Stay updated with the latest developments in the life sciences and healthcare sectors with our April 2024 newsletter. This month's edition covers a range of important regulatory updates from the Central Drugs Standard Control Organization including initiatives to strengthen private medical device testing facilities, a shift to online applications for NOCs for specific drugs, and draft guidance documents for clinical trial applications and in-vitro diagnostic medical devices. We also highlight the launch of a mobile app to improve access to healthcare services for beneficiaries of the Central Government Health Scheme, and a noteworthy Supreme Court judgement on medical negligence.
Industry Updates
1. Central Drugs Standard Control Organization ("CDSCO") notifies all stakeholders for Strengthening of Private Medical Device Testing Laboratory
In order to strengthen the private testing facility for medical devices in the country, the CDSCO is in the process of identifying the existing private labs having the facility to test the medical devices, with testing facilities for carrying out various tests including physical, chemical, microbiology, mechanical and electrical, so that the labs may be registered under the Medical Devices Rules, 2017 ("MDR, 2017").
In view of the same the CDSCO vide notification dated April 3, 2024, has requested all stakeholders having such facilities for testing of medical devices, to submit the application in Form MD-39 along with the requisite information with fees as per the MDR, 2017 for registration of testing laboratory on behalf of the manufacturer.
2. NOCs for manufacture of Unapproved/Banned/New Drugs Solely for Export Purpose to be obtained from CDSCO Zonal offices via Sugam Portal
On April 3, 2024, the Ministry of Health and Family Welfare decided that applications for NOCs for manufacture of unapproved/banned/new drugs solely for export purpose from May 15, 2024, must be done online through CDSCO Zonal Offices. Accordingly, the power delegated to State/UT Licensing Authority stands withdrawn w.e.f May 15, 2024, and such NOCs shall be granted by the Head of the respective CDSCO Zonal Office. All Manufacturers are required to obtain NOC from respective Zonal Offices of the CDSCO through the online SUGAM Portal with effect from May 15,2024 before issuing Manufacturing License from State Licensing Authority for manufacture of unapproved/banned/ new drugs for export purpose. Further, all State/UT Drug Controllers are required to handover all NOCs issued from August 20, 2018, to May 14, 2024, to the respective Zonal Offices of the CDSCO.
3. On April 10, 2024, CDSCO published draft 'Guidance for Industry, Version 1.2.'
CDSCO prepared a draft 'Guidance for Industry, Version 1.2' on submission of clinical trial application for evaluating safety and efficacy in consultation with the stakeholders to align with the New Drugs and Clinical Trial Rules, 2019 and the SUGAM application process.
4. CDSCO published draft Guidance Document on Stability Studies of In-vitro Diagnostic Medical Device
On April 5, 2024, the CDSCO published the 'Guidance on Stability Studies of In-vitro Diagnostic Medical Device ("IVDMD"),' aimed for creating public awareness about In-Vitro Diagnostic Devices Regulation by CDSCO. It is a guidance for manufacturers in preparation of a premarket review document for IVDMD import or manufacturing license applications. This guidance is intended to aid manufacturers in the preparation of scientific information to be provided in support of claimed shelf life, in use stability and shipping studies for IVDMD license applications and post approval change application filed in pursuant to the MDR 2017.
General Updates
1. On April 3, 2024, the Ministry of Health and Family Welfare launched the myCGHS iOS ecosystem of devices app. The app is designed to enhance access to Electronic Health Records, information, and resources for Central Government Health Scheme ("CGHS") beneficiaries. The myCGHS app facilitates a wide range of services, including booking and cancellation of online appointments, downloading CGHS card and index card, accessing lab reports from CGHS labs, checking medicine history, checking medical reimbursement claim status, accessing referral details, locating nearby wellness centers, staying updated with news and highlights, locating nearby empaneled hospitals, labs, and dental units and accessing contact details of wellness centers and offices. Read more
Key Judgements
Noteworthy judgements in the realm of Healthcare and Lifesciences to increase awareness and knowledge.
Medical Negligence: An 'Eggshell Skull' Perspective
1. Jyoti Devi v. Suket Hospital and Ors. – 2024 SCC Online SC 581 (Decided on April 23, 2024)
The appellant, in this case, was admitted to Suket Hospital, Himachal Pradesh, in 2005 for appendicitis surgery which was performed by a senior surgeon. Post-surgery, the appellant was discharged but continued to experience continuous pain. After multiple admissions and discharges over four years at various places, the appellant eventually sought treatment at the Post Graduate Institute of Medical Science, Chandigarh. Upon investigation, it was revealed that a 2.5 cm foreign body (needle) was found below the anterior abdominal wall of the appellant, necessitating another surgery for its removal. The appellant alleged medical negligence by Suket hospital and claimed compensation for physical pain, mental agony, and expenses amounting to INR 19,80,000.
The court in this case delved into the scope of the Consumer Protection Act, 2019, and the law of medical negligence. The court examined the "Eggshell Skull Rule," a common law doctrine that holds a defendant liable for the plaintiff's unforeseeable and uncommon reactions to the defendant's negligent or intentional tort. The court further explained the Rule in simple terms, by stating that 'a person who has an eggshell skull is one who would be more severely impacted by an act, which an otherwise "normal person" would be able to withstand. Hence the term eggshell is to denote this as an eggshell is by its very nature, brittle.'
The court noted that the jurisprudence of the application of the Rule has fit into four categories: (1) when a latent condition is unearthed; (2) when negligence reactivates a pre-existing condition that had subsided due to treatment; (3) when actions aggravate a known pre-existing condition that have not yet received medical attention; and (4) when actions accelerate an inevitable disability or loss of life, even if the eventuality would have occurred with time in the absence of the wrongdoer's actions. The apex court further re-iterated that this Rule can only be applied to persons who have pre-existing conditions.
The court found that the State Commission and National Consumer District Redressal Commission's reasoning for reducing compensation was questionable, given their observations about the hospital's deficient service and the appellant's prolonged suffering. The apex court set aside the awards of the NCDRC and State Commission and restored the Award amounting to INR 5,00,000 as passed by the District Forum accompanied with an interest of 9% from the date of award passed by District Forum and additionally imposed litigation costs.
Contributors to the newsletter:
- Nusrat Hassan, Managing Partner
- Pradnesh Warke, Partner
- Tanay Jha, Associate
- Khushi Shah, Associate
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.