Sell of Substandard Drugs by Major Pharma Companies

It is a reason of foremost concern for all that at least six major pharmaceutical companies, including Cipla, Ipca Labs, Alkem Labs, Morepen Labs, Abbott and Sanofi were found manufacturing substandard drugs by the Central Drugs Standard Control Organization in 2015–16, of the 181 drug alerts through the year. However, it is not clear if Ipca Labs and Cipla have recalled the affected batches from the market. Alkem Labs, Morepen Labs and Sanofi has informed CDSCO that they have recalled their affected batches. It is learnt that Abbott’s affected batches had expired by the time the drug regulator had issued the alert. The six companies mentioned above were sent seven alerts last fincial year. Cipla was issued the alert in February for its tablet Cip–Zox. The drug has an annual sales of around Rs 1 crore according to IMS Health, global information and technology services company. The tablet works as a muscle relaxant or painkiller. According to CDSCO, the tablet failed the disintegration test –– which is used to check the time taken by the molecule to dissolve in the bloodstream. Ipca Labs was issued a drug alert in December for its popular drug Zerodol–SP used to give relief to joints pain. According to IMS Health, it has an annual sales of Rs 92.3 crore in India, making it the leader in the market. Alkem Labs was issued drug alerts twice last year.

The company said, of its total annual drug sales of about Rs 3,500 crore the annual sales of the drug was in few lakh rupees. But can that be an excuse? Certainly not. Similarly, Morepen Labs, which received an alert for its anti–inflammatory drug Dypen 100 SR in April last year, had recalled the drug after the report from the regulator. The batch was nearing its expiry date when it was asked to be recalled. As reported last week, the regulator found Sanofi’s popular painkiller drug, Combiflam, to be of substandard quality twice in the past three months. Consequently, the company has recalled the affected batches. Combiflam is prescribed by Pediatrician for treating high fever in small children. Time for the regulators to be more vigilant and strict in monitoring the quality of drugs that are produced and supplied to the markets for consumption by people. Even a trivial discrepancy may cause lives of many.

Debajit Goswami,
Ambikagiri gar, Guwahati–24.