This edition of the JSA Healthcare Newsletter focuses on key developments undertaken in the Indian healthcare ecosystem for the months of May and June 2024.
Regulatory updates
Medical Termination of Pregnancy (Amendment) Rules, 2024
The Ministry of Health and Family Welfare ("MoHFW") vide notification dated June 10, 2024, amended the Medical Termination of Pregnancy Rules, 2003. Under Rule 3B and in Form E of the Medical Termination of Pregnancy Rules, 2003, the word 'mental retardation' is substituted with 'women with intellectual disability'.
Circular on medical device licence holder under materiovigilance programme of India
The Central Drugs Standard Control Organisation ("CDSCO") issued a circular dated May 15, 2024, regarding the Materiovigilance Programme of India ("MvPI"). The MvPI is an important program for reporting of adverse events, and coordinated analysis related to the medical devices including in-vitro diagnostic devices. In this regard, the license holders are suggested to use the MvPI platform for reporting of any adverse events/serious adverse events associated with the devices to enhance the procedure for identifying risk associated with medical devices.
Circular on blood centre situated in hospital
CDSCO, vide circular dated May 22, 2024, clarified that the blood centre run by hospital means the blood centre situated in the hospital premises. Further, the applications for grant/renewal of license are accepted by the state drugs department and CDSCO for operation of blood centre/processing of human blood components run by the Government, Indian Red Cross Society, hospitals, charitable trust or voluntary organisation.
Circular on regulation of all Class C and D medical devices under licensing regime
CDSCO, vide circular dated May 16, 2024, stated that if an existing importer/manufacturer who is already importing/manufacturing any of the Class C or Class D medical devices, has submitted application on or before September 30, 2023 to the Central Licensing Authority, for the grant of import/manufacturing licence under the provisions of Medical Devices Rules, 2017, the said application must be deemed valid. The importer/manufacturer can continue to import/manufacture the said device(s) for up to 3 (three) months from the date of issue of this circular or till the Central Licensing Authority, takes a decision on the said application (whichever is earlier).
Circular on retention of license/certificates under Medical Devices Rules, 2017
CDSCO, vide circular dated May 15, 2024, requested all the stakeholders to ensure that the requisite fee payable under the Medical Devices Rules, 2017 ("MDR 2017") for manufacturing/import license of medical devices and registration of quality management system certification, may be deposited in appropriate account of the Government, before the stipulated timeline under MOR, 2017. The stakeholders must also submit the application to the licensing authority in order to maintain continuity of the product in the market.
Employees' State Insurance Corporation issues revised guidelines and standard operating procedure for home delivery of drugs
The Employees' State Insurance Corporation ("ESIC") vide circular dated January 10, 2024, revised the guidelines and Standard Operating Procedure ("SOP") relating to home delivery of drugs to the ESIC beneficiaries. ESIC medical colleges, on a pilot project basis, are authorised to provide the facility of home drug delivery to ESIC beneficiaries. These services are limited to the districts as decided by the dean/medical superintendent of the concerned hospitals.
Eligibility: (a) all senior citizens with chronic illness entitled for treatment with ESIC, receiving consultations from the hospital and prescribed for more than 30 (thirty) days; (b) all ESIC beneficiaries, ESIC employees and their dependents, pensioners seeking consultation through e-Sanjeevani; and (c) handicapped and bed ridden patients on medication for chronic disease.
Hospital's responsibility: Hospitals are required to float a bid on the Government e-Marketplace (GeM) portal for procuring doorstep delivery services for drugs, including packaging, collection and electronic notifications to the beneficiary via SMS/WhatsApp regarding dispatch and delivery confirmation. The medical stores' in-charge are to act as nodal officer to monitor smooth functioning of the delivery process. Further, each hospital is required to adopt its own SOPs basis the process flow requirement and local needs, guidance for the vendor, pharmacist, other stake holders and grievance redressal system.
Vendor's responsibility: The vendor must ensure that the delivery of the drugs should be done through one time password based/signature of the authorised recipient. The vendor will be responsible for sending an SMS/WhatsApp notification to the beneficiary intimating: (a) parcel tracking number along with the link of tracking webpage; and (b) delivery of drug packet information. Additionally, vendors are required to ensure maintenance of cold chain as and when required for certain drugs.
