Introduction
Welcome to the June 2025 edition of our Life Sciences and Healthcare Newsletter, where we delve into the latest developments shaping the industry. This month, we explored a range of significant legal and regulatory updates, including the modification of the Operational Guidelines of sub-scheme Capacity Building and Skill Development for Medical Devices by Department of Pharmaceuticals (DoP) and CDSCO's decision of manufacturers not requiring a loan license for outsourcing sterilization of medical devices to a licensed sterilization facility. 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.
Pharmaceuticals
Legal and regulatory
1. Grant of WHO-GMP COPP through One Nation One Drug Licensing (ONDLS) portal
The Central Drugs Standard Control Organization (CDSCO) has directed that all WHO-GMP (COPP) certificate applications to be submitted exclusively through the ONDS Portal from June 15, 2025. Physical copies of submissions will no longer be entertained for approval of grant of manufacturing license and WHO-GMP (COPP). A step-by-step procedure and contact details for support have also been provided.
ONDLS portal has been developed by CDAC in coordination with States for processing of application and online licensing of Sale/ Manufacturing license, Blood Centre license and Grant of manufacturing license and Large Volume Parenterals.
Health and wellness
Government initiatives
2. AYUSH Ministry launches Ayush Suraksha Portal to monitor misleading advertisements and adverse drug reactions
The Ministry of Ayush has launched the 'Ayush Suraksha Portal' to monitor and address issues of misleading advertisements and adverse drug reactions. The platform was launched on May 30, 2025 and it will serve as a vigilant watchtower against misleading advertisements and ensure that only safe and credible products reach the people. The said portal reflects the government's unwavering commitment to responsible governance, evidence-based practices, and the safety of millions of citizens who trust and rely on India's traditional systems of medicine.
3. Ministry of Ayush and Invest India has introduced the Ayush Nivesh Saarthi Portal to boost investment of traditional medicine
This portal is going to serve as a dedicated gateway for international and domestic investors seeking opportunities in India's Ayush sector (Ayurveda, Yoga & Naturopathy, Unani, Siddha, Sowa-Rigpa, Homeopathy). It offers comprehensive information on establishing operations in India, including business guidelines, governmental policies, and regulatory frameworks. The launch of this portal reinforces the government's vision of positioning Ayush as a cornerstone of public health and economic growth, fostering foreign direct investment, empowering entrepreneurs, and showcasing India's leadership in traditional medicine and wellness on the global stage.
4. Department Of Animal Husbandry and Dairying on anti-microbial resistance migration
CDSCO has asked the Department of Animal Husbandry and Dairying (DAHD) to provide information on producers involved in the manufacturing, distribution, and sale of veterinary antibiotics for the purpose of development of structured Antimicrobial Use (AMU) reporting framework.
To facilitate the implementation of this initiative, it is proposed to constitute a Joint Working Group comprising of representatives from CDSCO, DAHD and SLAs. The Joint Working Group will serve as a collaborative mechanism to coordinate efforts, and to streamline the process for AMU data collection, reporting and monitoring at national level.
5. Think Tank Nutrition Advocacy in Public Interest (NAPi) and 28 endorsers published a report calling for Front-of-Pack Nutrition Labelling (FOPNL) warning systems on pre-packaged foods and beverage products
A coalition of NAPi and 28 leading public health and consumer organizations released an updated Position Statement urging the Government of India to mandate front-of-pack warning labels on pre-packaged food and beverage products high in sugar, salt, and saturated fat. The call responds to the mounting evidence of health risks posed by High Fat, Sugar, and Salt (HFSS) / ultra-processed food (UPF) products. The said joint Position Statement has been developed by the endorsers concerning various issues of health, public health, consumer rights, food and nutrition, women and children's health. This lays emphasis on the key strategy i.e. FOPNL to reduce the consumption of ultra-processed unhealthy food or drink products or HFSS in order to curtail non-communicable diseases. Even the Supreme Court of India had also recently expressed concern over misleading and insufficient food labelling practices in India.
6. Directorate General of Foreign Trade (DGFT) has now authorized Ayush Export Promotion Council (AYUSHEXCIL) to issue certificates of origin (non-preferential) to boost Ayush exports
AYUSHEXCIL has been authorized by DGFT to issue non-preferential Certificates of Origin, enabling it to certify the origin of goods not covered under preferential trade agreements under the Foreign Trade Policy (FTP) 2023. This move aims to support Ayush product exporters by simplifying export procedures and offering sector-specific certification.
