P A FrancisTuesday, November 28, 2017, 08:00 Hrs  [IST]

Timely recall of date expired drugs from the market is a major responsibility of the pharmaceutical industry towards the trade and the public at large. The task has become gigantic for the drug makers today with the growth in production of pharmaceuticals in the country and in the number of retail chemists over the last 25 years. According to an industry estimate the quantum of date expired drugs ranges between 1.5 to 2 per cent of the total drug market. It is important to ensure that these drugs are not sold to patients as they are unsafe and lack efficacy due to reduction in potency with likely dissolution and disintegration failures. But not many pharmaceutical companies withdraw date expired drugs from the trade channels on a regular basis and retailers are forced to bear that responsibility and consequent losses, according to trade circles. All India Chemists & Distributors Federation, in a representation to the Department of Pharmaceuticals, had named several prominent companies including some multinationals who refuse to recall expired and damaged stocks of drugs from the dealers in the past. The Federation has also appealed to DoP, CDSCO and pollution control boards to initiate action against a number of such drug companies and their carrying & forwarding agents (CFAs) for not recalling expired and damaged stocks from trade.

As per the clause 56(17) of Drugs & Cosmetics Rules, no drug shall be sold or stocked by the trade licensee after the date of expiration of potency recorded on the label or in violation of any direction recorded on such label. The clause further says that such date expired drugs may be stocked separately from the trade stocks. Now, instead of complying with the provisions of 56(17) of D&C Rules regarding return of expired drugs, these companies insert a clause in the contract and agreement of sale of medicines with the dealers as a mandate and refuse to take back the expired stocks. In fact, the Rule 56 (17) is not very specific on the responsibility or obligation of the industry to take back expired drugs and there is no exclusive provisions for return or disposal of the same. Recalling expired stocks, currently, is more of an understanding between the company and the trade. Therefore, there is need to lay down specific set of regulations for the same. The pharmaceutical companies should be made liable for the same as they usually factor that costs also in fixing the price of the drugs. The companies have to make timely payments for the stocks of expired drugs and also look at ways to destroy them in the right manner. Recalling date expired medicines is a world wide practice and it is considered to be the sole responsibility of the manufacturers.