Pharmaceutical units in many parts of the country are found to be not recalling and destroying date expired drugs from the market as required under D&C Rules. The drug companies are expected to collect such date expired stocks from the trade on a regular basis and destroy them in a place away from human settlements.

It is a guideline given to the companies as per Schedule M and GMP conditions. But most of the companies are not following this guideline very often, according to Joydeep Sarkar, general secretary of the All India Chemists and Distributors Federation (AICDF).

“More violations of this kind are seen in West Bengal, especially in Kolkata. Neither the manufacturing companies nor their C&F agents pay any heed to the request of the traders for taking back the unsold medicines from the shops and destroy them without creating any health hazard to the public. The situation creates unhealthy environmental problems,” he added.

In a telephonic chat with Pharmabiz, he spoke from Kolkata about the grave environmental situation created by the drug manufacturers leaving their expired products at the wholesalers’ and retailers’ premises. He accuses the Indian Drugs Manufacturers Association (IDMA) for not interfering in the problems and disputes between the traders and manufacturers in this regard. He said there was an agreement between the associations of manufacturers and traders to deal with the expired goods, and as per that the date expired products are to be recalled within six months’ time. After six months, the traders need not pay the prices of the unsold drugs. But this agreement is not followed by the companies in any part of West Bengal.

“A drug is effective and benign when it is used within the stipulated expiry date. Generally it acts till close to its date expiry, but with a lesser impact. Suppose, it is used just after the expiry date, it will cause fatal conditions. That is why, a specific expiry date is given to all kinds of medicines. It has been noticed that usage of eye drops causes adverse side effects if it is used for a prolonged period after opening the container even if within the expiry date,” Joydeep said.

In West Bengal, the recent media reports highlighted the misuse and mishandling of different medicines including antibiotics affecting the quality of meat and poultry. They are among the daily food habit of several people of the state. Indirectly and unknowingly people are taking polluted food, vegetables, fish and meat which are fatal for health.

Several studies and reports have unveiled one fact that improper destruction and recycling of expired drugs are the major cause for ‘resistance of life saving medicines’ among humans. So, proper destruction and recycling of expired medicines are very much essential. Mishandling of expired medicines by destroying them in open places is extremely dangerous.

There should be a system to recall the time-barred products from the market, promptly and effectively. The authorised persons should be responsible for the execution and coordination of recalls. They should have sufficient staff to handle all aspects of the recalls with the appropriate degree of urgency. The progress of the recall process should be monitored and recorded, and the records should include the disposition of the products, commented the AICDF secretary who is one of the partners of Hindustan Medical Syndicate in Kolkata.