Dentons US LLP
10/04/2024 | News release | Distributed by Public on 10/04/2024 04:44
Lifesciences and Healthcare Newsletter | August 2024
October 4, 2024
Introduction: Welcome to the August 2024 edition of our Life Sciences and Healthcare Newsletter, where we delve into the latest developments shaping the industry. This month, we explore a range of significant legal and regulatory updates, including the waiver from requirement of clinical trials for certain categories of drugs approved in identified jurisdictions; initiation of the first dengue vaccine Phase 3 clinical trial in India; Supreme Court's stay on a notification issued by Ministry of AAYUSH. In addition, we examine recent judicial decisions and government initiatives that impact the pharmaceutical, and healthcare sectors. Stay informed on the evolving landscape with our comprehensive analysis and expert insights.
PHARMACEUTICAL
A. LEGAL AND REGULATORY
1. The Drugs Controller General of India has waived the requirement of clinical trials if the drugs are approved in the United States, United Kingdom, Japan, Australia, Canada, and the European Union
On August 7, 2024, the Drugs Controller General of India vide an order has waived the requirement of clinical trials in India if the drugs are approved in the United States, United Kingdom, Japan, Australia, Canada, and European Union if they fall in the categories of Orphan Drugs for Rare Diseases, Gene and Cellular Therapy Products, New Drugs used in Pandemic Situations, New Drugs for Special Defense Purposes, and New Drugs having significant therapeutic advance over the current standard of care, in accordance with Rule 101 of the New Drugs and Clinical Trial Rules, 2019.
2. The Central Drugs Standard Control Organization (CDSCO) has mandated all manufacturers to comply with the revised Schedule M and various World Health Organization (WHO) Technical Report Series (TRS) guidelines
On August 7, 2024, the CDSCO mandated that all manufacturers should take necessary steps for compliance with respect to the requirements under the revised Schedule M and various WHO TRS guidelines which are published from time to time, including WHO TRS 1044 Annexure-2 "WHO good manufacturing practices for sterile pharmaceutical products".
3. CDSCO Releases Draft Guidelines on Good Distribution Practices for Pharmaceutical Products
On August 9, 2024, the CDSCO released Draft Guidelines on Good Distribution Practices for Pharmaceutical Products in line with the WHO TRS on Good Storage and Distribution practices, and other guidelines and applicable rules. These guidelines set out steps to assist in fulfilling the responsibilities involved in the different stages within the supply chain and to avoid the introduction of spurious, adulterated, misbranded, and not-of-standard quality products into the market and is intended to apply to all entities involved in any aspect of the storage and distribution of pharmaceutical products. Accordingly, the said draft guidelines have been published on the CDSCO website for public consultation for a period of 30 days.
4. CDSCO Restricts Number of Cosmetics Products to 50 Per Application on SUGAM Portal
In order to streamline the process of registration and import of cosmetics including post-approval change through the SUGAM portal, the CDSCO has decided to limit the number of products to a maximum of 50 per single online application, w.e.f. August 16, 2024. Further, multiple applications can be made. This change has been made to process and dispose of applications within the stipulated timeline as per the Cosmetics Rules, 2020.
5. Ministry of Health and Family Welfare Bans 156 Fixed-Dose Combination Drugs Over Safety Concerns
On August 2, 2024, the Ministry of Health and Family Welfare banned 156 fixed-dose combination ("FDC") medications commonly known as "cocktail drugs," including multivitamins, antibiotics, painkillers, and medicines for treating fever and hypertension, as these FDCs are likely to involve risk to human beings. Whereas safer alternatives to the said drugs are available The Ministry of Health and Family Welfare has officially prohibited the manufacture, sale, or distribution of these FDCs for human use.
B. GOVERNMENT INITIATIVES
6. Launch of the Adverse Drug Monitoring System (ADRMS) Online Portal
To fulfill the vision of Hon'ble Prime Minister, Shri Narendra Modi's 'Digital India', an online indigenously developed ADRMS software of the Pharmacovigilance Programme of India ("PvPI") was launched by the Hon'ble Minister of Health & Family Welfare and Minister of Chemicals and Fertilizers, Shri J.P. Nadda during the 1st Policy Makers Forum meeting on August 19, 2024.
