The Delhi High Court on Wednesday, 20 May issued notice to the Centre and multiple regulatory bodies on a public interest litigation (PIL) alleging the illegal export of life-saving anti-cancer drugs labelled 'for sale in India only' — drugs meant exclusively for domestic consumption. The case raises urgent questions about gaps in India's pharmaceutical supply-chain oversight.

What the PIL Alleges

The petition, filed by Ripan Wadhwa and Ramesh Kumar Sharma through advocate Dhruv Chawla, contends that certain exporters exploit loopholes in the regulatory verification system to procure domestically restricted drugs and illegally route them into export consignments. According to the plea, these high-value pharmaceuticals — including drugs imported under strict regulatory conditions — are being diverted from authorised supply chains and mixed with otherwise permissible export cargo to bypass scrutiny.

The petition further argued that this diversion violates statutory and regulatory provisions governing the import, labelling, distribution, and export of pharmaceuticals in India.

Regulators Put on Notice

A Division Bench comprising Chief Justice Devendra Kumar Upadhyaya and Justice Tejas Karia directed responses from six authorities: the Union government, the Central Drugs Standard Control Organisation (CDSCO), the Directorate General of Foreign Trade (DGFT), the Central Board of Indirect Taxes and Customs (CBIC), the Directorate of Revenue Intelligence (DRI), and the Directorate General of GST Intelligence (DGGI).

CDSCO Had Already Flagged the Problem

Notably, the PIL cited an Office Memorandum dated 19 January 2024 issued by the CDSCO, in which the regulatory body had itself recorded instances of merchant exporters shipping products marked 'for sale in India only' and had directed that such practices be stopped. The petitioners argued that despite this acknowledgement, and despite detailed representations submitted to the authorities, no effective or comprehensive investigation had been initiated to determine the scale and mechanism of the alleged diversion.

The plea contended that a scrutiny of shipping documents, customs declarations, and export records would reveal the extent of violations and regulatory lapses.

Public Health Stakes

The petition emphasised that the alleged diversion has serious implications for drug availability and public health in India. Anti-cancer drugs are often in short supply domestically; their illegal export could directly affect patients dependent on these medicines. The petitioners have sought court directions for a thorough probe and for the strengthening of regulatory mechanisms to prevent further such exports.

What Happens Next

With notice now issued, the Centre and the named regulatory agencies must file their responses before the court. The case is expected to test the coordination between India's drug regulator, customs intelligence, and trade authorities — and whether existing frameworks are adequate to prevent the diversion of restricted pharmaceuticals. All eyes will be on whether the government's response acknowledges the scale of the problem flagged in the CDSCO's own 2024 memorandum.