A Fatehpur-based drug wholesaler Sri Balaji Medicine Centre has moved Allahabad High Court seeking judicial intervention to address the issue of taking back expired/damaged medicines by pharmaceutical companies.
In the case, the wholesaler has urged 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 despite repeated requests, the pharma company is not taking back the soiled stock from the wholesaler. The stock of expired drugs caused contamination, bio-hazards to society and financial losses to the dealer, said Ravindra Kumar, lawyer of Sri Balaji Medicine Centre.
Sri Balaji Medicine Centre had earlier written to NPPA seeking its intervention to resolve 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 initiate process of manufacturing, distribution and sale etc.
Contesting the wholesaler's argument for taking remedial measures in this case, NPPA rejected the plea saying that it has no role in directing the concerned pharma company to take back the damaged/expired drugs from the trader.
“As regards, the trader's contention that NPPA approves the introductory prices of formulations considering different costs including logistics cost and cost in lieu of losses to initiate process of manufacturing, distribution and sale etc., it is intimated that there is no specific provision in the Drugs Prices Control Order, (DPCO) 2013 to examine and regulate the actual cost of production of drugs with reference to the ceiling price/retail prices, as DPCO 2013 follows a market based methodology and not cost based methodology,” said Arun Kumar Diwan, deputy director (monitoring), NPPA.
Upset with NPPA and FDC Ltd's lackadaisical attitude towards resolving the expired drug issue, the trader has filed the case against NPPA and FDC Ltd in the High Court.
NPPA fixes prices of medicines which also include costs of damaged/expired medicines. Hence the remedy should have been given by the drug pricing authority but it has simply rejected the Sri Balaji's plea, said advocate Ravindra Kumar.
On January 30, 2018 Balaji Medicine Centre had written to Food and Drug Administration (FDA), Uttar Pradesh urging it to take requisite step to ensure that the pharmaceutical firm takes back expired and damaged drugs from traders and maintain equity and parity in their services.
Regular disposal of expired medicines was required for preventing contamination, toxicity, bio-hazards and the drug resistance of humans.
Like Sri Balaji Medicine Centre, thousands of wholesale and retail traders in Uttar Pradesh are forced to sit on huge stock of expired drugs of FDC Ltd following its Lucknow based carrying & forwarding agents (CFA)'s refusal to recall expired and damaged stock from them.
Around 60,000 wholesalers and one lakh retailers are forced to sit on the expired drugs of the company due to whimsical attitude of CFAs, said Rajesh Soni from Sri Balaji Medicine Centre.
There are 1.25 lakh drug wholesalers and around 2 lakh retailers in UP.
The Directorate General of Health Services in response to an RTI filed by AICDF in 2017 clarified that the direction for disposal of waste is provided under the Schedule M of the Drugs and Cosmetics Rules and is required to be followed by the drug manufacturers.
The offenders deliberately denying to recall expired drugs for disposal can be taken to task as per provisions of Drugs and Cosmetic Rules and the Bio-Medical Waste (Management and Handling) Rules, 1998.