Plea in HC for removal of drugs like NDMA, DCGI & FDCA get notice

Appearing before the bench of Acting Chief Justice A J Desai and Justice Biren Vaishnav, Senior advocate Percy Kavina, representing Mishra, crushed the green-coloured pill, revealing a brown substance. Kavina maintained that the brown substance should not be present in the medicine.

A visibly intrigued bench requested Kavina to pass the strip of medicine even as Justice Vaishnav asked Kavina, “While consuming antacid, you’re exposing yourself to cancer?” To this, Kavina responded in the affirmative.

The HC permitted Mishra to add two pharma firms – Cadila Pharmaceuticals Limited and JB Chemicals and Pharma Limited – as respondent parties to the litigation and issued notice to the government authorities as well, seeking responses by June 15.

The two companies together make up 90 per cent of the Indian market share of Ranitidine, according to the PIL.

The PIL noted that while some companies, such as Sanofi, have recalled their brand of antacid (Zantac) for safety reasons after presence of NDMA (N-nitrosodimethylamine) was found, despite it causing a loss of $186 million to the company, similar action has not been taken in India.

According to the petitioner, last September, of the 1,456 samples tested by Central Drugs Standard Control Organisation (CDSCO), Aciloc (comprising Ranitidine) of Cadila Pharmaceuticals failed the standard quality check.

The PIL said that the active pharmaceutical ingredient sourced has impurities and the process of manufacturing is not as per standard, with the same also being notified by the United States Food and Drug Administration (USFDA) in 2015 to Rajiv Modi, Chairman and MD of Cadila Pharma.

It added that while Cadila sold Aciloc worth Rs 190 crore in 2021 and Rs 220 crore in 2022, only about Rs 8 crore worth of the drug was recalled and destroyed in nearly 30 cities since December 2021. The PIL alleged that such substandard medicines were sold not only in India but other Asian countries like Indonesia, Philippines and Nepal.

Citing internal sources in the company, the petition alleged that the Aciloc brand has been marred by quality issues for over five years.

The PIL pointed out that in the Indian context, “with temperature rising to 45-48 degrees Celsius, NDMA will cross the permissible threshold even if NDMA was in permissible limits at the time of manufacturing”. The logistics and storage of Ranitidine is not regulated in India, leaving huge scope for drug sellers to store and ship the same at higher and unregulated temperature, it added.