Posted on

Permissibility to Use of Drug-Grade Ingredients in Food Products

Introduction

In India, the regulatory framework of quality and pricing for Drugs and Food are separate. However, in practice, the distinction is not always clear. Certain substances such as vitamins and nutraceutical ingredients are commonly used in both pharmaceutical and food products. This leads to a regulatory question, can a food business operator procure and use ingredients that are manufactured under a drug licence (i.e., drug-grade ingredients) for the preparation of food product?

The article will examine this issue and clarifies the regulatory position for industry stakeholders.

Procurement of raw materials from drug manufacturers

Under the Food Safety and Standards (Licensing and Registration of Food Businesses) Regulations, 2011 (“FSSLR Regulation”), one of the conditions of licence requires that:

“The manufacturer/importer/distributor shall buy and sell food products only from, or to, licensed/registered vendor.”

This raises a question as to whether “licensed/registered vendor” refers only to vendors licensed under the FSSLR Regulation, or whether it can include entities licensed under other regulatory frameworks such as the Drugs Rules, 1945 (“Drugs Rules”).

This can be interpreted from a language used in few guidance documents released by Food Safety and Standards Authority of India, which states that:

“All raw material, process aids, ingredients consignments shall be procured from internally approved suppliers who are FSSAI/FDA/ Ayush licensed/ registered or licensed from other regulatory authorities. An approved supplier should be evaluated as per the quality supplied and other relevant factors”

Hence, the condition of food manufacturing license, which require food manufacturers to buy from registered or licensed vendor, may be interpreted as registered or licensed by any regulatory authority including Food and Drug Administration (“FDA”), by taking into consideration the above language which appears in the guidance document.

Therefore, a food manufacturer may procure raw materials from a manufacturer licenced under Drug Rules, subject to compliance with applicable food safety requirements.

Irrespective of the source of procurement, the food manufacturer must ensure that all raw materials meet prescribed safety and quality requirements under the Food Safety and Standards Act, 2006 (“FSSAI Act”) and its regulations and must maintain proper records of procurement and related documentation for traceability and compliance.

It is clear that food manufacturers may procure raw materials from drug manufacturers. However, whether drug manufacturers can supply or sell such ingredients to food manufacturers remains to be examined.

Conclusion

In light of the above, a food business operator may procure ingredients from a drug-licensed manufacturer, provided the ingredient is permitted under FSSAI Act and its regulations, meets safety and quality standards, and is used strictly for non-medicinal purposes.

It is also advisable to obtain a No Objection Certificate (NOC) from the FDA or inform the FDA in writing regarding such use, to avoid any regulatory issues.

Posted on

TOP 5 HEALTH LAWS AND POLICY UPDATES

Dear Readers, we are happy to share the most interesting legal and policy updates concerning health industry that we read today. We hope you enjoy reading it.

1. The Central Drugs Standard Control Organization (CDSCO) has advised stakeholders to submit clinical trial protocols simultaneously to CDSCO and Ethics Committees under Chapter III of the New Drugs and Clinical Trial Rules, 2019. This is important as it aims to reduce approval timelines and improve regulatory efficiency, enabling faster initiation of clinical trials and quicker patient access to innovative therapies.
Source: shortlink.uk/1pAw-

2. The Parliamentary Panel on Health and Family Welfare has reportedly urged the Ministry of AYUSH to strengthen international cooperation by prioritising partner countries for joint research, clinical studies, academic exchanges and capacity building in traditional medicine. The panel also recommended improving the Ayush Global Portal for better accessibility and global engagement. it could improve scientific validation, expand international acceptance of Ayurveda and yoga, and enhance India’s global influence in healthcare.
Source: shortlink.uk/1pAx1

3. The Food Safety and Standards Authority of India has reportedly issued a show-cause notice to a clean label food brand over claims that its chocolates contain “no added sugar” despite using dates and date powder as sweeteners. The action follows complaints by a rival brand and raises questions over compliance with FSSAI’s rules over claiming “non-addition of sugars”. The dispute could influence how food companies market sugar-free or no-added-sugar products in India’s growing chocolate sector.
Source: shortlink.uk/1uVZF

4. Private hospital associations have raised concerns over CGHS reimbursement caps, warning that limiting payouts to 70% of MRP for high-cost immunotherapy drugs may hinder access to advanced cancer care. This is important as this could increase patient costs, restrict use of costly treatments, and strain hospitals’ ability to provide life-saving oncology therapies.
Source: shortlink.uk/1pAx9

5. A lawsuit filed in California has raised concerns around AI-generated health and substance-use advice after allegations that chatbot interactions contributed to a teenager’s fatal overdose. The suit reportedly alleges that unsafe guidance on drug combinations was provided without adequate safeguards or warnings. The matter reflects growing regulatory oversight for AI tools used in healthcare, mental health, and wellness contexts.
Source: shortlink.uk/1pAxb

Posted on

TOP 5 HEALTH LAWS AND POLICY UPDATES

Dear Readers, we are happy to share the most interesting legal and policy updates concerning health industry that we read today. We hope you enjoy reading it.