PvPI's ADRMS software is India's first medical product safety database tailored to the needs of the Indian population. It will facilitate the users reporting adverse events related to medicines and medical devices. This software will not only streamline the reporting process by patients/their caregivers and healthcare professionals but also empower Indian Pharmaceutical Industries/Marketing Authorizations Holders (MAHs) to report adverse events through direct User Gateway.
7. Launch of the Indian Pharmacopoeia (IP) Online Portal
On August 19, 2024, the Indian Pharmacopoeia (IP) Online Portal (www.iponline.ipc.gov.in) was launched by the Hon'ble Minister of Health & Family Welfare and Minister of Chemicals and Fertilizers, Shri J.P. Nadda during the 1st Policy Makers Forum held at Dr. Ambedkar International Centre, New Delhi. The launch of the IP Online Portal will revolutionize the accessibility of IP standards, allowing users to refer to drug monographs seamlessly on their computers and mobile devices. This enhanced accessibility is expected to extend the reach of the IP to a broad audience, ensuring that all stakeholders have easy access to vital information.
C. GENERAL UPDATES
8. National Pharmaceutical Pricing Authority's (NPPA) Multidisciplinary Committee (MDC) recommends retail prices for anti-diabetes combinations of empagliflozin
NPPA's MDC has recommended retail prices for diabetes drug combinations involving empagliflozin. With the drug expected to go off-patent in March 2025, this pricing move is aimed at increasing accessibility and affordability for diabetic patients. These measures are part of a broader effort to regulate essential medicines and make life-saving treatments more cost-effective in India.
9. Indian Council of Medical Research (ICMR) and Panacea Biotech initiate the First Dengue Vaccine Phase 3 Clinical Trial in India with Indigenous Dengue Vaccine, DengiAll
The ICMR and Panacea Biotech announced the initiation of the first-ever Phase 3 clinical trial for a dengue vaccine in India. This trial will evaluate the efficacy of the indigenous tetravalent dengue vaccine, DengiAll, developed by Panacea Biotech. The first participant in this trial was vaccinated at a Pandit Bhagwat Dayal Sharma Post Graduate Institute of Medical Sciences (PGIMS), Rohtak on August 14, 2024.
Currently, there are no licensed antiviral treatments or licensed vaccines for dengue in India. Developing an effective vaccine is challenging due to the need to achieve good efficacy for all four dengue virus serotypes. In India, all four serotypes of Dengue virus are known to circulate or co-circulate in many regions.
Heath-Tech, Hospitals and Healthcare Institutions
A. LEGAL AND REGULATORY
10. Union Cabinet Approves BioE3 (Biotechnology for Economy, Environment and Employment) Policy for Fostering High-Performance Biomanufacturing
On August 24, 2024, the Union Cabinet, chaired by Prime Minister Shri Narendra Modi, approved the proposal 'BioE3 (Biotechnology for Economy, Environment and Employment) Policy for Fostering High Performance Biomanufacturing' of the Department of Biotechnology.
The salient features of BioE3 policy include innovation-driven support to Research and Development (R&D) and entrepreneurship across thematic sectors. This will accelerate technology development and commercialization by establishing Biomanufacturing & Bio-AI hubs and Biofoundry. Along with prioritizing regenerative bioeconomy models of green growth, this policy will facilitate the expansion of India's skilled workforce and provide a surge in job creation.
Overall, this Policy will further strengthen the Government's initiatives such as 'Net Zero' carbon economy & 'Lifestyle for Environment' and will steer India on the path of accelerated 'Green Growth' by promoting 'Circular Bioeconomy'. The BioE3 Policy will foster and advance a future that is more sustainable, innovative, and responsive to global challenges and lays down the Bio-vision for Viksit Bharat.
11. Food and Agriculture Organization under the Department of Animal Husbandry and Dairying organized a two-day workshop on Finalization of Standard Veterinary Treatment Guidelines
A two-day workshop on 'Finalization of Standard Veterinary Treatment Guidelines' (SVTG) was organised by the Food and Agriculture Organization (FAO) of the United Nations, under the aegis of the Department of Animal Husbandry and Dairying (DAHD), Government of India at New Delhi on August 8 and 9, 2024.
The said guidelines aim to provide a robust framework for Animal Health Practitioners, ensuring consistency in prescription practices, reducing variability, and enhancing compliance among veterinarians and other prescribers. By establishing clear and standardized treatment protocols, the SVTGs will empower policymakers with effective tools to control and manage animal diseases more efficiently, ultimately contributing to broader public health goals.
