Clean chit to Maiden

The clean chit to Sonepat-based Maiden Pharmaceuticals over the deaths of 66 children in the Gambia will come as a relief for India’s flourishing pharma industry. It would be an error of judgement to proclaim it as a vindication of safe practices being followed in drug manufacturing units and maintenance of standards. The pharmaceutical sector and India’s drug regulators would do themselves and the country a favour by viewing it as a moment to introspect. Both have been found wanting. Both need to draw urgent lessons and tighten controls. It’s not a question of India’s image as the pharma hub being tarnished. Any medicine being allowed to enter the market despite falling short of standards is a crime against humanity.

Control samples of the four cough syrups that were exported to the African nation and allegedly caused the deaths have been found to be of standard quality. The World Health Organisation (WHO), the Centre has said, drew a premature deduction in linking Maiden’s products with the deaths. Specific information to establish the causality has not been exchanged. The last word is yet to be heard on the Gambian deaths. India showcased its prowess in drug research and production during the pandemic. The glaring inadequacies in the drug regulation mechanism can mar its dreams. Fixing the gaping holes is the only way forward.

Following the WHO alert, investigations at Maiden’s plants revealed several violations and discrepancies. It’s indicative of the scale of laxity, lack of quality testing, corruption, understaffing and inadequately-equipped laboratories that define the pharma sector. The routine reports of irregularities in Himachal Pradesh’s Baddi and Kala Amb units point to the malaise. Without the course correction of regulatory capacity-building and institutionalising stringent norms, the pharma sector is inviting trouble for itself, and worse, jeopardising lives. The Centre and the states must combine their energies, it is too serious an issue to be left unattended.

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