In order to curb the movement of the not-of-standard quality and defective packaging drugs in the state, Karnataka drugs controller Dr BR Jagashetty has suggested that the Drugs & Cosmetics Act should be amended to allow the recall of such drugs. The drugs controller wants to include a new Schedule to enable the immediate recall of the drug found of not-of-standard quality and defective in packaging by the pharma companies engaged in its production.

This is part of the recommendations, which Pharmabiz had reported earlier, to be made to the Drugs Control General of India (DCGI) for a strict and immediate implementation of the Good Distribution Practices (GDP) to prevent the prevalence of substandard drugs because of poor storage conditions and faulty packaging in the scores of pharmacy outlets across India.

Good distribution practices will need to focus on making recall of the drug the first priority once the drug test samples are found to indicate discrepancies in the content or packaging. It is the responsibility of the manufacturer to make efforts to recall the drug once it is notified as not-of-standard quality, Dr Jagashetty said.

A drug is declared defective when the bottle closure is found damaged, or its content is found to have sterility variations or if it fails in assays.

Manufacturers should make all efforts to recall the product within 48 hours to a week. When the drug from the manufacturer goes to the stockists, wholesaler and retail, its movement is tracked only till the stockist. But it is the onus of the pharma company to see that the drug is tracked till the retailer and check if the drug is stored in an appropriate manner at the retail outlets in keeping with good distribution practices.

In the interest of the consumers, the pharma manufacturers should act immediately because these drugs should no longer be sold when they are defective. There should be a clause in the Drugs and Cosmetics Act that if the recall is not made within a stipulated time frame, then it would become a punishable offence, said Dr Jagashetty.

According to Dr Jagashetty, at least 60 per cent of the problems are solved if there is recall of the drug and hence the Drugs &Cosmetics Act should make it mandatory. When international regulators like UK MHRA insist on drug recall from the market within 72 hours, it is high time Indian regulators impose this.

GDP should be part of Drugs & Cosmetic Act and a new schedule should be incorporated at the earliest. Manufacturers should follow the book of standards by Indian Pharmacopeia, British Pharmacopeia, and US Pharmacopeia, stated Dr Jagashetty.