12. Deadline Extended for Feedback on Amendments to Rule 3 of the Legal Metrology (Packaged Commodities) Rules, 2011
The Department of Consumer Affairs has extended the deadline for submitting comments on proposed changes to Rule 3 of the Legal Metrology (Packaged Commodities) Rules, 2011, to August 30, 2024. The amendment proposes to mandatorily declare all information on pre-packaged commodities meant for retail sale, except the packaged commodities meant for industrial consumers or institutional consumers. The amendment will bring clarity among manufacturers/ packers/ importers of packaged commodities of any quantity to make declarations if packed for retail sale. The changes aim to promote transparency, standardization, and consistency for consumers across different products.
B. GENERAL UPDATES
13. The National Medical Commission (NMC) Advises Medical Colleges to Implement Comprehensive Safety Policies for Staff and Students
The NMC published a notice advising medical colleges and institutions to ensure safe workplace environments. All medical colleges are requested to develop a policy for a safe work environment within the college and hospital campus for all the staff members including faculty, medical students and resident doctors. The said policy should ensure adequate safety measures at OPD, wards, casualty, hostels, and other open areas in the campus and residential quarters. The corridors and campus should be well-lit in the evening for staff to walk safely from one place to another and all sensitive areas should be covered by CCTV for monitoring. Adequate measures including the post of adequate security staff (male and female) should be made available as well.
Further, any incident of violence against the medical students should be promptly investigated by the college management, an FIR should be lodged with the police, and a detailed action taken report should be sent to the NMC within 48 hours of the incident.
14. Ministry of Environment flags illegal imports of banned Chlorinated Gloves, calls for compliance
The Ministry of Environment has flagged the continued import of banned chlorinated gloves, raising concerns about compliance with regulations. The Ministry has sought a detailed status report from the Drugs Controller General of India (DCGI) and the Bureau of Indian Standards (BIS) regarding the enforcement of rules prohibiting these imports. This matter was brought to the notice of the ministry by the Indian Rubber Gloves Manufacturers Association. The Chlorinated gloves often used in healthcare, are unsafe and pose environmental risks. Their continued import violates India's existing environmental and safety standards, even as the phase-out date for such gloves as prescribed in the Biomedical Waste Management Rules, 2016 expired long ago.
HEALTHCARE AND ALLIED SECTOR
A. LEGAL AND REGULATORY
15. Food Safety and Standards Authority of India (FSSAI) has extended the deadline for utilizing pre-printed packaging materials using the claim '100% fruit juice' on labels and advertisements
On August 14, 2024, the FSSAI mandated that all FBOs must cease using the claim '100% fruit juice' on labels and advertisements for reconstituted fruit juices. Basis the various representations received from stakeholders, the FSSAI has extended the deadline for using pre-printed packaging materials. The new deadline for utilizing these materials is now December 31, 2024. Additionally, products manufactured by FBOs are allowed to be sold in the market across all channels until the end of their shelf life.
16. Selling/ Marketing of Milk and Milk Products in the name of A1 and A2
FSSAI issued an advisory on August 21, 2024, stating that several Food Business Operators are selling/ marketing Milk and Milk Products such as Ghee, Butter, Curd, etc. in the name of A1 and A2 products under FSSAI License Number and/or Registration Certificate Number. The FSSAI noted that the A1 and A2 differentiation of milk is essentially linked to the difference in the structure of the protein. Hence, the use of A2 claims on milk fat products is misleading and not in conformance with the provisions of the FSS Act, 2006, and regulations made thereunder.
However, on August 26, 2024, the FSSAI withdrew the aforementioned advisory for further consultation and engagement with stakeholders.
Link to withdrawal of advisory here
B. GENERAL UPDATES
17. Union Minister for Health & Family Welfare Launches National Medical Register Portal for MBBS Doctors
The Union Minister for Health & Family Welfare Shri J.P. Nadda launched the National Medical Register (NMR) Portal of the NMC, on August 23, 2024, for the registration of all MBBS doctors who are eligible for registration in India. The NMR is mandated under Section 31 of the NMC Act, 2019, and will be a comprehensive and dynamic database for all MBBS-registered doctors in India. Linked to Aadhaar, the NMR ensures the authenticity of practitioners and aims to streamline the registration process. The portal is a significant step in building a digital healthcare ecosystem, ensuring transparency, and improving the quality of healthcare. It will also expand to paramedics and other healthcare professionals in the future.
