Please click here to download the Newsletter as a PDF.

 

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:

1. health supplements;
2. nutraceuticals;
3. food for special dietary use;
4. food for special medical purpose; and
5. 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:

1. 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;
2. 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
3. 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 Sinha^[1] 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 Nadu[2] 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 Limited[3] 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]

 

This Newsletter has been prepared by:

Sidharrth Shankar Partner

Ayisha Mansoor Partner

 

For more details, please contact [email protected]

[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

 

Please click here to download the Newsletter as PDF.

This edition of the JSA Healthcare Newsletter focuses on key developments undertaken in the Indian healthcare ecosystem for the months of January and February 2024.

 

Regulatory updates

Launching of National Single Window System

The Central Drugs Standard Control Organisation (“CDSCO”), on January 1, 2024, issued a public notice that with effect from January 15, 2024, applications in relation to regulatory approvals for medical devices (specifically, the certificate of registration, and licenses to manufacture and import) would only be accepted through online filing at the National Single Window System (NSWS) Portal, and that applications would no longer be accepted in the existing SUGAM portal[1].

 

New guidelines issued for intensive care unit admission and discharge criteria 

The Ministry of Health and Family Welfare (“MoHFW”) has introduced guidelines for regulating the admission and discharge criteria for intensive care units for hospitals to decide the need of admitting a patient for treatment in an intensive care unit (“ICU”).  Altered level of consciousness of recent onset, hemodynamic instability, need for respiratory support, patients with severe acute (or acute-on-chronic) illnesses requiring intensive monitoring or organ support or any medical condition or disease with anticipation of deterioration, patients who have undergone major surgery, among others, have been listed as criteria for ICU admission. Blood pressure, pulse rate, respiratory rate, breathing pattern, heart rate, oxygen saturation, urine output and neurological status among other parameters should be monitored in a patient awaiting an ICU bed.

 

CDSCO issues notice regarding pathway for clearance of fixed dose combinations (“FDCs”) for sale in India

The CDSCO had issued a letter on January 15, 2013, stating that all State/UT Drugs Controllers were requested to ask the concerned manufacturers in their state to prove the safety and efficacy of FDC’s within 18 (eighteen) months which were permitted by the State Licencing Authorities without due approval from the office of Drug Controller General of India (“DCGI“). An expert committee was constituted based on the Supreme Court order dated February 15, 2017 to examine certain FDCs licensed for manufacturing without due approval from the DCGI. The expert committee subsequently provided recommendations with respect to 3 specific FDCs.

The CDSCO has issued a public notice on January 11, 2024, providing a pathway for clearance of such FDCs based on whether (a) manufacturers are holding licenses for such FDCs from State Licensing Authorities prior to October 1, 2012; (b) manufacturers are new manufacturers for the proposed FDCs; (c) manufacturers are holding licenses from State Licensing Authorities prior to October 1, 2012, and did not apply to DCGI.

 

Surrogacy Amendment Rules, 2024

The MoHFW on February 21, 2024, has notified the Surrogacy (Regulation) Amendment Rules 2024. The earlier requirement was that the couple undergoing surrogacy was supposed to have both gametes from the intending couple and donor gametes for surrogacy was not permitted. Following this amendment, couples can now opt for surrogacy, and use donor gametes if either spouse is certified by the District Medical Board as having a medical condition which prevents the spouse from contributing the gamete.

 

Interesting Reads

Dispensation of antibiotics only on doctor prescriptions

The Director General of Health Services has issued an appeal to all pharmacy associations to ensure that antibiotics are only sold on a prescription from a registered medical practitioner. This has been issued following the over usage of antibiotics resulting in antimicrobial resistance (AMR). The concerned official also observed that AMR has resulted in non-effective treatment of infections leading to prolonged illness and often death.

 

Proposed amendment to the Drugs and Magic Remedies (Objectional Advertisements) Act, 1954

The Government of India proposes to amend the aforementioned statute to include the prohibition of misleading advertisements in relation to AYUSH drugs. These amendments were originally proposed in 2020 and sought to prevent misleading advertisements in relation to drugs for treatment for enhancing sexual performance, fairness of skin, improvement in the height of kids and adults, and premature ageing.

 

Closing down of small pharma units

Following inspections of various pharma manufacturing units, as part of a crackdown on spurious and sub-standard drugs, the CDSCO along with state regulatory authorities, has issued show cause notices to several small and medium scale pharma units, including requiring some units to close down.

 

Sale of antibiotics in Kerala

The government of Kerala, with a view to controlling the extensive use of antibiotics, has required all pharmacies and hospitals in Ernakulam to only sell antibiotics in a blue cover, and only with the prescription of a doctor. All pharmacies and hospitals are required to put up posters indicating that any antibiotic will be sold only with a doctor’s prescription.

 

Reimbursement of durable medical equipment

The Vadodara District Consumer Disputes Redressal Commission (“District Commission”) has ruled that a patient is entitled to be reimbursed for durable equipment used in medical treatment after getting discharged from the hospital. The patient, Vijay Joshi had been admitted to hospital and diagnosed with a disorder similar to sleep apnea. The insurance company paid only a part of his claim, on the grounds that all external durable equipment that could be used at home were excluded under the insurance policy. Rejecting this argument, the District Commission, taking note of the hospital discharge summary, held that the treatment was to continue at home, and hence the use of durable equipment at home was a continuation of the treatment in the hospital, and directed the insurance company to compensate the patient.

 

Rejection of European free trade agreements ‘data exclusivity’ provisions

The Government of India, with an aim to protect the generic drug manufacturers in India, has rejected the ‘data exclusivity’ provisions in proposed free trade agreements with Iceland, Liechtenstein, Norway, and Switzerland. In the pharma sector, any data exclusivity would permit innovator companies to prevent their competitors from obtaining market licenses for low-cost versions of the drugs, during the tenure of the exclusivity.

 

Walk-in meetings

In a public notice dated February 14, 2024, the CDSCO has indicated that the DCGI would hold walk-in meetings with stakeholders every Tuesday and Thursday at New Delhi, with an aim to address all grievances and complaints in a swift and suitable manner. This move is introduced keeping in mind the government’s aim of easing doing business in India.

 

This Newsletter has been prepared by:

Ayisha Mansoor Partner

Prakriti Jaiswal Partner

[1] An online platform launched by CDSCO to facilitate the electronic submission of applications, tracking of status, and other regulatory services.