1. The Central Drugs Standard Control Organisation (CDSCO) has issued an advisory directing manufacturers and importers to submit Periodic Safety Update Reports (PSURs) from the actual marketing date of new drugs, not approval date. The regulator also mandated consolidated PSUR submissions covering all dosage forms and indications to prevent duplication and improve post-marketing safety monitoring. This is important because accurate PSUR timelines strengthen drug safety surveillance and help regulators detect adverse effects more effectively.
Source: shortlink.uk/1uTal

2. India’s central drug licensing authority has reportedly directed states to intensify action against the illegal sale and misuse of sexual enhancement drugs such as sildenafil, varde¬na¬fil and tadalafil, citing public safety and social concerns. The regulator has ordered raids against illegal clinics, pharmacies, and online platforms, alongside stricter monitoring, awareness measures, and legislative action to curb unauthorized sales without prescriptions.
Source: shortlink.uk/1uTas

3. The Delhi High Court granted interim relief in a trademark and copyright dispute concerning sexual wellness products marketed under the “Stand Up” branding. The Court found the competing packaging and labels deceptively similar and ordered removal of online listings, while restraining further use of the disputed branding pending adjudication.
Source: shortlink.uk/1uTax

4. The Delhi Commercial Court has granted a permanent injunction restraining the defendants from manufacturing, selling, or dealing in cosmetics under the deceptively similar “ROOP LADY” trademark and sindoor bottle design, holding that the defendants had no proprietary rights over the impugned mark/design and that their activities amounted to trademark infringement, design piracy, copyright infringement, and passing off. This is important as the ruling reinforces judicial protection of intellectual property rights in the cosmetics and personal care sector, particularly against counterfeit and deceptively similar products that may mislead consumers and dilute brand goodwill.
Source: shortlink.uk/1pxNP

5. Maharashtra’s State Blood Transfusion Council (SBTC) has reportedly launched stricter oversight of blood banks following reports of profiteering through the sale of excess plasma at inflated rates. The council has introduced a 50-point inspection checklist and warned against over-collection and unauthorized plasma transfers, aiming to strengthen ethical blood banking practices and patient safety.
Source: shortlink.uk/1uTaS

Posted on

TOP 5 HEALTH LAWS AND POLICY UPDATES

Dear Readers, we are happy to share the most interesting legal and policy updates concerning health industry that we read today. We hope you enjoy reading it.

1. India’s pharmaceutical industry has strengthened its position as the “Pharmacy of the World”, exporting affordable medicines and vaccines to more than 200 countries. The sector now earns over half its revenue from exports, supplies vaccine demand, and is expected to reach 130 billion dollars value by 2030.
Source: shortlink.uk/1uSYh

2. The All India Institute of Medical Sciences (AIIMS), New Delhi has introduced India’s first portable bedside MRI system for critically ill patients in ICUs and emergency settings. This is significant as it enables rapid brain imaging without shifting unstable patients, improving timely diagnosis, monitoring, and critical care outcomes.
Source: shortlink.uk/1uSYo

3. India’s Directorate General of Health Services has introduced its first comprehensive framework for Intensive Care Units (ICUs), laying down standardized norms. ICUs have been categorised into 3 levels, with each level prescribed minimum bed strength, infrastructure and equipment requirements, staffing ratios, and specialist qualifications.
Source: shortlink.uk/1pxBR

4. The Food Safety and Standards Authority of India (FSSAI) seized misbranded “alkaline water” products for alleged use of non-permitted ingredients and labelling violations, signalling increased scrutiny of functional and packaged drinking water products in the west region. The action highlights growing regulatory focus on misleading health claims, ingredient disclosures, and compliance with Indian food safety and labelling laws.
Source: shortlink.uk/1uSYx

5. The Union Health Ministry has launched JANANI (Journey of Antenatal, Natal and Neonatal Integrated Care), a QR-enabled digital platform aimed at strengthening maternal and child healthcare through longitudinal digital health records. The platform will track antenatal care, delivery, postnatal care, newborn care, and family planning services. The initiative is significant as it seeks to improve continuity of care, enable real-time monitoring of high-risk pregnancies, and strengthen technology-enabled public healthcare delivery across India.
Source: shortlink.uk/1uSYA

Posted on

TOP 5 HEALTH LAWS AND POLICY UPDATES

Dear Readers, we are happy to share the most interesting legal and policy updates concerning health industry that we read today. We hope you enjoy reading it.

