Blacklisted Drugs Used, 33%-47% Essential Medicines Unavailable, Delhi Still Using 1994 Drug Formulary: CAG Report

The report, which covers the period from 2016-17 to 2021-22, highlights blacklisted drug suppliers, delays in procurement, and critical staff shortages in regulatory bodies responsible for monitoring pharmaceutical safety.

Blacklisted Drug Suppliers and Substandard Medicines

One of the most alarming findings of the CAG report is that Delhi’s hospitals continued to receive drugs from blacklisted pharmaceutical firms, compromising patient safety. The Central Procurement Agency (CPA), responsible for procuring medicines, was found to be negligent in enforcing blacklisting policies. The report warns:

"Audit also noticed procurement of medicines from blacklisted and debarred firms."

Furthermore, substandard drugs were found in government hospitals, with some being administered to patients before quality test results were received. This issue arose because CPA issued drugs before obtaining lab test results, creating a dangerous situation where patients unknowingly consumed inferior medicines. The report states:

"Medicines procured by CPA are supplied directly to hospitals by the suppliers. After the stipulated supply period, samples are picked up from hospitals by CPA for quality testing in the empanelled laboratories."

It further highlights the delay in drug testing, noting:

"There was a time gap of two to three months between the receipt of drugs from the CPA and receipt of test reports regarding quality of the drugs supplied. A few drugs supplied by the CPA were later reported as inferior quality by the laboratory. Moreover, in some cases, inferior quality drugs were consumed in the hospitals."

Shortages of Essential Drugs and Outdated Drug Formulary

Delhi’s Essential Drug List (EDL), which should be updated annually to reflect current medical needs, was revised only three times in the last ten years. The report strongly criticized this failure, stating:

"Essential Drug List (EDL) was not prepared annually and was prepared only thrice during the last ten years."

Additionally, Delhi’s Drug Formulary has not been updated since 1994, making it nearly three decades outdated. The formulary serves as a reference for prescribing and dispensing medicines, and its lack of revision has resulted in inefficiencies in procurement and supply. The CAG report points out:

"The Drug Policy, 1994 of GNCTD provides for setting up a Formulary Committee every year for preparation of Delhi State Formulary. Audit noted that Formulary was last prepared in 1994."

Hospitals suffered from persistent shortages of essential medicines, forcing them to purchase drugs from local chemists at inflated prices. The CPA was responsible for delivering these medicines, but its failures forced hospitals into expensive last-minute purchases. The report noted:

"Hospitals had to procure 33 to 47 per cent of essential drugs contained in the EDL directly as CPA failed to deliver them."

Regulatory Failures and Drug Inspector Shortages

The report also exposes severe staff shortages in the Delhi Drug Control Department, which is responsible for enforcing pharmaceutical safety regulations. Shockingly, the post of Delhi Drug Controller remained vacant, severely affecting regulatory oversight. The report found a 63% shortage of Drug Inspectors, which made it impossible to adequately monitor drug safety and compliance. The audit states:

"There was overall shortage of 52 per cent staff in different cadres including 63 per cent shortage in key staff of Drug Inspector in Drugs Control Department."

Additionally, Delhi’s Drug Testing Laboratory (DTL) was found to be non-accredited by the National Accreditation Board for Testing and Calibration Laboratories (NABL), casting doubt on the reliability of drug quality assessments. The report recommends:

"DTL was not accredited by National Accreditation Board of Laboratories (NABL). DTL did not have modern equipment and manpower."

Failures in Medical Equipment Procurement

Along with issues in pharmaceuticals, the procurement of medical devices and hospital equipment also faced major delays. The CAG report found that out of 86 tenders floated for medical equipment between 2016-17 and 2021-22, only 24 were finalized, leaving hospitals severely under-equipped. The report observes:

"Out of 86 tenders floated for procurement of equipment by CPA, only 24 (28 per cent) were finally awarded."

Additionally, critical injections for life-threatening diseases like Haemophilia and Rabies were in short supply, affecting patient care. Hospitals also failed to properly maintain, repair, or replace medical equipment, leading to further gaps in healthcare delivery.

CAG’s Recommendations for Immediate Action

The CAG has recommended urgent reforms to rectify these systemic failures. It has emphasized the annual revision of the Essential Drug List (EDL) to align with medical needs and prevent shortages in government hospitals. The report also stresses the need for strict enforcement of blacklisting policies to ensure that drugs from banned firms do not re-enter the supply chain.

To improve drug safety, the CAG has called for drug samples to be tested before being distributed to hospitals, as delays in quality verification have led to the administration of substandard drugs to patients. It also highlights the need to accredit the Delhi Drug Testing Laboratory (DTL) with NABL to ensure reliable drug assessments. The report strongly urges the filling of the 63% shortage of Drug Inspectors and the immediate appointment of a Delhi Drug Controller to strengthen regulatory oversight.

Additionally, the CAG recommends timely procurement of medical equipment and drugs to prevent delays that could impact patient care. It highlights the need for a robust quality control system to ensure that hospitals receive safe and effective medicines. The report underscores:

"The Government should emphasize a good quality control and assurance system for providing safe and effective drugs at public healthcare facilities."