Medical devices
Legal and regulatory
7. The Department of Pharmaceuticals (DoP) modifies the Operational Guidelines of sub-scheme Capacity Building and Skill Development for Medical Devices under the scheme Strengthening of Medical Device Industry
The DoP has revised its 2024 Operational Guidelines for its 'Capacity Building and Skill Development for Medical Devices' sub scheme under the 'Strengthening of Medical Device Industry' initiative. Financial assistance will be provided to the Central Government and DoP will provide 75% of the cost of the course or INR 21,00,00,000 (Indian Rupees Twenty-One Crore) whichever is lower on reimbursement basis as and when expense incurred. The new criteria includes minimum admission thresholds at least 30% in the first year or 50% in subsequent years, failure of which results in the withdrawal of funding.
8. No loan license required by manufacturers for outsourcing sterilization of medical devices, provided the sterilization facility is licensed under Medical Device Rules, 2017
CDSCO has decided that a loan license is no longer required by manufacturers for outsourcing sterilization of medical devices, provided the sterilization facility is licensed under Medical Device Rules, 2017. Manufacturers must submit documentation to the Licensing Authority and include the sterilization site's license number on labels of the device. This said documentation may include mutual agreement between the manufacturer of the device and the sterilization site, Quality Management System document (Plant Master File, Device master File, etc.) of the manufacturer mentioning the details of such outsourced activity.
Key judgements
Noteworthy judgement in the realm of Healthcare and Lifesciences to increase awareness and knowledge.
M/s Bhagwati Medical Hall & Ors vs Central Drugs Standard Control Organization & Ors
Background
The Supreme Court of India on December 19, 2024 ruled that drug control officers from the Drug Control and Excise Department of any State cannot classify a licensed medicinal preparation as a 'prohibited article' unless a specific notification is issued under Section 26A of the Drugs & Cosmetics Act, 1940 ("Act") by the Central Government.
Case Overview
The Appellant engaged in selling aromatic tincture of cardamom for medicinal purposes, faced multiple inspections and eventual business closure by Drug Control officers in Uttar Pradesh. The District Magistrate passed an order restricting the trade of aromatic tincture of cardamom. Aggrieved by the order of the District Magistrate, the Appellant challenged the same before the Allahabad High Court. The Allahabad High Court dismissed the Petition upholding the order of the District Magistrate. Following the dismissal of their petitions by the Allahabad High Court, the Appellant filed a Special Leave Petition before the Supreme Court.
The Appellant contended that the Allahabad High Court erred in categorizing aromatic tincture of cardamom as a "prohibited article." According to the Appellants, no such prohibition exists under the Act, nor any notification was issued under the Act. Section 26A of the Act empowers only the Central Government to regulate, restrict, or prohibit the sale and distribution of any drug in the public interest. There being no notification prohibiting this tincture, the Respondent authorities had no jurisdiction to treat it as a banned substance.
The Respondent while denying any mala fide intent, argued that aromatic cardamom tincture has extremely high alcohol content. According to them, the substance is being misused as a cheap substitute for country liquor by vulnerable sections of society, including daily-wage earners and rickshaw pullers. Respondents argued that large quantities of this tincture are sold by the Appellants' shop without proper records or the presence of a registered pharmacist.
Supreme Court's Observation
The Supreme Court of India while interpreting Section 26A of the Act observed that Section 26A of the Act empowers the Central Government, to regulate, restrict, or prohibit its manufacture, sale, or distribution by a notification in the Official Gazette, if satisfied, that the use of any drug involves risk to human beings or animals, or that it lacks the therapeutic value claimed, or that it contains ingredients in a quantity for which there is no therapeutic justification.
Accordingly, the Supreme Court set aside the order passed by the Allahabad High Court and held as follows
"In the present case, there is no notification issued under Section 26A of the Act, 1940 prohibiting or restricting the aromatic tincture of cardamom. The absence of such a notification is decisive. Without it, the tincture remains a licensed medicinal preparation that can be manufactured and sold in accordance with the general rules and the conditions of the license held by the Appellants. The Respondent authorities cannot, on their own accord, treat this lawful product as a 'prohibited article.'
Supreme Court's Ruling
The Supreme Court of India clarified that while authorities may enforce regulatory measures to prevent misuse, they cannot independently prohibit a product without an official notification under Section 26A of the Act. The Apex Court stressed that the statutory framework upholds uniformity and legal certainty, which would be disrupted if local authorities were allowed to impose individual restrictions.
Inox Air Products Limited & Anr. vs State of Andhra Pradesh
The Supreme Court of India on January 30, 2025 set aside Andhra Pradesh High Court's decision, which refused to quash criminal proceedings against the Appellants for allegedly selling Nitrous Oxide I.P. to an unlicensed firm. The case was heard by a Division Bench consisting of Justices B.R. Gavai and Augustine George Masih.