1. A pharmaceutical company has paused its obesity awareness campaign in India following an advisory from CDSCO against surrogate promotions that may indirectly lead consumers to a medicine, which is prohibited across media platforms. This is important as Indian regulators are increasingly monitoring disease-awareness and indirect promotional campaigns to ensure adherence to drug advertising, particularly in rapidly growing therapy areas such as obesity management. Going forward, pharmaceutical and healthcare companies may face tighter scrutiny over patient awareness initiatives, digital outreach, and indirect marketing strategies, requiring stronger alignment with India’s evolving compliance and promotional framework.
Source: shortlink.uk/1uSTv

2. Manufacturers of platinum-based cancer medicines have reportedly urged the NPPA to revise the ceiling prices of regulated chemotherapy drugs such as cisplatin, carboplatin, and oxaliplatin after platinum API costs surged by nearly 200%–300%, making production commercially unviable. The industry warned that unchanged price caps could disrupt supplies of essential cancer medicines and adversely impact patient access to critical treatments.
Source: shortlink.uk/1pxx5

3. Pharmaceutical exporters continue to face delays in obtaining World Health Organization Good Manufacturing Practices Certificates (WHO-GMP) of Pharmaceutical Products through the Online National Drug Licensing System portal. Industry bodies warned that technical glitches and processing delays are disrupting exports and international regulatory commitments.
Source: shortlink.uk/1uSTF

4. The Uttarakhand High Court granted bail to a snake venom collector accused of illegally possessing venomous snakes and extracted venom. The court noted his licence had expired and renewal was pending, suggesting procedural lapses rather than deliberate wildlife trafficking. The case highlights regulatory and compliance sensitivities surrounding wildlife-derived substances used in research and pharmaceutical applications.
Source: shortlink.uk/1uSTJ

5. Singapore’s Health Sciences Authority (HSA), participating in INTERPOL’s Operation Pangea XVIII, removed 959 illegal online health product listings and seized 6,641 units of unregistered medicines and medical devices at borders. Operation Pangea XVIII is a coordinated enforcement drive across 90 countries targeting illegal and counterfeit health products. The crackdown targeted products including contact lenses, ivermectin, dermal fillers, and prescription medicines. HSA also warned 152 sellers and cautioned consumers against purchasing illegal or self-administered health products online due to serious safety risks.
Source: shortlink.uk/1uSTM

Posted on

TOP 5 HEALTH LAWS AND POLICY UPDATES

Dear Readers, we are happy to share the most interesting legal and policy updates concerning health industry that we read today. We hope you enjoy reading it.

1. The Government of India is considering capping billing margins charged by private hospitals on medical devices to curb overcharging and reduce treatment costs. This is important as excessive markups increase patient expenses and insurance premiums. If implemented, it will limit hospital margins, improving pricing transparency and affordability.
Source: shortlink.uk/1olUB

2. The Central Government has established the Online Gaming Authority of India (OGAI), with effect from May 1, 2026, under the Promotion and Regulation of Online Gaming Act, 2025, to regulate the gaming sector. Operating under MeitY, this multi-sectoral authority will oversee licensing, mandate registration for esports, and enforce stringent compliance requirements, with a view to enhancing user safety and strengthening regulatory oversight of online gaming.
Source: shortlink.uk/1tDQe

3. Indias central drug ministry has proposed amendment to Drugs Rules 1945 by expanding the list of licences that may be exempted from requiring a Form 29 licence for manufacturing of drugs for test or analysis. The amendment proposes to include Forms 25A (loan licences), 25F (Schedule X drugs), 28A/28B (Schedule C, C(1), and X drugs), 28D/28DA (vaccines, sera, r-DNA drugs), and 28F (umbilical cord blood stem cells). Objections and suggestions from the industry will be considered for thirty days.
Source: shortlink.uk/1tDQk

4. The Delhi High Court has restrained the use of the trademark “MARQ,” finding it deceptively similar to “MARC” and likely to confuse consumers. This reinforces trademark protection by emphasizing that minor spelling differences, use of house marks, or later registrations do not override prior rights and established goodwill.
Source: shortlink.uk/1tDQs

5. Government of India plans a Health Claims Index to transparency and standardize pricing in India health insurance sector. Using anonymized data from the National Health Claims Exchange, it will benchmark claims timelines, approvals and costs, enabling underwriting, reducing inefficiencies, and supporting informed consumer decisions, subject to scale and execution.
Source: shortlink.uk/1olUW

Posted on

TOP 5 HEALTH LAWS AND POLICY UPDATES

Dear Readers, we are happy to share the most interesting legal and policy updates concerning health industry that we read today. We hope you enjoy reading it.

