American drug giant Abbott’s India unit is not withdrawing expired drugs from West Bengal, the All India Chemists and Distributors Federation (AICDF) has said in a complaint to the Central Drugs Standard Control Organisation (CDSCO).
The trade association has also registered its complaint with regulators in Uttarakhand, Gujarat and Himachal Pradesh, where Abbott has manufacturing units, along with the Pollution Control Board of West Bengal.
“The matter has been referred to the Food and Drug Administration in West Bengal for further investigation,” said a CDSCO official.
The complaint says the company and its carrier and forwarder in Kolkata, Shyam Shakti Vyapar, is not doing away with the expired drugs.
"We follow all laws and regulations. Stockists and chemists are supposed to return expired products purchased from the company to our CFA, which then arranges for their disposal in accordance with statutory requirements,” an Abbott spokesperson said in an email response.
According to the rules, a drug manufacturer is bound to withdraw all expired and damaged drugs from the market with the help of its associates. This is to ensure scientific disposal and also to ensure proper reimbursement to traders.
Regular disposal of medicines is required for preventing contamination, toxicity, bio-hazard and drug resistance.
“Abbott India is not following this stipulation but is compelling traders to dump unused medicines,” says the complaint.
“The company has refused to compensate for any drug that is taken back after the expiry date. The CFA has to undergo losses. Because of this, the CFA keeps drugs beyond their expiry date,” said Joydeep Sarkar, secretary of the AICDF.
The complaint adds Shyam Shakti Vyapar has also refused to take back expired insulin stock manufactured by Novo Nordisk, though it is the authorised franchisee.
graph