Re-operationalisation of the regulations governing health supplements, nutraceuticals, special dietary food and medical purpose and prebiotic and probiotic food
While Food Safety and Standards Authority of India ("FSSAI") is finalising the provisions of draft FSS (Health Supplements, Nutraceuticals, Food for Special Dietary Use, Food for Special Medical Purpose, and Prebiotic and Probiotic Food) Regulations, 2022 ("Heath Supplements Regulations"), it has vide direction dated June 5, 2024 decided to re-operationalise the provisions of the Health Supplements Regulations from April 1, 2024. These regulations are applicable to:
- health supplements;
- nutraceuticals;
- food for special dietary use;
- food for special medical purpose; and
- prebiotic food and probiotic food.
Mandatory Ayushman Bharat Health Account ID for patient registration
The National Medical Commission ("NMC") vide public notice dated June 4, 2024, has mandated that all medical colleges are required to ensure that patients visiting for outpatient department/inpatient department/emergency services are registered with an Ayushman Bharat Health Account ("ABHA") ID in addition to the hospital's registration number. The authentication of patients and clinical material using ABHA ID is crucial for decisions regarding college assessments, such as increasing under graduate/post graduate seats, establishing new colleges, and renewing permissions/recognitions to admit students.
Press release on reforms in health insurance
The Insurance Regulatory and Development Authority on May 29, 2024, issued the Master Circular on health insurance business, repealing 55 (fifty five) circulars. Key aspects of the master circular are as follows:
- wider choice to be provided by the insurers by making available products/add-ons/riders by offering diverse insurance products catering to all ages, regions, occupational categories, medical conditions/ treatments, all types of hospitals and health care providers to suit the affordability of the policyholders/prospects;
- introduction of customer information sheet which is provided by the insurer along with every policy document, which explains the basic features of insurance policies in simple words; and
- customer to be provided with the flexibility to choose products/add-ons/riders as per his/her medical conditions/specific needs.
Centre withdraws the powers of states for issuing no objection certificate for export of drugs
CDSCO, vide an order dated April 30, 2024 has withdrawn the power of State Governments to issue no-objection certificates ("NOC") for the manufacture of unapproved/banned/new drugs solely for export amid the heightened global scrutiny of Indian drugs. This power currently remains solely with CDSCO, and the existing players can file fresh applications for the NOC from May 15, 2024, via online mode through CDSCO zonal offices.
CDSCO drafts norms to report adverse effects of vaccines
The CDSCO on May 29, 2024, released "Guidance for industry on Pharmacovigilance requirements for Human Vaccines' directing the manufacturers and importers of vaccines to report Serious Adverse Events (SAEs) in India and distributing countries within 15 (fifteen) days to the CDSCO. After a vaccine is approved, requirement of stringent follow-up is essential, to monitor vaccine safety in routine use through phase IV-post marketing trials, practice management system, observational or non-interventional study for active surveillance, including assessment of Adverse Events Following Immunisation (AEFI) and Adverse Events of Special Interest (AESI).
CDSCO mandates adherence to Bureau of Indian Standards for medical devices
CDSCO, vide circular dated May 29, 2024, has mandated that medical device manufacturers and in-vitro diagnostic testing laboratories comply with the Bureau of Indian Standards ("BIS") for product testing. The circular was issued in consonance with the observation that the testing of the Medical Devices which have BIS Standards available has not be carried out as per the standards.
Self-Certificate for advertisement
On June 3, 2024, the Ministry of Information and Broadcasting in line with the directions issued by the Supreme Court of India ("Supreme Court") issued press release requiring a self-declaration certificate ("SDC") to be submitted before publishing or broadcasting any content effective from June 18, 2024. The advertising agencies are required to file their SDCs through the Broadcast Seva Portal and print and digital Media must submit the same via the Press Council of India's portal.
Case laws
The complaint of medical negligence may not be entertained unless supported by credible opinion given by another doctor
The High Court of Jharkhand in the case of Dr. Suman Kumar Pathak vs. the State of Jharkhand and Ritesh Kumar Sinha1 has quashed the criminal proceedings against the petitioner citing the need for credible medical evidence to support claims of negligence. The court emphasised that mere allegations without expert medical opinion are insufficient for criminal prosecution. The judgment referenced the Supreme Court's guidelines in the Jacob Mathew case, highlighting the need for caution in prosecuting medical professionals for negligence.
No person should be denied of quality medical treatment: Madras High Court
In B Anantha Lakshmi and S Kiruthika vs. the State of Tamil Nadu2 while adjudicating the bond period of post graduate doctors, the Madras High Court observed that any poor person who is unable to afford paid treatment can in no way be treated differently. A life is a life, and it has its value. No person should be denied quality treatment on economic grounds. The court dismissed the petitions, stating that the petitioners must fulfil the bond conditions as agreed, emphasising the importance of serving the poor and needy in government hospitals. The court upheld the bond conditions, requiring the petitioners to complete their service period in government hospitals.