1. The Food Safety and Standards Authority of India has issued an advisory directing food businesses to avoid the use of Ashwagandha (Withania somnifera) leaves in crude, extract, or any other form in food products. This is important as Ashwagandha is widely used in nutraceutical and functional food formulations, signalling tighter scrutiny on botanical ingredients. Companies may now need to review formulations and ensure regulatory compliance.
Source: shortlink.uk/1tzwL

2. The Delhi District Consumer Disputes Redressal Commission issued a non-bailable warrant against the managing director of a multinational fast food company, for failing to comply with a November 2024 order to discontinue levying packing charges, pay compensation for unfair trade practices, and repeated non-appearance. This is important as it signals stricter enforcement of consumer rulings and increased personal accountability of senior leadership.
Source: shortlink.uk/1tzwQ

3. Pharmaceutical traders have opposed draft amendments to the Medical Devices Rules, 2017, mandating disclosure of sterilization site licence numbers on labels and revising testing fees. The industry warns this may restrict vendor flexibility, delay supplies, and increase compliance burden, particularly impacting SMEs and overall supply chain efficiency.
Source: shortlink.uk/1ohJu

4. The Ministry of Health and Family Welfare has proposed amendments to the Medical Devices Rules 2017 requiring manufacturers to include sterilization site licence numbers on labels when sterilization is outsourced, along with revised testing and annual fees, prompting concerns from industry stakeholders. This is important as the changes may increase compliance costs and disrupt supply chains. Companies may need to redesign labels, reassess vendors, and adjust operations.
Source: shortlink.uk/1tzwY

5. National Comprehensive Cancer Network has updated global breast cancer screening guidelines to include image-based AI risk assessment using mammograms, recommending risk evaluation starting at age 35 to enable personalized screening strategies. This shifts screening from detection to early risk prediction, enabling earlier intervention. Healthcare providers may now adopt AI-based tools and adjust screening protocols.
Source: shortlink.uk/1tzx8

Posted on

TOP 5 HEALTH LAWS AND POLICY UPDATES

Dear Readers, we are happy to share the most interesting legal and policy updates concerning health industry that we read today. We hope you enjoy reading it.

1. The Central Drugs Standard Control Organization (CDSCO) has issued a regulatory update outlining revised procedural and compliance requirements for industry stakeholders, aimed at strengthening regulatory oversight and streamlining approval processes. This is important as evolving CDSCO requirements may affect licensing, submissions, and regulatory timelines. Companies may now need to review internal compliance processes and align documentation and approval strategies accordingly.
Source: shortlink.uk/1tzqM

2. The Thrissur Consumer Commission held both the seller and the e-commerce platform liable for delivering an expired consumable product, ruling it an unfair trade practice and deficiency in service. Rejecting reliance on a “non-returnable” policy, the Commission ordered refund, compensation, and costs. It emphasized that platforms must ensure grievance redressal and cannot evade liability where defective or unsafe goods are supplied through their marketplace.
Source: shortlink.uk/1tzqU

3. The Ministry of Environment, Forest and Climate Change has amended the Bio-Medical Waste Management Rules, 2016, to include the Department of AYUSH and its nominated representatives in state and district-level waste management committees. This is important as it expands regulatory oversight to AYUSH healthcare facilities and strengthens compliance expectations. AYUSH institutions and related healthcare providers may now need to align with enhanced bio-medical waste management governance and monitoring requirements.
Source: shortlink.uk/1tzqI

4. Stakeholders have urged greater drug regulator oversight of nutraceuticals, citing concerns over quality standards, therapeutic claims, and wide pricing variations, with calls to shift certain nutraceuticals from food regulation to drug-level oversight. This is important as nutraceuticals are increasingly prescribed alongside medicines but lack uniform quality and pricing controls. Companies may now face stricter compliance requirements, enhanced quality standards, and potential regulatory scrutiny.
Source: shortlink.uk/1tzqY

5. The Central Drugs Standard Control Organization (CDSCO) has introduced a prior intimation system pursuant to amendments in the New Drugs and Clinical Trials Rules, 2019 effective April 21, 2026. It applies to bioavailability and bioequivalence studies for export-only drugs, excluding certain high-risk categories. CT-05 applications must be filed via Sugam with ethics approval, while other categories remain under prior approval. This is important as evolving CDSCO requirements may affect licensing, submissions, and regulatory timelines.
Source: shortlink.uk/1ohEa

Posted on

TOP 5 HEALTH LAWS AND POLICY UPDATES

Dear Readers, we are happy to share the most interesting legal and policy updates concerning health industry that we read today. We hope you enjoy reading it.

