Bengal maternal death highlights concerns surrounding handling of medicines

The laxity in enforcing regulatory norms is one of the key issues that need to be addressed to check such incidents, especially with some of the drugs being made by small companies, experts said

The death of one woman and the critical state of three more, all from a reaction to the infusion of contaminated IV fluids during childbirth in a West Bengal hospital has once again put the spotlight on the need for an effective surveillance mechanism on drugs manufacturing units and better monitoring of how medicine stock is handled in health facilities across the country, said experts.

Bengal maternal death highlights concerns surrounding handling of medicines

The laxity in enforcing regulatory norms is one of the key issues that need to be addressed to check such incidents, especially with some of the drugs being made by small companies, they said.

Dinesh S Thakur, senior pharma expert and co-author of The Truth Pill: The Myth of Drug Regulation in India, said, “Look at this in the context of recent events. It has been reported that the Small and Medium Scale industry has been demanding that despite being given over two years to comply, they want additional time to upgrade their facilities, systems, processes and training to the WHO cGMP standard. Not just that, the health ministry seems to indulge their demand by considering such an extension. What does this tell you?”

WHO cGMP refers to the UN body’s current good manufacturing practices.

“Quality of our drug supply is no one’s priority, least of which is the government and the ministry of health. Their priority is the profitability of the SME industry. If this is the case, what does you expect the value of a life of a citizen is? The fact that these incidents happen at a regular frequency and no one is held accountable says it all,” Thakur added.

“We can’t fix this age old problem until and unless we are honest with ourselves that our drug regulation and our regulatory system is irretrievably broken,” he said.

In India, health is on the concurrent list, which means it comes under the purview of both the Centre and the states. However, this has also meant multiple regulatory regimes, with state and federal regulators not always on the same page or even the same book.

India Pharmaceutical Alliance secretary general Sudarshan Jain said, “Though I am not aware of the specifics of the [West Bengal maternal death] case, there can be no compromise on the quality of medicines, no matter what the drug is, as we are dealing with the health of people.”

The administration of intravenous (IV) fluids is one of the most common and universal interventions in medicine. Crystalloid solutions (water-based electrolytes) are the most frequently chosen, by far, with normal saline (sodium chloride in water) and lactated Ringer’s (containing sodium chloride, sodium lactate, potassium chloride, and calcium chloride in water) both being frequent choices globally. The women in the West Bengal hospital were administered Ringer’s.

According to the Central Drugs Standard Control Organisation’s guidelines on IV fluid’s storage, distribution, and administration, intravenous fluids are liable to microbial growth, contamination of particulate matter leading to adverse drug reaction. “LVPs (typically bags or bottles containing larger volumes of intravenous solutions) are marketed in various primary packaging materials which needs careful handling to prevent damage from cracks which leads to contamination of fluids meant for IV administration. In this context the guideline will ensure maximum precautions during temporary storage, transportation and handling,” according to the body.

CDSCO’s guidelines add that “the manufacturing will be conducted under the active direction and personal supervision of competent technical staff consisting at least of one person who is a whole time employee… the factory premises shall comply with the conditions prescribed in Schedule M2 (covers Good manufacturing practice requirements)… The applicant shall provide and maintain adequate staff, premises and laboratory equipment for carrying out such tests of the strength, quality and purity of the substances…”

The guidelines also elaborate upon the need for hospitals also to maintain good storage practices. “To maintain proper practices to ensure Quality, Efficacy and Safety of I.V. Fluids after receiving the same in the Hospital store till the end User’s points it is recommended…”

Dr MC Misra, former director, Delhi’s All India Institute of Medical Sciences, said that contamination of IV fluids is largely unheard of these days. “Earlier it used to happen because of the use of glass bottles for storage, so there were standard instructions put in place to examine the bottle carefully before transfusing for any fungal growth. Since disposable PVC storage packs came in, this problem hasn’t been heard of even though large quantities are bought regularly in hospitals”

“Even if one may think of the drip set being contaminated because of lack of hand-hygiene that may cause a reaction but not to the magnitude that causes death. Even contamination should not cause death; therefore it needs to be clearly investigated what was transfused,” he added.