Regulator introduces “One Brand – One Formulation” policy to improve patient safety and reduce medication errors
In a landmark move aimed at strengthening medication safety and improving transparency in the pharmaceutical sector, the Central Drugs Standard Control Organisation (CDSCO) has proposed a new regulatory framework based on the principle of “One Brand – One Formulation.”
The draft notification, issued for public comments on 6 July 2026, seeks to prohibit pharmaceutical companies from marketing different medicines under the same or deceptively similar brand names—a practice that has increasingly contributed to prescribing, dispensing, and patient medication errors.
However, this was due since 2012. It was pointed out in the 59 th Parliamentary Committee Report on working of CDSCO which was submitted to the government on 8th May, 2012.
Background
According to CDSCO, confusion arising from similar brand names has become one of the important causes of medication errors in India. Patients, pharmacists, and even healthcare professionals may mistakenly assume that medicines carrying the same brand name contain identical active ingredients.
Several examples have highlighted the seriousness of the problem.
- AZ has been marketed by different manufacturers for Cetirizine, Albendazole, and Azithromycin, three medicines used for entirely different clinical conditions.
- Linamac has been marketed for diabetes, whereas Linamac 5 was introduced for a cancer medication, a matter that attracted the attention of the National Human Rights Commission (NHRC).
Such practices create avoidable risks of incorrect dispensing, therapeutic failure, and adverse drug events.
Mirror brands: Another regulatory concern
Apart from “Same Brand – Different Drug,” the pharmaceutical industry has also adopted another marketing strategy commonly referred to as “Mirror Brands.”
In this practice, the same active pharmaceutical ingredient is marketed under multiple different brand names by the same company.
Although the formulation remains identical, multiple brand identities may:
- create unnecessary market confusion,
- complicate rational prescribing,
- increase promotional competition,
- reduce prescription transparency, and
- potentially increase healthcare expenditure.
The CDSCO proposal is expected to stimulate wider discussion on whether such branding practices also require future regulatory scrutiny.
Previous regulatory action
The proposal follows earlier regulatory interventions.
During 2024–25, CDSCO withdrew 35 unapproved cough and cold fixed-dose combinations, including products marketed under well-known brand names such as:
- Corex – Tossex and Ascoril D
These products had continued to use familiar brand names despite significant changes in their formulations, increasing the possibility of medication errors.
Key features of the draft proposal
The proposed regulatory framework includes several important reforms:
- One Brand – One Formulation
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- Each registered brand name will be linked to only one approved pharmaceutical formulation
- Mandatory Brand Database
All pharmaceutical companies will upload approved brand names and corresponding formulations onto the Sugam Portal.
- Verification Before Approval
State Licensing Authorities will verify the national database before approving any new brand name.
- Public Access
The brand-name database will be publicly accessible, enabling healthcare professionals and patients to verify medicines before prescribing or dispensing.
- Resolution of Existing Duplicate Brands
Where duplicate brand names already exist: the company with the earliest valid registration under the Drugs Rules, 1945 will retain the brand name;
subsequent users will be required to discontinue or rename their products.
CDSCO’s Objective
The regulator states that the proposed amendment is intended to:
- improve patient safety,
- reduce medication errors,
- eliminate misleading branding practices,
- strengthen regulatory transparency, and
- build greater public confidence in India’s pharmaceutical market.
“One brand must mean one formulation. No more trading on old trust for new drugs.”
— CDSCO Draft Proposal, July 2026
Implications for healthcare
For Patients
- Verify the generic (salt) name and strength, not merely the brand name.
- Never assume that medicines with similar or identical brand names contain the same drug.
For doctors and pharmacists
- Prefer prescribing using Generic Name + Brand Name.
- Verify formulations using the forthcoming public Sugam database before prescribing or dispensing.
For pharmaceutical companies
- Conduct a comprehensive review of existing brand portfolios.
- Identify duplicate or conflicting brand names.
- Certify that every newly proposed brand name is unique and not already registered.
Editorial perspective
The proposed “One Brand – One Formulation” policy represents one of the most significant pharmaceutical regulatory reforms in recent years. By addressing confusing and potentially misleading branding practices, CDSCO aims to strengthen medication safety, enhance prescribing accuracy, and improve public trust in medicines.
Successful implementation, however, will depend upon robust coordination among CDSCO, State Licensing Authorities, pharmaceutical manufacturers, healthcare professionals, and patients. If effectively enforced, the initiative has the potential to become a landmark reform in India’s drug regulatory system and may serve as a model for other countries confronting similar challenges in pharmaceutical brand management.
About the author
Dr Suresh R Saravdekar, Project head – Keshav Srishti Gram Swasthya Projects; Former Assistant Director – Ministry of Medical Education, Maharashtra & Honorary Consultant Institute of Medical Sciences, Banaras Hindu University (IMS-BHU) Varanasi- INDIA
Dr Suresh R Saravdekar has more than four decades of experience in pharmacy education, public procurement of medicines, healthcare administration, hospital pharmacy, quality assurance, and public health. His work spans government service, academic leadership, healthcare consultancy, and innovative community health initiatives, with a continuing focus on strengthening pharmacy practice and improving healthcare delivery in India and abroad ….