1. The National Health Authority is developing a national artificial intelligence policy for healthcare to guide wider use of technology to address health challenges including diagnostics, public health programmes, and digital health platforms. This will be a major shift toward structured, large-scale adoption of technology in India’s health system. It can improve access, efficiency, and data-driven decision-making across public healthcare delivery.
Source: shortlink.uk/1tzfD

2. India’s Central government has directed states to uniformise package rates for common medical procedures, adopt uniform treatment guidelines, and implement digital claims processing through the National Health Claims Exchange to improve billing transparency and reduce pricing variations across private hospitals. These disparities have been identified in driving higher insurance premiums and affecting affordability.
Source: shortlink.uk/1ohsz

3. The Bombay High Court delivered a judgment after scrutinising enforcement under the Drugs (Prices Control) Order (DPCO), holding that overcharging determinations and recovery demands must strictly adhere to statutory methodology, including correct price fixation, computation, and grant of hearing. Finding procedural infirmities and inadequate reasoning, the Court set aside the demand and directed fresh adjudication, reinforcing due process and curbing arbitrary.
Source: shortlink.uk/1tzfM

4. The Central Drugs Standard Control Organization (CDSCO) has issued a regulatory communication outlining updated requirements related to drug approvals, compliance, and regulatory submissions for industry stakeholders. This is important as increased regulatory scrutiny may impact approval timelines and documentation standards. Companies may now need to review regulatory submissions, strengthen compliance processes, and align product lifecycle strategies with evolving CDSCO expectations.
Source: shortlink.uk/1tzfQ

5. The Drugs Technical Advisory Board has approved a proposal to amend the Medical Devices Rules, 2017 to introduce a definition of reportable events and mandate adverse event reporting, including for in-vitro diagnostic devices. This is important as it strengthens post-market surveillance and device safety oversight. Manufacturers and importers may now need enhanced reporting systems and tighter compliance processes.
Source: shortlink.uk/1ohsK

Posted on

TOP 5 HEALTH LAWS AND POLICY UPDATES

Dear Readers, we are happy to share the most interesting legal and policy updates concerning health industry that we read today. We hope you enjoy reading it.

1. Indonesia’s health ministry has directed food companies to introduce coloured labels indicating nutritional content, within two years. Red and green labels will indicate high and low sugar, salt, and fat content respectively. Companies must revise packaging and validate nutritional content to meet the new labelling requirements, but detailed sanctions for non-compliance have not been informed yet.
Source: shortlink.uk/1nEyC

2. Gujarat Food and Drug Control Administration has reportedly directed all ayurvedic medicine manufacturers to register on the ayudmla.gujarat.gov.in portal and upload complete legacy records, mandating digital compliance for licensing processes across the state. It strengthens regulatory oversight and promotes digital compliance in the ayurvedic sector.
Source: shortlink.uk/1sU3e

3. The Bangalore District Chemists and Druggists Association and other retail pharmacy groups have urged regulators to mandate licensing requirements for e-pharmacies displaying medicines online, similar to physical stores under the Drugs and Cosmetics Act, 1940. This is important as it highlights growing concerns around patient safety, regulatory gaps, and unfair competition. If implemented, e-pharmacy platforms may face stricter compliance, licensing requirements, and potential changes to their marketplace and digital medicine distribution models.
Source: shortlink.uk/1sU3h

4. A leading weight loss drug manufacturer has partnered with OpenAI to deploy artificial intelligence across drug discovery, manufacturing, and operations, while training its workforce globally. The initiative will help to enhance productivity, strengthen competitive positioning in the obesity therapeutics market, and improve overall efficiency without immediate workforce reductions.
Source: shortlink.uk/1nEyI

5. The Bangalore District Chemists and Druggists Association and other retail pharmacy groups have urged regulators to extend licensing norms for medicine display to e-pharmacies, seeking clarity on “offer for sale” under the Drugs and Cosmetics Act. This is important to curb unlicensed digital sales and ensure parity, potentially bringing online platforms under stricter licensing and compliance requirements.
Source: shortlink.uk/1sU3l