18. The Supreme Court has ordered the Union and State Governments to establish the National Commission and State Councils
The Supreme Court has ordered the Union and State Governments to establish the National Commission and State Councils under the National Commission for Allied and Healthcare Professions Act, 2021 within two months. The Supreme Court warned of coercive action against department secretaries if the given deadline is not met.
19. Supreme Court stays AYUSH Ministry's notification omitting Rule 170 of Drug and Cosmetics Rules,1945 for prohibiting misleading advertisements
On 27th August 2024, the Supreme Court criticized the AYUSH Ministry regarding Rule 170 of the Drugs and Cosmetics Rules, 1945. This rule, established in 2018, requires AYUSH drug manufacturers to obtain approval and a unique identification number from the state licensing authority before advertising their products. The rule aims to prevent misleading advertisements of Ayurvedic, Siddha, and Unani medicines.
During a case involving Patanjali Ayurved Limited, the Supreme Court questioned the AYUSH Ministry's July 1, 2024 notification, which instructed state licensing authorities not to enforce Rule 170. This notification reiterated a previous stance from August 29, 2023.
Rule 170 mandates that manufacturers submit detailed information about their products, including references from authoritative texts, evidence of safety and effectiveness, and quality of drugs. Applications can be rejected for various reasons, such as lack of contact details, obscene content, or misleading claims.
Challenges in regulating AYUSH drugs include the fact that, unlike allopathic medicines, AYUSH drugs do not require extensive clinical trials for approval. Most AYUSH drugs can be approved based on traditional texts, except those containing specific ingredients like snake venom or heavy metals, which require safety trials.
The AYUSH Ministry's directive to ignore Rule 170 was influenced by the Ayurvedic, Siddha, and Unani Drugs Technical Advisory Board (ASUDTAB). The board suggested omitting the rule due to ongoing amendments in the Drugs and Magic Remedies Act, which also addresses misleading advertisements.
The Supreme Court accordingly stayed the said notification dated 1st July 2024, issued by the Ministry of AAYUSH.
20. The Ministry of AYUSH has received 38,539 complaints of misleading advertisements
The Ministry of AYUSH is taking action against misleading advertisements related to Ayurveda, Siddha, Unani, and Homoeopathy (ASU&H) products through its Pharmacovigilance Program under the Ayush Oushadhi Gunvatta evam Uttpadan Samvardhan Yojana (AOGUSY). So far, over 38,000 misleading ads have been reported. The said Ministry has urged State Drug authorities to prevent inappropriate ads and enforce stricter compliance under the Drugs and Magic Remedies Act, 1954.
21. Odisha declares Bhang as an intoxicant
The Odisha government has officially classified 'Bhang' as an intoxicant, as per a notification issued by the Excise Department on August 12, 2024. Bhang, derived from the leaves or small stalks of the Indian hemp plant (Cannabis Sativa), can be smoked, chewed, eaten, or infused into drinks. This classification is due to Bhang's potential to cause symptoms such as grandiosity, excitement, hostility, disorientation, hallucinations, and thought disorders.
22. Kerala Drug Control Administration directs Discount Pharmacies to display Price Lists of drugs available on discount
Following the order of the Kerala High Court, the Drug Control Administration in Kerala has directed all discount pharmacies to display a list of items with applicable discounts. The court direction is not only applicable to the chain pharmacies, but it applies to all medical shops that are offering price discounts, as the consumers have the right to know which medicines are available at discounted rates.
23. WHO Encourages Early Discussions for Mpox Vaccine Purchases
The World Health Organization (WHO) has announced that partners such as Gavi and UNICEF can begin commercial discussions to procure Mpox (monkeypox) vaccines even before formal regulatory approval is granted by the UN health agency. This proactive measure is aimed at ensuring a timely response to potential outbreaks. By initiating early procurement negotiations, global health authorities aim to increase preparedness and ensure vaccines are available swiftly once approved.
24. 'Pradhan Mantri Surakshit Matritva Abhiyan' (PMSMA) strategy launched to ensure quality Antenatal care to pregnant women for individual tracking of high-risk pregnancies and provision of additional PMSMA sessions.