Case Overview
The dispute arose when the Drug Inspector issued notice to the Appellants, calling upon them to submit their drug manufacturing license and sale records. The Appellants complied, but a complaint was subsequently filed, alleging that the Appellant sold Nitrous Oxide I.P. to an unlicensed firm in violation of Section 18(a)(vi) of the Act and Rule 65(5)(1)(b) of the Drugs and Cosmetics Rules, 1945. The Appellants sought to quash the complaint before the Andra Pradesh High Court, but their plea was dismissed, prompting them to appeal to the Supreme Court of India.
Supreme Court's Observations
The Apex Court examined Section 3 of the Act, 1940, which sets out an inclusive and broad definition of 'manufacture.' The Court observed that the definition covers various processes such as making, altering, packing, labeling, breaking up, or treating any drug or cosmetic for sale or distribution. However, it excludes compounding, dispensing, or packaging in the ordinary course of retail business.
The Apex Court noted that the Appellants and the purchasing firm both held manufacturing licenses under Form 25, which permits wholesale distribution and certain processes related to drugs. The Respondent argued that the purchasing firm required an additional license under Form 20B to legally acquire the drug. However, the Apex Court found this argument flawed, as the definition of "manufacture" is broad to include license holders to undertake processes necessary for sale or distribution.
The Apex Court emphasized that since both the Appellant and the purchasing firm held manufacturing licenses, they were legally authorized to carry out any process or part of a process, including altering or breaking up the drug, for the purpose of its further sale or distribution, as the same fell within the definition of "manufacture".
The Apex Court further observed that issuing summons in a criminal case is a serious matter. The Magistrate's order lacked sufficient reasoning and failed to demonstrate proper application of mind to the allegations and legal provisions. The Andhra Pradesh High Court, in dismissing the Appellants' plea, also misdirected itself.
Supreme Court's Ruling
The Supreme Court of India quashed the Andhra Pradesh High Court's order and the criminal complaint. The decision reinforces the broad scope of the term 'manufacture' under the Act and also clarifies the importance of judicial scrutiny when summoning accused individuals in criminal cases.
Indian Medical Association & Anr. vs Union of India & Ors
In a recent development, the Hon'ble Supreme Court has issued comprehensive and time-bound directions concerning misleading advertisements and claims, and implementation of the Drugs and Magic Remedies (Objectionable Advertisements) Act, 1954 (DMR Act) read with the Drugs and Magic Remedies (Objectionable Advertisements) Rules, 1955 (DMR Rules).
The Supreme Court had appointed Senior Advocate Shadan Farasat as an Amicus Curiae in the matter to inter-alia examine the implementation of the DMR Act and DMR Rules, in view of the rampant violation of the DMR Act due to unregulated and misleading advertisements, lack of enforcement by State and Union authorities and with a need to protect the public, especially ignorant and vulnerable individuals, from harmful and deceptive medical claims.
The Apex Court, while examining the definition of "advertisement" under the DMR Act, observed that it is broad and inclusive, encompassing not only printed and broadcast media, but also oral communications and visual effects, including those conveyed through light, sound, or smoke.
Further, the Apex Court also analyzed the relevant provisions of the DMR Act, which include:
- Section 3-prohibits advertisements suggesting the use of drugs for ailments such as miscarriage, sexual pleasure, menstrual disorders, or diseases listed in the Schedule to the Act.
- Section 4- bars misleading advertisements related to drugs.
- Section 5- prohibits the advertisement of magic remedies for certain conditions.
- Section 7- prescribes penalties while Section 9A makes violations a cognizable offence.
- Section 8-empowers Gazetted Officers to seize objectionable material.
On perusal of Sections 3, 4 and 5 of the DMR Act, the Supreme Court observed that the prohibition is not restricted only to advertising. It also provides that no person shall take part in the publication of any advertisements which are prohibited by Sections 3, 4 and 5 of the DMR Act. Accordingly, the prohibition will also apply to those who design and publish advertisements.
Further, the Court also observed that implementation of the DMR Act has been inadequate due to the lack of appointed officers, absence of grievance mechanisms, and public ignorance.
Accordingly, the Supreme Court issued directions for immediate implementation of the DMR Act. The key directions include:
- Appointment of Gazetted Officers under Section 8(1) of the DMR Act within one month by States/UTs to enforce seizure of illegal ads.
- Appointment of officers under Rule 3 of the DMR Rules within one month.
- Sensitization of police officers through training institutes.
- Creation of Grievance Redressal Mechanism within two months, including toll-free numbers and email systems for public complaints.
- Concerned Officers ought to take immediate action on complaints by filing FIRs.
- National Legal Services Authority and State/District Legal Services Authorities to run public awareness campaigns on the dangers of such advertisements.
- Union of India to develop a dashboard to track complaints and enforcement actions under the Act within three months.
Conclusion
The Supreme Court has issued strong, time-bound directions for enforcing the DMR Act.
It emphasized the urgent need to curb misleading medical advertisements and protect public health. The judgment provides a clear framework for regulatory action, accountability, and public awareness going forward.
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.
