Expired drugs to be moved out of stores in 15 days

CHENNAI, 1 JUNE: Unsold medicines will be cleared out of pharmacies within 15 days of their date of expiry and drug inspectors will be empowered to cancel trade licences of erring pharmacies . These are the recommendations of a high-level panel for amendments to the Drugs and Cosmetics Act. The existing rules ban sale of expired drugs, but do not specify their disposal. A group of senior drug officials from Tamil Nadu, Andhra Pradesh, Karnataka, Delhi and Punjab who met in Chennai on Monday also recommended that it should be made mandatory for drug manufacturers to track medicines and ensure they are destroyed within 20 days of the date of expiry. The medicines should be destroyed as per the guidelines of a state pollution control board and in accordance with the biomedical waste rules. The committee was formed last year after the Tamil Nadu Drug Control Directorate found expired drugs being sold with new labels in pharmaceutical stores. "That was when we first realized the loopholes in the act," said state drugs controller M Bhaskaran, who retired from service on Tuesday. In the present form, the Drugs and Cosmetics Act prevents a chemist from selling expired drugs, but it does not insist on a timeframe for disposal of these drugs. The legislation does not specify penalties for the chemist stocking such medicines. Many chemists complained they were not getting the cost of the expired drug reimbursed while returning them to the manufacturer. "The medical representative pushes us to buy products, but if we don't sell them, they return only 20% of the cost price," said S Manikkam, who owns a medical shop. At present, the act does not put the onus of safe disposal on the manufacturers . "We have recommended both. The pharmacist can dispose the drug as per pollution norms or hand it over to the manufacturer. The manufacturer has to dispose it within two days," he said. The manufacturer and the pharmacy would now be asked to maintain records of batchwise details of expired drugs that were disposed of. To ensure tracking of medicines from pharmacies, chemists have been asked to issue bills to customers that will include the name of the drug, quantity purchased, cost, batch numbers and the date of expiry . "This is being done even today in cities like Chennai," Bhaskaran said. But senior drug inspectors in his team agree that chemists still do not insist on prescriptions for some sensitive drugs like antibiotics. The committee will soon send its recommendations to the drugs controller general for approval. After seeking permissions from the health department, the law would be amended.

Economic Times