On August 2, 2024, the Government of India launched the PMSMA to provide fixed-day, free-of-cost, assured, comprehensive, and quality antenatal care on the 9th day of each month to all pregnant women in their 2nd and 3rd trimesters of pregnancy at designated public health facilities by Obstetricians/Medical officers.
C. KEY JUDGMENTS
1. Prashant S/o Gokul Tipale vs State of Maharashtra (Criminal Application (Apl) No. 638 of 2023)
In a significant judgment delivered by the Nagpur Bench of Hon'ble Bombay High Court in a Criminal Application filed by Applicant under Section 482 of the Code of Criminal Procedure, 1973, the Hon'ble Court quashed a Special (Drugs & Cosmetics) Criminal Case No. 25 of 2022 (Complaint) registered against the Applicant who was a registered medical practitioner as a psychiatrist. The judgment protects doctors from prosecution for selling medicines to their patients provided they comply with the Drug and Cosmetics Act, 1940 (Act)and its rules.
Background of the Case
A complaint was filed against the Applicant by a drug inspector on information that the Applicant was indulging in the sale of medicine to his patients without any license. Therefore, a dummy patient was sent to the clinic. The said patient was examined by the Applicant. The Applicant then prescribed medicines and sold him the medicines available with him under the bill. It was the case of the Respondent (Drug Inspector, Food and Drugs Administration) in the Complaint that the stock and sale of the medicines by the Applicant to the patient was in contravention of provisions of Section 18(c) of the Act.
Accordingly, the Complaint was filed before the learned Special Court. Pursuant to which, the learned Sessions Judge issued notice against the Applicant. The Applicant was therefore constrained to file the present Application seeking to quash the Complaint inter-alia on the ground that he was a registered medical practitioner.
As per the Drugs and Cosmetics Rules, 1945 (DC Rules) more particularly Rule 123 of the DC Rules, the drugs specified in Schedule K are exempted from the operation of Chapter IV of the Act. Section 18(c) is a part of Chapter IV of the Act. The Applicant contended that he was governed by Clause (5) of Schedule K r/w Rule 123 of the DC Rules which exempted registered medical practitioners from certain provisions when supplying drugs to their patients. The Applicant further contended that the entire stock was duly accounted for at the time of the inspection itself. The report of the analyst also showed that the drug was of standard quality and therefore the Applicant contended that he could not be criminally prosecuted under Section 27 of the Act.
The Respondent contended that the drug was stocked for sale and that the provisions of Rule 123 r/w Clause 5 of Schedule K of the DC Rules did not apply to the case of the Applicant. It was contended that the Applicant was not supposed to maintain the stock and sell drugs out of the stock to his patient.
After hearing submissions of both parties, the Hon'ble Court basis the facts of the matter made the following observation:
(i) Registered Medical Practitioner Status: It was an undisputed position that the Applicant was a licensed psychiatrist.
(ii) Exemption Under Rule 123: The court affirmed that the act of the Applicant squarely falls within Rule 123 r/w Clause 5 of Schedule K of the DC Rules and therefore the Applicant is exempted from provisions of Chapter IV of the Act for supplying drugs to the patient he examined.
(iii) Proper Documentation: The Applicant had maintained records of his stock and provided necessary documentation to the drug inspector upon request. There was no evidence suggesting that the Applicant had sold drugs unlawfully or failed to account for the medications dispensed.
(iv) Lack of Cognizable Offense: The Hon'ble Court observed that the prosecution had not established a prima facie case against the Applicant. The complaint lacked sufficient grounds to substantiate the charges, and the learned Special Judge failed to record reasons for issuing the process against the Applicant, which is a procedural requirement under Section 204 of the Code of Criminal Procedure.
Basis the above observation, the Hon'ble Court passed the judgment allowing the Application holding that the prosecution against the Applicant was unsustainable in law.
Conclusion
This judgment underscores the importance of recognizing the legal rights of registered medical practitioners under the Act and emphasizes the need for proper judicial reasoning before initiating criminal proceedings.
This ruling serves as a precedent for similar cases, affirming that registered medical practitioners may dispense certain medications without the burden of criminal liability, provided their actions fall within the legal framework of the Act and its rules. The ruling is expected to provide clarity and reassurance to doctors across India who routinely dispense medication as part of their practice.
Contributors to the Newsletter:
- Nusrat Hassan, Managing Partner
- Abhinav Anand, Principal Associate
- Khushi Shah, Associate