Pharma laxity

AN international news agency has reported that the Uttar Pradesh authorities have permitted a pharma company — whose cough syrups were linked by Uzbekistan to the death of 65 children last year — to resume the production and sale of most of its items. The shocking report has quoted the state drug controller as saying that there is no known case of lack of quality in other medicines manufactured by the firm, Marion Biotech. ‘Therefore, in view of natural justice, the appeal of the firm is partially accepted…’ the officer purportedly said in an order dated September 14. Though the Centre has rejected the report, the news agency is sticking its neck out. This has triggered fears and doubts about the working of the regulatory system.

Have some or all of Marion’s products been subjected to stringent quality tests? The specifics are conspicuous by their absence. The Noida-based firm, whose licence was cancelled earlier this year, has not been given permission to restart manufacturing of products using propylene glycol, a cough syrup ingredient. Marion’s factory was closed after Uzbekistan’s health ministry found that two cough syrups made by it contained unacceptable amounts of diethylene glycol (DEG) and ethylene glycol (EG), both toxins which are normally used in products not fit for human consumption. DEG and EG are reportedly being used by unscrupulous manufacturers as a substitute for propylene glycol because they are cheaper.

Notably, Marion is yet to submit the corrective and preventive action (CAPA) plan, as sought by the Drugs Controller General of India. This plan contains guidelines that a pharma firm pledges to follow after it has been found violating good manufacturing practices. It is imperative that any company that has sullied India’s reputation as the pharmacy of the world should be given no concession or leeway unless there is verifiable evidence that it has initiated course correction. Any controversial decision will betray laxity on the part of the regulators and further undermine India’s credentials in the pharma sector.