THIRUVANANTHAPURAM: The state that pioneered comprehensive, state-funded care for rare diseases is now facing a major row as its flagship Spinal Muscular Atrophy (SMA) treatment programme set off widespread controversy and panic among patients and parents. The controversy erupted after families at SAT Hospital in Thiruvananthapuram were handed SMA drug packets explicitly stamped ‘Physician Sample, For Clinical Trials Only’. Panicked parents alleged their children were being used as human test subjects.
Public health experts have since clarified that the markings belonged to early promotional sample stock supplied to doctors from batches manufactured while Indian pharma firm Natco was fighting a high-stakes patent lawsuit against Swiss drugmaker Roche.
Despite Health Minister K Muraleedharan deflecting responsibility to the previous regime for initiating the switch to domestic generics, medical specialists maintain that the generic alternative – priced at `11,448 per bottle compared to the `6-lakh branded version – remains a scientifically sound choice for sustainable healthcare.
The crisis threatens to undermine KARE (Keralam United Against Rare Diseases), the state’s landmark programme supporting under 150 young SMA patients under the age of 12. Keralam’s push for generic Risdiplam was catalysed by Seba P A, an SMA patient from Kottayam, whose legal battle exposed severe national funding caps and paved the way for court rulings permitting generic production in 2025.
Health department officials stated that extensive counselling was provided to parents to explain that only the brand name had changed while the chemical formulation remained identical.
SAT Hospital superintendent Dr I Riaz emphasised that Natsmart has received full regulatory approval from the Central Drugs Standard Control Organisation (CDSCO) and has completed all clinical evaluations. However, a section of the affected families, whose children showed progress on the original drug, demanded formal clinical assurances that the generic would deliver identical results.
Addressing the fallout, the health minister stated that procedures to introduce the domestic generic drug were initiated under the LDF government following expert committee recommendations. He noted that while no quality complaints have been raised, many still hold an inherent bias toward foreign brands, adding that the government remains open to dissenting views from expert doctors.
However, the documents which surfaced on Wednesday showed that the government order in this regard was issued on July 5, close to two months after the UDF government assumed office. The tender for the generic drug was floated on September 22 and Natco was chosen for the supply of the drug on October 14.
However, the opposition launched a scathing attack. Leader of Opposition Pinarayi Vijayan termed the distribution of trial-labelled bottles a blatant violation of the Drugs and Cosmetics Act, questioning whether infants were turned into test subjects without informed consent. Former health minister K K Shailaja also raised sharp concerns, warning that low price alone should not dictate procurement in critical paediatric care.
Countering the alarm, Dr Gargeya Telakapalli, coordinator of the Working Group on Access to Medicines and Treatments, explained that generic medicines do not require new clinical trials because the core chemical structure remains identical to the branded version. He affirmed that the sample markings merely reflected early promotional batches, reinforcing that generic alternatives are essential to secure long-term, equitable access for rare-disease patients.
Dr Althaf A, director of the Kerala Centre for Disease Control (K-CDC) said a controversy was unnecessary and that it tended to only help multinational pharmaceutical companies.
‘Supplied due to temporary shortage'
SAT Hospital superintendent Dr I Riaz said the drugs with controversial labels which were used as physician samples were supplied as there was a temporary shortage. The measure was taken while procedures were ongoing to deliver ‘Natsmart’—a new brand of Risdiplam manufactured by Natco Pharma—to hospitals. To ensure that children visiting the SMA clinic this past Monday faced no disruption in receiving their critical, life-saving medication, the National Health Mission (NHM), through the Kerala Medical Services Corporation Limited (KMSCL), made sample medicines immediately available as an interim arrangement.
The official government-supplied stock arrived at the hospital the very next day. Following concerns raised by parents regarding the distribution of medicine clearly labeled as “Physician Sample,” hospital authorities promptly contacted the families, called them back, and administered the freshly arrived government-supplied medication on Wednesday.
