of duty-free imported or locally sourced raw materials under the Advance Authorization (AA) and Duty-Free Import Authorization (DFIA) schemes, are fully digitalized, as highlighted in Trade Notice No. 21/2024-25. Digital submission of these certificates is now mandatory for all pharma exporters.
Source: bit.ly/3YvCbES
Source: bit.ly/48fPe0g

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 Body, in its 91st meeting, has recommended the exemption of several chemical contraceptives at specific dosage values, from the labelling requirements under Schedule H which would have limited sale by prescription only.
Source: bit.ly/3ZWiqqU

2. The Directorate General of Foreign Trade has amended the export policy for cough Syrup, amending an earlier notification, exempting the requirement for pre-export testing for jurisdictions including the USA, EU, and South Korea which may already have granted approval.
Source: bit.ly/3YfvOVP
Source: bit.ly/3YeH6tI

3. The Ministry of Environment Forest and Climate change has notified the Liquid Waste Management Rules, 2024 set to come into force from 1st October; which govern the treatment and management of liquid effluents arising from domestic and industrial activities including treatment of wastewater, sludge generated during treatment of wastewater and reuse/reutilization of any wastewater or sludge generated.
Source: bit.ly/3YhCpzl

4. In a recent public notice, the Central Government Ministry of Ayurveda, Yoga and Naturopathy, Unani, Siddha and Homeopathy (AYUSH) has clarified that it does not license or ratify any AYUSH products or medicines, and warned against the advertising of AYUSH products as “Miracle Cures”. This comes in the light of the Ministry of AYUSH having repealed Rule 170 of the Drugs Rules, 1945, which regulated AYSUH advertising.
Source: bit.ly/4dzToBi
Source: bit.ly/3XXf9Fi

5. The European Commission’s Medical Device Coordination Group (MDCG) has issued a voluntary document to supplement its earlier Designation, re-assessment and notification of conformity assessment bodies and notified bodies, which is intended to guide notified bodies to impose corrective and preventative action.
Source: bit.ly/4eYr4JJ

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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 notified the New Drugs and Clinical Trials (Amendment) Rules, 2024 which will take effect from1st April, 2025.These amended rules outlines the requirements for registration of the Clinical Research Organizations.
Source:  https://bit.ly/4ddpX81

2. India’s Central Food Regulator (FSSAI), has issued a show cause notice to a Tamil Nadu-based company that supplied ghee for making laddoos (prasadam) at the Tirupati Balaji temple, following the detection of animal fat in the laddoos. The company is required to respond to the charges by 23rd September, 2024, failing which appropriate action will be taken against them.
Source: https://bit.ly/3BheNln

3. The Government of India is reportedly planning to adopt a risk-based approach for monitoring the quality of imported consignments of medical devices at ports. This will involve random sampling of consignments of medical devices and testing of entire cargoes in case of critical diagnostic kits.
Source: https://bit.ly/3BhePtv

4. India’s central health regulator has declared five samples of drugs to be spurious based on the physical comparison and analytical tests done by the manufacturers and on the reports from State Licensing Authorities. The actual manufacturers, as claimed on the labels, have stated that they are not the actual manufacturers of these drugs and the drugs are spurious.
Source: https://bit.ly/3XTfUjP

5. India’s Directorate General of Foreign Trade (DGFT) has amended Chapter 5 of the Handbook of Procedures (HBP) 2023 under the Export Promotion Capital Goods (EPCG) Scheme. The EPCG Scheme, which allows pharma industry to import capital goods duty-free for producing quality goods and services to boost exports, has been updated to streamline its reporting requirements. The amendment eliminates the previous requirement for annual reporting of Export Obligation (EO) fulfilment and has been replaced with a periodic reporting system.
Source: https://bit.ly/4dkMUWC

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 government has made it mandatory for students pursuing medical education in Ayurveda, Yoga & Naturopathy, Unani, Siddha, Sowa Rigpa, and Homoeopathy (AYUSH) to clear the National Exit Test (NExT) after graduation. This requirement will apply to medical graduates from the 2021-2022 batch.
Source: bit.ly/4egpEdy

2. India’s central drug regulator (CDSCO) has asked a pharmaceutical company to explain its claims that its eyedrops can augment near vision in 15 minutes and that it has received marketing approval from CDSCO.
Source: bit.ly/4eyIWLp

3. The Bombay High Court restricted the CEO of a leading e-commerce luxury brand from hiring individuals from another e-commerce beauty brand on grounds that the CEO was misusing employee personal data that it had access to when he was the Chief Business Officer of the rival e-commerce beauty brand.
Source: bit.ly/4glsuzN

4. India’s central drug regulator (CDSCO) has issued an order providing guidance for industry on Pharmacovigilance Requirements for biological products.
Source: bit.ly/4dVKiQ7

5. India’s Directorate General of Foreign Trade (DGFT) has released a public notice amending the timeline for meeting the export obligation of drugs which have been imported from unregistered source.
Source: bit.ly/47qXv1a

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TOP 5 HEALTH LAWS AND POLICY UPDATES

1. India’s Central Food Regulator the Food Safety Standards Authority, has introduced registration process for direct sellers to differentiate from Retailers, and make it easier to preserve exemption granted from regulation to direct sellers.

Source: bit.ly/4feuedl

 

2. The Kerala High Court in following with a recent decision of the Punjab High Court has held that the newly enforced Criminal Procedure (The Bharatiya Nagrik Suraksha Sanhita, 2024) will apply to all criminal appeals filed on or after 1st July 2024, the day of enforcement of the  new law. The court held that while the substantial right to appeal is preserved under the repealed statute, the procedural right will transfer over as per Sec. 531 of the new Code.

Source: bit.ly/4bQpMi4

 

3. Exports of Drugs and Pharmaceuticals have reportedly increased by 9.5% in the first quarter of FY 2024-25 year-on-year.

Source: bit.ly/4d3x3Nb

 

4. In response to recent reports that India has the 2nd highest number of unvaccinated children, the Indian government has clarified in a press release that, this statistic is misleading as such children only constitute a minute 0.11% of the nation’s population of children.

Source: bit.ly/3zQzFPw

 

5. The United States Food and Drug Administration has published Guidance for Human radiolabeled mass balanced studies, prescribing the information that sponsors need to submit, most notably now requiring a minimum of 6 participants for such studies as against the accepted variance between 4-6 participants.

Source: bit.ly/3y2UEy8

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.

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

 

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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.

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

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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.

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