January 05, 2012

Health ministry plans robust policy to recall faulty, ban

The health ministry is planning to develop a foolproof mechanism to ensure recall of all faulty and banned drugs from the Rs 60,000-crore domestic pharmaceutical market.

The move will strengthen the existing recall provisions under the Drugs and Cosmetic Rules. The current law, however, fails to prescribe time-bound recall formats.

Although India has so far banned around 90 products, mostly fixed dose combinations that were found to be irrational, it had never attempted to enforce it with a strict mechanism. In each of the cases, the drugs were available in the market while the notification preventing further manufacturing or marketing came into effect.
Mostly, such drugs got phased out as companies stopped production and retail chemists exhausted their stocks over a period of time.

The ministry’s attempt has become significant as the Central Drugs Standard Control Organisation (CDSCO) confiscated several banned drugs from retail chemist shops in key metro cities a few months earlier. These seizures took place despite pharmaceutical companies claiming to have stopped the production of the medicines and instructed their field forces to take them off the shelves.

The companies had blamed retail chemists for stocking the medicines.

According to officials, an expert committee will be tasked to prepare the draft. The new system may draw much from the experience of developed nations, where drug recall systems are being followed for decades.

According to a senior health ministry official, “drug recall system” is one of the key agenda before the Drugs Consultative Committee (DCC), the expert group that includes drug controllers from every state.

A sub-committee of the DCC had recently recommended the introduction of a unique identification, similar to bar coding for all the pharma products, as a measure to track and check the presence of counterfeit products.

The authorities feel that a proper system to track the sale of medicines will prove helpful in effective recall of the products also.

Currently, there is no standard practice of setting deadlines for recall of faulty or banned medicines. Companies may be allowed to sell until the stock exhausts or they may be asked to withdraw the products immediately.

The practices followed by the European Union, the United States and others have specific deadlines set for different types of drug recalls. Thus, there can be a 24-hour deadline in case of a serious adverse effect or a firm initiated recall that may go on for several months as it does not concern the safety of the patient.

Link: Original Article

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