A Fatehpur-based drug distributor Sri Balaji Medicine Center has moved Allahabad High Court seeking for legal intervention to address the issue of taking expired /harmed meds by pharmaceutical companies. For the situation, the distributor has asked the National Pharmaceutical Pricing Authority (NPPA) and pharmaceutical major FDC Ltd to address the issue at the earliest in the interest of patient safety.
Some of the medicines received from FDC Ltd are expired and damaged and in spite of repeated demands, the pharma company isn’t reclaiming the soiled stock from the distributor. The stock of expired medications caused contamination, bio-hazards to social and financial losses to the dealer, said Ravindra Kumar, legal counselor of Sri Balaji Medicine Center.
Sri Balaji Medicine Center had before written to NPPA seeking its intervention to determine the issue as the drug price regulator had approved the introductory prices of formulations considering different costs including logistics cost and cost in lieu of losses to start the procedure of manufacturing, distribution, and sale etc.
Challenging the distributer’s contention for taking remedial measures for this situation, NPPA rejected the request saying that it has no part in guiding the concerned pharma company to reclaim the damaged/expired drugs from the dealer.
“As regards, the trader’s conflict that NPPA approves the early prices of formulations considering different costs including coordinations cost and cost in lieu of losses to start process of manufacturing, distribution, and sale etc., it is hinted that there is no particular provision in the Drugs Prices Control Order, (DPCO) 2013 to examine and regulate the actual price of production of drugs with reference to the ceiling price/retail prices, as DPCO 2013 takes after a market-based system and not cost based strategy,” said Arun Kumar Diwan, deputy director (monitoring), NPPA.
Upset with NPPA and FDC Ltd’s lackadaisical attitude towards settling the expired drug issue, the trader has documented the case against NPPA and FDC Ltd in the High Court. NPPA fixes costs of medicines which also include costs of damaged/expired drugs. Subsequently, the remedy should have been given by the drug pricing authority however it has essentially rejected the Sri Balaji’s request, said advocate Ravindra Kumar.
On January 30, 2018, Balaji Medicine Center had written to Food and Drug Administration (FDA), Uttar Pradesh asking it to make essential move to ensure that the pharmaceutical firm reclaims expired and damaged drugs from dealers and keep up equity and parity in their services. Regular disposal of expired medicines was required for preventing contamination, toxicity, bio-hazards and the drug resistance of people.
The offenders intentionally denying reviewing expired medications for disposal can be taken according to provisions of Drugs and Cosmetic Rules and the Bio-Medical Waste (Management and Handling) Rules, 1998.