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Developments from September signal a continued focus on strengthening oversight, improving patient and consumer protection. There has also been a marked uptick in regulatory intervention, with courts and regulators not only examining whether the industry is complying with existing laws, but also whether the objectives of these laws are being fulfilled.
This edition of the JSA Healthcare Newsletter focuses on the key developments undertaken in the Indian healthcare and life sciences ecosystem during September 2026.
Registration requirement for allied and healthcare professionals operationalized
Over 5 (five) years after the National Commission for Allied and Healthcare Professions Act, 2021 (“NCAHP Act”) was notified, the Ministry of Health and Family Welfare (“MoHFW”), vide a notification dated August 31, 2026, has notified the Registration of Allied and Healthcare Professionals Regulations, 2026 (“NCAHP Regulations”) which establishes the framework for the registration of allied and healthcare professionals. This covers over fifty types of allied and healthcare professionals, several of which were previously effectively unregulated.
The NCAHP Regulations establish the requirement for all duly qualified allied and healthcare professionals to register with the relevant state council, following which their name will be entered into the state and central register, and they will be issued a unique identification number which entitles them to practice. The NCAHP Regulations also lay down the requirements for obtaining an interim registration during internships and a temporary registration for foreign allied and healthcare professionals.
In April 2026, the MoHFW had released a draft version of the Registered Allied and Healthcare Professionals (Professional Conduct and Ethics) Regulations, 2026 for public consultation which, once finalized, will govern the professional conduct of allied and healthcare professionals as well as the grounds for professional misconduct and the procedure for conducting an inquiry into alleged misconduct by a registered professional. Separately, the NCAHP has also been issuing the curriculums for various courses for allied and healthcare professionals.
The operationalization of the regulatory scheme under the NCAHP Act represents a significant step in improving the quality of healthcare in India. Going forward, healthcare organisations and digital healthcare companies would need to revamp their hiring, credentialing and privileging policies for allied and healthcare professionals.
Discussions around trade margin rationalization revived
The Supreme Court, while hearing a petition seeking measures to regulate the costs associated with treatments, expressed concerns over the mark-ups on drugs and medical devices, and highlighted the implications that it has on government-funded healthcare schemes. The court also questioned the central government on the feasibility of a uniform markup rate for all drugs and devices. Parallelly, several state governments have also highlighted the disparity between the price at which hospitals procure drugs and devices and the declared maximum retail price. The fact that only a fraction of the drugs that are commonly used are subject to price caps has also been highlighted.
This has resulted in a renewed focus on adopting the trade margin rationalisation (“TMR”) approach to price control. TMR has previously been adopted by the National Pharmaceutical Pricing Authority for regulating the price of certain non-scheduled formulations and devices, most notably during the pandemic. While no concrete steps towards implementing TMR for hospitals have been taken, the prospect of reduced margins has caused widespread panic amongst hospitals and investors.
Guidelines on certification of brain stem death released
The National Organ and Tissue Transplantation Organisation (“NOTTO”) under the MoHFW vide notification has released the National Guidelines on Brain Stem Death Certification, which establishes a national framework for the clinical and medico-legal determination and certification of brain stem death.
Brain stem death is recognized as a legally valid form of death under the Transplantation of Human Organs and Tissues Act, 1994 (“THOTA”), and is a pre-requisite for the harvesting of organs including the kidneys, heart, liver, pancreas, lungs, and small intestines.
The guidelines have been released with the aim to “standardize clinical practice with improve patient safety, reduce unwarranted variation, minimize medico-legal uncertainty, support ethical decision-making, enhance professional confidence, and foster greater public trust in deceased organ donation.”
While the guidelines are presently not legally binding, the NOTTO has reportedly asked state governments to request hospitals follow the guidelines. For hospitals, it is advisable to implement the guidelines, since any deviations may attract scrutiny.
Heightened scrutiny on stem cell therapies
Following the Supreme Court’s decision earlier this year clarifying that stem cell therapy may only be offered commercially or in routine clinical practice for specified diseases and conditions, both the MoHFW and the National Medical Commission (“NMC”) have issued advisory reiterating the position.
The MoHFW advisory, dated September 16, 2026, has been issued to all states and union territories that have adopted the Clinical Establishment (Registration and Regulation) Act, 2010, for downstream circulation and implementation by registered clinical establishments. The NMC advisory, dated September 5, 2026, has been issued to all registered medical practitioners and state medical councils. Failure to comply could result in inquiries and suspension of licenses. Given the attempts to ensure maximum circulation, it is anticipated that the government will be actively monitoring centres offering stem cell therapies, and will be initiating action against any persons not complying.
Front-of-pack warnings for packaged foods
Nearly 8 (eight) years since the Food Safety and Standards Authority of India (“FSSAI”) commenced discussions around the inclusion of front-of-pack warnings for “unhealthy” packaged foods, the Supreme Court has expressed frustration over the lack of progress that has been made. While hearing a public interest litigation for the mandatory introduction of front-of-pack warning labels, the court observed that the issue directly impacted citizens’ health, and pushed the FSSAI to expedite the implementation of warnings for packaged foods high in sugar, salt and saturated fats. The proposed framework could have significant implications for food businesses, who are increasingly facing scrutiny from both regulators and consumers for claims, ingredients, product formulations, and marketing practices.
This Newsletter is prepared by:
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Sidharrth Shankar |
Nandini Seth |
Eshika Phadke |
For more details, please contact km@jsalaw.com.
