India's pharmaceutical industry is collating product data to mount a response to the government’s notice on drug brand name extensions.
To compile the database, pharma associations such as the Indian Drug Manufacturers Association (IDMA) have asked manufacturers to submit details of their affected product portfolios. The information sought includes brand names, active ingredients, dosage forms, strengths, the likely business impact, and sales data, even for FY26.
The Drugs Controller General of India (DCGI) sent a communication to pharma associations last week, warning them of strict action against the practice of extending a primary brand name to treat a completely different illness.
“Concerns have been raised that the use of the same brand name for drugs with different active ingredients may mislead consumers and create confusion regarding their therapeutic use,” the communication said, adding that authorities will carry out a stakeholder consultation to consider various aspects of the matter.
Leading drugmakers are evaluating whether to overhaul and rename their multimillion-dollar brand portfolios, a move that could reshape marketing strategies across the country's $60 billion pharmaceutical market, according to government data.
Legal requirements
Brand extension involves modifying a core brand name by adding specific suffixes or descriptors, such as DS or Forte, an official familiar with the matter explained.
While these products are legally distinct, sharing a major portion of the primary name inherently creates a significant risk of confusion for consumers and healthcare professionals alike.
The official added that these brand extensions can be used either for the same medical indication or applied across entirely different therapeutic categories.
However, the official warned that extending a primary brand name to treat a completely different illness significantly increases the potential danger to patient safety.
“A regulatory mechanism is being considered to prevent such interchangeable use of brand names and to examine the matter under relevant provisions of the Drugs and Cosmetics Act,” the official said.
To be sure, the Drugs and Cosmetics Act, 1940, requires drugmakers to furnish an undertaking to the licensing authority that no similar brand name or trade name already exists.
Mint reported on the government's plans for a crackdown in May and September 2024. Mint's queries emailed to the health ministry, DCGI office, and the IDMA remained unanswered.
Serious ramifications
“Brand recognition often influences how patients, caregivers and even pharmacists identify medicines, particularly in emergency situations or during repeat purchases," said Aashish Chaudhry, managing director, Aakash Healthcare in Delhi.
If two products share a similar brand identity but are intended for entirely different conditions, the risk of dispensing or consuming the wrong medicine increases substantially, he added.
Chaudhry said that globally, healthcare systems recognize the danger of ‘look-alike, sound-alike’ medicines and have adopted strict safeguards to minimize confusion. India should extend the same principle to brand names by ensuring a ‘one brand, one active ingredient’ policy.
Meanwhile, Rajesh Gupta, national head of the pharma wing of Laghu Udyog Bharati, which represents 2,000 micro, small and medium pharmaceutical companies, said the primary goal is ensuring patients aren't misled. However, patients and retail shops also share responsibility.
"The real issue is at the retail level. Regulators must ensure qualified pharmacists dispense medicines, rather than untrained workers. That said, if a manufacturer completely changes the underlying active ingredient while keeping the exact same brand name, we fully back the DCGI's stance,” Gupta said.
On the other hand, Rajiv Singhal, general secretary of the All India Organisation of Chemists and Druggists, representing 1.2 million pharmacists, said that community pharmacists are the last professional checkpoint before medicines reach patients, and that confusing brand names place an unnecessary burden on safe dispensing.
“The Central Drugs Standard Control Organization should ensure that brand names with different compositions are clearly distinguished."