Following pharmaceutical major FDC Ltd's Lucknow -based carrying & forwarding agents (CFA)'s refusal to recall expired and damaged stock from them, thousands of wholesale and retail traders in Uttar Pradesh are forced to sit on huge stock of expired drugs.

Despite repeated request, neither the drug manufacturer nor its C&F agents has looked into the demand of the traders for recalling expired and damaged medicines from the drug stores and destroy them without creating any health hazard to the public. It causes contamination, bio-hazards to society and financial losses to the dealers.

Regular disposal of expired medicines was required for preventing contamination, toxicity, bio-hazards and the drug resistance of humans.

Taking serious note of this, the Fatehpur based drug wholesaler Sri Balaji Medicine Centre, one of victims, has moved Allahabad High Court seeking judicial intervention to address the issue of taking back expired/damaged medicines by the pharmaceutical company.

In the case filed at Allahabad High Court, the wholesaler has urged National Pharmaceutical Pricing Authority (NPPA), Ministry of Chemicals and Fertilisers and pharmaceutical major FDC Ltd to address the issue at the earliest in the interest of patient safety.

The trader had earlier approached deputy director (pricing), NPPA seeking their intervention to resolve the issue.

Rajesh Soni from Sri Balaji Medicine Centre in his letter to NPPA said “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. Hence its responsibility of manufacturer to take back damaged and expired drugs as the prices of drugs are fixed while considering damage and loss of the products in transit. We are seeking intervention of the drug pricing authority to resolve the issue.”

“Despite repeated appeals, the CFAs of company have not recalled damaged and expired drugs from a section of traders. 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,” he said.

There are 1.25 lakh drug wholesalers and around 2 lakh retailers in UP.

Contesting his 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.

According to Ravindra Kumar, lawyer of Sri Balaji Medicine Centre, NPPA fixes prices of medicines which also includes costs of damaged/expired medicines. Hence the remedy should have been given by the drug pricing authority but they have simply rejected the plea.

On January 30, 2018 Sri Balaji Medicine Centre had written to Food and Drug Administration (FDA) 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.

Besides this, the CFAs are not arranging the delivery of invoices of certain traders and compelling them for self delivery at their cost while the logistics expenses are already included in the price of the brands. They are also not allowing any additional discount in lieu of logistics charges for not arranging the same as per their whims, he said.

Despite valid requisite with respective assured payment, we find it obligatory to have a consent from certain authority to resume business normally, otherwise the manufacturers and/ or their appointed authorised CFAs are causing above mentioned disturbances in disguise of commercial terms and conditions lacking uniformity and parity thus encouraging monopolistic practice and anti competitive atmosphere in the trade, said Soni.

He said “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.”

As per clause 56(17) of Drugs and Cosmetics Rules, no drug shall be sold or stocked by the licensee after the date of expiration of potency recorded on its label or in violation of any statement or direction recorded on such label. It further says that any such drug in respect of which the licensee has taken steps with the manufacturer or his representative for the withdrawal, reimbursement or disposal of the same, may be stocked after the date of expiration of potency pending such withdrawal, reimbursement or disposal, as the case may be, subject to the condition that the same shall be stored separately from the trade stocks.

The Directorate General of Health Services in response to an RTI filed by AICDF early this year 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.