Thiruvananthapuram, 24 Oct (H.S.):

Opposition Leader Pinarayi Vijayan has demanded a comprehensive investigation into the supply of medicines labelled “clinical trial” to children with spinal muscular atrophy (SMA) at Thiruvananthapuram’s SAT Hospital, alleging serious government lapses and a lack of transparency.

In a statement, Vijayan said the government had failed to adequately address concerns raised by patients, their families and the public. Instead, he alleged, the Health Minister was attempting to portray questions about procurement and patient safety as opposition to generic medicines.

The opposition supports generic drugs as essential to checking pharmaceutical monopolies and making treatment affordable, he said. He cited the CPI(M)’s interventions on patent legislation and access to lifesaving medicines to underline that position.

Vijayan referred to Section 3(d) of the Indian Patents Act, which restricts patent “evergreening”, and the Supreme Court’s 2013 ruling in the Novartis case involving the cancer medicine Glivec. He described the judgment as a milestone in protecting patient interests and India’s generic pharmaceutical industry.

The present controversy, however, concerned whether mandatory safety safeguards and procurement procedures had been followed, he said.

According to Vijayan, government approval to purchase the medicine was granted in July 2026. Information subsequently emerging suggested that a short tender was hurriedly issued in September and a purchase order awarded to Natco.

He asked the government to explain how medicines explicitly labelled for clinical trials entered the public healthcare system and were administered to children.

Even if clinical trials were unnecessary in India, the authorities must explain the labelling, its intended purpose and whether parents were informed, he said.

Vijayan sought disclosure of all decisions and procedures followed, alongside an investigation into alleged distribution irregularities and ministerial involvement.

The government must ensure uninterrupted treatment and children’s safety, he said, adding that young patients must never become experimental subjects, knowingly or otherwise, under government supervision.

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Hindusthan Samachar / Arun Lakshman