Bombay High Court emphasised on the importance of preventing confusion in medicinal products, citing potential health risks
Glenmark Pharmaceuticals Limited3 sought an injunction against Gleck Pharma for using the trademark "XIGAMET," claiming it was deceptively similar to their trademark "ZITA-MET. The court granted the ad-interim injunction, restraining Gleck Pharma from using "XIGAMET" due to the likelihood of confusion between the 2 (two) trademarks, especially given the medicinal nature of the products.
Fundamental right to health includes customer's right to be made aware of quality of products: Supreme Court
The Supreme Court in the case of Indian Medical Association and Anr. vs. Unions of India and Ors.4 has held that the fundamental right to health encompasses the right of a consumer to be made aware of the quality of products being offered for sale by manufacturers, service providers, advertisers and advertising agencies. To protect this right, the Court directed that henceforth, before an advertisement is printed/aired/displayed, a self-declaration shall be submitted by the advertiser/advertising agency on the lines contemplated in Rule 7 of the Cable Television Networks Rules, 1994.
Not every death in hospital indicates medical negligence unless proven otherwise: National Consumer Disputes Redressal Commission
The National Consumer Disputes Redressal Commission ("NCDRC") presided by AVM J. Rajendra, in Hridylal Sahu vs. Dr. Roshan Upadhyay and Anr.5 held that not every death occurring in a hospital setting can automatically be considered medical negligence based on an assumption of inadequate medical care. It was further held that in order to prove medical negligence, concrete evidence has to be submitted.
Unsuccessful treatment or differing opinions does not equate to medical negligence: NCDRC
NCDRC presided by Mr. Binoy Kumar, in the case of Jagdish K Sharma vs. Medanta, the Medicity,6 dismissed a complaint against Medanta Hospital and ruled that an unfavorable outcome of treatment alone or a divergence in professional opinion does not amount to negligence on the part of the medical professionals as long as they're acting as per the accepted practice.
Interesting Reads
Expedite framing of policy on online sale of medicines, Madras High Court directs Centre
The Madras High Court has directed MoHFW as well as CDSCO to expedite the process of finalising a policy for the online sale of medicines and notify it at the earliest. A Division Bench made it clear that till then only licensed druggist and chemists could indulge in online sales and the competent authorities must initiate actions in the event of any violation.
Punjab and Haryana High Court seeks response from Punjab and Haryana Governments on establishing community home for persons with mental illnesses
The Punjab and Haryana High Court has sought response from both the states on public interest litigation filed seeking directions to establish community-based group homes for persons with mental illness and to frame comprehensive guidelines as per the Mental Health Care Act, 2017.7
MoHFW and Ministry of Defence sign memorandum of understanding to set up dedicated Tele MANAS cell for armed forces
A memorandum of understanding was signed between MoHFW and the Ministry of Defence on June 5, 2024, to facilitate collaboration between the 2 (two) ministries in operating a special cell of Tele MANAS, the National Telemental Health Helpline of MoHFW, as a pilot project for a period of 2 (two) years at the Armed Forces Medical College in Pune.8
FSSAI directs food business operators to remove claim of 100% fruit Juices from the label and advertisement of fruit juices
FSSAI has issued a directive mandating all Food Business Operators ("FBOs") to remove any claim of '100% fruit juices' from the labels and advertisements of reconstituted fruit juices with an immediate effect. All the FBOs have also been instructed to exhaust all existing pre-printed packaging materials before September 1, 2024.9
Central council for research in ayurvedic sciences launches "PRAGATI-2024", an initiative to shape the future of ayurveda
The Central Council for Research in Ayurvedic Sciences ("CCRAS"), an autonomous body under the Union Ministry of Ayush, has launched "PRAGATI- 2024" (Pharma Research in AyurGyan and Techno Innovation). It offers an efficacious opportunity for collaborative research in the field of Ayurveda. It aims to explore research opportunities and foster collaboration between CCRAS and the Ayurveda drug industry.10
Footnotes
1 Cr.M.P. No. 2866 of 2016 dated June 18, 2024.
2 WP N 6432 and 6434 of 2024 dated April 30, 2024
3 Glenmark Pharmaceuticals Ltd. v. Gleck Pharma (OPC) Pvt. Ltd IP Suit (L) No 30149 of 2023
4 W.P.(C) No. 645/2022
5 F.A. No. 2482/2017
6 C.C. No. 1934/2018
7 livelaw.in
8 pib.com
9 pib.com
10 pib.com
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