The Delhi High Court on Wednesday sought the response of the Central government and multiple regulatory authorities to a public interest litigation (PIL) petition alleging the illegal diversion and export of life-saving drugs meant for domestic use [Ripan Wadhwa & Anr. v Union of India & Ors.].
A Bench comprising Chief Justice Devendra Kumar Upadhyaya and Justice Tejas Karia directed the Central Drugs Standard Control Organisation (CDSCO) to specifically clarify the steps taken to ensure compliance with its January 19, 2024 circular, which had flagged the export of drugs 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," directed the Court.
The matter will be heard next on August 19.
The PIL was filed by Ripan Wadhwa and Ramesh Kumar Sharma.
Wadhwa is a partner in a licensed pharmaceutical distribution firm that has been supplying drugs and medical devices to hospitals and corporate clients for over three decades. The second petitioner, Ramesh Kumar Sharma, is associated with a media house.
The petitioners approached the Court after conducting an independent inquiry and making representations to authorities, having come across irregularities in the pharmaceutical sector.
The petition contended that the alleged diversion of life-saving drugs from the domestic supply chain into export channels reflects a serious breakdown of the regulatory regime, requiring urgent judicial intervention.
The plea centred on high-value, life-saving drugs, particularly imported cancer therapies like Pembrolizumab and other patented medicines marked “for sale in India only."
It argued their diversion or export created shortages and undermined access, especially for patients reliant 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,” said the petition.
It further submitted that despite regulatory acknowledgment of such practices, authorities have failed to take meaningful steps to curb them, resulting in continued violations. This inaction, it argued, has direct consequences for 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,” contended the petitioners.
The plea adds that the problem cannot be fixed through isolated or case-by-case action, as it stems from deeper gaps in coordination, monitoring and verification across agencies.
“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 have submitted.
The petition was filed through advocate Dhruv Chawla.