The Delhi High Court on Wednesday sought responses from the Central government and various regulatory authorities on a public interest litigation (PIL) alleging the illegal diversion and export of life-saving medicines intended for domestic use.

A Division Bench of Chief Justice Devendra Kumar Upadhyaya and Justice Tejas Karia directed the Central Drugs Standard Control Organisation (CDSCO) to explain the measures taken to enforce its January 19, 2024 circular, which had raised concerns over the export of medicines labelled “for sale in India only.”

“While filing the Counter Affidavit, the respondent 2 (Central Drugs Standard Control Organisation/CDSCO) shall specifically state as to what further steps have been taken to ensure compliance of the circular dated 19 January 2024,” the Court ordered.

The matter has been listed for hearing on August 19.

The PIL was filed by Ripan Wadhwa and Ramesh Kumar Sharma. Wadhwa is a partner in a licensed pharmaceutical distribution firm supplying medicines and medical devices to hospitals and corporate clients for over 30 years, while Sharma is associated with a media organisation.

According to the petition, the plea was filed after the petitioners conducted an independent inquiry and submitted representations to authorities regarding alleged irregularities in the pharmaceutical sector.

The petition argued that the diversion of life-saving drugs from the domestic supply chain into export channels reflects a major failure of the regulatory framework and requires urgent judicial intervention.

The plea particularly referred to high-value imported cancer drugs such as Pembrolizumab and other patented medicines marked “for sale in India only.” It claimed that their diversion and export created shortages in the domestic market and adversely affected patients dependent on affordable treatment.

“The diversion and export of pharmaceutical drugs meant for domestic use is ex facie contrary to the statutory and regulatory framework governing their import, labelling, distribution and export, thereby warranting immediate investigation and enforcement action,” the petition stated.

The petitioners further alleged that despite regulatory authorities acknowledging such practices, effective enforcement measures have not been taken, leading to continued violations and affecting access to essential medicines.

“The continued inaction of the Respondent authorities in addressing the diversion, counterfeiting and unlawful movement of life-saving pharmaceutical drugs amounts to a violation of the Right to Life and Health under Article 21 of the Constitution of India, particularly affecting vulnerable and economically weaker patients,” the plea contended.

The petition also argued that the issue stems from systemic gaps in coordination, monitoring and verification mechanisms across agencies, and cannot be addressed through isolated enforcement actions alone.

“Such systemic deficiencies cannot be remedied through isolated enforcement actions or case-specific investigations and require a comprehensive examination of the regulatory framework and its implementation,” the petitioners submitted.

The petition was filed through advocate Dhruv Chawla.